Article(id=1218290944638632928, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1218290941232861879, articleNumber=1001-2494(2024)15-1445-08, orderNo=null, doi=10.11669/cpj.2024.15.012, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1719676800000, receivedDateStr=2024-06-30, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1768392795952, onlineDateStr=2026-01-14, pubDate=1723046400000, pubDateStr=2024-08-08, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1768392795952, onlineIssueDateStr=2026-01-14, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1768392795952, creator=13701087609, updateTime=1768392795952, updator=13701087609, issue=Issue{id=1218290941232861879, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='15', pageStart='1361', pageEnd='1452', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1768392795141, creator=13701087609, updateTime=1768394622953, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1218298607682376061, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1218290941232861879, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1218298607682376062, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1218290941232861879, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1445, endPage=1452, ext={EN=ArticleExt(id=1218290945305527286, articleId=1218290944638632928, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=UPLC-MS/MS Multi-Index Component Analysis of Red Ginseng Combined with Chemometrics and EW-TOPSIS Method to Evaluate the Quality of Shenmai Granules, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To establish a UPLC-MS/MS method for simultaneous determination of 14 components in Shenmai granules, and analyze the quality differences of red ginseng feed from different manufacturers. METHODS Shimadzu Shim-pack gist C18(2.1 mm×100 mm,2 μm) chromatographic column with acetonitrile-water as the mobile phase were used to determine the contents of 14 saponin components in 71 batches of Shenmai Granules. And then analyzed the main material basis affecting the difference in red ginseng feeding in Shenmai granules combined with chemometrics and evaluated the quality of red ginseng feeding in Shenmai granules from different manufacturers combined with EW-TOPSIS. RESULTS The concentrations of 14 components had a good linear relationship (r≥0.998 5); and the average recovery rate was 95.6%-105.0%(RSD<4.7%). According to the analysis of chemometrics and EW-TOPSIS, the samples produced by the three manufacturers were grouped into three categories, among which the quality of red ginseng feeding by manufacturer B was generally good, and the red ginseng feeding by manufacturer C was adulterated. CONCLUSION This method is specific, sensitive, efficient, and reliable, and can be used for the quality control of Shenmai granules.

, correspAuthors=Rong LEI, Yongli LIU, 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=Yaru LIU, Rong LEI, Jian SU, Yongli LIU), CN=ArticleExt(id=1218290947960520761, articleId=1218290944638632928, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=UPLC-MS/MS法测定红参多指标成分分析结合化学计量学和熵权优劣解距离法评价参麦颗粒质量, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 建立超高效液相色谱-串联质谱(UPLC-MS/MS)法同时测定参麦颗粒中14个成分含量的方法,分析不同厂家红参投料的质量差异。方法 采用Shimadzu Shim-pack gist C18(2.1 mm×100 mm,2 μm)色谱柱,以乙腈和水为流动相,同时测定71批参麦颗粒中14个皂苷类成分的含量,结合化学计量学分析影响参麦颗粒中红参投料差异的主要物质基础,并运用熵权优劣解距离法(EW-TOPSIS)对不同厂家参麦颗粒红参投料质量进行优劣性评价。结果 14个成分在一定浓度范围内与峰面积呈良好线性关系(r≥0.998 5);平均加样回收率范围均为95.6%~105.0%[相对标准偏差(RSD)<4.7%];经化学计量学以及熵权优劣解距离法分析可知,3个厂家生产的样品分别聚为3类,其中B厂家投入红参质量整体较好,C厂家红参投料存在掺伪现象。结论 该方法特异、灵敏、高效、可靠,可用于参麦颗粒的质量控制。

, correspAuthors=雷蓉, 刘永利, authorNote=null, correspAuthorsNote=
* 雷蓉,女,硕士,高级工程师 研究方向:中药质量控制方法与质量评价 Tel:(0311)85212007-8042;
刘永利,男,硕士,硕士生导师 研究方向:中药质量控制方法与质量评价 Tel:(0311)69086006
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刘亚茹,女,硕士研究生 研究方向:药物分析

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刘亚茹,女,硕士研究生 研究方向:药物分析

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Ginseng Res(人参研究), 2021, 33(6): 13-15., articleTitle=Study on optimization of red ginseng processing technology, refAbstract=null)], funds=[Fund(id=1218484901117088221, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, awardId=NMPAJGKX-2023-024, language=CN, fundingSource=中药有效性安全性评价及全过程质量控制研究项目(NMPAJGKX-2023-024), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1218484896578851082, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, xref=1, ext=[AuthorCompanyExt(id=1218484896587239693, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, companyId=1218484896578851082, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 Hebei Medical University, Shijiazhuang 050017, China), AuthorCompanyExt(id=1218484896599822605, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, companyId=1218484896578851082, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=1 河北医科大学, 石家庄 050017)]), AuthorCompany(id=1218484896687902993, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, xref=2, ext=[AuthorCompanyExt(id=1218484896692097300, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, companyId=1218484896687902993, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 Hebei Key Laboratory for Quality Evaluation and Standard of Traditional Chinese Medicine, Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China), AuthorCompanyExt(id=1218484896700485908, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, companyId=1218484896687902993, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=2 河北省药品医疗器械检验研究院, 河北省中药质量评价与标准研究重点实验室, 石家庄 050227)])], figs=[ArticleFig(id=1218484899103822223, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Fig.1, caption=Multiple reaction monitoring(MRM) extraction ion flow diagrams of 14 saponin components in Shenmai granules, figureFileSmall=CNl6oPtcI7/trwteO02r7g==, figureFileBig=DAZsYwU4BwaTu7VyE4DOuQ==, tableContent=null), ArticleFig(id=1218484899175125395, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=图1, caption=参麦颗粒中14个皂苷成分的质谱多反应监测(MRM)提取离子流图, figureFileSmall=CNl6oPtcI7/trwteO02r7g==, figureFileBig=DAZsYwU4BwaTu7VyE4DOuQ==, tableContent=null), ArticleFig(id=1218484899259011478, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Fig.2, caption=Hierarchical cluster analysis(HCA) diagram of the sample of Shenmai granules, figureFileSmall=RZpfD+YtR2kfDLYDPUOOkw==, figureFileBig=ttFzCu0zJSDc+cWgKcK0tQ==, tableContent=null), ArticleFig(id=1218484899330314650, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=图2, caption=参麦颗粒样品的系统聚类分析(HCA)图, figureFileSmall=RZpfD+YtR2kfDLYDPUOOkw==, figureFileBig=ttFzCu0zJSDc+cWgKcK0tQ==, tableContent=null), ArticleFig(id=1218484899405812126, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Fig.3, caption=OPLS-DA diagram of the sample of Shenmai granules

