首页 期刊 论文 学科刊群 资讯 加盟 关于
EN
image
Article(id=1239173815637439293, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239173808419033435, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2024.02.21, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1680883200000, receivedDateStr=2023-04-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1773371660383, onlineDateStr=2026-03-13, pubDate=1709136000000, pubDateStr=2024-02-29, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773371660383, onlineIssueDateStr=2026-03-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773371660383, creator=13701087609, updateTime=1773371660383, updator=13701087609, issue=Issue{id=1239173808419033435, tenantId=1146029695717560320, journalId=1205117023404326918, year='2024', volume='44', issue='2', pageStart='185', pageEnd='372', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773371658663, creator=13701087609, updateTime=1773371757717, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1239174223944536397, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239173808419033435, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1239174223944536398, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1239173808419033435, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=368, endPage=372, ext={EN=ArticleExt(id=1239173815993955160, articleId=1239173815637439293, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Improvement study on the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules*, columnId=1206272758774821315, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Standard Deliberation, runingTitle=null, highlight=null, articleAbstract=
Objective:

To compare the differences in identification tests of vacant gelatin capsules and enterosoluble vacant gelatin capsules in the four national pharmacopoeias, optimize the identification test methods and improve the specificity of identification results.

Methods:

The biuret method was used to identify vacant gelatin capsules and enterosoluble vacant gelatin capsules, and an appropriate amount of adsorbed activated carbon was added to eliminate the masking effect of pigments in capsules.

Results:

The identification method was optimized, the pigment in the capsule solution was adsorbed by activated carbon, and the capsule solution showed a clarified colorless solution, which could produce a distinct violet after the color development by biuret reaction.

Conclusion:

This method can significantly improve the specificity of vacant gelatin capsules and enterosoluble vacant gelatin capsules identification compared with domestic and foreign pharmacopoeia methods. It can provide scientific and reasonable revision suggestions for the optimization and improvement of the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules in the Chinese Pharmacopoeia.

, correspAuthors=Dan-dan WANG, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Wen-xu GUO, Dan-dan WANG, Tao ZHOU, Ai-jing ZHANG, Yue CHEN), CN=ArticleExt(id=1239173818523120574, articleId=1239173815637439293, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=明胶空心胶囊以及肠溶明胶空心胶囊鉴别试验改进研究*, columnId=1206272758971953622, journalTitle=药物分析杂志, columnName=标准研讨, runingTitle=null, highlight=null, articleAbstract=
目的：

对比国内外药典中明胶类空心胶囊鉴别试验的差异，优化鉴别试验方法，提高鉴别结果的专属性。

方法：

采用双缩脲反应对明胶类空心胶囊进行鉴别，通过加入适量的吸附活性炭，消除空心胶囊中色素的遮蔽效应。

结果：

鉴别方法经优化后，胶囊溶液中色素被活性炭吸附，胶囊溶液呈现澄清无色溶液，双缩脲反应显色后能产生明显的蓝紫色。

结论：

该方法对比国内外药典方法，能显著提高对明胶类空心胶囊鉴别的专属性，可为《中华人民共和国药典》中明胶空心胶囊和肠溶明胶空心胶囊鉴别试验的优化改进提供科学合理的修订建议。

, correspAuthors=王丹丹, authorNote=null, correspAuthorsNote=
**Tel：18058705250；E-mail：
, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=v50KSjscfxs6Ht2A5DBqLA==, magXml=hGkGDmDCoSemNKs69S1S1w==, pdfUrl=null, pdf=mKW64ALgHJ2NzWtgNfvTxg==, pdfFileSize=6602098, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=0oi6HSAVuS8TcIbG6+zs/g==, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=Ns2AJSRckHsMS9yJFsJO8g==, mapNumber=null, authorCompany=null, fund=null, authors=

Tel：17861313137；E-mail：

, authorsList=郭文旭, 王丹丹, 周涛, 章蔼静, 陈悦)}, authors=[Author(id=1239173819127100399, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, orderNo=0, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=1191547318@qq.com, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1239173819273901046, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173819127100399, language=EN, stringName=Wen-xu GUO, firstName=Wen-xu, middleName=null, lastName=GUO, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China
2.China Pharmaceutical University, Nanjing 210009, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1239173819370369024, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173819127100399, language=CN, stringName=郭文旭, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, 2, address=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052
2.中国药科大学，南京 210009, bio={"content":"

