采用多条溶出曲线评价国产盐酸普罗帕酮片的内在质量  

Quality evaluation of domestic propafenone hydrochloride tablets by multiple dissolution curves

作　　者：杨林 侯小梅 龚士学 罗立骏 

机构地区：[1]重庆市食品药品检验所,重庆401121 [2]永川区食品药品检验所,永川402160

出　　处：《药物分析杂志》2014年第2期372-375,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:利用光纤药物溶出度实时测定仪,研究国产盐酸普罗帕酮片在不同pH介质中的溶出曲线,评价制剂质量。方法:采用浆法,转速50 r·min-1,以pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水为溶出介质,采用光纤药物溶出度实时测定仪测定国产盐酸普罗帕酮片与进口制剂的溶出曲线,并用AV值法与日本橙皮书公布的溶出曲线进行比较。结果:国产样品在4种介质中溶出行为差异很大,溶出曲线与橙皮书参比曲线全部不相似。结论:国产盐酸普罗帕酮片制剂工艺与国外有较大差异,各厂家产品质量参差不齐。Objective： To study dissolution curve profiles of domestic propafenone hydrochloride tablets in different pH media by the fiber-optic real time dissolution test system and evaluate the drug quality. Methods： The paddle method was used at a rate of 50 r·min^-1,the dissolution curves of domestic and imported propafenone hydrochloride tablets were detected in the following four media including water,pH 1.2 hydrochloric acid solution,pH 4.0 acetate buffer solution,and pH 6.8 phosphate buffer solution by the fiber-optic real time dissolution test system,and the results were compared with the dissolution curves published in the Japanese Orange Book by method of AV value. Results： The comparison indicated that the dissolution process of domestic products were quite different in the four media,the dissolution curves were all distinctly dissimilar with the reference curves in the Orange Book. Conclusion： There is significant difference in the quality of domestic products from several manufacturers and a pronounced gap exists as compared between the domestic manufacturing technique and the abroad.

关 键 词：盐酸普托帕酮片 溶出曲线 光纤药物溶出度实时测定仪 AV值法 不良反应 

分 类 号：R917[医药卫生—药物分析学]