UV法测定盐酸二甲双胍肠溶胶囊酸中释放度方法的探讨  

Study on the method for determinate in vitro releasing ratio of metformin hydrochloride enteric-coated capsules

作　　者：吕昭云 张艳红 张秋佳 吕亚光 赵显贵 

机构地区：[1]北京协和药厂,北京102600 [2]国家新药开发工程技术研究中心,北京102600

出　　处：《药物分析杂志》2007年第8期1278-1280,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立盐酸二甲双胍肠溶胶囊释放度测定方法。方法:采用 UV 法测定盐酸二甲双胍肠溶胶囊在0.1 mol·L^(-1)盐酸溶液及 pH 6.8磷酸盐缓冲液中的释放度。结果:0.1 mol·L^(-1)盐酸溶液对释放度测定的影响较大,依现行药品标准直接测定,回收率仅为40.5%;我们将酸中释放液用0.2 mol·L^(-1)磷酸钠溶液调 pH 约6.8后测定,回收率为100.3%。结论:现行药品标准中盐酸二甲双胍肠溶胶囊酸中释放度测定方法不合理,须进行调整。Objective： To establish an UV method to determinate vitro releasing ratio of metformin hydrochloride enteric - coated capsules. Methods： An UV method was applied to determinate vitro releasing ratio of mefformin hydrochloride enteric - coated capsules in 0. 1 mol · L^-1 hydrochloric acid solution and pH 6.8 phosphate buffer saline. Results： The outcome of the vitro releasing ratio of metformin hydrochloride enteric - coated capsules in 0. 1 mol·L^-1 hydrochloric acid solution was not accurate when determinated with the method following the state drug specification, and the recovery was only 40.5 % ;we adjusted the pH of the sample of 0. 1 mol·L^-1 hydrochloric acid solution to pH 6. 8 by adding 0. 2 mol·L^-1 sodium phosphate, and the recovery reached 100. 3%. Conclusion ： The method of the state drug specification to determinate vitro releasing ratio of mefformin hydrochloride enteric -coated capsules in 0. 1mol·L^-1 hydrochloric acid solution is unreasonable and must to be adjusted.

关 键 词：盐酸二甲双胍 UV法 释放度 

分 类 号：R917[医药卫生—药物分析学]