Tel：17861313137；E-mail：

"}, bioImg=null, bioContent=

Tel：17861313137；E-mail：

, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1239173818753807313, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=1., ext=[AuthorCompanyExt(id=1239173818762195922, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China), AuthorCompanyExt(id=1239173818770584534, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052)]), AuthorCompany(id=1239173818913190876, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=2., ext=[AuthorCompanyExt(id=1239173818917385181, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818913190876, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.China Pharmaceutical University, Nanjing 210009, China), AuthorCompanyExt(id=1239173818925773791, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818913190876, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.中国药科大学，南京 210009)])]), Author(id=1239173819479420936, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, orderNo=1, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=bailifenlan2009@126.com, emailSecond=null, emailThird=null, correspondingAuthor=1, authorType=1, ext={EN=AuthorExt(id=1239173819613638673, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173819479420936, language=EN, stringName=Dan-dan WANG, firstName=Dan-dan, middleName=null, lastName=WANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, **, address=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1239173819726884886, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173819479420936, language=CN, stringName=王丹丹, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, **, address=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1239173818753807313, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=1., ext=[AuthorCompanyExt(id=1239173818762195922, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China), AuthorCompanyExt(id=1239173818770584534, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052)])]), Author(id=1239173819819159581, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, orderNo=2, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1239173819928211489, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173819819159581, language=EN, stringName=Tao ZHOU, firstName=Tao, middleName=null, lastName=ZHOU, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.Guangdong Kaiping Jinyi Capsule Co, Kaiping 529300, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1239173820012097572, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173819819159581, language=CN, stringName=周涛, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=3, address=3.广东开平金亿胶囊有限公司，开平 529300, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1239173819005465572, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=3., ext=[AuthorCompanyExt(id=1239173819018048486, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173819005465572, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Guangdong Kaiping Jinyi Capsule Co, Kaiping 529300, China), AuthorCompanyExt(id=1239173819039020008, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173819005465572, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.广东开平金亿胶囊有限公司，开平 529300)])]), Author(id=1239173820104372269, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, orderNo=3, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1239173820234395706, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173820104372269, language=EN, stringName=Ai-jing ZHANG, firstName=Ai-jing, middleName=null, lastName=ZHANG, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1239173820389584960, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173820104372269, language=CN, stringName=章蔼静, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1239173818753807313, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=1., ext=[AuthorCompanyExt(id=1239173818762195922, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China), AuthorCompanyExt(id=1239173818770584534, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052)])]), Author(id=1239173821878562886, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, orderNo=4, firstName=null, middleName=null, lastName=null, nameCn=null, orcid=null, stid=null, country=null, authorPic=null, dead=0, email=null, emailSecond=null, emailThird=null, correspondingAuthor=0, authorType=1, ext={EN=AuthorExt(id=1239173821975031888, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173821878562886, language=EN, stringName=Yue CHEN, firstName=Yue, middleName=null, lastName=CHEN, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null), CN=AuthorExt(id=1239173822058917973, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, authorId=1239173821878562886, language=CN, stringName=陈悦, firstName=null, middleName=null, lastName=null, prefix=null, suffix=null, authorComment=null, nameInitials=null, affiliation=null, department=null, xref=1, address=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052, bio=null, bioImg=null, bioContent=null, aboutCorrespAuthor=null)}, companyList=[AuthorCompany(id=1239173818753807313, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=1., ext=[AuthorCompanyExt(id=1239173818762195922, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China), AuthorCompanyExt(id=1239173818770584534, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052)])])], keywords=[Keyword(id=1239173822197330015, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, orderNo=1, keyword=pharmacopoeia), Keyword(id=1239173822281216100, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, orderNo=2, keyword=vacant gelatin capsules), Keyword(id=1239173822411239526, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, orderNo=3, keyword=enterosoluble vacant gelatin capsules), Keyword(id=1239173822507708526, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, orderNo=4, keyword=identification test), Keyword(id=1239173822633537651, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, orderNo=5, keyword=biuret reaction), Keyword(id=1239173822738395254, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, orderNo=6, keyword=activated carbon adsorption), Keyword(id=1239173822881001600, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, orderNo=1, keyword=药典), Keyword(id=1239173822994247810, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, orderNo=2, keyword=明胶空心胶囊), Keyword(id=1239173823120076936, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, orderNo=3, keyword=肠溶明胶空心胶囊), Keyword(id=1239173823245906063, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, orderNo=4, keyword=鉴别试验), Keyword(id=1239173823476592787, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, orderNo=5, keyword=双缩脲反应), Keyword(id=1239173823589838999, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, orderNo=6, keyword=活性炭吸附)], refs=[Reference(id=1239173826622320873, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2017, volume=106, issue=6, pageStart=1453, pageEnd=null, url=null, language=null, rfNumber=[1], rfOrder=0, authorNames=GULLAPALLI RP, MAZZITELLI CL, journalName=J Pharm Sci, refType=null, unstructuredReference=GULLAPALLI RP， MAZZITELLI CL. Gelatin and non-gelatin capsule dosage forms[J]. J Pharm Sci， 2017， 106(6)：1453, articleTitle=Gelatin and non-gelatin capsule dosage forms, refAbstract=null), Reference(id=1239173826714595567, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2011, volume=25, issue=8, pageStart=1813, pageEnd=null, url=null, language=null, rfNumber=[2], rfOrder=1, authorNames=GÓMEZ-GUILLÉN MC, GIMÉNEZ B, LÓPEZ-CABALLERO ME, journalName=Food Hydrocolloids, refType=null, unstructuredReference=GÓMEZ-GUILLÉN MC， GIMÉNEZ B， LÓPEZ-CABALLERO ME， et al. Functional and bioactive properties of collagen and gelatin from alternative sources： a review[J]. Food Hydrocolloids， 2011， 25(8)： 1813, articleTitle=Functional and bioactive properties of collagen and gelatin from alternative sources： a review, refAbstract=null), Reference(id=1239173826811064562, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2013, volume=30, issue=11, pageStart=1228, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=2, authorNames=朱琳娇, 陈运动, 吴永江, journalName=中国现代应用药学, refType=null, unstructuredReference=朱琳娇，陈运动，吴永江. 电感耦合等离子体质谱法检测明胶空心胶囊中10种元素的含量[J]. 中国现代应用药学， 2013，30(11)：1228, articleTitle=电感耦合等离子体质谱法检测明胶空心胶囊中10种元素的含量, refAbstract=null), Reference(id=1239173826882367735, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2013, volume=30, issue=11, pageStart=1228, pageEnd=null, url=null, language=null, rfNumber=[3], rfOrder=3, authorNames=ZHU LJ, CHEN YD, WU YJ, journalName=Chin J Mod Appl Pharm, refType=null, unstructuredReference=ZHU LJ， CHEN YD， WU YJ. Determination of 10 elements in vacant gelatin capsules by ICP-MS [J]. Chin J Mod Appl Pharm， 2013， 30(11)： 1228, articleTitle=Determination of 10 elements in vacant gelatin capsules by ICP-MS, refAbstract=null), Reference(id=1239173827004002556, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2016, volume=28, issue=6, pageStart=51, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=4, authorNames=王丹丹, 金立, 陈越, journalName=海峡药学, refType=null, unstructuredReference=王丹丹，金立，陈越，等.水浸洗法测定明胶空心胶囊中六种焦油色素含量及结果分析[J]. 海峡药学，2016，28(6)：51, articleTitle=水浸洗法测定明胶空心胶囊中六种焦油色素含量及结果分析, refAbstract=null), Reference(id=1239173827100471552, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2016, volume=28, issue=6, pageStart=51, pageEnd=null, url=null, language=null, rfNumber=[4], rfOrder=5, authorNames=WANG DD, JIN L, CHEN Y, journalName=Strait Pharm J, refType=null, unstructuredReference=WANG DD， JIN L， CHEN Y， et al. Determination of six tar colorants in vacant capsules by water immersing and results analysis[J]. Strait Pharm J， 2016， 28(6)： 51, articleTitle=Determination of six tar colorants in vacant capsules by water immersing and results analysis, refAbstract=null), Reference(id=1239173827247272200, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2016, volume=36, issue=10, pageStart=1857, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=6, authorNames=王翀, 杜明荦, 仲平, journalName=药物分析杂志, refType=null, unstructuredReference=王翀，杜明荦，仲平.UPLC法检测明胶空心胶囊中9种合成着色剂[J]. 