二甲双胍的溶出度试验

目的建立二甲双胍片的溶出度试验方法,对3厂家生产的二甲双胍片（普通片,格华止和倍顺）的含量和溶出度进行比较。方法以蒸馏水1000mL为溶出介质,采用转篮法测定溶出度,转速为100r·min^-1,温度为（37.0±0.5）℃;用紫外分光光度法测定含量,测定波长为233nm,并对溶出参数进行了统计学处理。结果各厂家二甲双胍片的溶出曲线有较大差异。结论不同厂家生产的不同二甲双胍片的溶出度明显不一致,进行溶出度检查有助于控制药品质量。

The dissolution rates of metformin

OBJECTIVE To establish a dissolution measurement method for Metformin and to determine the contents and dissolution of Metformin（Metformin tablets,Ge Hua Zhi,Bei Shun）produced in 3 factories.METHODS The dissolution was measured in Distilled water as medium,according to the first method described in the appendix XC of Chinese Pharmacopoeia（edition 2000）.The rotational speed was 100 r·min-1,and the temperature was（37.0±0.5）℃。The contents was measured by UV at the wavelength of 233nm.The dissolution parameters of the different products were processed with statistical analysis.RESULTS The dissolution curve for Metformin from the different manufactures had significant difference.CONCLUSION The dissolution rate of Metformin from the different manufactures is remarkably different,the dissolution measurement is necessary for quality control.