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Article(id=1195664142444053106, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195664138694341616, articleNumber=1001-2494(2024)02-0128-08, orderNo=null, doi=10.11669/cpj.2024.02.004, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1662566400000, receivedDateStr=2022-09-08, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1762998145924, onlineDateStr=2025-11-13, pubDate=1705852800000, pubDateStr=2024-01-22, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1762998145924, onlineIssueDateStr=2025-11-13, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1762998145924, creator=13701087609, updateTime=1762998145924, updator=13701087609, issue=Issue{id=1195664138694341616, tenantId=1146029695717560320, journalId=1190317699101192196, year='2024', volume='59', issue='2', pageStart='101', pageEnd='190', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1762998145030, creator=13701087609, updateTime=1762998511460, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1195665675697045692, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195664138694341616, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1195665675701239997, tenantId=1146029695717560320, journalId=1190317699101192196, issueId=1195664138694341616, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=128, endPage=135, ext={EN=ArticleExt(id=1195664142687322739, articleId=1195664142444053106, tenantId=1146029695717560320, journalId=1190317699101192196, language=EN, title=Quality Value Transfer of Substance Benchmarks in Qianghuo Shengshi Decoction, columnId=null, journalTitle=Chinese Pharmaceutical Journal, columnName=null, runingTitle=null, highlight=null, articleAbstract=

OBJECTIVE To establish the fingerprint of the substance benchmark of Qianghuo shengshi decoction (QSD) and the determination method of multi-index composition content, study the transfer rule of the substance benchmark value of QSD, and provide a scientific basis for the subsequent development of QSD and quality control evaluation. METHODS Fifteen batches of QSD substance benchmark samples were prepared according to the method recorded in ancient medical books, and their fingerprint was established and evaluated, its characteristic peaks was clarified and assigned to the characteristic peaks, and we complete the content determination and transfer rate calculation of the 8 index components in the QSD substance benchmark. RESULTS The similarity of the fingerprint of 15 batches of QSD substance benchmark was between 0.882 and 0.938. A total of 24 common peaks were identified, and 8 common peaks were identified as chlorogenic acid, prim-O-glucosylcimifugin, ferulic acid, senkyunolide I, 5-O-methylvisammioside, ammonium glycyrrhizinate, notopterygol, osthole. The paste yield of 15 batches of QSD was 22.54%-29.92%, and the average paste transfer rate was 70.69%. The content and average transfer rate of each index component from decoction pieces to substance benchmarks were 0.077 2%-0.106 6% and 128.05% for chlorogenic acid,prim-O-glucosylcimifugin 0.015 5%-0.023 8% and 120.26%, ferulic acid 0.047 5%-0.076 0% and 114.49%, senkyunolide I 0.006 6%-0.008 9% and 132.93%, 5-O-methylvisammioside 0.007 2%-0.009 9% and 90.27%, ammonium glycyrrhizinate 0.181 6%-0.273 5% and 80.53%, notopterygol 0.000 7%-0.001 3% and 50.97%, osthole 0.000 9%-0.002 2% and 13.67%. CONCLUSION In this experiment, a combination of fingerprint, paste yield and multi-index composition content determination could be used to analysis the transfer rate of QSD decoction pieces to substance benchmarks, and provide a method reference for the quality control and subsequent development of this prescription.

, correspAuthors=ZHAO Feng, TIAN Huan, 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=QI Qingrui, ZHAI Bingtao, YUE Baosen, ZHAO Feng, TIAN Huan), CN=ArticleExt(id=1195664283959870297, articleId=1195664142444053106, tenantId=1146029695717560320, journalId=1190317699101192196, language=CN, title=羌活胜湿汤物质基准量值传递分析, columnId=1190352405612040510, journalTitle=中国药学杂志, columnName=论著, runingTitle=null, highlight=null, articleAbstract=

目的 建立羌活胜湿汤(Qianghuo Shengshi decoction,QSD)物质基准的指纹图谱及多指标成分含量测定方法,研究QSD物质基准量值传递规律,为QSD后续开发及质量控制评价提供依据。方法 依据古籍记载制备15批QSD物质基准样品溶液,测定其出膏率,建立指纹图谱并进行相似度评价,明确特征峰及特征峰归属,完成QSD物质基准中8个指标成分的含量测定及饮片-物质基准量值传递分析。结果 15 批QSD物质基准指纹图谱相似度处于0.882~0.938之间,共确定24个共有峰,并指认出8个共有峰分别为绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素。15批QSD物质基准的出膏率为22.54%~29.92%,平均出膏转移率为70.69%。各指标性成分的含量及饮片-基准样品的平均转移率分别为绿原酸0.077 2%~0.106 6%和128.05%;升麻素苷0.015 5%~0.023 8%和120.26%;阿魏酸0.047 5%~0.076 0%和114.49%;洋川芎内脂Ⅰ 0.006 6%~0.008 9%和132.93%;5-O-甲基维斯阿米醇苷0.007 2%~0.009 9%和90.27%;甘草酸铵0.181 6%~0.273 5%和80.53%;羌活醇0.000 7%~0.001 3%和50.97%;蛇床子素0.000 9%~0.002 2%和13.67%。结论 本实验采用指纹图谱、出膏率及多指标成分含量测定相结合的方法,对QSD饮片-物质基准的全过程进行量值传递分析,为该方的质量控制及复方制剂的开发提供参考。

, correspAuthors=赵锋, 田欢, authorNote=null, correspAuthorsNote=
*赵锋,男,主任中药师,硕士生导师 研究方向:临床中药学及中药复方物质基准研究 Tel:(029)89626683;
田欢,女,中药师 研究方向:临床中药学及中药复方物质基准研究 Tel:(029)89626635
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祁庆瑞,女,硕士研究生 研究方向:临床中药学及中药制剂新剂型研究

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祁庆瑞,女,硕士研究生 研究方向:临床中药学及中药制剂新剂型研究

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祁庆瑞,女,硕士研究生 研究方向:临床中药学及中药制剂新剂型研究

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1-chlorogenic acid; 3-prim-O-glucosylcimifugin; 4-ferulic acid; 6-serotonin Ⅰ; 7-5-O-methylvisammioside; 20-ammonium glycyrrhetate; 23-notopterol; 24-osthol;2,5,8-19,21-22-unknow peaks.

, figureFileSmall=pKfuCMQ75OA2kPeVVigBng==, figureFileBig=vPFS1PpD59ef/T3yAgKijQ==, tableContent=null), ArticleFig(id=1197098037714662100, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=CN, label=图2, caption=混合对照品(A)及QSD基准样品(B)的HPLC指纹图谱

1-绿原酸;3-升麻素苷;4-阿魏酸;6-洋川芎内酯Ⅰ;7-5-O-甲基维斯阿米醇苷;20-甘草酸铵;23-羌活醇;24-蛇床子素;2,5,8~19,21~22-未知峰。

, figureFileSmall=pKfuCMQ75OA2kPeVVigBng==, figureFileBig=vPFS1PpD59ef/T3yAgKijQ==, tableContent=null), ArticleFig(id=1197098037781770965, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=EN, label=Fig.3, caption=HPLC characteristic chromatograms of single medicinal materials and negative medicinal materials for QSD substances, figureFileSmall=PafS7KBDB7QuEVvLbW5PRA==, figureFileBig=jdTzJCLLo3qyoOCir+wcMw==, tableContent=null), ArticleFig(id=1197098037840491222, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=CN, label=图3, caption=QSD物质基准单味药材及阴性药材HPLC指纹图谱, figureFileSmall=PafS7KBDB7QuEVvLbW5PRA==, figureFileBig=jdTzJCLLo3qyoOCir+wcMw==, tableContent=null), ArticleFig(id=1197098037907600087, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=EN, label=Tab.1, caption=

