酒石酸美托洛尔片仿制药与原研药溶出曲线的相似性评价
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篇名: 酒石酸美托洛尔片仿制药与原研药溶出曲线的相似性评价
TITLE:
摘要: 目的:建立酒石酸美托洛尔片的溶出度测定方法,并评价仿制药与原研药的质量一致性。方法:采用桨法,转速为50 r/min,分别以pH 1.2盐酸溶液、pH 4.5醋酸盐缓冲液和pH 6.8磷酸盐缓冲液为溶出介质,用光纤药物溶出度实时测定仪以10 mm的测定光程,分别测定酒石酸美托洛尔片仿制药与原研药的溶出曲线,并采用相似因子(f2)法评价二者溶出曲线的相似性。结果:在3种溶出介质中,酒石酸美托洛尔片仿制药与原研药的f2分别为80.5、66.8、69.4,说明二者溶出曲线具有相似性。结论:所建立的实时溶出度过程分析方法适用于酒石酸美托洛尔片的溶出度测定;仿制药与原研药的体外溶出行为具有相似性,故其质量一致性较好。
ABSTRACT: OBJECTIVE: To establish the method for dissolution determination of Metoprolol tartrate tablets, and to evaluate the similarity of dissolution curves of generics and original drugs. METHODS: The paddle method was adopted with rotational the speed of 50 r/min, using pH 1.2 hydrochloric acid solution, pH 4.5 acetate buffer solution and pH 6.8 phosphate buffer solution as dissolution media. Fiber-optical drug dissolution real-time measurement instrument was used to determine the dissolution curves of generic and original Metoprolol tartrate tablets with optical distance of 10 mm. Similarity factor (f2) method was used to evaluate its similarity. RESULTS: In 3 dissolution mediums, the f2 of generic and original Metoprolon tartrate tablets were 80.5, 66.8, 69.4, respectively, which indicated that the dissolution curves showed similarity. CONCLUSIONS:Established real-time dissolution process analysis method is suitabe for the dissolution determination of Metoprolol tartrate tablets. Generic and eriginal show the similarity in dissolation behavier,so they have good consistency in quality.
期刊: 2017年第28卷第9期
作者: 孔彬,李新霞,裴贵珍,漆新文,李文军
AUTHORS: KONG Bin,LI Xinxia,PEI Guizhen,QI Xinwen,LI Wenjun
关键字: 酒石酸美托洛尔片;溶出曲线;光纤药物溶出度实时测定仪;相似因子
KEYWORDS: Metoprolol tartrate tablets; Dissolution curves; Fiber-optical drug dissolution real-time measurement instrument; Similarity factor
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