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Article(id=1240945596979278685, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1240945593548337937, articleNumber=null, orderNo=null, doi=10.16155/j.0254-1793.2023-0565, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=1725292800000, revisedDateStr=2024-09-03, acceptedDate=null, acceptedDateStr=null, onlineDate=1773794085974, onlineDateStr=2026-03-18, pubDate=1732982400000, pubDateStr=2024-12-01, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1773794085974, onlineIssueDateStr=2026-03-18, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1773794085974, creator=13701087609, updateTime=1773794085974, updator=13701087609, issue=Issue{id=1240945593548337937, tenantId=1146029695717560320, journalId=1205117023404326918, year='2024', volume='44', issue='11', pageStart='1827', pageEnd='2010', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1773794085156, creator=13701087609, updateTime=1773796488495, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1240955673937236736, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1240945593548337937, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1240955673937236737, tenantId=1146029695717560320, journalId=1205117023404326918, issueId=1240945593548337937, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1875, endPage=1884, ext={EN=ArticleExt(id=1240945597239325543, articleId=1240945596979278685, tenantId=1146029695717560320, journalId=1205117023404326918, language=EN, title=Characteristic chromatogram and quality evaluation of Gujing Maisiha tablets by HPLC coupled with chemometrics, columnId=1239148838318043851, journalTitle=Chinese Journal of Pharmaceutical Analysis, columnName=Ingredient Analys, runingTitle=null, highlight=null, articleAbstract=
Objective:

To establish the HPLC characteristic chromatogram for Gujing Maisiha tablets，and evaluate the quality using chemical pattern recognition.

Methods:

The Welch Xtimate C18 column (250 mm × 4.6 mm, 5 μm) was used and the mobile phases were acetonitrile (A) and 0.1% formic acid (B) in gradient elution (0-10 min，5%A→15%A；10-20 min，15%A；20-40 min，15%A→40%A；40-65 min，40%A→70%A；65-66 min，70%A→90%A；66-80 min，90%A；80-81 min，90%A→5%A；81-85 min，5%A). The detection wavelength was 254 nm. The column temperature was 35 ℃ and the flow rate was 1.0 mL·min-1. Gujing Maisiha tablets were analyzed to construct characteristic chromatogram. The quality of Gujing Maisiha tablets was assessed through similarity evaluation，cluster analysis，principal component analysis (PCA)，and partial least squares discriminant analysis (PLS-DA).

Results:

The characteristic chromatogram of Gujing Maisiha tablets was established，which contained the twenty-eight distinct peaks，and seven compounds identified as gallic acid，chlorogenic acid，picrocrocin，isoquercitrin，crocin-Ⅰ，crocin-Ⅱ，eugenol. The similarities for the ten batches of Gujing Maisiha tablets were more than 0.98，with no significant difference observed. Cluster analysis segregated the samples into two distinct groups according to the Euclidean distance of 10，which was consistent with the results of PCA analysis. PLS-DA analysis screened out five components from Flos Caryophylli，Rosae Rugosae Flos，Olibanum that may cause differences between samples.

Conclusion:

The method of HPLC characteristic chromatogram of Gujing Maisiha tablets is effective，feasible and reproducible，which can provide reference for the study of quality standard of this product.

, correspAuthors=Zhen 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=Dao-xiao CHANG, Xiao-xiu GENG, Hui LI, Jin-rong WEN, Zhen WANG), CN=ArticleExt(id=1240945599646856139, articleId=1240945596979278685, tenantId=1146029695717560320, journalId=1205117023404326918, language=CN, title=固精麦斯哈片的HPLC特征图谱与化学模式识别研究, columnId=1206272756476342615, journalTitle=药物分析杂志, columnName=成分分析, runingTitle=null, highlight=null, articleAbstract=
目的：

建立固精麦斯哈片HPLC特征图谱，并运用化学模式识别进行质量评价研究。

方法：

采用Welch Xtimate C18（250 mm×4.6 mm，5 μm）色谱柱，以乙腈（A）-0.1%甲酸（B）为流动相进行梯度洗脱（0~10 min，5%A→15%A；10~20 min，15%A；20~40 min，15%A→40%A；40~65 min，40%A→70%A；65~66 min，70%A→90%A；66~80 min，90%A；80~81 min，90%A→5%A；81~85 min，5%A），流速1.0 mL·min-1，检测波长254 nm，柱温35 ℃。建立固精麦斯哈片特征图谱，并进行相似度评价、聚类分析、主成分分析和正交偏最小二乘判别分析。

结果：

建立了固精麦斯哈片的特征图谱，从10批样品中共确定28个共有峰，指认了其中7个成分，分别为没食子酸、绿原酸、苦番红花素、异槲皮苷、西红花苷-Ⅰ、西红花苷-Ⅱ、丁香酚。10批固精麦斯哈片特征图谱与对照图谱的相似度结果均大于0.98，聚类分析按照欧氏距离为10可将样品分为2类，与主成分分析结果一致。正交偏最小二乘判别分析筛选出5个差异性成分，分别来自丁香、玫瑰花和熏鲁香药材。

结论：

本次建立的固精麦斯哈片HPLC特征图谱方法高效可行，重复性好，可为本品质量标准提高研究提供参考。

, correspAuthors=王震, authorNote=null, correspAuthorsNote=
*Tel：13709210027；E-mail：
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Tel：17795121324；E-mail：