药物分析杂志，2016，36(10)：1857, articleTitle=UPLC法检测明胶空心胶囊中9种合成着色剂, refAbstract=null), Reference(id=1239173827352129804, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2016, volume=36, issue=10, pageStart=1857, pageEnd=null, url=null, language=null, rfNumber=[5], rfOrder=7, authorNames=WANG C, DU ML, ZHONG P, journalName=Chin J Pharm Anal, refType=null, unstructuredReference=WANG C， DU ML， ZHONG P. Simultaneous detection of 9 synthetic pigments in vacant gelatin capsules by UPLC[J]. Chin J Pharm Anal， 2016，36(10)：1857, articleTitle=Simultaneous detection of 9 synthetic pigments in vacant gelatin capsules by UPLC, refAbstract=null), Reference(id=1239173827436015889, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2018, volume=38, issue=2, pageStart=61, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=8, authorNames=苏铭晖, journalName=明胶科学与技术, refType=null, unstructuredReference=苏铭晖.明胶应用领域的概述[J]. 明胶科学与技术，2018，38(2)：61, articleTitle=明胶应用领域的概述, refAbstract=null), Reference(id=1239173827536679189, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2018, volume=38, issue=2, pageStart=61, pageEnd=null, url=null, language=null, rfNumber=[6], rfOrder=9, authorNames=SU MH, journalName=Sci Technol Gelatin, refType=null, unstructuredReference=SU MH. Overview of gelatin and its fields of application [J]. Sci Technol Gelatin， 2018， 38(2)： 61, articleTitle=Overview of gelatin and its fields of application, refAbstract=null), Reference(id=1239173827624759575, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2020, volume=null, issue=null, pageStart=687，671，720，796, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=10, authorNames=null, journalName=null, refType=null, unstructuredReference=中华人民共和国药典 2020 年版. 四部[S]. 2020： 687，671，720，796, articleTitle=null, refAbstract=null), Reference(id=1239173827733811485, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2020, volume=null, issue=null, pageStart=687，671，720，796, pageEnd=null, url=null, language=null, rfNumber=[7], rfOrder=11, authorNames=null, journalName=null, refType=null, unstructuredReference=ChP 2020.Vol Ⅳ[S]. 2020： 687，671，720，796, articleTitle=null, refAbstract=null), Reference(id=1239173827847057696, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2022, volume=23, issue=4, pageStart=347, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=12, authorNames=王丹丹, 俞辉, journalName=中国药品标准, refType=null, unstructuredReference=王丹丹，俞辉.《中国药典》2020年版中胶囊用明胶标准注释[J]. 中国药品标准，2022，23(4)：347, articleTitle=《中国药典》2020年版中胶囊用明胶标准注释, refAbstract=null), Reference(id=1239173827947720996, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2022, volume=23, issue=4, pageStart=347, pageEnd=null, url=null, language=null, rfNumber=[8], rfOrder=13, authorNames=WANG DD, YU H, journalName=Drug Stand China, refType=null, unstructuredReference=WANG DD， YU H. Notes on gelatin for capsule in Chinese Pharmacopoeia 2020[J]. Drug Stand China， 2022， 23(4)： 347, articleTitle=Notes on gelatin for capsule in Chinese Pharmacopoeia 2020, refAbstract=null), Reference(id=1239173828048384297, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2021, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[9], rfOrder=14, authorNames=null, journalName=Official Monographs 1060, refType=null, unstructuredReference=JP ⅩⅧ. [S]. 2021： Official Monographs 1060, articleTitle=JP ⅩⅧ., refAbstract=null), Reference(id=1239173828144853289, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2023, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[10], rfOrder=15, authorNames=null, journalName=null, refType=null, unstructuredReference=EP 11.1 Vol Ⅰ [S]. 2023： Monographs 0330, articleTitle=null, refAbstract=null), Reference(id=1239173828241322284, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2022, volume=null, issue=null, pageStart=null, pageEnd=null, url=null, language=null, rfNumber=[11], rfOrder=16, authorNames=null, journalName=null, refType=null, unstructuredReference=USP-PF 48[S]. 2022： C315397, articleTitle=null, refAbstract=null), Reference(id=1239173828371345712, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2017, volume=38, issue=4, pageStart=15, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=17, authorNames=胡立立, 王蕾, journalName=辽宁医学院学报, refType=null, unstructuredReference=胡立立， 王蕾.HPLC法同时测定胶囊囊壳中9种合成色素的含量[J]. 辽宁医学院学报， 2017， 38(4)：15, articleTitle=HPLC法同时测定胶囊囊壳中9种合成色素的含量, refAbstract=null), Reference(id=1239173828451037491, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2017, volume=38, issue=4, pageStart=15, pageEnd=null, url=null, language=null, rfNumber=[12], rfOrder=18, authorNames=HU LL, WANG L, journalName=Liaoning Med Univ, refType=null, unstructuredReference=HU LL， WANG L.The simultaneous determination of nine kinds of synthetic pigments in capsule shells by high performance liquid chromatography[J]. Liaoning Med Univ， 2017，38(4)：15, articleTitle=The simultaneous determination of nine kinds of synthetic pigments in capsule shells by high performance liquid chromatography, refAbstract=null), Reference(id=1239173828576866615, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2022, volume=41, issue=3, pageStart=377, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=19, authorNames=孙健, 胡青, 冯睿, journalName=医药导报, refType=null, unstructuredReference=孙健，胡青，冯睿，等.色素在药品中使用的监管及检测方法[J]. 医药导报，2022， 41(3)：377, articleTitle=色素在药品中使用的监管及检测方法, refAbstract=null), Reference(id=1239173828673335610, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2022, volume=41, issue=3, pageStart=377, pageEnd=null, url=null, language=null, rfNumber=[13], rfOrder=20, authorNames=SUN J, HU Q, FENG R, journalName=Herb Med, refType=null, unstructuredReference=SUN J， HU Q， FENG R， et al. Supervision and detection methods of colorants in drugs[J]. Herb Med， 2022， 41(3)：377, articleTitle=Supervision and detection methods of colorants in drugs, refAbstract=null), Reference(id=1239173828769804605, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2017, volume=37, issue=7, pageStart=1329, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=21, authorNames=赵海云, 李玉杰, 张冬梅, journalName=药物分析杂志, refType=null, unstructuredReference=赵海云，李玉杰，张冬梅，等. LC-MS/MS定量分析药用明胶空心胶囊中合成色素的含量[J]. 药物分析杂志，2017，37(7)：1329, articleTitle=LC-MS/MS定量分析药用明胶空心胶囊中合成色素的含量, refAbstract=null), Reference(id=1239173828870467903, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2017, volume=37, issue=7, pageStart=1329, pageEnd=null, url=null, language=null, rfNumber=[14], rfOrder=22, authorNames=ZHAO HY, LI YJ, ZHANG DM, journalName=Chin J Pharm Anal, refType=null, unstructuredReference=ZHAO HY， LI YJ， ZHANG DM， et al. Quantitative determination for 22 synthetic pigments in medical gelatin capsule shells by liquid chromatography-MS/MS[J]. Chin J Pharm Anal， 2017，37(7)：1329, articleTitle=Quantitative determination for 22 synthetic pigments in medical gelatin capsule shells by liquid chromatography-MS/MS, refAbstract=null), Reference(id=1239173828975325509, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2020, volume=38, issue=7, pageStart=64, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=23, authorNames=董宇, journalName=中国资源综合利用, refType=null, unstructuredReference=董宇.活性炭的吸附性能及表征方法[J]. 中国资源综合利用， 2020， 38(7)： 64, articleTitle=活性炭的吸附性能及表征方法, refAbstract=null), Reference(id=1239173829075988808, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, doi=null, pmid=null, pmcid=null, year=2020, volume=38, issue=7, pageStart=64, pageEnd=null, url=null, language=null, rfNumber=[15], rfOrder=24, authorNames=DONG Y, journalName=China Res Compr Utiliz, refType=null, unstructuredReference=DONG Y. The adsorption performance and characterization method of activated carbon[J]. China Res Compr Utiliz， 2020，38(7)： 64, articleTitle=The adsorption performance and characterization method of activated carbon, refAbstract=null)], funds=[Fund(id=1239173826509074661, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, awardId=2022004, language=CN, fundingSource=*浙江省药品监管系统科技计划项目(2022004), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1239173818753807313, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=1., ext=[AuthorCompanyExt(id=1239173818762195922, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China), AuthorCompanyExt(id=1239173818770584534, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818753807313, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052)]), AuthorCompany(id=1239173818913190876, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=2., ext=[AuthorCompanyExt(id=1239173818917385181, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818913190876, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.China Pharmaceutical University, Nanjing 210009, China), AuthorCompanyExt(id=1239173818925773791, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173818913190876, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.中国药科大学，南京 210009)]), AuthorCompany(id=1239173819005465572, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, xref=3., ext=[AuthorCompanyExt(id=1239173819018048486, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173819005465572, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.Guangdong Kaiping Jinyi Capsule Co, Kaiping 529300, China), AuthorCompanyExt(id=1239173819039020008, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, companyId=1239173819005465572, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=3.广东开平金亿胶囊有限公司，开平 529300)])], figs=[ArticleFig(id=1239173823782776995, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, label=Fig.1, caption=Color development reaction of 13 test solutions before optimization, figureFileSmall=CnFjJkm9PTdANbPcs7V8Tw==, figureFileBig=0oi6HSAVuS8TcIbG6+zs/g==, tableContent=null), ArticleFig(id=1239173823908606120, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, label=图1, caption=优化前13批供试品溶液显色反应, figureFileSmall=CnFjJkm9PTdANbPcs7V8Tw==, figureFileBig=0oi6HSAVuS8TcIbG6+zs/g==, tableContent=null), ArticleFig(id=1239173824093155505, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, label=Fig.2, caption=Color development reaction of 13 test solutions after optimization, figureFileSmall=xZWH/X8UwNenRNee+2iQ/w==, figureFileBig=qqNFZMT8PyjCSFgRrzSGUg==, tableContent=null), ArticleFig(id=1239173824177041590, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, label=图2, caption=优化后13批供试品溶液显色结果, figureFileSmall=xZWH/X8UwNenRNee+2iQ/w==, figureFileBig=qqNFZMT8PyjCSFgRrzSGUg==, tableContent=null), ArticleFig(id=1239173824260927676, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, label=Fig.3, caption=The effect of centrifugal filtration on the results, figureFileSmall=e6NIlmIx9T+JdwIZ8/1JyA==, figureFileBig=0KBi1milyDzN3oXO9dGcow==, tableContent=null), ArticleFig(id=1239173824365785282, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, label=图3, caption=离心过滤对结果的影响