Origin information of 15 batches of decoction pieces of QSD

, figureFileSmall=null, figureFileBig=null, tableContent=
No. Notopterygii
Rhizoma Et Radix
(in Chinese)		 Angelicae
Pubescentis
Radix (in Chinese)		 Saposhnikoviae
Radix
(in Chinese)		 Chuanxiong
Rhizoma
(in Chinese)		 Ligustici Rhizoma
Et Radix
(in Chinese)		 Viticis
Fructus
(in Chinese)		 Glycyrrhizae Radix Et
Rhizoma Praeparata
Cum Melle (in Chinese)
S1 Sichuan Aba Prefecture
(四川阿坝州)		 Sichuan Jinyang
(四川锦阳)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Dujiangyan
(四川都江堰)		 Shannxi Shangluo
(陕西商洛)		 Zhejiang Jinhua
(浙江金华)		 Gansu Minqin
(甘肃民勤)
S2 Gansu Wuwei
(甘肃武威)		 Sichuan Jinyang
(四川锦阳)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S3 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Xinbalhu Banner
(新巴尔虎旗)		 Sichuan Pengshan
(四川彭山)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S4 Gansu Wuwei
(甘肃武威)		 Hubei Badong
(湖北巴东)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Shifang
(四川什邡)		 Shannxi Shangluo
(陕西商洛)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S5 Gansu Wuwei
(甘肃武威)		 Gansu Pingliang
(甘肃平凉)		 Arun Banner
(阿荣旗)		 Sichuan Dujiangyan
(四川都江堰)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Jinhua
(浙江金华)		 Gansu Minqin
(甘肃民勤)
S6 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Liaoning Haizhou
(辽宁海州)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S7 Qinghai Qilian
(青海祁连)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S8 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Xinbalhu Banner
(新巴尔虎旗)		 Sichuan Dujiangyan
(四川都江堰)		 Liaoning Haizhou
(辽宁海州)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S9 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Dujiangyan
(四川都江堰)		 Liaoning Haizhou
(辽宁海州)		 Guangxi Guigang
(广西贵港)		 Shannxi Yulin
(陕西榆林)
S10 Qinghai Qilian
(青海祁连)		 Gansu Pingliang
(甘肃平凉)		 Arun Banner
(阿荣旗)		 Sichuan Dujiangyan
(四川都江堰)		 Shannxi Shangluo
(陕西商洛)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S11 Gansu Wuwei
(甘肃武威)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Guangxi Guigang
(广西贵港)		 Shannxi Yulin
(陕西榆林)
S12 Sichuan Aba Prefecture
(四川阿坝州)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S13 Qinghai Qilian
(青海祁连)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Guangxi Guigang
(广西贵港)		 Gansu Minqin
(甘肃民勤)
S14 Sichuan Aba Prefecture
(四川阿坝州)		 Gansu Pingliang
(甘肃平凉)		 Xinbalhu Banner
(新巴尔虎旗)		 Sichuan Shifang
(四川什邡)		 Shannxi Shangluo
(陕西商洛)		 Zhejiang Jinhua
(浙江金华)		 Gansu Minqin
(甘肃民勤)
S15 Gansu Wuwei
(甘肃武威)		 Hubei Badong
(湖北巴东)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Shifang
(四川什邡)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Jinhua
(浙江金华)		 Xinjiang Bachu
(新疆巴楚)
), ArticleFig(id=1197098037978903256, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=CN, label=表1, caption=

15批羌活胜湿汤(QSD)物质基准样品中各饮片的产地信息

, figureFileSmall=null, figureFileBig=null, tableContent=
No. Notopterygii
Rhizoma Et Radix
(in Chinese)		 Angelicae
Pubescentis
Radix (in Chinese)		 Saposhnikoviae
Radix
(in Chinese)		 Chuanxiong
Rhizoma
(in Chinese)		 Ligustici Rhizoma
Et Radix
(in Chinese)		 Viticis
Fructus
(in Chinese)		 Glycyrrhizae Radix Et
Rhizoma Praeparata
Cum Melle (in Chinese)
S1 Sichuan Aba Prefecture
(四川阿坝州)		 Sichuan Jinyang
(四川锦阳)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Dujiangyan
(四川都江堰)		 Shannxi Shangluo
(陕西商洛)		 Zhejiang Jinhua
(浙江金华)		 Gansu Minqin
(甘肃民勤)
S2 Gansu Wuwei
(甘肃武威)		 Sichuan Jinyang
(四川锦阳)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S3 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Xinbalhu Banner
(新巴尔虎旗)		 Sichuan Pengshan
(四川彭山)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S4 Gansu Wuwei
(甘肃武威)		 Hubei Badong
(湖北巴东)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Shifang
(四川什邡)		 Shannxi Shangluo
(陕西商洛)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S5 Gansu Wuwei
(甘肃武威)		 Gansu Pingliang
(甘肃平凉)		 Arun Banner
(阿荣旗)		 Sichuan Dujiangyan
(四川都江堰)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Jinhua
(浙江金华)		 Gansu Minqin
(甘肃民勤)
S6 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Liaoning Haizhou
(辽宁海州)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S7 Qinghai Qilian
(青海祁连)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Pingyang
(浙江平阳)		 Shannxi Yulin
(陕西榆林)
S8 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Xinbalhu Banner
(新巴尔虎旗)		 Sichuan Dujiangyan
(四川都江堰)		 Liaoning Haizhou
(辽宁海州)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S9 Sichuan Aba Prefecture
(四川阿坝州)		 Hubei Badong
(湖北巴东)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Dujiangyan
(四川都江堰)		 Liaoning Haizhou
(辽宁海州)		 Guangxi Guigang
(广西贵港)		 Shannxi Yulin
(陕西榆林)
S10 Qinghai Qilian
(青海祁连)		 Gansu Pingliang
(甘肃平凉)		 Arun Banner
(阿荣旗)		 Sichuan Dujiangyan
(四川都江堰)		 Shannxi Shangluo
(陕西商洛)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S11 Gansu Wuwei
(甘肃武威)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Guangxi Guigang
(广西贵港)		 Shannxi Yulin
(陕西榆林)
S12 Sichuan Aba Prefecture
(四川阿坝州)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Guangxi Guigang
(广西贵港)		 Xinjiang Bachu
(新疆巴楚)
S13 Qinghai Qilian
(青海祁连)		 Sichuan Jinyang
(四川锦阳)		 Arun Banner
(阿荣旗)		 Sichuan Pengshan
(四川彭山)		 Hubei Hefeng
(湖北鹤峰)		 Guangxi Guigang
(广西贵港)		 Gansu Minqin
(甘肃民勤)
S14 Sichuan Aba Prefecture
(四川阿坝州)		 Gansu Pingliang
(甘肃平凉)		 Xinbalhu Banner
(新巴尔虎旗)		 Sichuan Shifang
(四川什邡)		 Shannxi Shangluo
(陕西商洛)		 Zhejiang Jinhua
(浙江金华)		 Gansu Minqin
(甘肃民勤)
S15 Gansu Wuwei
(甘肃武威)		 Hubei Badong
(湖北巴东)		 Bayan Tuohai Banner
(巴彦托海旗)		 Sichuan Shifang
(四川什邡)		 Liaoning Haizhou
(辽宁海州)		 Zhejiang Jinhua
(浙江金华)		 Xinjiang Bachu
(新疆巴楚)
), ArticleFig(id=1197098038046012121, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=EN, label=Tab.2, caption=

