提高硫酸氢氯吡格雷片内在质量

Improve the quality of Clopidogrel Bisulfate Tablets

目的比较硫酸氢氯吡格雷片在研药与原研药在四种溶出介质中的溶出曲线,计算f2相似因子,从而提高在研硫酸氢氯吡格雷片内在质量。方法分别测定2种片剂在p H 1.2盐酸缓冲液、p H 6.8磷酸盐缓冲液、p H4.5磷酸盐缓冲液和水中的溶出曲线,通过f2相似因子确定相似性。结果在四种溶出介质中的f2相似因子分别为71.4、51.8、86.8、60.1。结论在研药与原研药在四种溶出介质中的溶出曲线相似。

Objective To improve the quality of generics of Clopidogrel Bisulfate Tablets,the stripping curves of brand name drug and generics of Clopidogrel Bisulfate Tablets in four different mediums were compared,then calculate the f2 factor. Methods The stripping curves of the two tablets in p H 1. 2 hydrochloric acid-potassium chloride buffer solution,p H6. 8 phosphate buffer,p H 4. 5 phosphate buffer and water were tested respectively,the similarity was investigated according to the f2 factor. Results The f2 factors between two tablets in four different mediums were 71. 4,51. 8,86. 8 and 60. 1,respectively. Conclusion There were significant similarity between the stripping curves of brand name drug and generics in four different mediums