A.不做处理试样(the sample without treatment)　B.离心滤过后试样(the sample after centrifugal filtration)

, figureFileSmall=e6NIlmIx9T+JdwIZ8/1JyA==, figureFileBig=0KBi1milyDzN3oXO9dGcow==, tableContent=null), ArticleFig(id=1239173824437088455, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, label=Fig.4, caption=The effect of different activated carbon addition amounts on the results, figureFileSmall=W3LbQrg8wI3nNdHhp3QA5g==, figureFileBig=drNB7mBeQJMjEBwp5jELgA==, tableContent=null), ArticleFig(id=1239173824562917581, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, label=图4, caption=活性炭加入量对结果的影响, figureFileSmall=W3LbQrg8wI3nNdHhp3QA5g==, figureFileBig=drNB7mBeQJMjEBwp5jELgA==, tableContent=null), ArticleFig(id=1239173824650997973, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, label=Tab.1, caption=

Sample number and color

, figureFileSmall=null, figureFileBig=null, tableContent=
编号(No.)类型(type)批号(lot No.)颜色(colour)
A0阴性空白对照(negative control)\无色(colourless)
A1明胶空心胶囊(vacant gelatin capsules)22022014朱红色(vermilion)
A2明胶空心胶囊(vacant gelatin capsules)P003176橙色(orange)
A3明胶空心胶囊(vacant gelatin capsules)20222017深黄色(deep yellow)
A4明胶空心胶囊(vacant gelatin capsules)22021618深绿色(deep green)
A5明胶空心胶囊(vacant gelatin capsules)20220407淡蓝色+白色(light blue+white)
A6明胶空心胶囊(vacant gelatin capsules)21021903蓝色+青色(blue+cyan)
A7明胶空心胶囊(vacant gelatin capsules)20220109紫色(violet)
A8明胶空心胶囊(vacant gelatin capsules)936144黑色+红色(black+red)
A9明胶空心胶囊(vacant gelatin capsules)220708乳白色(milky white)
A10明胶空心胶囊(vacant gelatin capsules)22110114无色(colourless)
A11肠溶明胶空心胶囊(enterosoluble vacant gelatin capsules)C222040761青色(cyan)
A12肠溶明胶空心胶囊(enterosoluble vacant gelatin capsules)C222040972红色+白色(red+white)
A13肠溶明胶空心胶囊(enterosoluble vacant gelatin capsules)C222050981蓝色(blue)
), ArticleFig(id=1239173824797798616, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, label=表1, caption=

供试品编号及颜色

, figureFileSmall=null, figureFileBig=null, tableContent=
编号(No.)类型(type)批号(lot No.)颜色(colour)
A0阴性空白对照(negative control)\无色(colourless)
A1明胶空心胶囊(vacant gelatin capsules)22022014朱红色(vermilion)
A2明胶空心胶囊(vacant gelatin capsules)P003176橙色(orange)
A3明胶空心胶囊(vacant gelatin capsules)20222017深黄色(deep yellow)
A4明胶空心胶囊(vacant gelatin capsules)22021618深绿色(deep green)
A5明胶空心胶囊(vacant gelatin capsules)20220407淡蓝色+白色(light blue+white)
A6明胶空心胶囊(vacant gelatin capsules)21021903蓝色+青色(blue+cyan)
A7明胶空心胶囊(vacant gelatin capsules)20220109紫色(violet)
A8明胶空心胶囊(vacant gelatin capsules)936144黑色+红色(black+red)
A9明胶空心胶囊(vacant gelatin capsules)220708乳白色(milky white)
A10明胶空心胶囊(vacant gelatin capsules)22110114无色(colourless)
A11肠溶明胶空心胶囊(enterosoluble vacant gelatin capsules)C222040761青色(cyan)
A12肠溶明胶空心胶囊(enterosoluble vacant gelatin capsules)C222040972红色+白色(red+white)
A13肠溶明胶空心胶囊(enterosoluble vacant gelatin capsules)C222050981蓝色(blue)
), ArticleFig(id=1239173824885879002, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=EN, label=Tab.2, caption=