Paste yield rate and transfer rate of the substance benchmark of QSD

, figureFileSmall=null, figureFileBig=null, tableContent=
No. Dry extract rate/% Transfer
rate
/%
Notopterygii
Rhizoma
Et Radix		 Angelicae
Pubescentis
Radix		 Saposhnikoviae
Radix		 Chuanxiong
Rhizoma		 Ligustici
Rhizoma
Et Radix		 Viticis
Fructus		 Glycyrrhizae Radix
Et Rhizoma Praeparata
Cum Melle		 Theoretical
Value		 Actual
value
S1 30.71 35.22 43.58 42.87 41.57 14.54 37.40 35.89 22.54 62.81
S2 33.87 35.22 43.58 47.63 40.70 16.87 35.91 37.04 25.44 68.70
S3 30.71 39.65 46.36 47.63 43.66 16.87 35.91 38.02 29.08 76.48
S4 33.87 39.65 43.58 43.45 41.57 16.87 35.91 37.66 28.65 76.06
S5 33.87 36.72 46.36 42.87 43.66 14.54 37.40 37.55 28.28 75.33
S6 30.71 39.65 46.36 47.63 43.66 15.35 39.16 38.32 29.92 78.07
S7 31.62 35.22 46.36 47.63 43.66 16.87 35.91 37.21 26.27 70.60
S8 30.71 39.65 44.03 42.87 43.66 13.10 39.16 37.34 27.78 74.39
S9 30.71 39.65 43.58 42.87 43.66 15.35 35.91 37.03 25.14 67.90
S10 31.62 36.72 46.36 42.87 41.57 15.35 39.16 37.04 25.37 68.50
S11 33.87 35.22 46.36 47.63 40.70 15.35 35.91 37.28 26.45 70.94
S12 30.71 35.22 46.36 47.63 40.70 15.35 39.16 36.95 24.94 67.51
S13 31.62 35.22 46.36 47.63 40.70 15.35 37.40 36.94 23.13 62.62
S14 30.71 36.72 44.03 43.45 41.57 14.54 37.40 36.36 22.92 63.05
S15 33.87 39.65 43.58 43.45 43.66 14.54 39.16 38.16 29.53 77.39
), ArticleFig(id=1197098038108926682, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=CN, label=表2, caption=

QSD基准样品和单味药出膏率及出膏转移率

, figureFileSmall=null, figureFileBig=null, tableContent=
No. Dry extract rate/% Transfer
rate
/%
Notopterygii
Rhizoma
Et Radix		 Angelicae
Pubescentis
Radix		 Saposhnikoviae
Radix		 Chuanxiong
Rhizoma		 Ligustici
Rhizoma
Et Radix		 Viticis
Fructus		 Glycyrrhizae Radix
Et Rhizoma Praeparata
Cum Melle		 Theoretical
Value		 Actual
value
S1 30.71 35.22 43.58 42.87 41.57 14.54 37.40 35.89 22.54 62.81
S2 33.87 35.22 43.58 47.63 40.70 16.87 35.91 37.04 25.44 68.70
S3 30.71 39.65 46.36 47.63 43.66 16.87 35.91 38.02 29.08 76.48
S4 33.87 39.65 43.58 43.45 41.57 16.87 35.91 37.66 28.65 76.06
S5 33.87 36.72 46.36 42.87 43.66 14.54 37.40 37.55 28.28 75.33
S6 30.71 39.65 46.36 47.63 43.66 15.35 39.16 38.32 29.92 78.07
S7 31.62 35.22 46.36 47.63 43.66 16.87 35.91 37.21 26.27 70.60
S8 30.71 39.65 44.03 42.87 43.66 13.10 39.16 37.34 27.78 74.39
S9 30.71 39.65 43.58 42.87 43.66 15.35 35.91 37.03 25.14 67.90
S10 31.62 36.72 46.36 42.87 41.57 15.35 39.16 37.04 25.37 68.50
S11 33.87 35.22 46.36 47.63 40.70 15.35 35.91 37.28 26.45 70.94
S12 30.71 35.22 46.36 47.63 40.70 15.35 39.16 36.95 24.94 67.51
S13 31.62 35.22 46.36 47.63 40.70 15.35 37.40 36.94 23.13 62.62
S14 30.71 36.72 44.03 43.45 41.57 14.54 37.40 36.36 22.92 63.05
S15 33.87 39.65 43.58 43.45 43.66 14.54 39.16 38.16 29.53 77.39
), ArticleFig(id=1197098038176035547, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=EN, label=Tab.3, caption=

Regression equation, correlation coefficient and linear range of index components in QSD

, figureFileSmall=null, figureFileBig=null, tableContent=
Index
components		 Regression
equation		 r2 linear range
/μg·mL-1
Chlorogenic acid y=12 718x+105 699 0.999 4 11.60-232.00
Prim-O-glucosylcimifugin y=38 844x+60 304 0.999 4 3.63-72.50
Ferulic acid y=34 695x+46 100 0.999 0 13.77-275.40
Senkyunolide I y=82 668x-34 195 0.999 9 2.70-54.00
5-O-methylvisammioside y=83 416x-10 464 0.999 8 1.65-33.00
Ammonium glycyrrhizinate y=9 334x-35 273 0.999 9 33.75-675.00
Notopterygol y=35 615x+1 201 0.999 6 0.17-3.33
Osthole y=40 239x-1 731 0.999 1 0.48-9.60
), ArticleFig(id=1197098038238950108, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=CN, label=表3, caption=

QSD中各指标成分线性回归方程

, figureFileSmall=null, figureFileBig=null, tableContent=
Index
components		 Regression
equation		 r2 linear range
/μg·mL-1
Chlorogenic acid y=12 718x+105 699 0.999 4 11.60-232.00
Prim-O-glucosylcimifugin y=38 844x+60 304 0.999 4 3.63-72.50
Ferulic acid y=34 695x+46 100 0.999 0 13.77-275.40
Senkyunolide I y=82 668x-34 195 0.999 9 2.70-54.00
5-O-methylvisammioside y=83 416x-10 464 0.999 8 1.65-33.00
Ammonium glycyrrhizinate y=9 334x-35 273 0.999 9 33.75-675.00
Notopterygol y=35 615x+1 201 0.999 6 0.17-3.33
Osthole y=40 239x-1 731 0.999 1 0.48-9.60
), ArticleFig(id=1197098038306058973, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=EN, label=Tab.4, caption=

