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目的:通过考察国内不同药品生产企业辛伐他汀胶囊的溶出情况评价药品质量。方法:参照日本在“药品品质再评价”拟定流程中对溶出度试验条件的规定,分别考察不同厂家辛伐他汀胶囊在含0.5%十二烷基硫酸钠(SDS)的蒸馏水、含0.5%SDS的pH 1.2溶液、含0.5%SDS的pH 4.0醋酸盐缓冲液、含0.5%SDS的pH 7.0磷酸盐缓冲液四种溶出介质中的体外溶出行为,溶出方法采用篮法,转速为100 r.min-1。采用f 2相似因子法,考察国内9家企业的辛伐他汀胶囊与参比制剂溶出度的差异。结果:国内9家企业的辛伐他汀胶囊与参比制剂比较,其f 2因子基本上均小于50,溶出度与参比制剂不相似。结论:国内不同生产企业的辛伐他汀胶囊与参比制剂的溶出度有显著差异,仿制药品的质量有待提高。
Objective: To evaluate the quality of medicines by examining the dissolution of simvastatin capsules in different domestic pharmaceutical manufacturers. Methods: With reference to Japan’s prescription of dissolution test conditions in the process of “re-evaluation of drug quality” in Japan, simvastatin capsules of different manufacturers were respectively tested in 0.5% sodium dodecyl sulfate (SDS) % SDS in pH 1.2, 0.5% SDS in pH 4.0 acetate buffer, 0.5% SDS in pH 7.0 phosphate buffer in vitro dissolution behavior of the four dissolution media, dissolution method using the basket method, the speed of 100 r.min-1. Using f 2 similarity factor method, the differences of dissolution rate of simvastatin capsules and reference preparations in 9 domestic enterprises were investigated. Results: Compared with the reference preparations, the simvastatin capsules in nine domestic enterprises showed that the f 2 factors were all less than 50, and the dissolution rates were not similar to the reference preparations. Conclusion: The dissolution rates of simvastatin capsules and reference preparations in different domestic manufacturing enterprises are significantly different, and the quality of generic drugs needs to be improved.