D-OPLS-DA diagram of the sample;E-variable important in projection(VIP) diagram of the sample;F-sample load diagram;G-OPLS-DA displacement detection diagram of the sample; X-compounds; Y-manufacturer; R-interpret ability; Q-predictive ability.

, figureFileSmall=u7a1ilqt4PypRZxpE6wy+g==, figureFileBig=11Nw6IpAIiowtsk53ArEPQ==, tableContent=null), ArticleFig(id=1218484899481309600, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=图3, caption=参麦颗粒样品的正交偏最小二乘法判别分析(OPLS-DA)图

D-样品OPLS-DA图;E-样品变量投影重要度(VIP)图;F-样品载荷图;G-样品OPLS-DA置换检测结果图;X-成分;Y-厂家;R-解释能力;Q-预测能力。

, figureFileSmall=u7a1ilqt4PypRZxpE6wy+g==, figureFileBig=11Nw6IpAIiowtsk53ArEPQ==, tableContent=null), ArticleFig(id=1218484899552612771, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Fig.4, caption=Marginal map of Shenmai granules, figureFileSmall=OeGFzKGN36HYC3pQa7xaVQ==, figureFileBig=RcGTrt1VBOgQHd4B+XLXOw==, tableContent=null), ArticleFig(id=1218484899615527335, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=图4, caption=参麦颗粒组边际图, figureFileSmall=OeGFzKGN36HYC3pQa7xaVQ==, figureFileBig=RcGTrt1VBOgQHd4B+XLXOw==, tableContent=null), ArticleFig(id=1218484899707802024, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Fig.5, caption=Box diagram of entropy weight ranking of different manufacture of Shenmai granules, figureFileSmall=ETRj/Ih4ithYVqKYbcrm7A==, figureFileBig=7P7KDPMGnuSqSf0o9EM61A==, tableContent=null), ArticleFig(id=1218484899770716588, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=图5, caption=参麦颗粒不同厂家熵权排名箱线图, figureFileSmall=ETRj/Ih4ithYVqKYbcrm7A==, figureFileBig=7P7KDPMGnuSqSf0o9EM61A==, tableContent=null), ArticleFig(id=1218484899858796978, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Tab.1, caption=

Mass spectrometry parameters of various components in Shenmai granules

, figureFileSmall=null, figureFileBig=null, tableContent=
Compounds Parent ion
(m/z)
Daughter ion
(m/z)
Declustering
potential/V
Collision
energy/V
Pseudoginsenoside F11 799.6 653.7 -20 -50
Ginsenoside Rf 799.6 637.6 -20 -45
Ginsenoside Ro 955.6 793.4 -44 -56
Ginsenoside Rb1 1 107.5 945.5 -20 -55
Ginsenoside Rg1 799.4 637.4 -20 -35
Ginsenoside Re 945.5 637.3 -20 -56
Ginsenoside Rd 945.5 783.5 -60 -52
Ginsenoside Rb2 1 077.6 783.4 -70 -69
Ginsenoside Rb3 1 077.6 783.5 -82 -67
Ginsenoside Rg2 783.6 475.5 -35 -48
Ginsenoside Rg3 783.5 621.4 -60 -42
Ginsenoside Rc 1 077.5 783.5 -20 -63
Ginsenoside Rh1 637.4 161.1 -27 -20
Notoginsenoside R1 931.5 637.4 -40 -50
), ArticleFig(id=1218484899938488760, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=表1, caption=

参麦颗粒各成分质谱参数

, figureFileSmall=null, figureFileBig=null, tableContent=
Compounds Parent ion
(m/z)
Daughter ion
(m/z)
Declustering
potential/V
Collision
energy/V
Pseudoginsenoside F11 799.6 653.7 -20 -50
Ginsenoside Rf 799.6 637.6 -20 -45
Ginsenoside Ro 955.6 793.4 -44 -56
Ginsenoside Rb1 1 107.5 945.5 -20 -55
Ginsenoside Rg1 799.4 637.4 -20 -35
Ginsenoside Re 945.5 637.3 -20 -56
Ginsenoside Rd 945.5 783.5 -60 -52
Ginsenoside Rb2 1 077.6 783.4 -70 -69
Ginsenoside Rb3 1 077.6 783.5 -82 -67
Ginsenoside Rg2 783.6 475.5 -35 -48
Ginsenoside Rg3 783.5 621.4 -60 -42
Ginsenoside Rc 1 077.5 783.5 -20 -63
Ginsenoside Rh1 637.4 161.1 -27 -20
Notoginsenoside R1 931.5 637.4 -40 -50
), ArticleFig(id=1218484900026569145, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Tab.2, caption=