HSV of the test samples

, figureFileSmall=null, figureFileBig=null, tableContent=
活性炭加入量
(activated carbon addition amount)/g		色相
(hue)		饱和度
(saturation)		明度
(value)
对照(control)2519139
0.025(0.5%)2523322
0.050(1%)2616629
0.10(2%)2527941
0.15(3%)2519140
0.20(4%)2529144
0.25(5%)2529244
0.50(10%)2446748
0.75(15%)2436648
1.0(20%)2405247
), ArticleFig(id=1239173826383245535, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1239173815637439293, language=CN, label=表2, caption=

供试品HSV

, figureFileSmall=null, figureFileBig=null, tableContent=
活性炭加入量
(activated carbon addition amount)/g		色相
(hue)		饱和度
(saturation)		明度
(value)
对照(control)2519139
0.025(0.5%)2523322
0.050(1%)2616629
0.10(2%)2527941
0.15(3%)2519140
0.20(4%)2529144
0.25(5%)2529244
0.50(10%)2446748
0.75(15%)2436648
1.0(20%)2405247
)], attaches=null, journal=Journal(id=1205114436974182403, delFlag=0, nameCn=药物分析杂志, nameEn=Chinese Journal of Pharmaceutical Analysis, nameHistory1=null, nameHistory2=null, issn=0254-1793, eissn=, cn=11-2224/R, coden=null, periodic=月刊, language=CN, oaType=1, ccby=null, superviseOffice=null, ownerOffice=null, pubOffice=null, editorOffice=null, officeType=null, aims=null, clcCode=null, officeProv=null, officeCity=null, officeAddr=null, officeZip=null, officeEmail=, officePhone=, editDirector=null, officeDirector=null, officeDirectorPhone=null, officeStaffNum=null, officeEmpNum=null, coverPicUrl=E+iq5BU+frOtpo6YF6JpQQ==, journalPrice=null, startedYear=null, abbrevIsoEn=Chinese Journal of Pharmaceutical Analysis, journalRemark=null, publicationField=null, createdTime=1765251271721, updatedTime=1765252167692, createdBy=18614031015, updatedBy=13701087609, firstLetterCn=C, firstLetterEn=C, subjectCode=Life Sciences, subjectName=生命医学, subjectCodeEn=Life Sciences, subjectNameEn=null, picCn=E+iq5BU+frOtpo6YF6JpQQ==, picEn=n/3T/+AptjYTGmmMsE/a0Q==, jcr=null, cjcr=null, exts=[JournalExt(id=1205118195070906572, language=CN, name=药物分析杂志, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1765252167718, updatedTime=1765252167718, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=https://ywfxauthor.manuscriptcloud.com/login, submissionEditorUrl=https://ywfxeditor.manuscriptcloud.com/login, submissionReviewUrl=https://ywfxauthor.manuscriptcloud.com/login, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""}), JournalExt(id=1205118195133821133, language=EN, name=Chinese Journal of Pharmaceutical Analysis, nameHistory1=null, nameHistory2=null, managedBy=, sponsoredBy=, publishedBy=, editorOffice=, officeProv=null, officeCity=null, officeAddr=, officeZip=, editDirector=, officeDirector=null, officePhone=null, coverPicUrl=null, journalRemark=, submitArticleUrl=null, websiteUrl=, createdTime=1765252167733, updatedTime=1765252167733, createdBy=13701087609, updatedBy=13701087609, submissionGuidelinesUrl=, submissionAuthorUrl=https://ywfxauthor.manuscriptcloud.com/login, submissionEditorUrl=https://ywfxeditor.manuscriptcloud.com/login, submissionReviewUrl=https://ywfxauthor.manuscriptcloud.com/login, submissionCeEditorUrl=, submissionAeEditorUrl=, option={"copyright":""})], databaseList=null, tenantJournalId=1205117023404326918, websiteList=[Website(id=1205118568045195478, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1205117023404326918, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/ywfxzz/CN, language=CN, createTime=1765252256642, createBy=18614031015, updateTime=1765252521924, updateBy=18614031015, name=药物分析杂志-中文, tplId=1146099689490845704, title=药物分析杂志, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1205154326156128935, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=articleTextType, value=kx, createTime=1765260782040, updateTime=1765260782040, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326135157412, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=banner, value=null, createTime=1765260782035, updateTime=1765260782035, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326172906154, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=grayFlag, value=0, createTime=1765260782044, updateTime=1765260782044, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326126768803, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=logo, value=https://castjournals.cast.org.cn/joweb/ywfxzz/CN/file/pic?fileId=5+7UKv7ckvsJ8AsWJeRI6g==, createTime=1765260782033, updateTime=1765260782033, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326181294764, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=minRunFlag, value=0, createTime=1765260782046, updateTime=1765260782046, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326147740326, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/ywfxzz/CN/file/pic, createTime=1765260782038, updateTime=1765260782038, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326177100459, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=silenceFlag, value=0, createTime=1765260782045, updateTime=1765260782045, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326143546021, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_cn_619/, createTime=1765260782037, updateTime=1765260782037, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326160323240, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=themeColor, value=null, createTime=1765260782041, updateTime=1765260782041, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154326164517545, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568045195478, code=themeStyle, value=null, createTime=1765260782042, updateTime=1765260782042, creator=18614031015, updator=18614031015)]), Website(id=1205118568124887259, webName=null, webTitle=null, webDomain=null, webCopyrigh=null, webIpcNo=null, seoTitle=null, seoKeywords=null, seoDescription=null, tenantJournalId=null, journalId=1205117023404326918, journalNameCn=null, journalNameEn=null, grayFlag=null, tenantId=1146029695717560320, platformId=null, journalGroupId=null, journalGroupNameCn=null, journalGroupNameEn=null, type=1, domain=https://castjournals.cast.org.cn/joweb/ywfxzz/EN, language=EN, createTime=1765252256661, createBy=18614031015, updateTime=1765252537379, updateBy=18614031015, name=药物分析杂志-英文, tplId=1146101810881728533, title=Chinese Journal of Pharmaceutical Analysis, delFlag=0, indexPage=/home, props=[WebsiteProps(id=1205154361170174338, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=articleTextType, value=kx, createTime=1765260790388, updateTime=1765260790388, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361145008511, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=banner, value=null, createTime=1765260790382, updateTime=1765260790382, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361195340165, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=grayFlag, value=0, createTime=1765260790394, updateTime=1765260790394, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361132425598, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=logo, value=https://castjournals.cast.org.cn/joweb/ywfxzz/EN/file/pic?fileId=5+7UKv7ckvsJ8AsWJeRI6g==, createTime=1765260790379, updateTime=1765260790379, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361207923079, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=minRunFlag, value=0, createTime=1765260790397, updateTime=1765260790397, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361157591425, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=picServerUrl, value=https://castjournals.cast.org.cn/joweb/ywfxzz/EN/file/pic, createTime=1765260790385, updateTime=1765260790385, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361199534470, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=silenceFlag, value=0, createTime=1765260790396, updateTime=1765260790396, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361149202816, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=staticResourcePath, value=https://castjournals.cast.org.cn/joweb/cast_kjdb_en_623/, createTime=1765260790383, updateTime=1765260790383, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361174368643, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=themeColor, value=null, createTime=1765260790389, updateTime=1765260790389, creator=18614031015, updator=18614031015), WebsiteProps(id=1205154361186951556, tenantId=1146029695717560320, journalId=null, journalGroupId=null, siteId=1205118568124887259, code=themeStyle, value=null, createTime=1765260790392, updateTime=1765260790392, creator=18614031015, updator=18614031015)])], journalTitle=药物分析杂志, weixinUrl=null, journalUrl=null, iacademicId=null, status=1, seqNo=null, journalTitleEn=Chinese Journal of Pharmaceutical Analysis, journalPhotoCn=E+iq5BU+frOtpo6YF6JpQQ==, journalPhotoEn=n/3T/+AptjYTGmmMsE/a0Q==, journalFirstLetter=C, journalRecommend=null, journalNew=null, journalCollection=null, jcrJf=null, cjcrJf=null, jcrJfStr=null, cjcrJfStr=null, submissionFirstDecision=null, sciSubjectClassification=null, casSubjectClassification=null, citeScore=null, totalCitationFrequency=null, icpCode=null, psCode=null, advertisingLicenseCode=null, copyrightInformation=null, country=null, option=, provinceCode=null, provinceName=null, collectFlag=false), detailUrlCn=https://castjournals.cast.org.cn/joweb/ywfxzz/CN/10.16155/j.0254-1793.2024.02.21, detailUrlEn=https://castjournals.cast.org.cn/joweb/ywfxzz/EN/10.16155/j.0254-1793.2024.02.21, pdfUrlCn=https://castjournals.cast.org.cn/joweb/ywfxzz/CN/PDF/10.16155/j.0254-1793.2024.02.21, pdfUrlEn=https://castjournals.cast.org.cn/joweb/ywfxzz/EN/PDF/10.16155/j.0254-1793.2024.02.21, aliStartDate=null, aliEndDate=null, collectionFlag=false, citedCount=null, citedUrl=null, reference=null)
收藏切换
明胶空心胶囊以及肠溶明胶空心胶囊鉴别试验改进研究*
收藏切换
PDF下载
郭文旭 1, 2 , 王丹丹 1, ** , 周涛 3 , 章蔼静 1 , 陈悦 1
药物分析杂志 | 标准研讨 2024,44(2): 368-372
收起
收藏切换
药物分析杂志 | 标准研讨 2024, 44(2): 368-372
明胶空心胶囊以及肠溶明胶空心胶囊鉴别试验改进研究*
全屏
郭文旭1, 2 , 王丹丹1, ** , 周涛3, 章蔼静1, 陈悦1
作者信息
  • 1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052
  • 2.中国药科大学，南京 210009
  • 3.广东开平金亿胶囊有限公司，开平 529300

