用多条溶出曲线评价盐酸氟桂利嗪胶囊的质量  

Quality evaluation of Flunarizine Hydrochloride Capsules by dissolution profiles in different dissolution mediums

作　　者：李青翠 解钰 高平[2] LI Qingcui;XIE Yu;GAO Ping(Shanxi Institute for Food and Drug Control,Taiyuan 030001,China;Shanxi Medical University,Taiyuan 030001,China)

机构地区：[1]山西省食品药品检验所,山西太原030001 [2]山西医科大学,山西太原030001

出　　处：《药学研究》2018年第11期649-653,共5页Journal of Pharmaceutical Research

摘　　要：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、p H 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pH4.0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。Objective To study the dissolution profiles of domestic Flunarizine Hydrochloride Capsules and the reference preparation in four dissolution mediums,so as to evaluate the drug quality. Methods The solubility and stability of flunarizine hydrochloride in pH 1.2 hydrochloric acid solution,pH 4.5 acetate buffer solution,pH 6.8 phosphate buffer solutions and water were investigated.The dissolution media of Flunarizine Hydrochloride Capsules were optimized and the dissolution profiles were determined by basket method at a rotated speed of 100 rpm.The Results were compared and analyzed by f 2 factor. Results The imported localized Flunarizine Hydrochloride Capsules from manufacturer A were taken as reference preparation.The dissolution profiles of Flunarizine Hydrochloride Capsules from manufacturer B and E were similar to the reference preparation only in pH 1.2 hydrochloric acid solution,the dissolution process of preparations from manufacturer C was similar to reference preparation in pH 1.2 hydrochloric acid solution and water,and the dissolution profiles of flunarizine hydrochloride capsules from manufacturer D were similar to reference preparation in pH 1.2 hydrochloric acid solution and pH 4.0 acetate buffer.pH 4.0 acetate buffer was selected as the dissolution medium to determine the dissolution of Flunarizine Hydrochloride Capsules. Conclusion There were differences in quality between domestic generic drugs and reference preparations,which still need to be improved in the prescription technology and control of drug production process.

关 键 词：盐酸氟桂利嗪胶囊 溶出曲线 F2因子 

分 类 号：R927.11[医药卫生—药学]