盐酸地芬尼多片体外溶出一致性评价研究  

Consistency Evaluation of In Vitro Dissolution of Difenidol Hydrochloride Tablets

作　　者：唐小鹏 陈莉 陈珉珉 欧阳春华 TANG Xiao-peng;CHEN Li;CHEN Min-min;OU YANG Chun-hua(Zhuzhou Institute for Food and Drug Control,Zhuzhou 412011,China)

机构地区：[1]株洲市食品药品检验所,湖南株洲412011

出　　处：《食品与药品》2018年第2期132-135,共4页Food and Drug

基　　金：湖南省食品药品监督管理局食品药品安全科技项目(湘食药科R201618)

摘　　要：目的考察盐酸地芬尼多片国产仿制药与原研药的体外溶出一致性。方法采用高效液相色谱法(HPLC)测定盐酸地芬尼多在不同溶出介质中的溶解度,绘制溶解度曲线。测定A、B、C三厂家自研剂与原研药在4种不同溶出介质(pH 1.2盐酸溶液、pH 4.0醋酸盐溶液、pH 6.8磷酸盐溶液、水)中的溶出度,分别绘制溶出曲线,并采用相似因子(f_2)法对自研剂和原研剂的溶出曲线进行拟合分析。结果 A、B、C三厂家国产仿制药在pH 1.2盐酸溶液、pH 4.0醋酸盐溶液、水中的溶出行为与原研药一致,而在pH 6.8磷酸盐溶液中,仅B厂产品与原研药溶出曲线一致。结论部分国产仿制药尚需进行工艺改进,以达到与原研药体外溶出一致。Objective To research the in vitro dissolution consistency between the generic and original preparations of Difenidol Hydrochloride Tablets.Methods The solubility of difenidol hydrochloride in different dissolution mediums were determined by HPLC,and the solubility curves were drawn.The dissolution of the generic preparations from A,B,C companies and the original preparation in 4 different dissolution mediums(pH 1.2 hydrochloric acid solution,pH 4.0 sodium acetate solution,pH 6.8 phosphate solution,water)were determined,then the dissolution curves of those preparations were drawn,and the similarity factors(f2)were calculated to evaluate the in vitro dissolution consistency between the generic and original preparations.Results The dissolution properties of the generic preparations from A,B,C companies were similar to the original preparation in pH 1.2 hydrochloric acid solution,pH 4.0 sodium acetate solution and water.But in pH 6.8 phosphate solution,only the preparation B has similar dissolution curve to original preparation.Conclusion Some generic preparations need to be improved in order to have the same in vitro dissolution as original preparation.

关 键 词：盐酸地芬尼多片 体外溶出 一致性评价 相似因子 

分 类 号：R943[医药卫生—药剂学]