盐酸二甲双胍缓释片的研制及稳定性考察

Synthesis and stability investigation of metformin hydrochloride extended release tablets

目的研究开发盐酸二甲双胍缓释片,筛选制剂处方工艺,并考察其稳定性。方法通过对缓释材料种类、缓释材料用量、填充剂用量、润湿剂种类等进行筛选确定产品处方;通过分析研究原料药粒径、制粒的粒化时间、干燥温度、混合时间、片剂硬度对产品稳定性的影响,从而确定盐酸二甲双胍缓释片的制备工艺。结果按照优化的处方工艺制备三批样品进行关键质量属性比对及稳定性考察,结果均合格。结论该制剂处方合理,工艺可行,产品质量水平与参比制剂相当,质量可控,稳定性良好。

Objective To research and develop the prescription and process of metformin hydrochloride extended release tablet,and investigate its stability.Methods The prescription was determined by screening the type of sustained-release material,the dosages of extended release material and filler,and the types of wetting agent et.al.The effects on the stability of the product were studied by the evaluation of the particle size of drug substance,the granulation time,the drying temperature,the mixing time and the tablet hardness,and then the preparation process of metformin hydrochloride extended release tablets was determined.Results The key quality parameters and stability of three batches of samples according to the optimized prescription and process were compared with the reference preparation.The results are all qualified.Conclusions The prescription of the product is reasonable and the craft process is feasible.The quality of metformin hydrochloride extended release tablets prepared via the optimized prescription and craft is equivalent to the reference preparation,and the stability is qualified.