不同厂家银杏叶分散片中总黄酮醇苷溶出度的研究  

Study on dissolution of total flavonoid glycoside in ginkgo biloba leaves dispersible tablets from different manufactures

作　　者：钱璟 郑成 QIAN Jing;ZHENG Cheng(Zhejiang Province Drug Cosmetics Review Center, Hangzhou 310000,China)

机构地区：[1]浙江省药品化妆品审评中心,310000

出　　处：《中国现代药物应用》2017年第8期193-194,共2页Chinese Journal of Modern Drug Application

摘　　要：目的建立银杏叶分散片的总黄酮醇苷溶出度测定方法 ,并测定比较不同厂家的银杏叶分散片的溶出度。方法采用桨法,以0.1 mol/L盐酸溶液为溶出介质,转速为100转/min,经30 min取样,离心取上清液,依照紫外可见分光光度测定法(UV)在265 nm的波长处测定吸光度,采用自身对照法计算溶出度。结果滤膜对银杏叶分散片有部分吸附,故采用离心取上清液测定;辅料基本无干扰;溶液稳定性良好。5个厂家9批银杏叶分散片样品30 min平均溶出度均达到80.0%,且均一性良好;B厂样品溶出相对偏慢,与其他厂样品溶出行为存在差异,且批间差异较大。结论紫外可见分光光度测定法用于银杏叶分散片的溶出度测定快速、简便,且具有区分力。对不同厂家银杏叶分散片的溶出度考察表明B厂制剂工艺欠稳定,产品质量可控性有待进一步提高,应关注工艺过程的中间控制。Objective To establish a dissolution test method for the total flavonoid glycoside in ginkgo biloba leaves dispersible tablets and compare the dissolution of ginkgo biloba leaves dispersible tablets from different manufactures.Methods The paddle method is applied in dissolution medium of0.1mol/L hydrochloric solution,with revolving speed as100r/min,and after30min,centrifugal clear liquid after centrifugation was sampled.Absorbance was determined at the wavelength of265nm according to ultraviolet-visible spectrophotometry(UV)method,and self-contrasted method was used to calculate the dissolution.Results Membrane had partial adsorption of ginkgo biloba leaves dispersible tablets,so determination was made on centrifugal clear liquid after centrifugation.Supplementary material was basically not interfered and the solution stability was good.The average30-min dissolution of ginkgo biloba leaves dispersible tablets in9batches of5factories was80.0%,and its uniformity was good.B factory had relatively slow sample dissolution,and there was differences in sample dissolution behavior compating with other factories,and it had large differences between batches.Conclusion Ultraviolet-visible spectrophotometry method applying for determining dissolution of ginkgo biloba leaves dispersible tablets is simple,rapid and discriminating.Dissolution investigation of ginkgo biloba leaves dispersible tablets from different manufacturers shows that B factory preparation process is unstable.Product quality controllability remains to be further improved,and more attention should be payed to middle control of craft process.

关 键 词：银杏叶分散片 溶出度 紫外分光光度法 

分 类 号：R286.0[医药卫生—中药学]