国产和进口盐酸二甲双胍片溶出对比研究

目的比较国产与进口盐酸二甲双胍片在不同介质中的溶出行为,评价其相似性。方法采用桨法(转速为50 r/min)、温度(37±5)℃溶出、紫外-可见分光光度法在波长233 nm处测定吸光度,测定进口和国产盐酸二甲双胍片在4种不同介质(水、pH 1.2、pH 4.0、pH 6.8缓冲液)中的累积溶出度。结果在pH 1.2介质中,进口片剂在不同时间点的累积溶出度明显高于国产片剂;在pH 4.0介质中,片剂在不同时间点累积溶出度进口比国产高;在水和pH 6.8介质中,国产片剂与进口片剂溶出行为和累积溶出度比较接近。结论本品国产与进口片剂存在差异。

Dissolution contrast between domestic and imported metformin hydrochloride tablets

Objective To compare the domestic and imported metformin hydrochloride in dissolution behavior of different media and evaluate its similarity. Methods Imported and domestic metformin hydrochloride in four different medium（Water,pH 1.2,pH 4.0,pH 6.8 buffer） of the accumulation of dissolution were detected through the paddle method（speed of 50 r/min） for dissolution,ultraviolet-visible spectrophotometry for absorbance. Results In pH 1.2medium,imported tablets at different time points,acumulative dissolution was obvious higher than that of domestic tablets;In pH 4.0 medium,the tablet at different time points accumulated dissolution import was higher than domestic;In water and pH 6.8 medium,domestic and imported tablet dissolution behavior tablet and cumulative dissolution were basically identical. Conclusion There was difference between domestic and imported tablet in high acidity medium dissolution.