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Chin Tradit Herb Drugs，2022，53(20)：6319, articleTitle=Research progress and application of innovative methods for quality control and evaluation of traditional Chinese medicine, refAbstract=null)], funds=null, companyList=[AuthorCompany(id=1240954728037798122, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, xref=1., ext=[AuthorCompanyExt(id=1240954728041992427, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, companyId=1240954728037798122, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.Shaanxi Shengde Tailin Biological Safety Technical Testing Co.，Ltd.，Xi’an 710065，China), AuthorCompanyExt(id=1240954728050381037, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, companyId=1240954728037798122, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1.陕西盛德泰林生物安全技术检测有限公司，西安 710065)]), AuthorCompany(id=1240954728146850035, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, xref=2., ext=[AuthorCompanyExt(id=1240954728159432950, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, companyId=1240954728146850035, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.Xi’an Wanlong Pharmaceutical Co.，Ltd.，Xi’an 710119，China), AuthorCompanyExt(id=1240954728163627256, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, companyId=1240954728146850035, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2.西安万隆制药股份有限公司，西安 710119)])], figs=[ArticleFig(id=1240954733981127129, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.1, caption=Overlay characteristic chromatogram of 10 batches of Gujing Maisiha tablets, figureFileSmall=875a+fNL6E7FQP/WZqG2mQ==, figureFileBig=HG0CgrrehZCqKa3t+tTQ9g==, tableContent=null), ArticleFig(id=1240954734073401818, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图1　, caption=10批固精麦斯哈片HPLC叠加图谱, figureFileSmall=875a+fNL6E7FQP/WZqG2mQ==, figureFileBig=HG0CgrrehZCqKa3t+tTQ9g==, tableContent=null), ArticleFig(id=1240954734216008158, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.2, caption=HPLC reference chromatogram of Gujing Maisiha tablets, figureFileSmall=sfAJU3ATIendaU+99oMH1g==, figureFileBig=CPDOl3tbuIZrxXytwx7VZg==, tableContent=null), ArticleFig(id=1240954734333448675, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图2　, caption=固精麦斯哈片对照图谱

1.没食子酸(gallic acid)　4.绿原酸(chlorogenic acid)　8.苦番红花素(picrocrocin)　12.异槲皮苷(isoquercitrin)　15.西红花苷-Ⅰ(crocin-Ⅰ)　16.西红花苷-Ⅱ(crocin-Ⅱ)　21.丁香酚(eugenol)

, figureFileSmall=sfAJU3ATIendaU+99oMH1g==, figureFileBig=CPDOl3tbuIZrxXytwx7VZg==, tableContent=null), ArticleFig(id=1240954734429917672, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.3, caption=Overlay characteristic chromatogram of medicinal herbs, figureFileSmall=3q+ZZdk+fPNm4G4l6bHreQ==, figureFileBig=0mjR52kAnPX0tCdzsmRpKQ==, tableContent=null), ArticleFig(id=1240954734538969579, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图3　, caption=制剂中8味药材的特征图谱叠加图

S1.甘松(Nardostachyos Radix et Rhizoma)　S2.西红花(Croci Stigma)　S3.丁香(Flos Caryophylli)　S4.阿纳其根(Radix Anacycli Pyrethri) S5.草果(Tsaoko Fructus)　S6.玫瑰花(Rosae Rugosae Flos)　S7.小豆蔻(Fructus Cardamoni)　S8.熏鲁香(Mastiche)

, figureFileSmall=3q+ZZdk+fPNm4G4l6bHreQ==, figureFileBig=0mjR52kAnPX0tCdzsmRpKQ==, tableContent=null), ArticleFig(id=1240954734639632882, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.4, caption=Overlay HPLC chromatogram of standard substance, figureFileSmall=2Kj4fM1QLy5dqCZVhxLeWA==, figureFileBig=HYXgIhjf9FkUdKqhMUeZIQ==, tableContent=null), ArticleFig(id=1240954734757073397, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图4　, caption=不同对照品色谱图的叠加图

S1.丁香酚(eugenol)　S2.苦番红花素(picrocrocin)　S3.绿原酸(chlorogenic acid)　S4.没食子酸(gallic acid)　S5.西红花苷-Ⅰ(crocin-Ⅰ)　S6.西红花苷-Ⅱ(crocin-Ⅱ)　S7.异槲皮苷(isoquercitrin)

, figureFileSmall=2Kj4fM1QLy5dqCZVhxLeWA==, figureFileBig=HYXgIhjf9FkUdKqhMUeZIQ==, tableContent=null), ArticleFig(id=1240954734937428472, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.5, caption=Hierarchical cluster analysis for 10 batches of Gujing Maisiha tablets, figureFileSmall=dCJQ4V3Lh6fl4shc6lHKMA==, figureFileBig=oTQKVBxWOyAl6JGPlkP5+Q==, tableContent=null), ArticleFig(id=1240954735046480383, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图5　, caption=固精麦斯哈片10批样品的聚类分析图, figureFileSmall=dCJQ4V3Lh6fl4shc6lHKMA==, figureFileBig=oTQKVBxWOyAl6JGPlkP5+Q==, tableContent=null), ArticleFig(id=1240954735138755074, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.6, caption=Score matrix diagram of PLS-DA, figureFileSmall=ca+VU8USxHy+1oCzYqiTvQ==, figureFileBig=PzzDfdUQr1mivuskM/YPtA==, tableContent=null), ArticleFig(id=1240954735235224069, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图6　, caption=固精麦斯哈片正交偏最小二乘判别分析得分矩阵图, figureFileSmall=ca+VU8USxHy+1oCzYqiTvQ==, figureFileBig=PzzDfdUQr1mivuskM/YPtA==, tableContent=null), ArticleFig(id=1240954735306527241, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.7, caption=VIP value of PLS-DA, figureFileSmall=P41JWNdK7x2KkvCNVgYraQ==, figureFileBig=VEGb5xU3UU6yuisltc4uOQ==, tableContent=null), ArticleFig(id=1240954735407190541, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图7　, caption=固精麦斯哈片正交偏最小二乘判别分析VIP值图, figureFileSmall=P41JWNdK7x2KkvCNVgYraQ==, figureFileBig=VEGb5xU3UU6yuisltc4uOQ==, tableContent=null), ArticleFig(id=1240954735503659533, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Fig.8, caption=Load scatter plot of PLS-DA, figureFileSmall=c3RBHPz7G3Qdh4FXM415aw==, figureFileBig=iD9y4oa602L/kxW6oVbGQg==, tableContent=null), ArticleFig(id=1240954735633682961, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=图8　, caption=正交偏最小二乘判别分析载荷散点图, figureFileSmall=c3RBHPz7G3Qdh4FXM415aw==, figureFileBig=iD9y4oa602L/kxW6oVbGQg==, tableContent=null), ArticleFig(id=1240954735763706387, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Tab.1, caption=

