湿热痹片质量标准研究  

Quality Standards Research of Shirebi Tablets

作　　者：董斌 刘静 季雪 彭博 邵建芳[2] 施法 

机构地区：[1]大连市药品检验所,辽宁大连116021 [2]大连市药品不良反应监测中心,辽宁大连116021 [3]辽宁省药品检验检测院,辽宁沈阳110000

出　　处：《中国药物评价》2016年第1期3-6,共4页Chinese Journal of Drug Evaluation

摘　　要：目的:修订湿热痹片质量标准。方法:采用薄层色谱(TLC)法鉴别防己、黄柏和地龙;采用高效液相色谱(HPLC)法测定湿热痹片中连翘的活性成分连翘苷的含量:使用安捷伦ZORBAX SB-C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈-0.1%磷酸溶液(20∶80)为流动相,流量1.0 m L·min^(-1)。结果:TLC鉴别专属性强,连翘苷在0.01665~0.1665μg线性关系良好,平均回收率为99.5%(RSD=1.1%,n=9)。结论:该方法准确,重复性好,可用于湿热痹片的质量控制。Objective： To establish a quality standard for shirebi tablets. Methods： The TLC method was used for thequalitative identification of Fourstamen Stephania Root,Cortex Phellodendri Amurensis and Pheretima Aspergillum. The content of Phillyrin was determind by HPLC. HPLC was carried on with a Agilent ZORBAX SB-C18（ 4. 6 mm × 250 mm,5 μm） column,acetonitrile-0. 1% phosphoric acid（ 20∶ 80） as the mobile phase at the flow rate of 1. 0 m L·min（- 1）. Results： The identification studys showed strong specificity. The calibration curves were linear in the range of 0. 01665-0. 1665 μg for Phillyrin. The average recovery rate was 99. 5% with RSD 1. 1%（ n = 9）. Conclusion： The method is accrate with a good reproducibility,and suitable for quality control of shirebi tablets.

关 键 词：湿热痹片 质量标准 薄层色谱法 连翘苷 高效液相色谱法 

分 类 号：R286.0[医药卫生—中药学]