盐酸二甲双胍片剂质量评价

Quality assessment of metformin tablets

目的 :选择对临床作用有影响的药剂学指标 ,参照中国药典方法对 10个厂家 18个批号的盐酸二甲双胍片剂进行质量评价。方法 :以紫外分光光度法测定含量 ,用转篮法测定溶出度 ,并就溶出和含量进行分析比较。结果 :所测产品的溶出均达到中国药典规定的 45min溶出应大于标示量 70 %的要求 ;中国药典规定其含量应为标示量的 95 .0 %～ 10 5 .0 %。经检测被评价的 10个厂家 18个批号上市产品中 9个厂家 17个批号的产品达到中国药典要求 ,约占厂家的 90 %和产品总数的 94%。结论

OBJECTIVE:In this paper,two pharmaceutical indice have been selected to evaluate the quality of eighteen lots of metformin tablets from ten factories which are sold in tianjin with reference to ChP.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 labelled amount,which complied with the requirement of ChP. The content of metformin of seventeen lots from nine factories met the requirement of ChP, being from 95.0 % to 105.0 % of the labelled amount. 90% of the faotories evaluated and 94% of the products tested are up to standard.CONCLUSIONS:It is proved that metformin tablets can meet basically the requirment of the pharmacopoeia. [