抗痨胶囊质量控制研究  

Quality Control for Kanglao Capsules

作　　者：程立方[1] 崔秀君[2] 

机构地区：[1]山东省中医药研究院,济南250014 [2]济南市妇幼保健院

出　　处：《中国药师》2007年第5期410-411,共2页China Pharmacist

基　　金：山东省中医管理局科技计划项目(ZY19981018)

摘　　要：目的:建立抗痨胶囊质量控制方法。方法:采用TLC法鉴别胶囊中异海松酸,HPLC法测定异海松酸含量,色谱条件Kromasil C_(18)柱(200 mm×4.6mm,5μm)甲醇-水-冰醋酸(60:37:3)为流动相,检测波长231 nm,流速1ml·min^(-1)。结果:TLC法能检出异海松酸,异海松酸的线性范围为1.25～10.00μg(r=1.000 0);加样回收率98.1%,RSD=2.3%(n=5)。结论:本法可作为抗痨胶囊质量控制方法。Objective： To establish a method of quality control for Kanglao Capsules, Method： the isopimaric acid in Kanglao capsules was identified by TLC, the content of isopimarie acid in Kanglao capsules was determined by HPLC, the Kromasil C18 column （200 mm× 4.6 ram, 5μm） was used, the methanol-water-glacial acetic acid （60：37：3 ）as mobile phase, the detection wavelength was 231 nm, the flow rate was 1. 0 ml·min^-1. Result： The isopimaricacid could be detected by TLC, the linear range of isopimaric acid was 1. 25 - 10.00 μg（ r = 1. 000 0）, the average recovery was 98, 1% with RSD 2.3% （ n = 5 ）. Conclusion： the method can be used for quality control of Kanglao capsules.

关 键 词：抗痨胶囊 薄层色谱 高效液相色谱法 质量控制 

分 类 号：TQ460.72[医药卫生—药物分析学]