不同厂家盐酸二甲双胍普通片和缓释片体外溶出度分析

目的：建立盐酸二甲双胍片的溶出度试验方法，对6个厂家生产的盐酸二甲双胍普通片和4个厂家生产的缓释片含量和溶出度进行测定。方法：以纯化水1000ml作为溶出介质，采用转篮法测定溶出度，转速均为100r·min-1，温度为（37．0±0．5）C，用紫外分光光度法测定含量，测定波长为233nm，并对溶出参数进行了S-N—K统计学处理。结果：各厂家生产的盐酸二甲双胍片含量均符合药典规定，但各厂家盐酸二甲双胍片的溶出参数（T50、Td、m）差异明显。结论：不同厂家生产的盐酸二甲双胍片的溶出度行为明显不一致，进行溶出度检查有助于控制质量。

Vitro dissolution of metform hydrochloride uncoated tablets and sustained -release tablets produced by different manufacturers

Objective To establish a dissolution measurement method for metformin hydroehloride tablets and to determine the content and vitro dissolution of metformin hydrochloride uncoated tablets produced by 6 factories and sustained--release tablets produced by 4 factories. Methods The dissolution was measured in distilled water 1000ml as medium,according to the first method described in Chinese pharmacopoeia（2010） appendix XC. The rotational speed was 100r · min-1,and the temperature was（37.0±0.5）C. The content was measured by UV spectrophotometry at 233nm, then the dissolutive parameters of different products were processed with S-N- K statistical analytics. Results The content of metformin hydrochloride tablets produced by different manufacturers were up to Chinese Pharmacopoeia standard but the tablets dissolution parameters（T50,Td,m）had obvious differences. Conclusions The dissolution rates of metformin hydrochloride tablets produced by different manufacturers are remarkably different ,so dissolution measurement is needed for quality control.