Linear inspection results of 14 components in Shenmai granules

, figureFileSmall=null, figureFileBig=null, tableContent=
Compounds Regression equation linear range/ng·mL-1 r Limit of quantitation/ng·mL-1
Pseudoginsenoside F11 Y=750.13X-1 078.3 3.44 -344 0.999 3 0.688
Ginsenoside Rf Y=2 045.70X+3 466.8 3.55 -355 0.999 4 0.711
Ginsenoside Ro Y=969.21X+8 731.6 7.60 -760 0.999 3 1.520
Ginsenoside Rb1 Y=191.86X+11 919 41.59 -4 159 0.999 0 4.159
Ginsenoside Rg1 Y=2 760.40X+100 048 16 -1 600 0.999 1 1.600
Ginsenoside Re Y=736.52X+2 835.9 6.14 -614 0.999 4 0.614
Ginsenoside Rd Y=588.80X+3 450.8 6.16 -616 0.999 7 1.232
Ginsenoside Rb2 Y=182.57X-130.34 4.56 -456 0.999 8 4.560
Ginsenoside Rb3 Y=98.98X+32.622 2.81 -140 0.999 4 28.096
Ginsenoside Rg2 Y=5 834.50X+5 609.6 1.01 -101 0.999 8 0.101
Ginsenoside Rg3 Y=1 531.80X-529.84 2.80 -280 0.999 6 0.280
Ginsenoside Rc Y=319.29X+2 367.3 5.35 -535 0.999 5 1.071
Ginsenoside Rh1 Y=1 715.50X+5 0295 10 -1 000 0.998 5 0.200
Notoginsenoside R1 Y=1 949.90X-3 079.6 1.07 -107 0.999 2 0.215
), ArticleFig(id=1218484900177564092, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=表2, caption=

参麦颗粒中14个成分线性考察结果

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Compounds Regression equation linear range/ng·mL-1 r Limit of quantitation/ng·mL-1
Pseudoginsenoside F11 Y=750.13X-1 078.3 3.44 -344 0.999 3 0.688
Ginsenoside Rf Y=2 045.70X+3 466.8 3.55 -355 0.999 4 0.711
Ginsenoside Ro Y=969.21X+8 731.6 7.60 -760 0.999 3 1.520
Ginsenoside Rb1 Y=191.86X+11 919 41.59 -4 159 0.999 0 4.159
Ginsenoside Rg1 Y=2 760.40X+100 048 16 -1 600 0.999 1 1.600
Ginsenoside Re Y=736.52X+2 835.9 6.14 -614 0.999 4 0.614
Ginsenoside Rd Y=588.80X+3 450.8 6.16 -616 0.999 7 1.232
Ginsenoside Rb2 Y=182.57X-130.34 4.56 -456 0.999 8 4.560
Ginsenoside Rb3 Y=98.98X+32.622 2.81 -140 0.999 4 28.096
Ginsenoside Rg2 Y=5 834.50X+5 609.6 1.01 -101 0.999 8 0.101
Ginsenoside Rg3 Y=1 531.80X-529.84 2.80 -280 0.999 6 0.280
Ginsenoside Rc Y=319.29X+2 367.3 5.35 -535 0.999 5 1.071
Ginsenoside Rh1 Y=1 715.50X+5 0295 10 -1 000 0.998 5 0.200
Notoginsenoside R1 Y=1 949.90X-3 079.6 1.07 -107 0.999 2 0.215
), ArticleFig(id=1218484900299198912, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Tab.3, caption=

Recovery rate of 14 components in Shenmai granules

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Compounds m(Original)/ng m(Added)/ng m(Measured)/ng Recovery/% RSD/%
Pseudoginsenoside F11 8.383 9.632 18.190 102.1 1.1
Ginsenoside Rf 244.945 231.786 485.153 103.5 0.9
Ginsenoside Ro 809.044 779.000 1 604.999 102.5 1.6
Ginsenoside Rb1 472.663 476.922 966.907 103.5 1.8
Ginsenoside Rg1 81.301 73.618 157.222 103.1 1.9
Ginsenoside Re 89.632 86.083 179.036 102.3 1.8
Ginsenoside Rd 232.779 226.439 460.891 100.4 1.9
Ginsenoside Rb2 318.999 305.600 630.915 102.9 2.2
Ginsenoside Rb3 30.809 29.501 60.960 95.6 4.0
Ginsenoside Rg2 371.276 385.024 774.941 104.0 2.9
Ginsenoside Rg3 1 577.700 1 783.715 2 972.700 103.5 4.7
Ginsenoside Rc 268.326 262.326 537.057 102.0 2.4
Ginsenoside Rh1 124.582 126.330 257.460 105.0 0.4
Notoginsenoside R1 9.109 10.030 19.545 103.2 1.3
), ArticleFig(id=1218484900399862212, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=表3, caption=

参麦颗粒14个成分的回收率

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Compounds m(Original)/ng m(Added)/ng m(Measured)/ng Recovery/% RSD/%
Pseudoginsenoside F11 8.383 9.632 18.190 102.1 1.1
Ginsenoside Rf 244.945 231.786 485.153 103.5 0.9
Ginsenoside Ro 809.044 779.000 1 604.999 102.5 1.6
Ginsenoside Rb1 472.663 476.922 966.907 103.5 1.8
Ginsenoside Rg1 81.301 73.618 157.222 103.1 1.9
Ginsenoside Re 89.632 86.083 179.036 102.3 1.8
Ginsenoside Rd 232.779 226.439 460.891 100.4 1.9
Ginsenoside Rb2 318.999 305.600 630.915 102.9 2.2
Ginsenoside Rb3 30.809 29.501 60.960 95.6 4.0
Ginsenoside Rg2 371.276 385.024 774.941 104.0 2.9
Ginsenoside Rg3 1 577.700 1 783.715 2 972.700 103.5 4.7
Ginsenoside Rc 268.326 262.326 537.057 102.0 2.4
Ginsenoside Rh1 124.582 126.330 257.460 105.0 0.4
Notoginsenoside R1 9.109 10.030 19.545 103.2 1.3
), ArticleFig(id=1218484900508914121, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Tab.4, caption=

Analysis of the content of 14 components in Shenmai granules from various manufacturers. ng·g-1

