论文部分内容阅读
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900 ml为溶出介质,转速100 r·min~(-1)。采用f_2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f_2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f_2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。
Objective: To investigate the dissolution of lovastatin capsules from different domestic pharmaceutical manufacturers and to evaluate the quality of medicines. Methods: Using spin basket, 900 ml phosphate solution of 1.0% sodium dodecyl sulfate was used as dissolution medium and the speed of rotation was 100 r · min ~ (-1). The f_2 factor method was used to investigate the dissolution of lovastatin capsules in 14 domestic pharmaceutical factories and lovastatin capsules in reference pharmaceutical factories. Results: The f_2 values of lovastatin capsules in four pharmaceutical factories were greater than 50, and their dissolution rates were similar to those of reference preparations. Lovastatin capsules of the other 10 companies had a f 2 value of less than 50 and there was a clear difference in dissolution between the two formulations. Conclusion: The quality of generic drugs needs to be improved.