国产洛伐他汀胶囊溶出度质量评价

目的：考察国内不同药品生产企业洛伐他汀胶囊的溶出情况，评价药品质量。方法：采用转篮法，以1．0％十二烷基硫酸钠的磷酸盐溶液900ml为溶出介质，转速100r·min^-1。采用f2因子法，考察国内14个药厂的洛伐他汀胶囊与参比药厂的洛伐他汀胶囊溶出度的差异。结果：4个药厂的洛伐他汀胶囊f2值大于50，溶出度与参比制剂相似。其他10个公司的洛伐他汀胶囊f2值小于50，溶出度与参比制剂存在明显差异。结论：仿制药品的质量有待提高。

Quality Evaluation of Dissolution for Domestic-made Lovastatin Capsules

Objective ： To evaluate the quality of lovastatin capsules by determining the dissolution of lovastatin capsules from different manufactures. Method： The dissolution tests were proceeded using basket method at 100 r.min^-1, and 1.0% SDS-phosphate solution was used as medium. The different of dissolution rate was evaluated by f2 factor method. Result： The f2 factors of lovastatin capsules produced by four factories were over 50, the drug release behaviour were similar to that of the reference preparation. The f2 factors of the other ten factories were below 50, the drug release behaviour had significant difference from that of the reference preparation. Conclusion： The quality of imitative drug needes to be improved furthermore.