胆宁片质量标准研究  

Studies on Quality Standard for Danning Tablets

作　　者：胡剑 梁仪容 夏德豪 王伟姣 乐立源 李村子 

机构地区：[1]邵阳市药品检验所,湖南邵阳422001

出　　处：《中医药导报》2005年第12期59-61,共3页Guiding Journal of Traditional Chinese Medicine and Pharmacy

摘　　要：目的:对胆宁片进行质量标准研究.方法:采用薄层色谱法对人工牛黄中贝斯素进行定性鉴别,以异辛烷-甲苯-正丁醇-冰乙酸-乙醇-水(1:4:4:2:1:1)为展开剂.采用高效液相色谱法对人工牛黄中胆红素进行含量测定,采用Kromasil C18色谱柱(4.6mm×250mm,5μm),流动相:甲醇-氯仿-1%磷酸溶液(70:24:6),检测波长:450nm,流速:1.0ml·min-1.结果:薄层色谱鉴别方法专属性强,含量测定胆红素在2.45～17.2μg·ml-1浓度范围内呈良好的线性关系,r=0.9996,平均回收率为100.2%,RSD为1.8%(n=9),重复性试验RSD为0.7%(n=9),结论:所建立的方法可准确、快速地进行定性、定量检测,适用于该制剂的质量控制.Objective： To Study on quality Standard for Danning Tablets. Methods： TLC was used to quantitative identified Bei- sisu in artifical ox gallstone, using isooctane - toluene - n - butanol - glacial acetic acid - ethanol - water（ 1 ： 4 ： 4 ： 2 ： 1 ： 1 ） as developing solvent. To establish a determination method of bilirubin in artifical ox gallstone by HPLC, the Kromasil C18 column（4.6mm × 250mm, 5 μm） was used, mobile phase： methanol - chloroform - 1% phosphoric acid solution （70 ： 24 ： 6 ）, detection wavelength： 450nm, flow rate was 1.0 ml · min^-1. Results ： The TLC identification was highly specific. Bilirubin showed a good linear relationship at the range of 2.45 ～17.21μg·ml^-1, with a correlative coefficient 0.9996. The average recovery was 100.2%, and RSD was 1.8% （n =9）, and RSD in the repeatability test was 0.7% （n =9）. Conclusion： This method is accurate and quick, can be used for the quality control of this table.

关 键 词：胆宁片 人工牛黄 高效液相色谱法 胆红素 薄层色谱法 贝斯素 

分 类 号：R927.11[医药卫生—药学]