, figureFileSmall=null, figureFileBig=null, tableContent=
Compounds A manufacturer(n=21) B manufacturer(n=21) C manufacturer(n=29)
Xmin Xmax X ¯ δ Xmin Xmax X ¯ δ Xmin Xmax X ¯ δ
Pseudoginsenoside F11 8 162 28 34 0 352 116 81 191 467 328 76
Ginsenoside Rf 32 250 113 61 37 1 174 401 212 16 43 29 7
Ginsenoside Ro 461 3 401 1 469 858 158 3 179 1 805 578 1 104 2 560 1 788 389
Ginsenoside Rb1 279 6 942 2 404 1 899 61 6 094 2 828 1 942 3 167 15 175 6 807 2 878
Ginsenoside Rg1 68 819 316 208 0 259 143 94 59 562 183 127
Ginsenoside Re 52 1 332 429 367 20 624 231 171 125 1 732 463 337
Ginsenoside Rd 86 3 635 1 196 1 032 84 2 265 1 105 698 152 2 679 681 534
Ginsenoside Rb2 43 2 345 871 767 26 2 665 1 014 700 280 1 204 647 239
Ginsenoside Rb3 4 294 89 83 0 375 160 120 55 230 151 52
Ginsenoside Rg2 333 1 379 760 274 244 3 680 852 808 268 946 661 157
Ginsenoside Rg3 804 4 741 2 664 1 075 845 187 53 3 714 4 542 800 4 055 2 252 741
Ginsenoside Rc 123 2 390 803 680 19 2 432 1 006 679 405 1415 946 307
Ginsenoside Rh1 208 520 362 92 69 556 183 117 106 298 216 45
Notoginsenoside R1 3 117 34 28 0 47 30 16 12 105 42 23
), ArticleFig(id=1218484900609577421, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=表4, caption=

参麦颗粒各厂家14个成分含量结果。ng·g-1

, figureFileSmall=null, figureFileBig=null, tableContent=
Compounds A manufacturer(n=21) B manufacturer(n=21) C manufacturer(n=29)
Xmin Xmax X ¯ δ Xmin Xmax X ¯ δ Xmin Xmax X ¯ δ
Pseudoginsenoside F11 8 162 28 34 0 352 116 81 191 467 328 76
Ginsenoside Rf 32 250 113 61 37 1 174 401 212 16 43 29 7
Ginsenoside Ro 461 3 401 1 469 858 158 3 179 1 805 578 1 104 2 560 1 788 389
Ginsenoside Rb1 279 6 942 2 404 1 899 61 6 094 2 828 1 942 3 167 15 175 6 807 2 878
Ginsenoside Rg1 68 819 316 208 0 259 143 94 59 562 183 127
Ginsenoside Re 52 1 332 429 367 20 624 231 171 125 1 732 463 337
Ginsenoside Rd 86 3 635 1 196 1 032 84 2 265 1 105 698 152 2 679 681 534
Ginsenoside Rb2 43 2 345 871 767 26 2 665 1 014 700 280 1 204 647 239
Ginsenoside Rb3 4 294 89 83 0 375 160 120 55 230 151 52
Ginsenoside Rg2 333 1 379 760 274 244 3 680 852 808 268 946 661 157
Ginsenoside Rg3 804 4 741 2 664 1 075 845 187 53 3 714 4 542 800 4 055 2 252 741
Ginsenoside Rc 123 2 390 803 680 19 2 432 1 006 679 405 1415 946 307
Ginsenoside Rh1 208 520 362 92 69 556 183 117 106 298 216 45
Notoginsenoside R1 3 117 34 28 0 47 30 16 12 105 42 23
), ArticleFig(id=1218484900727017937, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=EN, label=Tab.5, caption=

Information entropy and weight of each index component of Shenmai granules

, figureFileSmall=null, figureFileBig=null, tableContent=
Compounds Ej Wj/% Compounds Ej Wj/%
Pseudoginsenoside F11 0.965 4 4.17 Ginsenoside Rd 0.920 1 9.64
Notoginsenoside R1 0.988 3 1.40 Ginsenoside Rb2 0.939 5 7.29
Ginsenoside Rf 0.859 7 16.91 Ginsenoside Rb3 0.946 4 6.46
Ginsenoside Ro 0.980 0 2.41 Ginsenoside Rg2 0.941 2 7.09
Ginsenoside Rb1 0.940 5 7.18 Ginsenoside Rg3 0.906 2 11.30
Ginsenoside Rg1 0.943 1 6.86 Ginsenoside Rc 0.953 6 5.59
Ginsenoside Re 0.929 9 8.45 Ginsenoside Rh1 0.956 6 5.24
), ArticleFig(id=1218484900928344532, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1218290944638632928, language=CN, label=表5, caption=

参麦颗粒样品各指标成分信息熵及权重

, figureFileSmall=null, figureFileBig=null, tableContent=
Compounds Ej Wj/% Compounds Ej Wj/%
Pseudoginsenoside F11 0.965 4 4.17 Ginsenoside Rd 0.920 1 9.64
Notoginsenoside R1 0.988 3 1.40 Ginsenoside Rb2 0.939 5 7.29
Ginsenoside Rf 0.859 7 16.91 Ginsenoside Rb3 0.946 4 6.46
Ginsenoside Ro 0.980 0 2.41 Ginsenoside Rg2 0.941 2 7.09
Ginsenoside Rb1 0.940 5 7.18 Ginsenoside Rg3 0.906 2 11.30
Ginsenoside Rg1 0.943 1 6.86 Ginsenoside Rc 0.953 6 5.59
Ginsenoside Re 0.929 9 8.45 Ginsenoside Rh1 0.956 6 5.24
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UPLC-MS/MS法测定红参多指标成分分析结合化学计量学和熵权优劣解距离法评价参麦颗粒质量
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刘亚茹 1, 2 , 雷蓉 2, * , 苏建 2 , 刘永利 1, 2, *
中国药学杂志 | 论著 2024,59(15): 1445-1452
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中国药学杂志 | 论著 2024, 59(15): 1445-1452
UPLC-MS/MS法测定红参多指标成分分析结合化学计量学和熵权优劣解距离法评价参麦颗粒质量
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刘亚茹1, 2, 雷蓉2, *, 苏建2, 刘永利1, 2, *
作者信息
  • 1 河北医科大学, 石家庄 050017
  • 2 河北省药品医疗器械检验研究院, 河北省中药质量评价与标准研究重点实验室, 石家庄 050227
  • 刘亚茹,女,硕士研究生 研究方向:药物分析

