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参芪肝康片(胶囊)质量标准研究
引用本文:毛丹,许勇,陈钶,毛秀红,季申.参芪肝康片(胶囊)质量标准研究[J].中国药师,2013(12):1830-1833.
作者姓名:毛丹  许勇  陈钶  毛秀红  季申
作者单位:上海市食品药品检验所 上海201203;上海市食品药品检验所 上海201203;上海市食品药品检验所 上海201203;上海市食品药品检验所 上海201203;上海市食品药品检验所 上海201203
摘    要:目的:研究修订参芪肝康片(胶囊)的质量标准。方法:采用薄层色谱法对制剂中当归、黄芪及五味子进行定性测定;采用高效液相色谱法对绿原酸进行定量测定,采用C18柱,流动相为乙腈-0.4%磷酸溶液(8:92),检测波长为327 nm。结果:薄层色谱斑点清晰,分离度好,阴性无干扰。含量测定中绿原酸在201 000 mg的范围内线性关系良好(r=0.999 9),片剂和胶囊剂的加样回收率分别为95.2%、102.4%。结论:修订方法简便、准确,进一步完善了参芪肝康片(胶囊)的质量标准,可作为两者的质量控制标准。

关 键 词:参芪肝康片(胶囊)  绿原酸  薄层色谱法  高效液相色谱法
收稿时间:2013/6/13 0:00:00
修稿时间:2013/9/18 0:00:00

Quality Standard for Shenqi Gankang Tablets (Capsules)
Mao Dan,Xu Yong,Chen Ke,Mao Xiuhong and Ji Shen.Quality Standard for Shenqi Gankang Tablets (Capsules)[J].China Pharmacist,2013(12):1830-1833.
Authors:Mao Dan  Xu Yong  Chen Ke  Mao Xiuhong and Ji Shen
Institution:(Shanghai Institute for Food and Drug Control, Shanghai 201203,China)
Abstract:Objective:To improve the quality standard for Shenqi Gankang tablets and capsules.Method:TLC was used to identify Radix Angelicae Sinensis,Radix Astragali and Fructus Schisnndrae Chinensis,and chlorogenic acid was determined by HPLC with a C18 column,the mobile phase of acetonitrile-0.4%pliosphoric aeid(8:92) and the detection wavelength at 327 nm.Result:The herbs could be identified by TLC.For chlorogenic acid,the linear range was from 20 to 1 000 ng,and the average recovery for Shenqi Gankang tablets and capsules was 95.2%and 102.4%,respectively.Conclusion:The method is simple and accurate,and can be used to control the quality of Shenqi Gankang tablets and capsules.
Keywords:Shenqi Gankang tablets(capsules)  Chlorogenic acid  TLC  HPLC
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