天芪降糖胶囊质量标准研究  

Study on Quality Specification of Tianqi Jiangtang Capsules

作　　者：曹飞[1] 张清波[1] 姜文红[1] 

机构地区：[1]黑龙江省药品检验所,哈尔滨150001

出　　处：《中国药品标准》2009年第5期346-349,共4页Drug Standards of China

摘　　要：目的:修订天芪降糖胶囊的质量标准。方法:建立及优化TLC对处方中女贞子、人参、黄芪、黄连、五倍子进行定性鉴别;采用HPLC法测定黄连中盐酸小檗碱的含量。色谱柱为Diamonsil C18(4.6mm×250mm,5μm);流动相为乙腈-0.05mol.L-1磷酸二氢钾溶液(28∶72);流速为1.0mL·min-1;检测波长为345nm。结果:鉴别方法专属性强,分离效果好。含量测定盐酸小檗碱的进样量在0.16305～1.35875μg范围内线性关系良好(r=1.0000),平均回收率为99.3%,RSD(n=6)为1.5%。结论:方法灵敏、准确,重现性好,可作为天芪降糖胶囊的质量控制方法。Objective：The quality specification for Tianqi Jiangtang Capsules was established. Methods： A TLC method was used for the qualitative identification of Fructus ligustri Lucidi, Radix Et Rhizoma Ginseng, Radix Astragali, Rhizoma Coptidis and Galla Chinensis in the formula. The content of Berberine Hydrochloride was determined by HPLC method with a Diamonsil C18 column （4.6mm×250mm,5μm） and a mobile phase of aeetonitrile-0. 05% solution of potassium dihydrogen phosphate （28： 72）. The flow rate was 1.0 mL · min^- 1. The detection wavelength was 345 nm. Results：The identification study showed strong specificity. The linear relation was good with the rang of 0. 163 05 - 1. 358 75 μg （r = 1. 000 0）. The average recovery was 99. 3% with RSD 1.5% （n =6） . Conclusions：The method was sensitive, accurate and reproducible. It could be used in the quality control of Tianqi Jiangtang Capsules.

关 键 词：天芪降糖胶囊 质量标准 薄层色谱法 高效液相色谱法 盐酸小檗碱 

分 类 号：R259.871[医药卫生—中西医结合] R286.0[医药卫生—中医内科学]