The results of common peak identification of characteristic chromatogram

, figureFileSmall=null, figureFileBig=null, tableContent=
峰号(peak No.)保留时间(retention time)/min成分(component)峰归属(attribution of chromatographic peaks)
15.799没食子酸(gallic acid)玫瑰花(Rosae Rugosae Flos)
丁香(Flos Caryophylli)
26.872/丁香(Flos Caryophylli)
312.082/丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
412.771绿原酸(chlorogenic acid)玫瑰花(Rosae Rugosae Flos)
513.133/丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
614.247/丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
西红花(Croci Stigma)
715.716/丁香(Flos Caryophylli)
818.129苦番红花素(picrocrocin)西红花(Croci Stigma)
918.984/玫瑰花(Rosae Rugosae Flos)
1022.728/玫瑰花(Rosae Rugosae Flos)
1126.753/玫瑰花(Rosae Rugosae Flos)
丁香(Flos Caryophylli)
1228.188异槲皮苷(isoquercitrin)丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
1328.648/丁香(Flos Caryophylli)
1432.161/丁香(Flos Caryophylli)
1532.684西红花苷-Ⅰ(crocin-Ⅰ)西红花(Croci Stigma)
1634.862西红花苷-Ⅱ(crocin-Ⅱ)西红花(Croci Stigma)
1735.891/甘松(Nardostachyos Radix et Rhizoma)
1839.831/甘松(Nardostachyos Radix et Rhizoma)
玫瑰花(Rosae Rugosae Flos)
1941.017/熏鲁香(Mastiche)
2045.744/丁香(Flos Caryophylli)
2146.191丁香酚(eugenol)丁香(Flos Caryophylli)
2252.304/阿纳其根(Radix Anacycli Pyrethri)
2354.104/丁香(Flos Caryophylli)
2456.153/阿纳其根(Radix Anacycli Pyrethri)
2561.729/阿纳其根(Radix Anacycli Pyrethri)
2663.028/阿纳其根(Radix Anacycli Pyrethri)
2769.324/熏鲁香(Mastiche)
阿纳其根(Radix Anacycli Pyrethri)
2870.539/熏鲁香(Mastiche)
), ArticleFig(id=1240954735872758296, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=表1, caption=

特征图谱共有峰定位及归属结果

, figureFileSmall=null, figureFileBig=null, tableContent=
峰号(peak No.)保留时间(retention time)/min成分(component)峰归属(attribution of chromatographic peaks)
15.799没食子酸(gallic acid)玫瑰花(Rosae Rugosae Flos)
丁香(Flos Caryophylli)
26.872/丁香(Flos Caryophylli)
312.082/丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
412.771绿原酸(chlorogenic acid)玫瑰花(Rosae Rugosae Flos)
513.133/丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
614.247/丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
西红花(Croci Stigma)
715.716/丁香(Flos Caryophylli)
818.129苦番红花素(picrocrocin)西红花(Croci Stigma)
918.984/玫瑰花(Rosae Rugosae Flos)
1022.728/玫瑰花(Rosae Rugosae Flos)
1126.753/玫瑰花(Rosae Rugosae Flos)
丁香(Flos Caryophylli)
1228.188异槲皮苷(isoquercitrin)丁香(Flos Caryophylli)
玫瑰花(Rosae Rugosae Flos)
1328.648/丁香(Flos Caryophylli)
1432.161/丁香(Flos Caryophylli)
1532.684西红花苷-Ⅰ(crocin-Ⅰ)西红花(Croci Stigma)
1634.862西红花苷-Ⅱ(crocin-Ⅱ)西红花(Croci Stigma)
1735.891/甘松(Nardostachyos Radix et Rhizoma)
1839.831/甘松(Nardostachyos Radix et Rhizoma)
玫瑰花(Rosae Rugosae Flos)
1941.017/熏鲁香(Mastiche)
2045.744/丁香(Flos Caryophylli)
2146.191丁香酚(eugenol)丁香(Flos Caryophylli)
2252.304/阿纳其根(Radix Anacycli Pyrethri)
2354.104/丁香(Flos Caryophylli)
2456.153/阿纳其根(Radix Anacycli Pyrethri)
2561.729/阿纳其根(Radix Anacycli Pyrethri)
2663.028/阿纳其根(Radix Anacycli Pyrethri)
2769.324/熏鲁香(Mastiche)
阿纳其根(Radix Anacycli Pyrethri)
2870.539/熏鲁香(Mastiche)
), ArticleFig(id=1240954735973421597, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Tab.2, caption=

HPLC characteristic chromatogram similarity evaluation of Gujing Maisiha tablets

, figureFileSmall=null, figureFileBig=null, tableContent=
样品编号
(sample No.)		批号
(lot No.)		非共有峰面积占比
(non-common peak area ratio)/%		相似度
(similarity)
S121010110.020.994
S221010210.350.993
S321010310.30.994
S421090110.240.998
S52109028.310.999
S62012019.650.999
S72012028.620.999
S82208017.160.991
S92208021.870.986
S102208031.350.984
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固精麦斯哈片HPLC特征图谱相似度评价结果

, figureFileSmall=null, figureFileBig=null, tableContent=
样品编号
(sample No.)		批号
(lot No.)		非共有峰面积占比
(non-common peak area ratio)/%		相似度
(similarity)
S121010110.020.994
S221010210.350.993
S321010310.30.994
S421090110.240.998
S52109028.310.999
S62012019.650.999
S72012028.620.999
S82208017.160.991
S92208021.870.986
S102208031.350.984
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Characteristic value and variance contribution rate