index component content and transfer rate of the substance benchmark of QSD. n=3

, figureFileSmall=null, figureFileBig=null, tableContent=
No. Chlorogenic acid/% Prim-O-glucosylcimifugin/% Ferulic acid/% Senkyunolide I/%
Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate
S1 0.095 6 0.352 8 136.42 0.020 7 0.142 8 125.59 0.061 6 0.434 0 112.42 0.008 6 0.036 1 137.65
S2 0.074 9 0.316 6 121.51 0.016 3 0.141 5 99.03 0.059 4 0.470 0 103.88 0.008 1 0.037 6 121.01
S3 0.086 3 0.384 2 112.22 0.022 1 0.247 5 134.52 0.054 7 0.457 2 98.19 0.007 6 0.031 2 131.87
S4 0.086 2 0.380 7 117.59 0.017 4 0.142 8 106.05 0.053 9 0.473 0 93.70 0.008 5 0.036 1 135.94
S5 0.103 6 0.412 6 124.44 0.018 7 0.247 5 113.37 0.060 5 0.414 7 115.04 0.006 6 0.027 1 136.18
S6 0.104 2 0.384 2 135.51 0.019 5 0.247 5 118.25 0.066 2 0.364 8 134.28 0.007 6 0.031 2 131.60
S7 0.102 6 0.355 6 145.64 0.020 3 0.247 3 123.59 0.069 9 0.457 7 125.46 0.007 1 0.030 6 126.97
S8 0.097 4 0.377 5 129.46 0.019 8 0.208 2 120.07 0.072 4 0.426 2 113.22 0.008 1 0.030 6 143.91
S9 0.077 2 0.319 5 125.24 0.019 8 0.141 5 120.31 0.058 8 0.361 2 120.36 0.007 7 0.032 6 126.56
S10 0.106 6 0.414 9 127.58 0.021 3 0.247 3 129.48 0.073 7 0.381 3 144.02 0.007 7 0.033 0 138.66
S11 0.099 1 0.386 6 128.39 0.021 5 0.247 5 130.47 0.058 6 0.376 8 115.57 0.008 1 0.036 1 126.74
S12 0.083 5 0.326 1 132.32 0.023 8 0.247 5 144.45 0.056 1 0.335 7 136.48 0.008 5 0.036 1 133.24
S13 0.101 2 0.386 6 131.17 0.021 4 0.247 5 130.07 0.076 0 0.376 8 107.36 0.008 0 0.036 1 125.95
S14 0.103 7 0.417 9 128.30 0.018 8 0.207 4 114.49 0.059 1 0.436 0 107.36 0.008 9 0.037 1 136.78
S15 0.100 7 0.415 6 124.98 0.015 5 0.141 5 94.13 0.047 5 0.416 2 90.07 0.008 2 0.031 2 140.93
Average 0.094 9 0.375 4 128.05 0.019 8 0.207 0 120.26 0.061 9 0.412 1 114.49 0.008 0 0.033 5 132.93
No. 5-O-Methylvisammioside/% Ammonium glycyrrhizinate/% Notopterygol/% Osthole/%
Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate
S1 0.008 3 0.066 5 107.00 0.273 5 3.025 7 77.75 0.001 2 0.008 0 65.66 0.001 6 0.046 3 14.93
S2 0.007 8 0.066 5 100.84 0.191 4 2.016 9 81.62 0.001 0 0.008 0 51.88 0.001 0 0.049 2 8.43
S3 0.008 2 0.066 3 107.03 0.204 0 2.009 7 87.28 0.001 3 0.009 0 62.03 0.001 9 0.046 2 17.48
S4 0.008 5 0.066 5 109.81 0.184 9 2.016 9 78.83 0.000 8 0.008 0 44.66 0.001 6 0.046 2 14.87
S5 0.007 7 0.089 8 73.69 0.213 6 3.022 6 60.78 0.001 1 0.009 0 54.64 0.001 1 0.029 4 15.64
S6 0.009 2 0.089 9 88.51 0.266 4 2.265 0 101.14 0.001 2 0.009 0 56.73 0.002 2 0.046 2 20.89
S7 0.008 8 0.089 8 84.61 0.203 5 2.016 9 86.77 0.001 3 0.009 0 64.08 0.001 3 0.046 3 12.33
S8 0.009 9 0.107 8 78.60 0.247 6 2.265 0 94.00 0.000 8 0.007 5 42.85 0.001 8 0.046 3 16.38
S9 0.007 8 0.066 3 101.71 0.196 6 2.009 7 84.13 0.001 0 0.009 0 47.88 0.000 9 0.048 5 8.26
S10 0.009 6 0.089 9 92.07 0.266 0 2.265 0 100.99 0.001 1 0.009 0 56.80 0.001 3 0.029 4 19.26
S11 0.009 1 0.089 9 87.35 0.182 7 2.009 7 78.17 0.000 8 0.009 0 44.69 0.000 9 0.046 2 8.81
S12 0.007 4 0.089 9 71.05 0.232 7 2.265 0 88.34 0.000 7 0.007 4 39.95 0.001 5 0.033 7 19.49
S13 0.009 8 0.089 9 94.09 0.232 9 3.022 6 66.28 0.000 9 0.009 0 49.32 0.000 8 0.046 2 7.67
S14 0.008 1 0.107 5 64.65 0.186 3 3.022 6 53.00 0.001 0 0.009 0 47.72 0.001 3 0.046 2 11.83
S15 0.007 2 0.066 3 93.13 0.181 6 2.265 0 68.94 0.000 7 0.008 0 35.71 0.000 9 0.046 2 8.76
Average 0.008 5 0.082 8 90.27 0.217 6 2.366 6 80.53 0.001 0 0.008 5 50.97 0.001 3 0.043 5 13.67
), ArticleFig(id=1197098038381556446, tenantId=1146029695717560320, journalId=1190317699101192196, articleId=1195664142444053106, language=CN, label=表4, caption=

