盐酸二甲双胍片制备及体外一致性评价

Preparation and External Consistency Evaluation of Metformin Hydrochloride Tablets

目的:以QbD理念为核心设计处方,以期制得与参比制剂溶出行为相似的样品。方法:以QbD为核心,利用风险评估的方法,选取高风险因素设计正交试验,使用软件对结果分析,并测定自制品的溶出曲线,计算f _2。结果:当甘露醇和玉米淀粉为10 mg/片、5 mg/片,羟丙甲纤维素8 mg/片,制粒时间为45 s时,溶出度和脆碎度最优,自制品与参比制剂比较,在四种介质(水、pH 1.2、pH4.0、pH 6.8)中溶出曲线相似因子f _2分别为66、69、76、72。结论:自制样品与参比制剂在4种介质中溶出行为相似。

Objective：To design the formulation based on the concept of QbD, in order to prepare the sample that has similar dissolution behavior with reference listed drug.Methods：With the methods of QbD and risk evaluation,high risk factors were used for designing orthogonal test, and the software was used to analyze the results. And then samples dissolution curve were determined and similarity factor f2 was calculated. Results：when the amount of mannitol,starch and HPMC was 10 mg/tablet,5 mg/tablet,8 mg/tablet,the granulation time was 45 s,the best solubility and crispness can be achieved. Compared reference listed drug,the f2 of self-prepared samples was respectively 66,69,76 and 72 in four kinds of dissolution media（water,pH1.2,pH4.0,pH6.8）. Conclusion：the dissolution behaviors of self-prepared samples and the reference listed drug are similar in four kinds of dissolution media.