    • Tel：17861313137；E-mail：

通讯作者:

**Tel：18058705250；E-mail：
Improvement study on the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules*
Wen-xu GUO1, 2 , Dan-dan WANG1, ** , Tao ZHOU3, Ai-jing ZHANG1, Yue CHEN1
Affiliations
  • 1.Zhejiang Institute for Food and Drug Control, Zhejiang Key Laboratory of Drug Contact Material Quality Control Research, Hangzhou 310052, China
  • 2.China Pharmaceutical University, Nanjing 210009, China
  • 3.Guangdong Kaiping Jinyi Capsule Co, Kaiping 529300, China
出版时间: 2024-02-29 doi: 10.16155/j.0254-1793.2024.02.21
文章导航
收藏切换
摘要
收起
目的：

对比国内外药典中明胶类空心胶囊鉴别试验的差异，优化鉴别试验方法，提高鉴别结果的专属性。

方法：

采用双缩脲反应对明胶类空心胶囊进行鉴别，通过加入适量的吸附活性炭，消除空心胶囊中色素的遮蔽效应。

结果：

鉴别方法经优化后，胶囊溶液中色素被活性炭吸附，胶囊溶液呈现澄清无色溶液，双缩脲反应显色后能产生明显的蓝紫色。

结论：

该方法对比国内外药典方法，能显著提高对明胶类空心胶囊鉴别的专属性，可为《中华人民共和国药典》中明胶空心胶囊和肠溶明胶空心胶囊鉴别试验的优化改进提供科学合理的修订建议。

药典  /  明胶空心胶囊  /  肠溶明胶空心胶囊  /  鉴别试验  /  双缩脲反应  /  活性炭吸附
Objective:

To compare the differences in identification tests of vacant gelatin capsules and enterosoluble vacant gelatin capsules in the four national pharmacopoeias, optimize the identification test methods and improve the specificity of identification results.

Methods:

The biuret method was used to identify vacant gelatin capsules and enterosoluble vacant gelatin capsules, and an appropriate amount of adsorbed activated carbon was added to eliminate the masking effect of pigments in capsules.

Results:

The identification method was optimized, the pigment in the capsule solution was adsorbed by activated carbon, and the capsule solution showed a clarified colorless solution, which could produce a distinct violet after the color development by biuret reaction.

