盐酸二甲双胍片的质量对比

Quality Assessment of Metformin Hydrochloride Tablets

目的对临床常用的盐酸二甲双胍片进行质量对比。方法采用中国药典方法,选择对临床作用有影响的药剂学指标,对本院曾用和在用的4个厂家5个批号的盐酸二甲双胍片进行质量对比。结果所测产品的溶出度均符合中国药典规定的45min溶出度大于标示量70%的规定,经检测含量测定均符合中国药典规定的应为标示量的95.0%～105.0%的要求。结论本院使用的盐酸二甲双胍片全部能达到药典规定的质量标准。

Aim In this paper ,two pharmaceutical indices have been selected to evaluate the quality of five lots of metformin hydrochloride tablets from four factories which are sold in PLA General Hospital with reference to Ch.P.Methods The content was determined by UV.The dissolution test was carried out using basket method,comparison was made between the results of assay and dissolution test.Results The result showed that the content of the ingredient dissolved within 45 minutes was more than 70% of the labeled amount, which complied with the requirement of Ch.P.The contents of metformin hydrochloride of five lots from four factories met the requirement of Ch.P.Being from 95.05%～105.0% of the labeled amount.Conclusion It is proved that metformin hydrochloride tablets can meet basically the requirement of the pharmacopoeia.