采用不同介质中的溶出曲线评价硫酸氢氯吡格雷片的内在质量

Evaluation of Clopidogrel Bisulfate Tablets by Dissolution Profiles in Different Mediums

关键词:  硫酸氢氯吡格雷片  溶出曲线  f₂相似因子

Key words:  clopidogrel bisulfate tablet  dissolution profile  f₂ similarity factor

摘要:

目的 比较硫酸氢氯吡格雷片仿制药与原研药在4种不同溶出介质中溶出曲线的相似性。方法 分别以pH 2.0盐酸缓冲液、pH 4.5磷酸盐缓冲液、pH 6.8磷酸盐缓冲液和水为溶出介质测定2种片剂的体外溶出曲线，并采用f₂相似因子法考察其相似性。结果 在4种不同溶出介质中，2种片剂溶出曲线的f₂值分别为56，80，78和75。结论 2种片剂的体外溶出曲线在4种不同溶出介质中均相似。

Abstract:

OBJECTIVE To compare the dissolution profiles of brand name drug and generics of clopidogrel bisulfate tablets in four different medium. METHODS The dissolution profiles of brand name drug and generics in four different medium (pH 2.0 hydrochloric acid-potassium chloride buffer solution, pH 4.5 phosphate buffer, pH 6.8 phosphate buffer and water) was determined and the similarity was investigated according to the f₂ factor method. RESULTS The f₂ factors between two tablets in four different medium were 56, 80, 78 and 75, respectively. CONCLUSION The dissolution profiles of brand name drug and generics in four different medium have significant similarity.