Conclusion:

This method can significantly improve the specificity of vacant gelatin capsules and enterosoluble vacant gelatin capsules identification compared with domestic and foreign pharmacopoeia methods. It can provide scientific and reasonable revision suggestions for the optimization and improvement of the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules in the Chinese Pharmacopoeia.

pharmacopoeia  /  vacant gelatin capsules  /  enterosoluble vacant gelatin capsules  /  identification test  /  biuret reaction  /  activated carbon adsorption
郭文旭, 王丹丹, 周涛, 章蔼静, 陈悦. 明胶空心胶囊以及肠溶明胶空心胶囊鉴别试验改进研究*. 药物分析杂志, 2024 , 44 (2) : 368 -372 . DOI: 10.16155/j.0254-1793.2024.02.21
Wen-xu GUO, Dan-dan WANG, Tao ZHOU, Ai-jing ZHANG, Yue CHEN. Improvement study on the identification test of vacant gelatin capsules and enterosoluble vacant gelatin capsules*[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (2) : 368 -372 . DOI: 10.16155/j.0254-1793.2024.02.21
正文
收起
明胶类空心胶囊是用于盛装固体药物最普遍的药用辅料剂型之一[1]，以牛、猪、鱼等动物皮、骨中的胶原蛋白经过水解制得[2]，加入适量辅料[3]及色素调成不同的颜色[4-5]，通过一定的加工工艺而制成。因此，明胶类空心胶囊的主要成分实际上是蛋白质，并具一定的理化性质[6]。
目前，2020年版《中华人民共和国药典》（简称《中国药典》）四部收载的明胶空心胶囊[7]687、肠溶明胶空心胶囊[7]671、胶囊用明胶[7]720以及明胶[7]796鉴别试验均包含3种相同的试验方法，其中，第二项是利用生物碱沉淀剂鞣酸与蛋白质形成沉淀进行鉴别，而世界卫生组织国际癌症研究机构明确将鞣酸归类为3类致癌物质；第三项利用钠石灰与明胶共热发生氧化反应并碱解，释放出氨[8]，对环境污染危害较大，所用试剂不符合2025年《中国药典》编制大纲中绿色、环保的发展需要。国外药典中JP 18[9]、EP 11.1[10]、USP PF 48[11]均采用双缩脲法对其进行鉴别。值得注意的是，USP PF 48中为明胶空心胶囊鉴别试验，方法中不仅包含了具体硫酸铜溶液与氢氧化钠溶液的浓度，还增加了“将溶液放置一段时间让任何悬浮固体沉淀到容器底部，如果胶囊的颜色影响检测，可用离心或滤过去除干扰。”这一项，其目的是去除杂质等遮蔽效应，使待测溶液澄清，以便进行显色反应。但是，胶囊中不仅含有悬浮的固体杂质，同时还包含大量的食用色素[12-14]，部分色素溶于水后仍然对试验结果造成遮蔽效应，影响最终显色结果的判断。活性炭是良好的色素吸附材料[15]，本文通过活性炭吸附作用，对上述方法进行改进研究，在供试品溶液中加入适量活性炭对溶液中色素进行吸附，以便更清楚、更简便地对明胶类空心胶囊进行鉴别，为《中国药典》提供合理且科学的修订建议。
1　仪器与试药
收起
ML304T十万分之一电子天平(梅特勒托利多公司)；Milli-Q adv超纯水机(密理博公司)；TW20电热恒温水浴锅(优莱博公司)；0.22 μm水系膜（津隆公司）。水为超纯水。
供试品共13批，其中明胶空心胶囊10批，肠溶明胶空心胶囊3批，详细信息见表1。氢氧化钠(昆山金城试剂有限公司，批号20201104)；五水硫酸铜(国药集团化学试剂有限公司，批号F20080613)；活性炭（上海麦克林生化科技有限公司，批号C14852097）。
2　试验方法
收起
2.1　溶液制备
2.1.1　显色溶液
取五水硫酸铜2.5 g，精密称定，置20 mL量瓶中，加超纯水稀释至刻度，摇匀使溶解，作为显色溶液A；取氢氧化钠1.7 g，精密称定，置20 mL量瓶中，同法使溶解，作为显色溶液B。
2.1.2　供试品溶液
分别取13批供试品约1.0 g，置烧杯中，加超纯水（除CO2）100 mL，并在55 ℃水浴中保温使充分溶解，即得。同法制备空白溶液并编号。
2.2　鉴别试验
2.2.1　优化前鉴别试验方法
取“2.1.2”项下供试品溶液2 mL于比色管中，分别加入显色溶液A 0.05 mL，混匀，再加入显色溶液B 0.5 mL，观察溶液显色结果。
2.2.2　优化后鉴别试验方法
向“2.1.2”项下供试品溶液中加入活性炭2 g，混匀，过滤，取2 mL于比色管中，分别加入显色溶液A 0.05 mL，混匀，再加入显色溶液B 0.5 mL，观察溶液显色结果。
3　试验结果
收起
在白背景下，对比13批供试品溶液方法优化前与优化后的显色结果，结果见图1、2。
图1显示：A0呈阴性反应；A10鉴别反应最典型，呈典型的阳性反应；其他胶囊的显色反应均受到不同程度的色素影响，与蓝紫色偏差较大，其中，A1显深棕色、A2显深红色、A3显黑灰色，A8显黑色，受到色素遮蔽效应最明显，严重影响结果判断。
图2显示：所有供试品鉴别试验结果均呈现典型的阳性反应，颜色一致；A10空心胶囊经方法优化后，显色反应与优化前无显著差别。
以上结果表明，部分胶囊中色素对鉴别试验结果影响较大，经活性炭吸附后，可有效去除色素对显色结果的遮蔽效应，因此，该方法能显著提高对明胶类空心胶囊鉴别的专属性。
4　讨论
收起
4.1　离心滤过对显色结果的影响
取对结果遮蔽效应最明显的黑红（A8）明胶空心胶囊2份，按“2.1.2”项下方法制备供试品溶液，分别取5 mL置离心管中，其中1份不做处理，另1份于7 800 r·min-1离心15 min使沉淀，取上层溶液2 mL，再次滤过后置比色管中，分别加入显色溶液A 0.05 mL，混匀，再加入显色溶液B 0.5 mL，观察溶液显色结果。见图3。
图3显示：离心滤过后的胶囊溶液更透澈，溶液中不溶性杂质均被沉淀，但没有去除对结果判断造成严重影响的色素，因此，采用离心滤过的方式不能完全去除色素的遮蔽效应。
4.2　活性炭加入量研究
取对结果遮蔽效应最明显的黑红（A8）明胶空心胶囊9份，按“2.1.2”项下方法制备供试品溶液，各取5 mL，分别向其中加入活性炭0.025、0.05、0.1、0.15、0.2、0.25、0.5、0.75、1.0 g（即0.5%、1%、2%、3%、4%、5%、10%、15%、20%活性炭），摇匀，过滤，取续滤液2 mL，再取1份空白对照，同法进行显色反应，结果见图4。
反应后颜色以HSV[即色相（hue，H），饱和度（saturation，S）和明度（value，V）]颜色模型，对数据进行分析，采用Colors Lite软件对结果图中各个供试品颜色的HSV进行取点，每个供试品取3个点，计算平均值，并将无色样品A10作为对照，结果见表2。
结果表明，加入活性炭可以吸附胶囊壳中的色素，但过量的活性炭会导致显色结果出现偏差。加入3%活性炭，原溶液已经转为无色；加入3%~5%活性炭显色后，与A10溶液显色结果相近；加入10%活性炭时，显色后溶液由深变浅，说明过量的活性炭将吸附溶液中的蛋白质，导致溶液颜色逐渐趋向于空白溶液。综上，3%~5%活性炭的加入量即可去除胶囊中的色素且不影响最终显色结果，由于A8为实验中遮蔽效应最明显的空心胶囊，因此考虑试剂消耗问题，将3%作为最终添加量。
5　结论
收起