QSD物质基准指标成分含量及转移率. n=3

, figureFileSmall=null, figureFileBig=null, tableContent=
No. Chlorogenic acid/% Prim-O-glucosylcimifugin/% Ferulic acid/% Senkyunolide I/%
Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate
S1 0.095 6 0.352 8 136.42 0.020 7 0.142 8 125.59 0.061 6 0.434 0 112.42 0.008 6 0.036 1 137.65
S2 0.074 9 0.316 6 121.51 0.016 3 0.141 5 99.03 0.059 4 0.470 0 103.88 0.008 1 0.037 6 121.01
S3 0.086 3 0.384 2 112.22 0.022 1 0.247 5 134.52 0.054 7 0.457 2 98.19 0.007 6 0.031 2 131.87
S4 0.086 2 0.380 7 117.59 0.017 4 0.142 8 106.05 0.053 9 0.473 0 93.70 0.008 5 0.036 1 135.94
S5 0.103 6 0.412 6 124.44 0.018 7 0.247 5 113.37 0.060 5 0.414 7 115.04 0.006 6 0.027 1 136.18
S6 0.104 2 0.384 2 135.51 0.019 5 0.247 5 118.25 0.066 2 0.364 8 134.28 0.007 6 0.031 2 131.60
S7 0.102 6 0.355 6 145.64 0.020 3 0.247 3 123.59 0.069 9 0.457 7 125.46 0.007 1 0.030 6 126.97
S8 0.097 4 0.377 5 129.46 0.019 8 0.208 2 120.07 0.072 4 0.426 2 113.22 0.008 1 0.030 6 143.91
S9 0.077 2 0.319 5 125.24 0.019 8 0.141 5 120.31 0.058 8 0.361 2 120.36 0.007 7 0.032 6 126.56
S10 0.106 6 0.414 9 127.58 0.021 3 0.247 3 129.48 0.073 7 0.381 3 144.02 0.007 7 0.033 0 138.66
S11 0.099 1 0.386 6 128.39 0.021 5 0.247 5 130.47 0.058 6 0.376 8 115.57 0.008 1 0.036 1 126.74
S12 0.083 5 0.326 1 132.32 0.023 8 0.247 5 144.45 0.056 1 0.335 7 136.48 0.008 5 0.036 1 133.24
S13 0.101 2 0.386 6 131.17 0.021 4 0.247 5 130.07 0.076 0 0.376 8 107.36 0.008 0 0.036 1 125.95
S14 0.103 7 0.417 9 128.30 0.018 8 0.207 4 114.49 0.059 1 0.436 0 107.36 0.008 9 0.037 1 136.78
S15 0.100 7 0.415 6 124.98 0.015 5 0.141 5 94.13 0.047 5 0.416 2 90.07 0.008 2 0.031 2 140.93
Average 0.094 9 0.375 4 128.05 0.019 8 0.207 0 120.26 0.061 9 0.412 1 114.49 0.008 0 0.033 5 132.93
No. 5-O-Methylvisammioside/% Ammonium glycyrrhizinate/% Notopterygol/% Osthole/%
Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate		 Substance
Benchmark		 Herbal
Pieces		 Transfer
Rate
S1 0.008 3 0.066 5 107.00 0.273 5 3.025 7 77.75 0.001 2 0.008 0 65.66 0.001 6 0.046 3 14.93
S2 0.007 8 0.066 5 100.84 0.191 4 2.016 9 81.62 0.001 0 0.008 0 51.88 0.001 0 0.049 2 8.43
S3 0.008 2 0.066 3 107.03 0.204 0 2.009 7 87.28 0.001 3 0.009 0 62.03 0.001 9 0.046 2 17.48
S4 0.008 5 0.066 5 109.81 0.184 9 2.016 9 78.83 0.000 8 0.008 0 44.66 0.001 6 0.046 2 14.87
S5 0.007 7 0.089 8 73.69 0.213 6 3.022 6 60.78 0.001 1 0.009 0 54.64 0.001 1 0.029 4 15.64
S6 0.009 2 0.089 9 88.51 0.266 4 2.265 0 101.14 0.001 2 0.009 0 56.73 0.002 2 0.046 2 20.89
S7 0.008 8 0.089 8 84.61 0.203 5 2.016 9 86.77 0.001 3 0.009 0 64.08 0.001 3 0.046 3 12.33
S8 0.009 9 0.107 8 78.60 0.247 6 2.265 0 94.00 0.000 8 0.007 5 42.85 0.001 8 0.046 3 16.38
S9 0.007 8 0.066 3 101.71 0.196 6 2.009 7 84.13 0.001 0 0.009 0 47.88 0.000 9 0.048 5 8.26
S10 0.009 6 0.089 9 92.07 0.266 0 2.265 0 100.99 0.001 1 0.009 0 56.80 0.001 3 0.029 4 19.26
S11 0.009 1 0.089 9 87.35 0.182 7 2.009 7 78.17 0.000 8 0.009 0 44.69 0.000 9 0.046 2 8.81
S12 0.007 4 0.089 9 71.05 0.232 7 2.265 0 88.34 0.000 7 0.007 4 39.95 0.001 5 0.033 7 19.49
S13 0.009 8 0.089 9 94.09 0.232 9 3.022 6 66.28 0.000 9 0.009 0 49.32 0.000 8 0.046 2 7.67
S14 0.008 1 0.107 5 64.65 0.186 3 3.022 6 53.00 0.001 0 0.009 0 47.72 0.001 3 0.046 2 11.83
S15 0.007 2 0.066 3 93.13 0.181 6 2.265 0 68.94 0.000 7 0.008 0 35.71 0.000 9 0.046 2 8.76
Average 0.008 5 0.082 8 90.27 0.217 6 2.366 6 80.53 0.001 0 0.008 5 50.97 0.001 3 0.043 5 13.67
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羌活胜湿汤物质基准量值传递分析
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祁庆瑞 1 , 翟秉涛 1 , 岳宝森 2 , 赵锋 2, * , 田欢 2, *
中国药学杂志 | 论著 2024,59(2): 128-135
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中国药学杂志 | 论著 2024, 59(2): 128-135
羌活胜湿汤物质基准量值传递分析
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祁庆瑞1, 翟秉涛1, 岳宝森2, 赵锋2, *, 田欢2, *
作者信息
  • 1 陕西中医药大学,陕西省中药基础与新药研究重点实验室, 西安 712046
  • 2 西安市中医医院药剂科, 西安 710021

    • 祁庆瑞,女,硕士研究生 研究方向:临床中药学及中药制剂新剂型研究

通讯作者:

*赵锋,男,主任中药师,硕士生导师 研究方向:临床中药学及中药复方物质基准研究 Tel:(029)89626683;
田欢,女,中药师 研究方向:临床中药学及中药复方物质基准研究 Tel:(029)89626635
Quality Value Transfer of Substance Benchmarks in Qianghuo Shengshi Decoction
QI Qingrui1, ZHAI Bingtao1, YUE Baosen2, ZHAO Feng2, *, TIAN Huan2, *
Affiliations
  • 1 Shaanxi Key Laboratory of Chinese Medicine Fundamentals and New Drugs Research, Shaanxi University of Chinese Medicine, Xi'an 712046, China
  • 2 Department of Pharmacy, Xi'an Hospital of Traditional Chinese Medicine, Xi'an 710021, China
出版时间: 2024-01-22 doi: 10.11669/cpj.2024.02.004
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摘要
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目的 建立羌活胜湿汤(Qianghuo Shengshi decoction,QSD)物质基准的指纹图谱及多指标成分含量测定方法,研究QSD物质基准量值传递规律,为QSD后续开发及质量控制评价提供依据。方法 依据古籍记载制备15批QSD物质基准样品溶液,测定其出膏率,建立指纹图谱并进行相似度评价,明确特征峰及特征峰归属,完成QSD物质基准中8个指标成分的含量测定及饮片-物质基准量值传递分析。结果 15 批QSD物质基准指纹图谱相似度处于0.882~0.938之间,共确定24个共有峰,并指认出8个共有峰分别为绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素。15批QSD物质基准的出膏率为22.54%~29.92%,平均出膏转移率为70.69%。各指标性成分的含量及饮片-基准样品的平均转移率分别为绿原酸0.077 2%~0.106 6%和128.05%;升麻素苷0.015 5%~0.023 8%和120.26%;阿魏酸0.047 5%~0.076 0%和114.49%;洋川芎内脂Ⅰ 0.006 6%~0.008 9%和132.93%;5-O-甲基维斯阿米醇苷0.007 2%~0.009 9%和90.27%;甘草酸铵0.181 6%~0.273 5%和80.53%;羌活醇0.000 7%~0.001 3%和50.97%;蛇床子素0.000 9%~0.002 2%和13.67%。结论 本实验采用指纹图谱、出膏率及多指标成分含量测定相结合的方法,对QSD饮片-物质基准的全过程进行量值传递分析,为该方的质量控制及复方制剂的开发提供参考。