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成分
(component)		特征值
(characteristic value)		方差贡献率
(variance contribution rate)/%		累积方差贡献率
(cumulative variance contribution rate)/%
121.06975.24775.247
23.30811.81587.062
31.9206.85793.919
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样品主成分特征值及方差贡献率

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成分
(component)		特征值
(characteristic value)		方差贡献率
(variance contribution rate)/%		累积方差贡献率
(cumulative variance contribution rate)/%
121.06975.24775.247
23.30811.81587.062
31.9206.85793.919
), ArticleFig(id=1240954736321548841, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Tab.4, caption=

Component martrix of Gujing Maisiha tablets

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峰号
(peak No.)		主成分1
(principal component 1)		主成分2
(principal component 2)		主成分3
(principal component 3)
10.871-0.4140.211
20.9640.2570.014
30.9820.0460.130
40.962-0.2490.094
50.9800.0420.146
60.974-0.1800.008
70.7640.325-0.519
80.930-0.1440.099
90.9590.191-0.056
100.9420.109-0.044
110.936-0.213-0.109
120.3070.167-0.658
130.9940.096-0.021
140.9880.0630.102
150.950-0.0530.198
160.844-0.3730.239
170.919-0.032-0.072
180.921-0.3560.135
19-0.6210.6830.284
200.9910.0660.003
21-0.2990.9210.215
22-0.079-0.0370.834
230.3830.8620.314
240.9900.1240.011
250.9930.1010.016
260.9870.132-0.040
270.9140.338-0.014
280.8350.470-0.216
), ArticleFig(id=1240954736405434924, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=表4, caption=

固精麦斯哈片主成分得分系数矩阵

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峰号
(peak No.)		主成分1
(principal component 1)		主成分2
(principal component 2)		主成分3
(principal component 3)
10.871-0.4140.211
20.9640.2570.014
30.9820.0460.130
40.962-0.2490.094
50.9800.0420.146
60.974-0.1800.008
70.7640.325-0.519
80.930-0.1440.099
90.9590.191-0.056
100.9420.109-0.044
110.936-0.213-0.109
120.3070.167-0.658
130.9940.096-0.021
140.9880.0630.102
150.950-0.0530.198
160.844-0.3730.239
170.919-0.032-0.072
180.921-0.3560.135
19-0.6210.6830.284
200.9910.0660.003
21-0.2990.9210.215
22-0.079-0.0370.834
230.3830.8620.314
240.9900.1240.011
250.9930.1010.016
260.9870.132-0.040
270.9140.338-0.014
280.8350.470-0.216
), ArticleFig(id=1240954736501903920, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=EN, label=Tab.5, caption=

Rank of principal component scores and comprehensive scores

, figureFileSmall=null, figureFileBig=null, tableContent=
编号(No.) F1 F2 F3 F排序(ranking)
S10.577 64-0.467 60-2.324 700.220 015
S20.486 24-1.329 470.183 050.221 364
S30.644 55-0.959 540.200 220.385 363
S41.037 940.736 990.846 200.926 121
S50.025 31-0.318 48-0.148 19-0.028 747
S60.891 140.764 851.116 720.837 502
S7-0.119 38-0.474 570.658 61-0.100 748
S8-0.058 612.054 92-0.976 730.131 716
S9-1.580 180.452 310.381 13-1.109 469
S10-1.904 65-0.459 420.063 68-1.483 1110
), ArticleFig(id=1240954736589984308, tenantId=1146029695717560320, journalId=1205117023404326918, articleId=1240945596979278685, language=CN, label=表5, caption=

固精麦斯哈片样品主成分综合得分及排序

, figureFileSmall=null, figureFileBig=null, tableContent=
编号(No.) F1 F2 F3 F排序(ranking)
S10.577 64-0.467 60-2.324 700.220 015
S20.486 24-1.329 470.183 050.221 364
S30.644 55-0.959 540.200 220.385 363
S41.037 940.736 990.846 200.926 121
S50.025 31-0.318 48-0.148 19-0.028 747
S60.891 140.764 851.116 720.837 502
S7-0.119 38-0.474 570.658 61-0.100 748
S8-0.058 612.054 92-0.976 730.131 716
S9-1.580 180.452 310.381 13-1.109 469
S10-1.904 65-0.459 420.063 68-1.483 1110
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固精麦斯哈片的HPLC特征图谱与化学模式识别研究
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常道潇 1 , 耿小秀 1 , 李辉 1 , 温锦荣 2 , 王震 2, *
药物分析杂志 | 成分分析 2024,44(11): 1875-1884
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药物分析杂志 | 成分分析 2024, 44(11): 1875-1884
固精麦斯哈片的HPLC特征图谱与化学模式识别研究
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常道潇1 , 耿小秀1, 李辉1, 温锦荣2, 王震2, *
作者信息
  • 1.陕西盛德泰林生物安全技术检测有限公司，西安 710065
  • 2.西安万隆制药股份有限公司，西安 710119

    • Tel：17795121324；E-mail：

通讯作者:

*Tel：13709210027；E-mail：
Characteristic chromatogram and quality evaluation of Gujing Maisiha tablets by HPLC coupled with chemometrics
Dao-xiao CHANG1 , Xiao-xiu GENG1, Hui LI1, Jin-rong WEN2, Zhen WANG2, *
Affiliations
  • 1.Shaanxi Shengde Tailin Biological Safety Technical Testing Co.，Ltd.，Xi’an 710065，China
  • 2.Xi’an Wanlong Pharmaceutical Co.，Ltd.，Xi’an 710119，China
出版时间: 2024-12-01 doi: 10.16155/j.0254-1793.2023-0565
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摘要
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目的：