通讯作者:

* 雷蓉,女,硕士,高级工程师 研究方向:中药质量控制方法与质量评价 Tel:(0311)85212007-8042;
刘永利,男,硕士,硕士生导师 研究方向:中药质量控制方法与质量评价 Tel:(0311)69086006
UPLC-MS/MS Multi-Index Component Analysis of Red Ginseng Combined with Chemometrics and EW-TOPSIS Method to Evaluate the Quality of Shenmai Granules
Yaru LIU1, 2, Rong LEI2, *, Jian SU2, Yongli LIU1, 2, *
Affiliations
  • 1 Hebei Medical University, Shijiazhuang 050017, China
  • 2 Hebei Key Laboratory for Quality Evaluation and Standard of Traditional Chinese Medicine, Hebei Institute for Drug and Medical Device Control, Shijiazhuang 050227, China
出版时间: 2024-08-08 doi: 10.11669/cpj.2024.15.012
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目的 建立超高效液相色谱-串联质谱(UPLC-MS/MS)法同时测定参麦颗粒中14个成分含量的方法,分析不同厂家红参投料的质量差异。方法 采用Shimadzu Shim-pack gist C18(2.1 mm×100 mm,2 μm)色谱柱,以乙腈和水为流动相,同时测定71批参麦颗粒中14个皂苷类成分的含量,结合化学计量学分析影响参麦颗粒中红参投料差异的主要物质基础,并运用熵权优劣解距离法(EW-TOPSIS)对不同厂家参麦颗粒红参投料质量进行优劣性评价。结果 14个成分在一定浓度范围内与峰面积呈良好线性关系(r≥0.998 5);平均加样回收率范围均为95.6%~105.0%[相对标准偏差(RSD)<4.7%];经化学计量学以及熵权优劣解距离法分析可知,3个厂家生产的样品分别聚为3类,其中B厂家投入红参质量整体较好,C厂家红参投料存在掺伪现象。结论 该方法特异、灵敏、高效、可靠,可用于参麦颗粒的质量控制。

参麦颗粒  /  红参  /  质量评价  /  化学计量学  /  熵权优劣解距离法

OBJECTIVE To establish a UPLC-MS/MS method for simultaneous determination of 14 components in Shenmai granules, and analyze the quality differences of red ginseng feed from different manufacturers. METHODS Shimadzu Shim-pack gist C18(2.1 mm×100 mm,2 μm) chromatographic column with acetonitrile-water as the mobile phase were used to determine the contents of 14 saponin components in 71 batches of Shenmai Granules. And then analyzed the main material basis affecting the difference in red ginseng feeding in Shenmai granules combined with chemometrics and evaluated the quality of red ginseng feeding in Shenmai granules from different manufacturers combined with EW-TOPSIS. RESULTS The concentrations of 14 components had a good linear relationship (r≥0.998 5); and the average recovery rate was 95.6%-105.0%(RSD<4.7%). According to the analysis of chemometrics and EW-TOPSIS, the samples produced by the three manufacturers were grouped into three categories, among which the quality of red ginseng feeding by manufacturer B was generally good, and the red ginseng feeding by manufacturer C was adulterated. CONCLUSION This method is specific, sensitive, efficient, and reliable, and can be used for the quality control of Shenmai granules.

