基于UPLC指纹图谱和多成分测定的天王补心丸质量控制研究
Quality control of Tianwang Buxin Pills based on UPLC fingerprint and multi-component quantification
沈丹萍 1姜鹏 1詹常森1
作者信息
- 1. 上海和黄药业有限公司,上海 201401;上海中药固体制剂创新工程技术研究中心,上海 201401
- 折叠
摘要
天王补心丸临床上已有一定疗效,但严重缺少较全面的质量控制,以期保证临床用药安全性和有效性.研究采用超高效液相色谱(UPLC)建立天王补心丸指纹图谱和7个成分含量同时测定的方法,并结合化学计量学等方法寻找天王补心丸质量稳定的关键因素,为其科学全面的质量控制和评价提供参考.建立了 15批天王补心丸指纹图谱,相似度均大于0.96,共标定了 25个共有峰,指认出13个成分,对其中7个药效成分(α-亚麻酸、丹酚酸B、甘草酸、五味子醇甲、β-细辛醚、3,6'-二芥子酰基蔗糖和藁本内酯)建立含量测定方法,进一步采用主成分分析(principal component analysis,PCA)和偏最小二乘法-判别分析(partial least square discriminate analysis,PLS-DA)得到控制天王补心丸质量稳定性的关键药效物质为3,6'-二芥子酰基蔗糖、α-亚麻酸和β-细辛醚.结果表明建立的指纹图谱及多成分含量测定方法专属性强,稳定,可靠,提示3,6'-二芥子酰基蔗糖、α-亚麻酸和β-细辛醚是保障天王补心丸批次间质量稳定性的关键药效物质,可较为全面地对天王补心丸进行质量控制,为其质量评价和标准建立提供科学依据.
Abstract
Tianwang Buxin Pills have demonstrated therapeutic effects in clinical practice,whereas there is a serious lack of com-prehensive quality control to ensure the safety and effectiveness of clinical medication.In this study,ultra-performance liquid chroma-tography(UPLC)was employed to establish the fingerprint and the method for simultaneously determining the content of seven compo-nents of Tianwang Buxin Pills.Furthermore,chemometrics was employed to identify the key factors for the stable quality,which pro-vided a reference for the comprehensive quality control and evaluation of this preparation.There were 25 common peaks in the UPLC fingerprints of 15 batches of Tianwang Buxin Pills,from which thirteen compounds were identified.A quantitation method was estab-lished for seven pharmacological components(α-linolenic acid,salvianolic acid B,glycyrrhetinic acid,schisandrin A,β-asarone,3,6'-disinapoylsucrose,and ligustilide).The principal component analysis(PCA)and partial least square discriminate analysis(PLS-DA)were performed to determine the key pharmacological components for controlling the quality stability of Tianwang Buxin Pills,which included 3,6'-disinapoylsucrose,α-linolenic acid,and β-asarone.The established fingerprint and multi-component con-tent determination method have strong specificity,stability,and reliability.In addition,3,6'-disinapoylsucrose,α-linolenic acid,andβ-asarone are the key pharmacological components that ensure the quality stability between batches and can be used to comprehensively control the quality of Tianwang Buxin Pills.The findings provide a scientific basis for the quality evaluation and standard establishment of Tianwang Buxin Pills.
关键词
天王补心丸/指纹图谱/多成分含量测定/统计学/质量评价Key words
Tianwang Buxin Pills/fingerprint/determination of multi-component content/statistics/quality evaluation引用本文复制引用
出版年
2024
NETL
NSTL
万方数据