多条溶出曲线评价盐酸二甲双胍片的溶出行为

Evaluation of Metformin Hydrochloride Tablets by Dissolution Curves in Different Media

目的:比较7个厂家盐酸二甲双胍片在4种溶出介质中的溶出曲线,评价进口制剂与仿制制剂的溶出行为。方法:采用篮法,转速为100 r·min-1,分别以p H 1.0盐酸溶液、p H 4.5醋酸盐缓冲液、p H 6.8磷酸盐缓冲液、水为溶出介质,以紫外分光光度法测定溶出曲线,采用f2因子对溶出曲线的相似度进行评价。结果:在4种不同溶出介质中,仅有1个厂家盐酸二甲双胍片的4条溶出曲线与进口制剂相似,还有4家制剂的4条溶出曲线与进口制剂均不相似。结论 :多数仿制制剂的溶出曲线与参比制剂不相似,建议改进制剂处方与工艺。

Objective: To compare the dissolution profiles of metform hydrochloride tables from seven pharmaceutical manufactures in four different dissolution media and evaluate the quality difference between the imported and the generic drugs. Methods: On the basis of the rotating basket method with the rotate speed at 100 r·min-1, the dissolution testing of tablets in various media at different p H values were performed by using UV spectrometry. The similarities of dissolution curves were analyzed by the f2 similarity factor. Results: Generic tablets from one manufacturer had similar dissolution profiles to the imported drugs in different dissolution media, while there were significant differences in the four dissolution curves between the generic tables from each of other manufacturers and the imported drugs. Conclusion: Most home manufactures cannot produce high-quality generic drugs with similar dissolution profiles to the original drugs.The results suggest that home manufactures should improve the production of generic drugs by changing the formulation and preparation process.