羌活胜湿汤  /  物质基准  /  指纹图谱  /  量值传递

OBJECTIVE To establish the fingerprint of the substance benchmark of Qianghuo shengshi decoction (QSD) and the determination method of multi-index composition content, study the transfer rule of the substance benchmark value of QSD, and provide a scientific basis for the subsequent development of QSD and quality control evaluation. METHODS Fifteen batches of QSD substance benchmark samples were prepared according to the method recorded in ancient medical books, and their fingerprint was established and evaluated, its characteristic peaks was clarified and assigned to the characteristic peaks, and we complete the content determination and transfer rate calculation of the 8 index components in the QSD substance benchmark. RESULTS The similarity of the fingerprint of 15 batches of QSD substance benchmark was between 0.882 and 0.938. A total of 24 common peaks were identified, and 8 common peaks were identified as chlorogenic acid, prim-O-glucosylcimifugin, ferulic acid, senkyunolide I, 5-O-methylvisammioside, ammonium glycyrrhizinate, notopterygol, osthole. The paste yield of 15 batches of QSD was 22.54%-29.92%, and the average paste transfer rate was 70.69%. The content and average transfer rate of each index component from decoction pieces to substance benchmarks were 0.077 2%-0.106 6% and 128.05% for chlorogenic acid,prim-O-glucosylcimifugin 0.015 5%-0.023 8% and 120.26%, ferulic acid 0.047 5%-0.076 0% and 114.49%, senkyunolide I 0.006 6%-0.008 9% and 132.93%, 5-O-methylvisammioside 0.007 2%-0.009 9% and 90.27%, ammonium glycyrrhizinate 0.181 6%-0.273 5% and 80.53%, notopterygol 0.000 7%-0.001 3% and 50.97%, osthole 0.000 9%-0.002 2% and 13.67%. CONCLUSION In this experiment, a combination of fingerprint, paste yield and multi-index composition content determination could be used to analysis the transfer rate of QSD decoction pieces to substance benchmarks, and provide a method reference for the quality control and subsequent development of this prescription.