Shenmai granule  /  red ginseng  /  quality evaluation  /  chemometrics  /  EW-TOPSIS
刘亚茹, 雷蓉, 苏建, 刘永利. UPLC-MS/MS法测定红参多指标成分分析结合化学计量学和熵权优劣解距离法评价参麦颗粒质量. 中国药学杂志, 2024 , 59 (15) : 1445 -1452 . DOI: 10.11669/cpj.2024.15.012
Yaru LIU, Rong LEI, Jian SU, Yongli LIU. UPLC-MS/MS Multi-Index Component Analysis of Red Ginseng Combined with Chemometrics and EW-TOPSIS Method to Evaluate the Quality of Shenmai Granules[J]. Chinese Pharmaceutical Journal, 2024 , 59 (15) : 1445 -1452 . DOI: 10.11669/cpj.2024.15.012
参麦颗粒是由红参、麦冬、南沙参、黄精、山药和枸杞子6味组成的中成药,具有养阴生津的功效,主要用于面黄肌瘦、津少口渴、腰膝酸软、食欲不振、头晕眼花,心悸气短、神经衰弱等疾病的治疗[1]。参麦颗粒收载于中药成方制剂第十三册,原质量标准较为简单,仅有性状、理化鉴别和检查项,无法满足质量监管需求。文献报道中,仅Tao等[2]采用高效液相色谱法(HPLC)波长切换法同时测定参麦颗粒中尿囊素、原儿茶醛、儿茶素、表儿茶素、麦冬甲基黄烷酮A和甲基麦冬二氢高异黄酮B 6种成分的含量,并未控制方中红参的质量,而红参为方中君药,具有大补元气、复脉固脱、益气摄血的功效[3-5],且现市场上存在人参投料掺伪西洋参及其边角料的现象[6-10]。为进一步有效控制参麦颗粒中红参的质量,同时考察红参中是否也存在西洋参掺伪投料情况,本研究通过运用超高效液相色谱-串联质谱(UPLC-MS/MS)法测定参麦颗粒中拟人参皂苷F11、人参皂苷Rf、Ro、Rb1、Rg1、Re、Rd、Rb2、Rb3、Rg2、Rg3、Rc、Rh1、三七皂苷R1等14个皂苷类成分的含量,其中拟人参皂苷F11为西洋参中特征性成分,结合化学计量学和熵权优劣解距离法分析不同厂家红参投料的质量差异及优劣,为参麦颗粒的质量评价与控制提供依据。
AB SCIEX Triple Quad 6500型高效液相色谱-质谱联用仪,Analyst 1.6.3工作站(美国AB SCIEX公司);XPE26型电子天平(0.001 mg)、XS105DU型电子天平(0.01 mg)(瑞士Mettler-Toledo公司);KQ-500DE型超声波清洗器(昆山超声仪器有限公司);Agilent Bond Elut C18柱(500 mg,6 mL,美国Agilent公司)。
对照品拟人参皂苷F11(批号:110841-201607,纯度99.5%)、人参皂苷Ro(批号:111903-202106,纯度95.0%)、人参皂苷Rb1(批号:110704-202028,纯度93.1%)、人参皂苷Rg1(批号:110703-202034,纯度94.0%)、人参皂苷Re(批号:110754-202028,纯度93.9%)、人参皂苷Rd(批号:111818-202104,纯度97.3%)、人参皂苷Rb2(批号:111715-201203,纯度93.8%)、人参皂苷Rb3(批号:111686-201504,纯度97.0%)、20(S)-人参皂苷Rg2(批号:111779-200801)、人参皂苷Rg3(批号:110804-201504,纯度99.5%)、三七皂苷R1(批号:110745-201619,纯度95.0%)(中国食品药品检定研究院),人参皂苷Rc(纯度HPLC≥98%)、人参皂苷Rh1(纯度HPLC≥98%)、人参皂苷Rf(纯度HPLC≥98%)(上海抚生实业有限公司);乙腈为色谱纯;水为屈臣氏饮用水。
71批次参麦颗粒样品抽自全国各地经营、使用单位,涉及3个厂家,其中A厂家样品21批次(S1~S21),B厂家样品21批次(S22~S42),C厂家样品29批(S43~S71)。
采用Shimadzu Shim-pack gist C18(2.1 mm×100 mm,2 μm)色谱柱,以乙腈为流动相A,水为流动相B,梯度洗脱(0~2 min,20%→33%A;2~10 min,33%→37%A;10~17 min,37%→80%A;17~20 min,80%→90%A;20.1~25 min,20%A),流速为0.35 mL·min-1,柱温40 ℃,进样量为5 μL。
采用电喷雾离子源(ESI),负离子模式下多反应离子监测(MRM),喷雾电压-4 500 V,辅助气1(N2)5.0×105 Pa,辅助气2(N2)5.0×105 Pa,辅助气加热温度500 ℃,气帘气3.7×104 Pa,碰撞气(N2)0.41×105 Pa。各成分的质谱参数见表1,MRM图谱见图1
精密称取各对照品适量,分别置于100 mL量瓶中,加入甲醇定容,配制各对照品储备液(拟人参皂苷F11 34.4 μg·mL-1、人参皂苷Rf 35.55 μg·mL-1、人参皂苷Rb136.78 μg·mL-1、人参皂苷Rg1 37.56 μg·mL-1、人参皂苷Re 36.98 μg·mL-1、人参皂苷Rd 38.51 μg·mL-1、人参皂苷Rb2 38.01 μg·mL-1、人参皂苷Rb3 35.12 μg·mL-1、人参皂苷Rg2 38.97 μg·mL-1、人参皂苷Rc 33.46 μg·mL-1、人参皂苷Rh1 42.11 μg·mL-1、三七皂苷R1 35.82 μg·mL-1);精密称取人参皂苷Rg3和人参皂苷Ro对照品适量,分别置于250和50 mL量瓶中,加甲醇定容,配制人参皂苷Rg3储备液 (17.508 μg·mL-1)和人参皂苷Ro(95 μg·mL-1)。分别取上述各对照品储备液适量,置于同一50 mL量瓶,用甲醇配制成含拟人参皂苷F11 344 ng·mL-1、人参皂苷Rf 355 ng·mL-1、人参皂苷Rb1 4 159 ng·mL-1、人参皂苷Rg1 1 600 ng·mL-1、人参皂苷Re 614 ng·mL-1、人参皂苷Rd 616 ng·mL-1、人参皂苷Rb2456 ng·mL-1、人参皂苷Rb3 140 ng·mL-1、人参皂苷Rg2 101.322 ng·mL-1、人参皂苷Rc 535 ng·mL-1、人参皂苷Rh1 1 000 ng·mL-1、三七皂苷R1 107.46 ng·mL-1、人参皂苷Rg3 280 ng·mL-1、人参皂苷Ro 760 ng·mL-1的混合对照品溶液。