建立固精麦斯哈片HPLC特征图谱，并运用化学模式识别进行质量评价研究。

方法：

采用Welch Xtimate C18（250 mm×4.6 mm，5 μm）色谱柱，以乙腈（A）-0.1%甲酸（B）为流动相进行梯度洗脱（0~10 min，5%A→15%A；10~20 min，15%A；20~40 min，15%A→40%A；40~65 min，40%A→70%A；65~66 min，70%A→90%A；66~80 min，90%A；80~81 min，90%A→5%A；81~85 min，5%A），流速1.0 mL·min-1，检测波长254 nm，柱温35 ℃。建立固精麦斯哈片特征图谱，并进行相似度评价、聚类分析、主成分分析和正交偏最小二乘判别分析。

结果：

建立了固精麦斯哈片的特征图谱，从10批样品中共确定28个共有峰，指认了其中7个成分，分别为没食子酸、绿原酸、苦番红花素、异槲皮苷、西红花苷-Ⅰ、西红花苷-Ⅱ、丁香酚。10批固精麦斯哈片特征图谱与对照图谱的相似度结果均大于0.98，聚类分析按照欧氏距离为10可将样品分为2类，与主成分分析结果一致。正交偏最小二乘判别分析筛选出5个差异性成分，分别来自丁香、玫瑰花和熏鲁香药材。

结论：

本次建立的固精麦斯哈片HPLC特征图谱方法高效可行，重复性好，可为本品质量标准提高研究提供参考。

固精麦斯哈片  /  特征图谱  /  相似度评价  /  化学模式识别  /  没食子酸  /  西红花苷-Ⅰ  /  西红花苷-Ⅱ  /  丁香酚
Objective:

To establish the HPLC characteristic chromatogram for Gujing Maisiha tablets，and evaluate the quality using chemical pattern recognition.

Methods:

The Welch Xtimate C18 column (250 mm × 4.6 mm, 5 μm) was used and the mobile phases were acetonitrile (A) and 0.1% formic acid (B) in gradient elution (0-10 min，5%A→15%A；10-20 min，15%A；20-40 min，15%A→40%A；40-65 min，40%A→70%A；65-66 min，70%A→90%A；66-80 min，90%A；80-81 min，90%A→5%A；81-85 min，5%A). The detection wavelength was 254 nm. The column temperature was 35 ℃ and the flow rate was 1.0 mL·min-1. Gujing Maisiha tablets were analyzed to construct characteristic chromatogram. The quality of Gujing Maisiha tablets was assessed through similarity evaluation，cluster analysis，principal component analysis (PCA)，and partial least squares discriminant analysis (PLS-DA).

Results:

The characteristic chromatogram of Gujing Maisiha tablets was established，which contained the twenty-eight distinct peaks，and seven compounds identified as gallic acid，chlorogenic acid，picrocrocin，isoquercitrin，crocin-Ⅰ，crocin-Ⅱ，eugenol. The similarities for the ten batches of Gujing Maisiha tablets were more than 0.98，with no significant difference observed. Cluster analysis segregated the samples into two distinct groups according to the Euclidean distance of 10，which was consistent with the results of PCA analysis. PLS-DA analysis screened out five components from Flos Caryophylli，Rosae Rugosae Flos，Olibanum that may cause differences between samples.

Conclusion:

The method of HPLC characteristic chromatogram of Gujing Maisiha tablets is effective，feasible and reproducible，which can provide reference for the study of quality standard of this product.