Qianghuo Shengshi decoction  /  substance benchmark  /  fingerprint  /  quantitative transmitting
祁庆瑞, 翟秉涛, 岳宝森, 赵锋, 田欢. 羌活胜湿汤物质基准量值传递分析. 中国药学杂志, 2024 , 59 (2) : 128 -135 . DOI: 10.11669/cpj.2024.02.004
QI Qingrui, ZHAI Bingtao, YUE Baosen, ZHAO Feng, TIAN Huan. Quality Value Transfer of Substance Benchmarks in Qianghuo Shengshi Decoction[J]. Chinese Pharmaceutical Journal, 2024 , 59 (2) : 128 -135 . DOI: 10.11669/cpj.2024.02.004
正文
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羌活胜湿汤(Qianghuo Shengshi decoction,QSD)为2018年由国家药品监督管理局发布的首批《古代经典名方目录》中的一方。由东代医家李东桓所创,收录于《内外伤辨惑论》[1],全方由羌活、独活、防风、川芎、藁本、蔓荆子、炙甘草七味药组成,用于治疗湿邪痹阻手足太阳经脉等病证,随着后世医家对该方的不断实践应用,其主治病症逐渐衍变至关节酸楚疼痛,屈伸不利,微热昏倦,恶寒头身疼痛,寐之卧而多惊等病症[2]。现代临床常用于治疗关节炎[3]、颈椎病[4]、偏头痛[5]、腰痛[6]等,应用广泛,疗效确切。
目前有关QSD的文献报道主要集中在临床疗效观察,有少量药理作用研究[7-8]以及指纹图谱和化学成分分析的相关研究[9-11],未见指纹图谱结合多指标成分含量测定的报道。由于指纹图谱和多指标成分含量测定是经典名方物质基准质量控制的两个重要手段,因此本研究结合《古代经典名方中药复方制剂简化注册审批管理规定》[12],以古代医籍中记载的制备方法为依据制备QSD物质基准溶液并通过建立指纹图谱,完成绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素多指标成分的含量测定,对QSD饮片至物质基准的传递过程进行质量控制,为后续QSD制剂的开发提供参考。
1 仪器与材料
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1.1 仪器
LC-20A型高效液相色谱仪系统(日本岛津)、FW-100型高速万能粉碎机(北京市永光明医疗仪器有限公司)、SHZ-D型循环水式多用真空泵(河南省予华仪器有限公司)、LD2-4X型台式低速离心机(陕西德祥实验设备有限公司)、CQ-150A-DST型超声波清洗机(上海跃进医用光学器械厂)、电热恒温水浴锅(上海科恒实业发展有限公司),十万分之一分析天平、千分之一精密天平(上海赞维衡器有限公司)。
1.2 材料
绿原酸(批号110753-201817,纯度96.80%)、升麻素苷(批号111522-201913,纯度94.60%)、阿魏酸(批号 110773-201915,纯度99.40%)、洋川芎内脂Ⅰ(批号21012506,纯度99.68%)、5-O-甲基维斯阿米醇苷(批号111523-201811,纯度97.40%)、甘草酸铵(批号110731-202021,纯度96.20%)、羌活醇(批号111820-202106,纯度98.00%)、蛇床子素(批号110822-202111,纯度99.70%),以上对照品均购于中国食品药品检定研究院。乙腈(色谱纯);甲醇、甲酸(分析纯);纯净水(娃哈哈集团有限公司)。各单味药材均购自主产区或道地产区,经西安市中医医院刘麦娥副主任药师鉴定,羌活为伞形科植物羌活(Notopterygium incisum Ting ex H. T. Chang.)的干燥根茎和根、独活为伞形科植物重齿毛当归(Angelica pubescens Maxim.f. biserrata Shan et Yuan.)的干燥根、防风为伞形科植物防风[Saposhnikovia divaricata(Turcz.)Schischk.] 的干燥根、川芎为伞形科植物川芎(Ligusticum chuanxiong Hort.)的干燥根茎、藁本为伞形科植物藁本 (Ligusticum sinense Oliv.)的干燥根茎和根、蔓荆子为马鞭草科植物蔓荆(Vitex trifolia L.)的干燥成熟果实、炙甘草为豆科植物胀果甘草(Glycyrrhiza inflata Batal) 的干燥根和根茎的炮制品。
2 方法与结果
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2.1 QSD基准样品的制备
根据《内外伤辨惑论》中记载的羌活胜湿汤处方原方“羌活、独活各一钱,藁本、防风、甘草(炙)、川芎各五分,蔓荆子三分。上 咀,都作一服,水二盏,煎至一盏,去渣,大温服,空心食前,煮散”,通过古今计量折算及文献查阅[13-14],确定QSD物质基准的制备方法为将上述药材粉碎,过1号筛,取羌活、独活各4.0 g,藁本、防风、甘草(炙)、川芎各2.0 g,蔓荆子1.2 g,加水700 mL,武火煮沸后,转文火煎至约350 mL,趁热过滤,将滤液浓缩至100 mL即得。
将羌活、独活、防风、川芎、藁本、蔓荆子、炙甘草各3批不同产地的饮片随机组合形成15批羌活胜湿汤物质基准样品,编号为S1~S15,具体信息见表1。
2.2 QSD基准样品指纹图谱的建立
2.2.1 色谱条件
Agilent 5 TC-C18色谱柱(4.6 mm×150 mm,5 μm),以乙腈-0.2%甲酸水溶液为流动相,梯度洗脱:0~5 min,12%乙腈,5~30 min,14%乙腈,30~45 min,20%乙腈,45~60 min,40%乙腈,60~65 min,50%乙腈,65~75 min,65%乙腈,75~77 min,12%乙腈,77~80 min,12%乙腈;柱温为31 ℃;进样量:20 μL;检测波长:254 nm。
2.2.2 对照品溶液的制备
取绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素适量,精密称定,加甲醇溶解制成质量浓度分别为232.00、72.50、275.40、54.00、33.00、675.00、3.33、9.60μg·mL -1的混合对照品溶液。
2.2.3 供试品溶液的制备
精密量取QSD物质基准溶液4 mL,置于10 mL量瓶中,加甲醇5 mL,加蒸馏水至刻度,定容,称定质量,超声30 min,放冷,称重,用体积分数50%甲醇补足失重,离心5 min(2 000 r·min-1),取上清液,过0.22 μm微孔滤膜,取滤液,即得。
取处方剂量的各单味药饮片及分别缺羌活、独活、防风、川芎、藁本、蔓荆子、炙甘草的处方量饮片,按“2.1”项制备后,同法制备各单味药及阴性样品的供试品溶液。
2.2.4 方法学考察
精密度试验:取批号为S1的物质基准溶液,按“2.2.3”项制备供试品,按“2.2.1”项色谱条件连续进样6次,以甘草酸铵为参照峰,分别计算各特征峰相对保留时间和相对峰面积,结果表明,各特征峰的相对保留时间相对标准差(RSD)均小于0.36%,相对峰面积RSD均小于4.44%,表明仪器精密度良好。
稳定性试验:取批号为S1的物质基准溶液,按“2.2.3”项制备供试品溶液,按“2.2.1”项色谱条件分别于0、2、4、8、12、24 h进样,以甘草酸铵为参照峰,计算各特征峰相对保留时间和相对峰面积,结果各特征峰的相对保留时间RSD均小于0.17%,相对峰面积RSD均小于4.42%,表明供试品溶液在24 h内稳定性良好。
重复性试验:取批号为S1的物质基准溶液,按“2.2.3”项制备供试品溶液,共6份,按“2.2.1”项色谱条件连续进样,以甘草酸铵为参照峰,计算各特征峰相对保留时间和相对峰面积,结果各特征峰的相对保留时间RSD均小于1.75%,相对峰面积RSD均小于4.46%,表明该方法重复性良好。
2.3 QSD基准样品指液纹图谱的考察
2.3.1 相似度评价
制备15批QSD物质基准供试品溶液,采用“2.2.1”色谱条件进行测定,记录15批色谱图,导入2012版《中药色谱指纹图谱相似度评价系统》,以S1为对照图谱,以平均数法进行多点校正和色谱峰匹配,得到15批物质基准的指纹图谱叠加图谱,见图1,计算各批次指纹图谱与对照图谱相似度,15批QSD指纹图谱的相似度分别为0.919、0.905、0.896、0.892、0.886、0.899、0.878、0.922、0.938、0.934、0.934、0.933、0.917、0.882、0.930,表明各批次间稳定性较好,符合指纹图谱要求。
2.3.2 指纹图谱峰归属
15批QSD物质基准样品中共确定出24个共有峰;通过与对照品色谱峰对比,指认出8个特征峰,其中1号峰为绿原酸、3号峰为升麻素苷、4号峰为阿魏酸、6号峰为洋川芎内脂Ⅰ、7号峰为5-O-甲基维斯阿米醇苷、20号峰为甘草酸铵、23号峰为羌活醇、24号峰为蛇床子素,见图2;根据各单味药材及阴性药材图谱对各特征峰进行归属研究,见图3、4,其中5,8,11,12,22,23号峰来源于羌活,15~17,24号峰来源于独活3,7,10号峰来源于防风,9,13,14,19~21号峰来源于炙甘草,其中1号峰为羌活,独活,川芎,藁本共有,2号峰为羌活,独活,川芎,蔓荆子共有,4号峰为羌活,川芎,藁本,蔓荆子共有,6号峰为独活,藁本共有,18号峰为独活,炙甘草共有。
2.4 15批QSD基准样品出膏率及出膏转移率的考察
按“2.1”项下方法制备QSD物质基准溶液,精密量取40 mL转移至蒸发皿中,浓缩至稠膏后,转移至真空干燥箱,60 ℃真空干燥至恒重,即得15批QSD物质基准干膏粉。取处方剂量的各单味药饮片,按“2.1”项制备后,同法制备即得各单味药饮片的干膏粉。
计算15批QSD物质基准、对应各单味药饮片的出膏率及出膏转移率,结果见表2。15 批QSD物质基准的实际出膏率(公式1)为22.54%~29.92%,平均出膏率为26.36%,各批次出膏率均处于均值的±30%范围内,理论出膏率(公式2)为35.89%~38.32%,各批次的实际出膏率低于理论出膏率。出膏转移率(公式3)均值为70.69%。
$实际出膏率（％）＝QSD 物质基准干膏粉的质量／全方总质量 \times 100 \%$
