妇科断红饮胶囊质量控制  

Quality Standard of Fuke Duanhongyin Capsules

作　　者：白璐 赵威 凌勇根 吉雅琪 张鹏 龚云 杨秀伟[3] 张英帅 陆才洋[4] BAI Lu;ZHAO Wei;LING Yong-gen;JI Ya-qi;ZHANG Peng;GONG Yun;YANG Xiu-wei;ZHANG Ying-shuai;LU Cai-yang(Zhuzhou Qianjin Pharmaceutical Co.,Ltd.,Zhuzhou 412007,China;Central South University of Forestry and Technology,Changsha 410004,China;State Key Laboratory of Natural and Biomimetic Drugs,School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;Hunan Center for Drug Evaluation Certification and Adverse Drug Reaction Monitoring,Changsha 410013,China)

机构地区：[1]株洲千金药业股份有限公司,湖南株洲412007 [2]中南林业科技大学,湖南长沙410004 [3]北京大学药学院天然药物及仿生药物国家重点实验室,北京100191 [4]湖南省药品审评认证与不良反应监测中心,湖南长沙410013

出　　处：《中国现代中药》2022年第7期1347-1357,共11页Modern Chinese Medicine

基　　金：国家中药保护品种质量标准提高项目。

摘　　要：目的:通过对妇科断红饮胶囊进行薄层色谱法(TLC)鉴别、高效液相色谱法特征图谱等定性研究,建立科学合理的妇科断红饮胶囊的质量控制方法。方法:采用TLC对妇科断红饮胶囊中的地榆炭、蒲黄炭进行定性鉴别,建立妇科断红饮胶囊的特征图谱,并进行方法学验证。结果:TLC鉴别方法能特征性地鉴别地榆炭、蒲黄炭,各斑点清晰、阴性无干扰、分离度良好;建立的特征图谱确定了11个特征峰,并指认出其中6个成分。结论:所建立方法准确、简便、重复性好,完善后的质量标准实现了妇科断红饮胶囊6味药的全处方质量控制,全面提升了其质量控制水平。Objective:To establish a scientific and reasonable quality control method for Fuke Duanhongyin Capsules through the qualitative research by thin layer chromatography(TLC)identification and high performance liquid chromatography(HPLC)characteristic spectrum.Methods:TLC was used to qualitatively identify Sanguisorbae Radix Preparata and Typhae Pollen Preparata in Fuke Duanhongyin Capsules,and the HPLC characteristic spectrum of Fuke Duanhongyin Capsules was established.Both methods were subjected to methodological validation.Results:Sanguisorbae Radix Preparata and Typhae Pollen Preparata were distinguished by TLC identification,with clear spots,no negative interference,desirable separation and high specificity.The characteristic spectrum determined 11 characteristic peaks and identified 6 components.Conclusion:The established methods were accurate,simple and reproducible,and with improved quality standard,the quality control of the whole prescription of 6 flavors was achieved,which comprehensively enhanced the quality control level of Fuke Duanghongyin Capsules.

关 键 词：妇科断红饮胶囊 薄层色谱法 高效液相色谱法特征图谱 地榆炭 蒲黄炭 

分 类 号：R286[医药卫生—中药学]