光纤过程分析考察14家盐酸二甲双胍片的溶出度  

Inspection of Dissolution Rate of Metformin Hydrochloride Tablets from Fourteen Different Manufacturers with Fiber-optic Process Analysis

作　　者：赵昕[1] 张鹏[1] 许志军[2] 王锦[1] 张广春[1] 

机构地区：[1]沈阳军区联勤部药品仪器检验所,沈阳110026 [2]吉林大学和平校区计算机系

出　　处：《中国药师》2010年第7期981-983,共3页China Pharmacist

摘　　要：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而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14个不同厂家的盐酸二甲双胍片进行了实时监测。结果:14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,对改进制剂工艺、监控制剂工艺稳定性及控制产品质量以及评价药品内在品质提供了有效方法。Objective： To establish a method to monitor the dissolution rate of mefformin hydroehloride tablets by fiber-optic dissolution test system. Through on-line monitoring the dissolution rate of tablets from different manufacturers, the different quality of tablets was obtained. Method： According to dissolution test condition of Ch. P,the dissolution of mefformin hydroehloride tablets from fourteen different manufacturers were tested by fiber-optic dissolution test system. Result： The dissolution curves of tablets from fourteen manufacturers were different. This process analysis showed the real dissolution performance of each tablet. Conclusion： The quality of tablets from different manufacturers can he evaluated by the fiber-optic dissolution test system. It can provided useful irfformation in preparation process improving, monitoring the stability of preparation and the quality control. And this method provides an effective way of evaluating the quality of the drug.

关 键 词：光纤过程分析 盐酸二甲双胍片 溶出度 

分 类 号：R927.2[医药卫生—药学]