取本品约2.0 g,研细,精密称定,置具塞锥形瓶中,精密加入水20 mL,密塞,超声处理(功率700 W,频率80 kHz)30 min,取出,放冷,滤过,取续滤液10 mL,加在C18固相萃取小柱(500 mg,容量为6 mL,预先用甲醇6 mL、水6 mL洗脱)上,用水15 mL洗脱,放置5 min,继用甲醇15 mL洗脱,收集洗脱液,置蒸发皿中蒸干,残渣加甲醇溶解并转移至5 mL量瓶中,加甲醇稀释至刻度,用0.22 μm滤膜滤过,即得。
精密吸取混合对照品溶液适量,按倍率稀释法用甲醇稀释配制成一系列6个浓度的混合对照品溶液,按“2.1”和“2.2”项下条件进行分析。以色谱峰面积Y为纵坐标,对照品质量浓度X为横坐标,绘制标准曲线。回归方程、线性范围结果见表2。结果表明,各成分在各自浓度范围内线性关系良好。配制混合对照品溶液,逐级稀释后进样测定,以信噪比(S/N)=10时的对照品质量浓度为各分析物的定量限,结果见表2
取“2.3.1”项下混合对照品储备液6份,按“2.1”和“2.2”项下条件进行分析,测得拟人参皂苷F11、人参皂苷Rf、Ro、Rb1、Rg1、Re、Rd、Rb2、Rb3、Rg2、Rg3、Rc、Rh1及三七皂苷R1峰面积的相对标准偏差(RSD)值分别为2.0%、1.5%、1.9%、2.8%、3.3%、3.6%、2.2%、2.3%、2.9%、1.7%、1.8%、2.2%、2.6%、2.5%,表明仪器精密度良好。
称取参麦颗粒(S2)6份,分别按“2.3.2”项下方法制备供试品溶液,按“2.1”和“2.2”项下条件进行分析,测得拟人参皂苷F11、人参皂苷Rf、Ro、Rb1、Rg1、Re、Rd、Rb2、Rb3、Rg2、Rg3、Rc、Rh1及三七皂苷R1的平均含量分别为16.398、488.326、1 600.800、942.311、160.864、178.691、455.358、631.181、61.017、726.282、3124.934、525.894、248.370、18.023 ng·g-1,RSD分别为2.3%、3.5%、2.8%、3.9%、4.0%、3.5%、3.3%、2.3%、1.9%、3.1%、2.2%、3.8%、3.2%、2.9%,表明本方法重复性好。
取“2.3.2”项下供试品溶液(S2),分别于0、4、8、12、24 h进行测定,结果拟人参皂苷F11、人参皂苷Rf、Ro、Rb1、Rg1、Re、Rd、Rb2、Rb3、Rg2、Rg3、Rc、Rh1及三七皂苷R1的色谱峰面积的RSD分别为2.1%、2.9%、3.1%、2.4%、1.7%、2.1%、2.9%、2.5%、3.8%、1.9%、1.4%、1.9%、1.4%、1.8%,表明供试品溶液在24 h内稳定性良好。
精密称取已知含量的参麦颗粒样品(S2)6份,每份约1.0 g,加入各对照储备液适量,按“2.3.2”项下方法制备所需溶液,进样分析,计算回收率及其RSD,结果见表3
71批次的参麦颗粒样品,按“2.3.2”项下方法制备供试品溶液,按“2.1”和“2.2”项下条件进行分析,运用线性回归方程计算样品含量,各厂家样品结果见表4
将参麦颗粒14种皂苷类成分的含量参数导入OriginPro 2021软件进行系统聚类分析(HCA),结果见图2。由图可知,当相对聚类距离为0.85时,71批样品按厂家分别聚为3类,聚类效果明显,表明3个厂家样品的皂苷类成分的含量有明显区别,其中S22样品单独聚为1类,差异性较大,结合14种皂苷类成分含量进行分析,可能是由于人参皂苷Rf、Rg2、Rg3 3种成分含量较高所致[11]
为了进一步筛选对不同生产厂家参麦颗粒样品质量影响较大的成分,以14种皂苷类成分的含量为变量,利用SIMCA14.1软件建立OPLS-DA模型,模型参数为 R X c u m 2为0.69, R Y c u m 2为0.973, Q c u m 2为0.966[12]。3个企业的样品按企业聚类明显,见图3D,S22样品产生偏离,其结果与聚类分析结果一致。筛选出5个VIP值>1的差异性成分,见图3E,分别为拟人参皂苷F11、人参皂苷Rf、人参皂苷Rh1、人参皂苷Rb1、人参皂苷Rg1。由Loading图可知(图3F),成分点距离原点越远表明该成分对样品的差异性贡献越大,A、B、C 3个企业分别以人参皂苷Rh1、人参皂苷Rf、拟人参皂苷F11得到区分,因此人参皂苷Rh1、人参皂苷Rf、拟人参皂苷F11 3个成分的含量差异是导致不同企业产生差异性的主要因素。为防止模型出现过拟合,通过200次置换检验对模型内部进行验证,结果见图3G,Q2回归线的截距为-0.217(<0),证明模型稳定可靠,不存在过拟合,可以用于不同企业参麦颗粒样品的分析。
现市场上存在用西洋参或其边角料替代人参投料的现象,在研究过程中从参麦颗粒样品中检出了拟人参皂苷F11,并且不同生产厂家的样品中拟人参皂苷F11有明显差别,为了评价不同企业红参投料是否存在掺伪现象,需选用合适的指标成分进行分析。通过上述分析可知人参皂苷Rh1、人参皂苷Rf、拟人参皂苷F11 3个成分的含量差异是导致不同企业样品差异性的主要因素,据文献报道,人参、西洋参在蒸制阶段,原人参三醇型皂苷(如Re、Rg1等)脱去C-20位糖基,水解生成Rg2和Rh1;原人参二醇型皂苷(如Rb1、Rd等)则生成Rg3,故人参皂苷Rh1不能作为评价指标,而拟人参皂苷F11是西洋参中的特征性成分,人参皂苷Rf是人参中的特征性成分[13-17],也是不同企业生产样品的差异性成分,因此选用拟人参皂苷F11、人参皂苷Rf两个成分评价不同企业投料用红参的质量,并同时评价是否存在掺伪投料问题。利用OriginPro 2021软件,以拟人参皂苷F11含量为横坐标,人参皂苷Rf的含量为纵坐标,作组边际图,见图4。由图4可知,厂家B各批次样品中人参皂苷Rf的含量普遍较高,红参投料质量整体较好,但各批次间的差异性较大;厂家C中人参皂苷Rf的含量最低,拟人参皂苷F11含量最高,存在红参投料掺伪西洋参的可能;厂家A中人参皂苷Rf和拟人参皂苷F11含量均低,存在红参掺伪投料的情况低,但可能存在红参投料不足或质量较差的嫌疑。
为了评价参麦颗粒样品中红参投料的质量差异,以14种成分为指标进行分析。其中人参皂苷Rf、Ro、Rb1、Rg1、Re、Rd、Rb2、Rb3、Rg2、Rg3、Rc、Rh1这12种成分属于越大越优型指标,为正向指标。拟人参皂苷F11、三七皂苷R1属于越小越优型指标,为逆向指标。正向指标根据公式1进行正向化处理,逆向指标根据公式2进行逆向化处理。xij为原始含量数据,XijYij分别为经正向化处理和逆向化处理后的数据;max(xj)和min(xj)分别为各成分含量数据的最大值和最小值。
Xij=[xij-min(xj)]/[max(xj)-min(xj)]