Gujing Maisiha tablets  /  characteristic chromatogram  /  similarity evaluation  /  chemical pattern recognition  /  gallic acid  /  crocin-Ⅰ  /  crocin-Ⅱ  /  eugenol
常道潇, 耿小秀, 李辉, 温锦荣, 王震. 固精麦斯哈片的HPLC特征图谱与化学模式识别研究. 药物分析杂志, 2024 , 44 (11) : 1875 -1884 . DOI: 10.16155/j.0254-1793.2023-0565
Dao-xiao CHANG, Xiao-xiu GENG, Hui LI, Jin-rong WEN, Zhen WANG. Characteristic chromatogram and quality evaluation of Gujing Maisiha tablets by HPLC coupled with chemometrics[J]. Chinese Journal of Pharmaceutical Analysis, 2024 , 44 (11) : 1875 -1884 . DOI: 10.16155/j.0254-1793.2023-0565
正文
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固精麦斯哈片是由阿纳其根、肉豆蔻、熏鲁香、玫瑰花、西红花和丁香等药材制成的中药复方制剂，为维药组方，来源于汗时代西域三十六国之一的莎车国，组方中药材是维吾尔医学家贾马力丁·阿克萨拉根据《哈孜巴依药书》特性配伍组成，并于11世纪收入阿克萨拉依所著的《白色宫殿》[1]，主治增加机体捏住力，强身补脑，固精缩尿，乌发，用于遗精遗尿，早泄体弱，头发早白，神疲乏力等。现代药理研究表明，固精麦斯哈片有改善患者体质黏液质的质量，改善并促进人体热能产生，促进物质代谢活动，祛湿，营养人体性腺和排泄系统等作用[2-6]。临床应用发现，固精麦斯哈片对于舌淡、苔白、边有齿痕等中医脾气虚所致的病症治疗效果显著[2]，联合天然维生素E对不明原因弱精子症亦有较好的临床效果[3]。
固精麦斯哈片最早为《中华人民共和国卫生部药品标准-维吾尔分册》（1999年版）收载品种，其质量控制主要是对阿纳其根、丁香及香附的鉴别项，无含量控制指标。国家药品监督管理局固精麦斯哈片药品标准WS3-BW-0153-98-1-2021，质量控制主要是对丁香及西红花的鉴别项，用气相色谱法测定制剂中丁香酚的含量。固精麦斯哈片质量控制研究文献较少，且基本集中在薄层色谱鉴别及丁香酚的含量控制[7-8]，无法充分有效地反映制剂的质量。
本文采用HPLC对10批固精麦斯哈片样品进行分析，以丁香酚为参照物(S)，建立了固精麦斯哈片的特征图谱，在70 min内标定了28个共有峰，并通过与对照品及药材参照物溶液的保留时间比对，确定制剂共有峰与各药材的相关性研究及归属。固精麦斯哈片处方组成除丁香[9]4、甘松[9]87、西红花[9]134、肉豆蔻[9]141药材外，其余均无含量控制指标，其中阿纳其根、熏鲁香、西红花等各收集10批次药材和对照药材，按生产工艺制备并检测，生成药材对照特征图谱，与制剂及阴性样品比对，确定各药材在制剂中的特征峰。建立了固精麦斯哈片HPLC特征图谱，并运用主成分分析和系统聚类分析等方法，对数据结果进行分析及进一步探讨，旨在评价产品从原料、工艺过程到最终制剂的传递性及均一稳定性，为本品的质量控制体系建立及全面质量控制提供数据支持。
1　仪器与试药
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1.1　仪器
Agilent 1260型高效液相色谱仪（DAD检测器，安捷伦科技有限公司）；U3000型高效液相色谱仪（UV检测器，赛默飞世尔科技有限公司）；BSA124S型万分之一天平、SQP型十万分之一天平（赛多利斯科学仪器有限公司）；SB5200DTD型超声波清洗机（宁波新芝生物科技股份有限公司）；HH-S8A电热恒温水浴锅（北京科伟永兴仪器有限公司）。
1.2　试药
对照品：西红花苷-Ⅱ（批号111589-201705，含量92.20%）、西红花苷-Ⅰ（批号111588-201704，含量88.40%）、丁香酚（批号110725-201917，含量99.10%）、苦番红花素（批号112056-202001，含量97.60%）、没食子酸（批号110831-201906，含量91.50%）、绿原酸（批号110753-202119，含量96.30%），中国食品药品检定研究院；异槲皮苷（批号X29O11Y128970，含量≥98%），上海源叶生物科技有限公司。
固精麦斯哈片样品10批(批号210101、210102、210103、210901、210902、201201、201202、220801、220802、220803)，西安万隆制药股份有限公司。
西红花药材10批（批号210801、171101、200501、21070201、211201002、20210801、20201201、20220301、01-20120101、02-20040101），阿纳其根药材10批（批号200501、171201、200701、210901、211101、210701-1、210701-2、200501-1、200501-2、210701），丁香药材10批（批号20200101、20170801、211224001、21120902、20210301、20201101、20211001、210501、203090401、210701），香附药材10批（批号171101、210801、22020802、20211001、20211002、20211003、20200701、220301、20190801、200401），郁金药材10批（批号210801、171101、211216004、21110501、20041603-3、20210903、20210901、220301、2101004、200402），肉豆蔻药材10批（批号171101、210801、220316002、21052502、20201001、20211101、20210201、190921101、211101、200401），甘松药材10批（批号200401、20171001、20112002-3、20210701、20211201、20210401、19120502、200901、190481001、210701），熏鲁香药材1批（批号210801），草果药材2批（批号210801、20200201），小豆蔻药材2批（批号210701、200501），玫瑰花药材2批（批号210801、200401），西安万隆制药股份有限公司。
乙腈（批号19801440，上海安谱实验科技股份有限公司）、甲酸（批号C2130066，上海阿拉丁生化科技股份有限公司）为色谱纯，甲醇（批号2022061302，成都市科隆化学品有限公司）为分析纯，水为超纯水。
