基于标准汤剂多指标含量分析的产后方配方颗粒剂质量评价
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摘要
目的:建立一测多评(QAMS)法同时测定产后方标准汤剂和配方颗粒剂中多指标含量,比较产后方标准汤剂及其配方颗粒剂的差异,为配方颗粒质量评价提供一种有效可行的方法。方法:采用HPLC及QAMS法对产后方标准汤剂和配方颗粒剂进行多指标含量测定,比较阿魏酸、毛蕊异黄酮葡萄糖苷、毛蕊异黄酮和芒柄花素含量在两者中的差异,分析缺不同药材的阴性样品确定4个成分的归属。结果:QAMS法与外标法结果无明显差异,产后方标准汤剂中阿魏酸、毛蕊异黄酮葡萄糖苷、毛蕊异黄酮和芒柄花素含量均大于配方颗粒。阿魏酸来源于川芎、当归及益母草;毛蕊异黄酮葡萄糖苷、毛蕊异黄酮和芒柄花素来源于黄芪。结论:产后方标准汤剂与配方颗粒剂存在一定的差异,QAMS法能够实现产后方中阿魏酸、毛蕊异黄酮葡萄糖苷、毛蕊异黄酮、芒柄花素成分的含量测定。
Objective: To establish quantitative analysis of multi-components by single-marker( QAMS) and simultaneously determine multi-component in Chanhou prescription standard decoction and dispensing granule,and compare the difference between the two preparations,so as to evaluate the quality of Chanhou prescription dispensing granule. Methods: HPLC and QAMS were used to determine the contents of ferulic acid,calycosin-7-glucoside,calycosin and formononetin,and compare the difference between Chanhou prescription standard decoction and dispensing granule. The negative control test was analyzed to match the four components with the original medicine. Results: No significant differences were found in Chanhou prescription standard decoction and dispensing granule between the quantitative results by QAMS and those by the external standard method,the contents of four components in standard decoction were higher than those in the dispensing granule. Ferulic acid was from Chuanxiong Rhizoma,Angelicae sinensis Radix and Leonuri Herba; calycosin-7-glucoside,calycosin and formononetin were from Astragali Radix. Conclusion: The contents of the chemical components in Chanhou prescription standard decoction are different from those in the dispensing granule,and QAMS can be used to determine ferulic acid,calycosin-7-glucoside,calycosin and formononetin in Chanhou prescription.
Objective: To establish quantitative analysis of multi-components by single-marker( QAMS) and simultaneously determine multi-component in Chanhou prescription standard decoction and dispensing granule,and compare the difference between the two preparations,so as to evaluate the quality of Chanhou prescription dispensing granule. Methods: HPLC and QAMS were used to determine the contents of ferulic acid,calycosin-7-glucoside,calycosin and formononetin,and compare the difference between Chanhou prescription standard decoction and dispensing granule. The negative control test was analyzed to match the four components with the original medicine. Results: No significant differences were found in Chanhou prescription standard decoction and dispensing granule between the quantitative results by QAMS and those by the external standard method,the contents of four components in standard decoction were higher than those in the dispensing granule. Ferulic acid was from Chuanxiong Rhizoma,Angelicae sinensis Radix and Leonuri Herba; calycosin-7-glucoside,calycosin and formononetin were from Astragali Radix. Conclusion: The contents of the chemical components in Chanhou prescription standard decoction are different from those in the dispensing granule,and QAMS can be used to determine ferulic acid,calycosin-7-glucoside,calycosin and formononetin in Chanhou prescription.
引文
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2郑江萍,雷震,黄良永.川芎及其配方颗粒中阿魏酸的含量比较[J].中医药信息,2014,31(2):73-76
3郑江萍,叶正德,梁俊,等.连翘药材及其配方颗粒中连翘酯苷A和连翘苷含量比较[J].中国中医药信息杂志,2014,21(11):88-91
4梁心,桂双英,王举涛,等.超高液相色谱法测定桔梗饮片和桔梗配方颗粒中桔梗皂苷D含量[J].安徽中医药大学学报,2015,34(6):79-82
5陈士林,刘安,李琦,等.中药饮片标准汤剂研究策略[J].中国中药杂志,2016,41(8):1367-1375
6王智民,钱忠直,张启伟,等.一测多评法建立的技术指南[J].中国中药杂志,2012,36(6):657-658
7何兵,刘艳,杨世艳,等.一测多评同时测定款冬花中10个成分的含量[J].药物分析杂志,2013,33(9):1518-1524
8杨友华,黄丹,杨荣,等.一测多评法同时测定安神补气丸中8种成分[J].中成药,2018,40(9):1973-1978