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Quality evaluation of Flunarizine Hydrochloride Capsules by dissolution profiles in different dissolution mediums
Author(s): 
Pages: 649-653
Year: Issue:  11
Journal: Qilu Pharmaceutical Affairs

Keyword:  盐酸氟桂利嗪胶囊溶出曲线f2因子;
Abstract: 目的 研究国产盐酸氟桂利嗪胶囊与参比制剂在4种溶出介质中的溶出曲线,以评价该制剂的质量.方法 考察盐酸氟桂利嗪原料在pH 1.2盐酸溶液、pH 4.0醋酸盐缓冲液、pH 6.8磷酸盐缓冲液和水中的溶解度与稳定性,并采用篮法,转速为100 rpm,优化盐酸氟桂利嗪胶囊溶出度测定的溶出介质,测定溶出曲线,并用f2因子法进行比较分析.结果 以A企业某进口本地化的上市产品为参比制剂,B、E企业只有在pH 1.2盐酸溶液中与参比制剂溶出过程相似,C企业在pH 1.2盐酸溶液和水中与参比制剂溶出过程相似,D企业在pH 1.2盐酸溶液和pH 4.0醋酸盐缓冲液中与参比制剂溶出过程相似.选择pH 4.0醋酸盐缓冲液作为测定盐酸氟桂利嗪胶囊溶出度的溶出介质.结论 国内仿制药与参比制剂在内在质量上存在差距,仍需在处方工艺和生产过程控制方面有所改进.
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