Article(id=1322180370037068687, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, articleNumber=null, orderNo=null, doi=null, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1609603200000, acceptedDateStr=2021-01-03, onlineDate=1793161965140, onlineDateStr=2026-10-28, pubDate=1628956800000, pubDateStr=2021-08-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793161965140, onlineIssueDateStr=2026-10-28, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793161965140, creator=13701087609, updateTime=1793161965140, updator=13701087609, issue=Issue{id=1322180330556076791, tenantId=1146029695717560320, journalId=1235980733773295621, year='2021', volume='30', issue='15', pageStart='1345', pageEnd='1440', issueExtLink='null', onlineDate='null', pubDate='1628956800000', pubDateStr='2021-08-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793161955726, creator='13701087609', updateTime=1793162082189, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322180861076816464, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322180861076816465, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1322180330556076791, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=1421, endPage=1427, ext={EN=ArticleExt(id=1322180370217423760, articleId=1322180370037068687, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Quality standard of Huoling Shengji Granules placebo, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective: Taking Huoling Shengji Granules (HLG) placebo as an example, the quality standards of TCM placebo was discussed using similarity, applicability, controllability and safety as the basic attributes.
Methods: On the basis of the quality standards of HLG granule, that of its simulated preparation HLG granule placebo were studied. Besides similarity, the quality control items that embody the other three attributes were established. Artificial evaluation was used to establish the similarity control between the placebo and the tested preparation. Thin layer chromatography (TLC) method was used for the qualitative examination of Atractylodes rhizome, Poria cocos and Astragalus membranaceus. HPLC was used to detect loganin and icariin in limited quantities to establish the applicability and controllability of placebo. The safety of placebo was assessed by numerical statistics of acceptable daily intake (ADI) values of components in the prescription.
Results: Using the method of artificial evaluation and scoring, the similarity between the placebo and the tested preparation was 0.992 5. In TLC, the HLG placebo had no corresponding spots or shallower spots compared to the 10% of the tested preparations and the tested preparation. In HPLC, the content in HLG placebo was lower than that of 10% tested preparations. In addition, the amounts of food additives were within the safe range. In terms of similarity, applicability, controllability and safety, the HLG placebo met the requirements of placebo quality standards.
Conclusion: The quality standard of HLG granule placebo can provide an empirical basis for the formulation of TCM placebo industry standards.
, authors=Ning GUO
1, Cheng-jie GUO
2, Mei WU
2, You-jie WANG
2, Fei WU
1, 2, Xiao LIN
1, Yi FENG
2, authorsList=Ning GUO, Cheng-jie GUO, Mei WU, You-jie WANG, Fei WU, Xiao LIN, Yi FENG, authorCompany=null, correspAuthors=Fei WU, Xiao LIN, 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, fund=null), CN=ArticleExt(id=1322180370536190865, articleId=1322180370037068687, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=中药藿苓生肌颗粒安慰剂的质量标准探讨, columnId=1236330556003242277, journalTitle=中国新药杂志, columnName=实验研究, runingTitle=null, highlight=null, articleAbstract=
目的： 以藿苓生肌颗粒安慰剂为例，以相似性、适用性、可控性和安全性为基本属性，对中药安慰剂的质量标准进行探讨。
方法： 在藿苓生肌颗粒质量标准的基础上，对其模拟制剂藿苓生肌颗粒安慰剂的质量标准进行研究。除相似性外，着重建立体现其他3个属性的质量控制项目。采用人工评价法建立安慰剂与受试制剂的相似性控制项；采用薄层色谱法对白术、茯苓和黄芪项目进行定性检查，采用HPLC法对马钱苷和淫羊藿苷进行限量测定，建立安慰剂的适用性和可控性控制项；通过对处方中材料成分的每日允许摄入量（ADI）数值统计，进行安慰剂的安全性评估。
结果： 通过人工评价打分的方法，计算得到藿苓生肌颗粒安慰剂与其受试制剂的相似度是0.992 5；在薄层色谱中，藿苓生肌颗粒安慰剂与10%的受试制剂和受试制剂色谱无对应的斑点或者斑点更浅；在HPLC中，藿苓生肌颗粒安慰剂与10%的受试制剂相比含量更低；此外，食品添加剂的用量均在安全使用剂量范围内，在相似性、适用性、可控性和安全性四方面均符合安慰剂质量标准的要求。
结论： 以藿苓生肌颗粒安慰剂为例，探索建立中药安慰剂的质量标准的方法，为中药安慰剂行业标准的制定提供经验基础。
, authors=郭宁
1, 郭成杰
2, 吴梅
2, 王优杰
2, 吴飞
1, 2, 林晓
1, 冯怡
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1College of Chinese Materia Medica, Shanghai University of Traditional Chinese Medicine, Shanghai 201203, China
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1上海中医药大学中药学院，上海 201203
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