过程分析考察不同厂家盐酸二甲双胍片的溶出度

A Comparison of the Dissolution Rate of Metformin Hydrochloride Tablets from Different Manufacturers with Process Analysis

目的利用光纤溶出度过程分析方法,监测盐酸二甲双胍片的溶出度,通过实时在线监测药片溶出情况反映不同厂家生产的药片质量的差异。方法采用《中国药典》中规定的检测盐酸二甲双胍片溶出度的条件,利用光纤传感溶出度实时过程分析方法对6个不同厂家的盐酸二甲双胍片进行了实时监测。结果6个厂家的溶出曲线明显不同,可真实地反映每粒药片的溶出过程。结论光纤溶出度过程分析,真实地反映了不同厂家药片的溶出行为,对评价药品内在品质提供了有效方法。

Aim To establish a method which can monitor the dissolution rate of metformin hydrochloride tablets by fiber-optic dissolution test system on line and reflect the quality difference of tablets from different manufacturers.Methods According to dissolution test conditions specified in Ch.P,the dissolution of metformin hydrochloride tablets from six different manufacturers was tested by fiber-optic dissolution test system.Results The dissolution curves of tablets from six manufacturers were different.This process analysis showed the real dissolution performance of each tablet.Conclusion The quality of tablets from different manufacturers can be evaluated by the fiber-optic dissolution test system,providing an effective mothod of evaluating the quality of the drug.