前列安通片质量评价研究  

Quality Evaluation of Qianlie Antong Tablets

作　　者：胥思彤 朱旭江 王兰霞 刘竞 叶青 高嘉雯 张迈娜 XU Sitong;ZHU Xujiang;WANG Lanxia;LIU Jing;YE Qing;GAO Jiawen;ZHANG Maina(Gansu University of Chinese Medicine,Lanzhou 730000 China;Gansu Institute for Drug Control,Lanzhou 730000,China)

机构地区：[1]甘肃中医药大学药学院,甘肃兰州730000 [2]甘肃省药品检验研究院,甘肃兰州730000

出　　处：《中国民族民间医药》2022年第14期71-77,共7页Chinese Journal of Ethnomedicine and Ethnopharmacy

基　　金：甘肃省药品产业技术扶持项目(No.2019KF003)。

摘　　要：目的:建立前列安通片薄层鉴别和多成分含量测定的方法。方法:采用薄层色谱法(Thin Layer chromatography,TLC)对关黄柏、赤芍、丹参、白芷进行定性鉴别;采用超高效液相色谱法(Ultra Performance Liquid Chromatography,UPLC)同时测定盐酸黄柏碱、木兰花碱、芍药内酯苷、芍药苷、盐酸小檗碱、盐酸巴马汀和丹酚酸B 7种成分的含量,并进行聚类分析和主成分分析。结果:TLC鉴别方法专属性强,能够有效鉴别4味药材;7种成分在各自范围内线性关系良好(r≥0.9997),平均加样回收率96.00%~100.99%,RSD<3.0%;批次间各成分含量RSD均>10.0%,其差异性主要来源于关黄柏。结论:本研究建立的质量控制方法稳定可行,为前列安通片质量标准提高提供参考,并提示厂家在生产的制剂的过程中要进一步加强对关黄柏药材的质量控制。Objective To establish a methods for chromatographic identification and quantitative determination in Qianlie Antong Tablets.Methods phellodendri Amuiensis Cortex,Paeoniae Rubra,Salviae Miltiorrhizae Radix et Rhizoma and Angelicae Dahuricae Radix in Qianlie Antong Tablets were identified by TLC;UPLC was applied to simultaneously determine phellodendrine hydrochloride,magnoflorine,alibiflorin,paeoniflorin,berberine hydrochloride,palmatine hydrochloride and salvianolic acid B,and cluster analysis and principal component analysis were carried out.Results TLC identification method was specific,which could effectively identify the four herbs;Seven constituents showed good linear relationship within their own ranges(r≥0.9997),whose average recoveries were 96.00%~100.99% with the RSDs of less than 3.0%.respectively(RSD<3.0%).The RSD of each component content was more than 10.0%,and the differences were mainly derived from phellodendri Amuiensis Cortex.Conclusion The established quality control method is stable and feasible,which can provide reference for improving the quality of Qianlie Antong Tablets.It is suggested that the quality control of phellodendri Amuiensis Cortex should be further strengthened in the process of producing preparations.

关 键 词：前列安通片 含量测定 质量评价 聚类分析 主成分分析 

分 类 号：R284.1[医药卫生—中药学]