$\begin{array}{c} 理论出膏率 (\%) = (0.23 \times 对应批次羌活出膏率 +0.23 \times \\对应批次独活出膏率+0.12 \times 对应批次防风出膏率 +0.12\\ \times 对应批次川芎出膏率+0.12 \times 对应批次藁本出膏率 +0.12 \times \\对应批次炙甘草出膏率 +0.06 \times 对应批次蔓荆子出膏率） \times 100 \% \end{array}$
$出膏转移率（％）＝实际出膏率／理论出膏率 \times 100 \% $
2.5 QSD基准样品指标成分含量测定及传递规律考察
2.5.1 方法学考察
线性关系考察:精密量取“2.2.2”项下对照品溶液,按“2.2.1”项下色谱条件分别进样1、2、6、10、14、18、20 μL,记录各指标成分峰面积,以各指标成分的峰面积为纵坐标(Y),质量浓度为横坐标(X),分别绘制标准曲线,结果见表3。
精密度试验:取批号为S1的物质基准溶液,按“2.2.3”项制备供试品溶液,按“2.2.1”项色谱条件,重复进样6次,记录各指标成分的峰面积,计算绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素含量的RSD值分别为2.14%、3.69%、1.19%、3.03%、4.42%、0.44%、4.69%、4.15%,表明仪器精密度良好。
稳定性试验:取批号为S1的物质基准溶液,按“2.2.3”项制备供试品溶液,按“2.2.1”项色谱条件分别于制备后0、2、4、6、8、12、24 h进样,记录各指标成分的峰面积,计算绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素含量的RSD值分别为0.89%、4.70%、0.52%、1.25%、4.07%、0.18%、4.54%、3.94%,表明QSD供试品溶液在24 h内能够保持稳定。
重复性试验:取批号为S1的物质基准溶液,按“2.2.3”项制备供试品溶液,共6份,按“2.2.1”项色谱条件连续进样,记录各指标成分的峰面积,计算绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素含量的RSD值分别为1.00%、3.66%、1.07%、2.71%、2.60%、0.17%、3.27%、4.24%,表明该方法重复性良好。
加样回收率试验:取6份已知含量的QSD物质基准样品溶液,分别加入与各成分含量相近的对照品溶液适量(绿原酸0.616 0 mg、升麻素苷0.150 8 mg、阿魏酸0.474 3 mg、洋川芎内脂Ⅰ 0.043 2 mg、5-O-甲基维斯阿米醇苷0.052 8 mg、甘草酸铵1.696 5 mg、羌活醇0.009 15 mg、蛇床子素0.005 28 mg),按“2.2.3”项制备供试品溶液,按“2.2.1”项色谱条件连续进样,记录各指标成分峰面积,计算绿原酸、升麻素苷、阿魏酸、洋川芎内脂Ⅰ、5-O-甲基维斯阿米醇苷、甘草酸铵、羌活醇、蛇床子素含量的RSD值分别为1.15%、0.56%、0.62%、2.15%、1.05%、0.20%、1.23%、0.86%,各成分的平均加样回收率分别为101.16%、103.18%、97.84%、100.93%、101.31%、104.76%、102.64%、99.86%,表明方法准确度良好。
2.5.2 多指标成分含量测定及量值传递关系
取15批QSD物质基准溶液,按“2.2.3”项下制备供试品溶液,按“2.2.1”项下色谱条件分别测定15个批次中指标成分的含量,计算饮片-物质基准指标成分的转移率(公式4),结果见表4。
$ \text { 转移率 }(\%)=\text {（物质基准中指标成分的含量／饮片中指标成分的含量）} \times 100 \%$
15批QSD基准样品中绿原酸质量分数0.077 2%~0.106 6%,平均转移率128.05%;升麻素苷质量分数0.015 5%~0.023 8%,平均转移率120.26%;阿魏酸0.047 5%~0.076 0%,平均转移率114.49%;洋川芎内酯I质量分数0.006 6%~0.008 9%,平均转移率132.93%;5-O-甲基维斯阿米醇苷质量分数0.007 2%~0.009 9%,平均转移率90.27%;甘草酸铵质量分数0.181 6%~0.273 5%,平均转移率80.53%;羌活醇质量分数0.000 7%~0.001 3%,平均转移率50.97%;蛇床子素质量分数0.000 9%~0.002 2%,平均转移率13.67%。根据相关规定,物质基准中指标成分的含量及转移率均应在其均值的±30%范围内,在本研究中绿原酸、升麻素苷、阿魏酸、洋川芎内酯Ⅰ、甘草酸铵、羌活醇的含量及转移率在其均值的±30%内,部分蛇床子素的含量及转移率未在其均值的± 30%内。说明QSD物质基准制备工艺基本能够实现饮片-物质基准的稳定传递。
3 讨论
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指标成分的选择依据《中国药典》(2020年版一部)及各成分的药理作用。方中羌活、独活共为君药,二者均为辛苦温燥之品,其中羌活善祛头项脊背之风湿,独活善祛腰膝之风湿,两药合用能散上下一身之风湿,发挥祛风胜湿、通痹止痛的功效。羌活醇和蛇床子素分别为羌活和独活的主要活性成分之一,二者均有抗炎镇痛、解热抗氧化的药理作用[15];防风、藁本共为臣药,能够祛风胜湿,止头痛。升麻素苷、5-O-甲基维斯阿米醇苷均为防风中的质量标志物[16],二者均有较好的抗炎药理活性作用,其中升麻素苷能抗炎镇痛、解热以及抗血小板聚集,可以通过抑制炎症反应以及基质金属蛋白酶的表达,治疗关节炎[17]。藁本中主要检测出洋川芎内酯Ⅰ,药理研究表明洋川芎内酯Ⅰ具有抗炎镇痛、抗氧化、抗血小板聚集、舒张血管等多种活性[18];川芎、蔓荆子共为佐药,能发挥活血行气,祛风止痛的功效,川芎和蔓荆子中均含有阿魏酸,阿魏酸能够抗氧化、抗血栓、降血脂、抗菌[19]。使药为甘草,甘草中所含的甘草酸铵能抗炎、抗过敏,在复方中起到益气和中,调和诸药的作用。指标成分的选择包括了方中的君臣佐使,能够较为全面地对QSD进行质量控制。
指纹图谱及指标成分含量测定的特征峰归属涵盖了全方7味药,其中绿原酸和阿魏酸分别归属于方中多个药材,绿原酸归属于羌活、独活、川芎、藁本,阿魏酸归属于羌活、藁本、川芎、蔓荆子,除此以外,未从川芎和蔓荆子中检测出其他特征峰,川芎和蔓荆子的信息未能很好地体现,这可能与川芎和蔓荆子中其他成分含量较低、提取或洗脱条件局限,在该色谱条件下响应值较低导致出峰不明显有关。后续研究可以针对川芎和蔓荆子建立单独的特征图谱或结合其他的检测仪器手段,从而对QSD进行更全面的质量控制。
指标成分的含量测定及转移率结果显示,绿原酸、升麻素苷、阿魏酸、洋川芎内酯Ⅰ、甘草酸铵、羌活醇的含量及转移率均在其均值的70%~130%的范围内,符合相关要求。其中部分蛇床子素的含量和转移率未能达到要求。蛇床子素本身为热不稳定成分,当加热温度较高,煎煮时间较长时,蛇床子素易被破坏分解[20],因此蛇床子素含量测定值较低,其均值的±30%波动范围较小,更容易出现离散数据。转移率低表明从饮片-物质基准传递过程中的含量损失较高,推测可能是共煎过程中,溶出的部分杂质对蛇床子素溶出有抑制作用。
在建立QSD指纹图谱和含量测定方法时,采用了PDA检测器对供试品溶液进行全波段扫描,结合3D图像分析发现,当检测波长小于250 nm时色谱图基线不平稳,检测波长大于280 nm时甘草酸铵无响应值,进一步在该范围内考察,当波长为254 nm时,特征峰峰形较好,响应值较高,能够较全面地获得QSD物质基准中的成分信息,故选定254 nm为检测波长。此外,分别考察了甲醇-水、乙腈-水、乙腈-0.1%甲酸水、乙腈-0.2%甲酸水等不同的流动相系统,结果表明,以乙腈-0.2%磷酸水为流动相洗脱效果最优。
本研究通过指纹图谱、出膏率及多指标成分含量测定相结合的方式,对QSD饮片-物质基准的量值传递过程进行了分析,实现了对QSD物质基准质量较为全面的控制,同时本研究所建立的方法稳定性强,准确度高,能够为经典名方QSD后续制剂开发提供参考。
基金
收起
  • 陕西省中医药管理局重点科学研究项目资助(2021-02-22-010)
  • 陕西省自然科学基础研究计划项目资助(2022JQ-932)
  • 西安市科技计划项目资助(23YXYJ0042)
  • 陕西省中药基础与新药研究重点实验室开放课题资助(KF202302)
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2024年第59卷第2期
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文章信息
doi: 10.11669/cpj.2024.02.004
  • 接收时间：2022-09-08
  • 首发时间：2025-11-13
  • 出版时间：2024-01-22
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  • 收稿日期：2022-09-08
基金
陕西省中医药管理局重点科学研究项目资助(2021-02-22-010)
陕西省自然科学基础研究计划项目资助(2022JQ-932)
西安市科技计划项目资助(23YXYJ0042)
陕西省中药基础与新药研究重点实验室开放课题资助(KF202302)
作者信息
    1 陕西中医药大学,陕西省中药基础与新药研究重点实验室, 西安 712046
    2 西安市中医医院药剂科, 西安 710021

通讯作者:

*赵锋,男,主任中药师,硕士生导师 研究方向:临床中药学及中药复方物质基准研究 Tel:(029)89626683;
田欢,女,中药师 研究方向:临床中药学及中药复方物质基准研究 Tel:(029)89626635
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2种不同金属材料的力学参数
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species		 占总种数比例
Percentage of
total species (%)		 属
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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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