盐酸二甲双胍薄膜衣片剂质量评价

Evaluation on the quality of metformin membrane tablets

目的:选择对临床作用有影响的药剂学指标,依照《中国药典》规定对天津地区市售6个厂家12个批号的盐酸二甲双胍薄膜衣片剂进行质量评价。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:6厂家产品的溶出度均达到《中国药典》规定的要求。结论:经检测被评价的6个厂家12个批号上市产品质量有差异,其中5个厂家11个批号的产品符合《中国药典》规定标准,1个厂家产品含量偏低。

Object： According to ChP, two pharmaceutical indices that hold effects on clinic have been selected to evaluate the quality of 12 lots of metformin tablets from six plants, which are sold in Tianjin area. Methods ： The total content determined by UV and the dissolution was compared. Results ： The results showed that the content of the ingredient dissolved within 45 minutes was more than 70% of labeled amount, which complies with the requirement of ChP. Conclusion： The criterion of ChP is that the normal content of the medicine should be between 95.0% and 105.0%. The qualities of the product of the six plants were of some difference. 11 lots of metformin tablets from 5 plants complied with the requirement of ChP, while one plant fails to meet the standard （batch No： 971217）, i.e. the content of metformin of the product was below 95.0%.