2　方法与结果
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2.1　色谱条件
采用Welch Xtimate C18（250 mm × 4.6 mm，5 μm）色谱柱，以乙腈（A）-0.1%甲酸（B）为流动相，梯度洗脱（0~10 min，5%A→15%A；10~20 min，15%A；20~40 min，15%A→40%A；40~65 min，40%A→70%A；65~66 min，70%A→90%A；66~80 min，90%A；80~81 min，90%A→5%A；81~85 min，5%A），流速1.0 mL·min-1，检测波长254 nm，柱温35 ℃，进样量10 μL。
2.2　溶液的制备
2.2.1　对照品溶液
精密称取丁香酚、西红花苷-Ⅰ、西红花苷-Ⅱ、苦番红花素的对照品适量，分别加甲醇制成每1 mL含0.1 mg的溶液；精密称取异槲皮苷对照品适量，加甲醇制成每1 mL含0.3 mg的溶液；精密称取没食子酸对照品适量，加甲醇制成每1 mL含0.25 mg的溶液；精密称取绿原酸对照品适量，加甲醇制成每1 mL含0.35 mg的溶液。
2.2.2　供试品溶液
取固精麦斯哈片，除去包衣，研细，取约0.5 g，精密称定，置具塞锥形瓶中，精密加入70%甲醇25 mL，密塞，称量，超声处理（功率240 W，频率36 kHz）20 min，放冷，再称量，用70%甲醇补足减失的量，摇匀，静置，上清液使用0.22 μm滤膜过滤，取续滤液，即得。
2.2.3　药材溶液
取阿纳其根、小豆蔻、草果、丁香、西红花药材细粉各约0.5 g，精密称定，分别置具塞锥形瓶中，精密加入70%甲醇50 mL，称量，自“超声处理”起，按“2.2.2”项下方法操作，即得；或取香附、肉豆蔻、甘松、玫瑰花、郁金药材粗粉各约0.5 g，精密称定，分别加水50 mL，煎煮1 h，离心，取上清液，蒸至近干，残渣精密加入70%甲醇50 mL，称量，自“超声处理”起，按“2.2.2”项下方法操作，即得。
2.3　HPLC方法学验证及特征图谱的建立
2.3.1　精密度试验
精密吸取同一供试品溶液（批号210101），按“2.1”项下色谱条件，连续进样6次，以丁香酚色谱峰的保留时间和色谱峰面积作为参照，计算各共有色谱峰相对保留时间的RSD为0~0.33%，相对峰面积的RSD为0~11.27%。非共有峰的色谱峰面积占比3%以下，相似度均>0.99。表明本仪器系统的精密度良好。
2.3.2　稳定性试验
精密吸取同一供试品溶液（批号210101），按“2.1”项下色谱条件，分别于0、3、6、9、12、24、36 h进样测定，以丁香酚色谱峰的保留时间和色谱峰面积作为参照，计算各共有色谱峰相对保留时间的RSD为0~0.53%，相对峰面积的RSD 6号峰为17.3%，7号峰为36.6%，其中6号色谱峰在0、24、36 h 3个时间间隔检测点的峰面积相差不大，7号色谱峰在3、24、36 3个时间间隔检测点的峰面积相差不大，6号、7号色谱峰相对峰面积的RSD偏高，均为中间时间段峰面积波动所致。10号峰相对峰面积的RSD为22.7%，除12、24 h外，各时间间隔检测点的峰面积相差不大，其余25个色谱峰相对峰面积的RSD为0~14.89%，非共有峰的色谱峰面积占比最高为5.30%，相似度均大于0.99。表明供试品溶液在36 h内基本稳定。
2.3.3　重复性试验
取同一批样品（批号210101）6份，按“2.2.2”项下方法制备供试品溶液，在“2.1”项色谱条件下测定，以丁香酚色谱峰的保留时间和色谱峰面积作为参照，计算各共有色谱峰相对保留时间的RSD为0~0.27%，相对峰面积的RSD为0~7.17%，非共有峰的色谱峰面积占比低于4%，相似度均大于0.99。表明本方法的重复性良好。
2.3.4　特征图谱的建立
取10批固精麦斯哈片样品进样测定，记录色谱图，将数据导入国家药典委员会制定的《中药色谱指纹图谱相似度评价系统》（2012.130723版本），选定210101批次样品的色谱图为参考图谱，进行多点校正和Mark峰匹配，采用中位数法，设定时间窗宽度为0.1，生成样品叠加图谱（图1）和相应的对照图谱（图2）。
通过对比10批样品的测定结果，选定色谱峰较稳定且峰面积较高的28个峰作为共有峰，并按照保留时间顺序依次编号为1~28号色谱峰。峰24和峰25之间响应较高的色谱峰，为阿纳其根药材中的成分，10批阿纳其根药材中，该成分在171201批次中基本未检出，在其他9批次中有较高响应，批间差异较大，故该色谱峰暂未列入特征图谱共有峰。
2.3.5　共有峰的指认与归属
对样品的共有峰在药材中的归属和对照品定位进行研究，按“2.2.1”项下方法制备对照品溶液，按“2.2.3”项下方法制备药材溶液，在“2.1”项色谱条件下进行测定，11味药材的特征图谱叠加对比结果见图3，因香附、肉豆蔻、郁金药材均未检测到明显的特征色谱峰，故无该3味药材的特征图谱。
汇总结果见表1，11味药材中有6味出现特征峰，1、2、3、5、6、7、11、12、13、14、20、21、23号峰来自丁香药材，1、3、4、5、6、9、10、11、12、18号峰来自玫瑰花药材，22、24、25、26、27号峰来自阿纳其根药材，19、27、28号峰来自熏鲁香药材，6、8、15、16号峰来自西红花药材，17、18号峰来自甘松药材。其中，1、3、5、11、12号峰为丁香和玫瑰花药材的共有峰，6号峰为丁香、玫瑰花和西红花药材的共有峰，18号峰为甘松和玫瑰花药材的共有峰，27号峰为熏鲁香和阿纳其根药材的共有峰。
为进一步验证各峰的归属，将丁香、玫瑰花、西红花中已知化学成分（现有药典或国家标准收载的）的相应对照品进样分析，经比对指认，共识别了7个已知化合物，结果见图4。没食子酸的保留时间为5.799 min，为玫瑰花和丁香的特征峰；绿原酸的保留时间为12.771 min，为玫瑰花的特征峰；苦番红花素的保留时间为18.129 min，为西红花的特征峰；异槲皮苷的保留时间为28.188 min，为丁香和玫瑰花的特征峰；西红花苷-Ⅰ的保留时间为32.684 min，为西红花的特征峰；西红花苷-Ⅱ的保留时间为34.862 min，为西红花的特征峰；丁香酚的保留时间为46.191 min，为丁香的特征峰。
由上述分析可知，对照图谱有28个共有峰，包含7个已知化合物。其中，丁香酚化学性质稳定，峰形对称，分离度符合要求[10]，无拖尾现象且峰面积稳定，因此选择丁香酚作为参照物。以丁香酚峰为参照峰（S峰），计算各峰的相对保留时间为：0.13（峰1）、0.15（峰2）、0.26（峰3）、0.28（峰4）、0.28（峰5）、0.31（峰6）、0.34（峰7）、0.39（峰8）、0.41（峰9）、0.49（峰10）、0.58（峰11）、0.61（峰12）、0.62（峰13）、0.70（峰14）、0.71（峰15）、0.75（峰16）、0.78（峰17）、0.86（峰18）、0.89（峰19）、0.99（峰20）、1.00（S峰/峰21）、1.13（峰22）、1.17（峰23）、1.22（峰24）、1.34（峰25）、1.36（峰26）、1.50（峰27）、1.53（峰28）。
