益肝胶囊质量标准的建立  

Study on the Quality Standard for Yigan Capsules

作　　者：吴丹[1] 张琰[1] 李晰[1] 张旸[1] 刘梅[1] Wu Dan;Zhang Yan;Li Xi;Zhang Yang;Liu Mei(Department of Pharmacy,Tangdu Hospital,the Fourth Military Medical Universi-ty,Xi＇ an 710038,China)

机构地区：[1]第四军医大学唐都医院药剂科,西安710038

出　　处：《中国药师》2018年第8期1473-1477,共5页China Pharmacist

基　　金：军队医疗机构制剂标准提高专项课题(编号:14ZJZ14-1)

摘　　要：目的:提高并完善益肝胶囊的质量标准。方法:采用TLC法对丹参、赤芍、柴胡、茵陈、莱菔子、泽泻进行定性鉴别,HPLC法对丹参酮ⅡA的含量进行定量测定。结果:TLC斑点分离清晰,阴性对照无干扰。丹参中有效成分丹参酮ⅡA在10.01~100.10μg·ml-1范围内线性关系良好,平均加样回收率为99.75%,RSD为0.59%(n=6)。结论:该方法简便,重复性良好,可为益肝胶囊的质量控制提供科学依据。Objective： To improve the quality standard for Yigan capsules. Methods： The components including salvia,red peony,bupleurum,capillaris radish seed and alisma were identified by TLC. The content of tanshinoneⅡAwas detected by HPLC. Results： The characteristic spots in TLC were clear without any interference. The linear range of tanshinoneⅡAwas 10. 01-100. 10μg·ml-1. The average recovery was 99. 75% with the RSD of 0. 59%（ n = 6）. Conclusion： The method is simple and reproducible,which can provide scientific reference for the quality control of Yigan capsules.

关 键 词：益肝胶囊 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：TQ460.72[医药卫生—药物分析学]