本文对明胶类空心胶囊鉴别试验进行改进研究，试验表明，USP PF 48仅采用离心过滤的方式，虽然可以去除原溶液中的不溶性杂质，但不能消除水溶性色素对结果的影响。利用吸附活性碳加双缩脲反应的方法，既克服了《中国药典》鉴别方法采用试剂不环保的不足，又克服了胶囊中色素对显色反应结果的遮蔽效应，提高了明胶类空心胶囊鉴别的专属性。因此，本文可为《中国药典》中明胶空心胶囊和肠溶明胶空心胶囊的鉴别试验改进提供科学合理的修订建议。
拟定鉴别标准如下：取本品1.0 g，加超纯水（除CO2）100 mL，55 ℃水浴中保温使溶解，如果胶囊的颜色影响显色结果，可加3%活性炭，摇匀，滤过，取续滤液2 mL，依次加125 g·L-1的五水硫酸铜溶液0.05 mL，85 g·L-1氢氧化钠溶液0.5 mL，即产生蓝紫色。
基金
收起
  • *浙江省药品监管系统科技计划项目(2022004)
文献
收起
参考文献 引证文献
排序方式：
[1]
GULLAPALLI RP， MAZZITELLI CL. Gelatin and non-gelatin capsule dosage forms[J]. J Pharm Sci， 2017， 106(6)：1453
[2]
GÓMEZ-GUILLÉN MC， GIMÉNEZ B， LÓPEZ-CABALLERO ME， et al. Functional and bioactive properties of collagen and gelatin from alternative sources： a review[J]. Food Hydrocolloids， 2011， 25(8)： 1813
[3]
朱琳娇，陈运动，吴永江. 电感耦合等离子体质谱法检测明胶空心胶囊中10种元素的含量[J]. 中国现代应用药学， 2013，30(11)：1228
ZHU LJ， CHEN YD， WU YJ. Determination of 10 elements in vacant gelatin capsules by ICP-MS [J]. Chin J Mod Appl Pharm， 2013， 30(11)： 1228
[4]
王丹丹，金立，陈越，等.水浸洗法测定明胶空心胶囊中六种焦油色素含量及结果分析[J]. 海峡药学，2016，28(6)：51
WANG DD， JIN L， CHEN Y， et al. Determination of six tar colorants in vacant capsules by water immersing and results analysis[J]. Strait Pharm J， 2016， 28(6)： 51
[5]
王翀，杜明荦，仲平.UPLC法检测明胶空心胶囊中9种合成着色剂[J]. 药物分析杂志，2016，36(10)：1857
WANG C， DU ML， ZHONG P. Simultaneous detection of 9 synthetic pigments in vacant gelatin capsules by UPLC[J]. Chin J Pharm Anal， 2016，36(10)：1857
[6]
苏铭晖.明胶应用领域的概述[J]. 明胶科学与技术，2018，38(2)：61
SU MH. Overview of gelatin and its fields of application [J]. Sci Technol Gelatin， 2018， 38(2)： 61
[7]
中华人民共和国药典 2020 年版. 四部[S]. 2020： 687，671，720，796
ChP 2020.Vol Ⅳ[S]. 2020： 687，671，720，796
[8]
王丹丹，俞辉.《中国药典》2020年版中胶囊用明胶标准注释[J]. 中国药品标准，2022，23(4)：347
WANG DD， YU H. Notes on gelatin for capsule in Chinese Pharmacopoeia 2020[J]. Drug Stand China， 2022， 23(4)： 347
[9]
JP ⅩⅧ. [S]. 2021： Official Monographs 1060
[10]
EP 11.1 Vol Ⅰ [S]. 2023： Monographs 0330
[11]
USP-PF 48[S]. 2022： C315397
[12]
胡立立， 王蕾.HPLC法同时测定胶囊囊壳中9种合成色素的含量[J]. 辽宁医学院学报， 2017， 38(4)：15
HU LL， WANG L.The simultaneous determination of nine kinds of synthetic pigments in capsule shells by high performance liquid chromatography[J]. Liaoning Med Univ， 2017，38(4)：15
[13]
孙健，胡青，冯睿，等.色素在药品中使用的监管及检测方法[J]. 医药导报，2022， 41(3)：377
SUN J， HU Q， FENG R， et al. Supervision and detection methods of colorants in drugs[J]. Herb Med， 2022， 41(3)：377
[14]
赵海云，李玉杰，张冬梅，等. LC-MS/MS定量分析药用明胶空心胶囊中合成色素的含量[J]. 药物分析杂志，2017，37(7)：1329
ZHAO HY， LI YJ， ZHANG DM， et al. Quantitative determination for 22 synthetic pigments in medical gelatin capsule shells by liquid chromatography-MS/MS[J]. Chin J Pharm Anal， 2017，37(7)：1329
[15]
董宇.活性炭的吸附性能及表征方法[J]. 中国资源综合利用， 2020， 38(7)： 64
DONG Y. The adsorption performance and characterization method of activated carbon[J]. China Res Compr Utiliz， 2020，38(7)： 64
2024年第44卷第2期
PDF下载
73
31
引用本文
BibTeX
文章信息
doi: 10.16155/j.0254-1793.2024.02.21
  • 接收时间：2023-04-08
  • 首发时间：2026-03-13
  • 出版时间：2024-02-29
补充材料
相关文章
文章信息
作者
出版历史
  • 收稿日期：2023-04-08
基金
*浙江省药品监管系统科技计划项目(2022004)
作者信息
    1.浙江省食品药品检验研究院 浙江省药品接触材料质量控制研究重点实验室，杭州 310052
    2.中国药科大学，南京 210009
    3.广东开平金亿胶囊有限公司，开平 529300

通讯作者:

**Tel：18058705250；E-mail：
参考文献
分享链接
https://castjournals.cast.org.cn/joweb/ywfxzz/CN/10.16155/j.0254-1793.2024.02.21
分享至
全文二维码

扫描看全文

引用本文
BibTeX
本文的引用情况
2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
关闭全屏
相关链接
论文
最新文章
热读文章
热点专题
内参
蓝皮书
产业发展报告
传播力报告
期刊分级目录
资讯
学术新闻
行业新闻
学术会议
行业会议
关于
关于我们
联系我们
北京市海淀区学院南路86号
100081
010-62199257
qkjq@cast.org.cn

中国科学技术协会版权所有 京ICP 备10216604号-4 海淀分局备案 1101084647
科技导报社主办 中国科协信息中心技术支持