2.3.6　相似度分析
将以上10批样品的测定结果与对照图谱结果进行对比分析，并计算相似度，结果见表2，非共有峰面积占比均<11%，相似度结果均>0.98，表明10批固精麦斯哈片样品间的差异较小，所含成分基本相似。
2.4　化学模式识别
2.4.1　聚类分析
将10批样品所得28个共有峰的峰面积导入SPSS统计分析软件，采用组间联接法，以平方欧氏距离为区间，进行聚类分析，结果见图5。当类间距为15时，可将10批样品分为2类，S5、S7、S8、S9和S10聚为一类，其他样品聚为一类；当类间距为10时，10批样品可分为3类，S5、S7和S8聚为一类，S9和S10聚为一类，其他样品聚为一类。
2.4.2　主成分分析
将10批样品中28个共有峰的峰面积导入SPSS统计分析软件，进行主成分分析，得到相关矩阵的特征值、方差贡献率及因子载荷矩阵，提取特征值>1的成分作为主成分（见表3），这3个成分的累积方差贡献率为93.919%，表明这3个成分能够代表28个共有峰中93.919%的信息，代表性较佳。由主成分得分系数矩阵（表4）可知，色谱峰19、21、23在第2主成分上具有较高载荷值，色谱峰12、22在第3主成分上具有较高载荷值，其余色谱峰均在第1主成分上具有较高载荷值，表示各色谱峰与主成分之间的相关性，载荷值越高，相关性越大。
为消除原始数据量纲和数量级对结果的影响，对数据进行标准化处理，以因子载荷值与特征值开平方后的比值计算3个主成分的得分系数，将其与标准化后的数据相乘计算各主成分得分，以各主成分对应的方差贡献率为权重，按照公式F=0.752 47F1+0.118 15F2+0.068 57F3，计算综合得分，结果见表5，对F值进行排序，其结果也是对固精麦斯哈片质量进行综合评价的结果，S1、S2、S3、S4、S6的排名为1~5位，与聚类分析的结果基本一致。
2.4.3　正交偏最小二乘判别分析
以10批固精麦斯哈片共有峰的峰面积作为变量，导入SIMCA统计分析软件，进行正交偏最小二乘判别分析。得分矩阵图见图6，模型参数R2X为1、R2Y为1、Q2为0.874，矩阵良好，S1、S2、S3、S4、S6被分为一组，分类结果与聚类分析和主成分分析的结果相一致。
综合上述结果，10批样品基本会被分为2组，引起组间差异的成分可用变量特征系数（VIP）进行筛选，由图7可见，以VIP>1作为标准，筛选得到1、11、3、5、19号峰可能为差异组分。由图8可见，1、11、3、5、19号峰距离原点较远，对样品的分组贡献较大。
正交偏最小二乘判别分析筛选出的差异性组分为1、11、3、5、19号峰，前4个均为玫瑰花和丁香的共有成分，其中1号峰为没食子酸，19号峰为熏鲁香中的成分，推测引起产品批间差异的成分可能主要来自于药材丁香、玫瑰花和熏鲁香。
3　讨论
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3.1　检测方法的选择
固精麦斯哈片中各味药材所含成分大部分具有紫外吸收[11-14]，结合制剂的制备工艺，选择HPLC法建立固精麦斯哈片的特征图谱，并使用DAD检测器获得各特征峰的紫外光谱信息，进一步强化该检测方法的专属性。通过对药材及样品的检测，发现主要物质群具有良好的传递性和相关性，归属清晰；从色谱峰的强度和个数进行分析，对于特征图谱贡献较大的药材有丁香、玫瑰花、西红花、阿纳其根等，所反映的化学成分信息较为全面；小豆蔻、草果等主要含挥发油成分[15-16]，不具备HPLC-DAD检测的结构特点，在该条件下未检出。
3.2　化学模式分析的选择
主成分分析和偏最小二乘判别等统计学方法，能加强对特征图谱规律的分析，进一步挖掘可用信息，可利用相对保留时间定位或者相对峰面积的规定，进行药材真伪鉴定，以及生品和炮制品的区分[17-18]；还可结合文献研究及网络药理学分析进行潜在的质量标志物预测[19]。本研究通过化学模式的分析，初步识别可能引起产品质量差异的成分，相关药材的采收及加工过程应该引起重视，这在保证产品质量稳定方面具有指导意义。
3.3　提取溶剂的选择
中药具有质量整体性与功效特异性，发挥药效是化学物质组群的综合生物效应，这就导致药效物质基础难以充分阐明，与药效属性相关的质量标志物难以确定，反映整体药效的质量控制方法难以建立[20]。本研究针对提取溶剂的选择，是从化合物整体的提取情况进行考察，使用HPLC对固精麦斯哈片的特征图谱前处理方法进行优化，以色谱峰的数量和整体分离情况作为评价指标，考察不同提取溶剂、提取方式、提取时间对结果的影响，确定供试品溶液制备方法；对比了50%乙醇、70%乙醇、甲醇、50%甲醇、70%甲醇5种提取溶剂，结果显示采用70%甲醇提取后样品的色谱峰个数最多，故确定提取溶剂为70%甲醇；对比超声和回流2种提取方式，发现测定结果基本一致，故选择超声方式进行提取；对比10、20、30、40 min 4种超声时间，测得结果无明显差异，均能提取完全。这虽然是目前常用的评价方法，但与产品功能主治即药效之间的关联程度尚不明确。在建立特征图谱方法时，提取溶剂的选择非常关键，需整合多学科技术方法进一步深入研究。
3.4　小结
本次建立的固精麦斯哈片HPLC特征图谱，方法操作简单，重复性好。对10批样品的共有峰进行了部分峰的定位和药材的归属，指认了没食子酸、苦番红花素等7个成分，通过相似度对比，样品相关性良好，但通过化学模式分析初步判定，不同批次样品组间存在质量差异。本研究为与药效属性相关的质量标志物预测提供研究思路，基于有效性开展功效关联物质的系统辨识与确认，为作用机制的研究提供借鉴，也为质量控制提供更全面的参考。
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doi: 10.16155/j.0254-1793.2023-0565
  • 首发时间：2026-03-18
  • 出版时间：2024-12-01
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    1.陕西盛德泰林生物安全技术检测有限公司，西安 710065
    2.西安万隆制药股份有限公司，西安 710119

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Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
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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
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