Yij=[max(xj)-xij]/[max(xj)-min(xj)]
据信息论中信息熵的定义,按公式3计算一组数据的信息熵(Ej),依据各指标成分的信息熵,按公式4计算各指标成分的权重(Wj),结果见表5。信息熵反映了指标的离散程度,熵越大,指标的离散程度越小,指标对于决策的重要值,即权重越小。
Ej=-ln(n)-1pijlnpij
Wj=(1-Ej)/(k-∑Ej)
式中,pij为第j项指标下第i个样本值所占比重;若pij=0,则定义lnpij=0;k为指标个数;n为样本量。
按公式5将同向化矩阵X ij(i=1,2,……n;j=1,2,……m;n=71,m=14)归一化得到矩阵Zij,再按公式6熵权化得到加权标准矩阵Vij[18]。确定标准矩阵Vij的正理想解 V j +和负理想解 V j -,按公式7~9计算评价对象与正理想解、负理想解的欧氏距离D+,D-以及各评价对象与最优解的相对贴近程度CijCij表示评价对象与最优方案的接近程度,该值越大说明越接近最优方案,根据Cij的大小进行排序,评价71批次参麦颗粒样品的优劣。利用OriginPro 2021软件,以Cij大小为指标作箱线图(图5),纵坐标为名次,由图5可知,厂家C整体排名靠后,红参投料质量差,厂家B的排名靠前,红参投料质量较好。
Zij=Xij/ Σ j = 1 m X i j 2
Vij=XijWj
D+=   j = 1 m ( V i j - V j + ) 2
D-=   j = 1 m ( V i j - V j - ) 2
Cij= D - D - + D +
人参皂苷Rf、拟人参皂苷F11分别为红参、西洋参中特征性成分,这两种指标可以科学评价红参投料是否存在掺伪西洋参的嫌疑,但对于红参投料质量优劣的整体评价还应综合考察红参中主要活性成分。人参高温蒸制为红参过程会造成人参中皂苷类成分的糖苷键以及酯键断裂,从而产生某些特有皂苷,比如人参皂苷Rh2等,还会导致人参皂苷Rb1、人参皂苷Rc、人参皂苷Rd等皂苷类成分含量增加[19-20],人参皂苷为红参的主要活性成分,含量越高,红参药理活性越强,红参质量越好。而拟人参皂苷F11、三七皂苷R1分别为西洋参和三七中的特征性成分,红参中含量越低则红参质量越好,本研究建立了红参中14种成分的含量测定方法,其中12种成分为越大越优型指标,2种成分为越小越优型指标,通过测定14种成分含量可以科学评价红参质量。
参麦颗粒由6味药及辅料蔗糖经工艺提取所制,辅料蔗糖的用量占比较大,因此对参麦颗粒主要药效成分的提取有较高要求。本实验先后考察了回流提取、萃取以及大孔吸附树脂等方法,发现经回流提取后溶液中仍存在较多糖,萃取乳化现象较为严重,后续又考察了通过固相萃取柱进行洗脱,发现该方法提取较为完全,操作简便,可以将大部分糖类成分洗脱去除。本实验还考察了不同品牌、不同规格的固相萃取柱,包括Agilent Bond Elut C18(500 mg,6 mL),Waters Sep-Pak Vac 6cc C18(500 mg),Waters Sep-Pak Vac 6cc C18(1 g),发现Agilent Bond Elut C18(500 mg,6 mL)固相萃取柱提取样品较为完全,可以使被测组分得到较好的分离,并且不会出现超载现象。
实验考察了乙腈-水、乙腈-甲酸水、乙腈-甲醇-甲酸水等流动相体系,结果发现使用乙腈-水作为流动相的分离效果好,所得的峰形好,因此选用乙腈-水作流动相。
系统聚类分析结果显示,3个厂家均以14种成分含量为依据分别聚为3类,表明3个厂家的14种成分含量有区别,即不同厂家间红参投料质量一致性差;进一步通过OPLS-DA分析造成不同厂家红参质量差异的主要成分,从而判断红参投料是否掺伪西洋参,结果表明厂家B掺伪嫌疑较小,厂家C掺伪嫌疑较大,厂家A可能存在红参投料不足或质量较差的嫌疑。最后结合熵权优劣解距离法整体评价红参质量,B厂家红参质量较好且各批次间质量较为一致,而C厂家红参质量较差,A厂家各批次间质量一致性较差。
本实验采用HCA、OPLS-DA等化学计量学方法对3个厂家71批参麦颗粒红参中14种成分含量测定结果进行了综合分析,结果显示同一厂家样品质量较为稳定,不同企业间产品质量差异明显,引起企业间差异性成分为人参皂苷Rh1、人参皂苷Rf、拟人参皂苷F11,提示某些样品存在红参掺伪西洋参投料问题,最终选择人参皂苷Rf为指标评价各企业的投料用红参的质量,提示有些企业存在红参投料不足的问题,同时所建立的熵权-优劣解距离法(EW-TOPSIS)法可对不同企业不同批次的产品质量优劣进行综合评价,为提升其整体质量提供了参考依据。
  • 中药有效性安全性评价及全过程质量控制研究项目(NMPAJGKX-2023-024)
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2024年第59卷第15期
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doi: 10.11669/cpj.2024.15.012
  • 接收时间:2024-06-30
  • 首发时间:2026-01-14
  • 出版时间:2024-08-08
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  • 收稿日期:2024-06-30
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中药有效性安全性评价及全过程质量控制研究项目(NMPAJGKX-2023-024)
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    1 河北医科大学, 石家庄 050017
    2 河北省药品医疗器械检验研究院, 河北省中药质量评价与标准研究重点实验室, 石家庄 050227

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* 雷蓉,女,硕士,高级工程师 研究方向:中药质量控制方法与质量评价 Tel:(0311)85212007-8042;
刘永利,男,硕士,硕士生导师 研究方向:中药质量控制方法与质量评价 Tel:(0311)69086006
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2种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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
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