今日药学

2012, v.22(03) 142-144+147

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氟康唑胶囊体外溶出度的质量评价
Evaluation of Dissolution in Vitro of Fluconazole Capsules

严小红;陈安丽;丘文嘉;江英桥;霍秀敏;邵颖;
YAN Xiao-hong1,CHEN An-li1,QIU Wen-jia1,JIANG Ying-qiao1,HUO Xiu-min2,SHAO Ying2(1.Guangzhou Institute for Drug Control,Guangzhou,Guangdong 510160,China; 2.Center for Drug Evaluation,SFDA,Beijing 100038,China)

摘要(Abstract):

目的比较氟康唑胶囊2个仿制厂家与原研制剂在3种溶出介质的溶出曲线,为评价氟康唑胶囊药品质量提供依据。方法采用《中国药典》2010年版二部附录X C第一法的装置,测定了3个厂家氟康唑胶囊在0.1 mol/L盐酸溶液、水和磷酸盐缓冲液(pH6.8)中的溶出曲线,并用f2因子法进行比较分析。结果在0.1 mol/L盐酸溶液和磷酸盐缓冲液(pH6.8)中,C厂家制剂与原研制剂的溶出曲线一致,B厂家制剂与原研制剂的溶出曲线有明显差异,但在水中仿制制剂与原研制剂的溶出曲线有明显差异,批内均一性的考察结果是C厂家优于B厂家制剂,B和C仿制厂家的批间重复性均良好。结论作为氟康唑胶囊的溶出介质,水比0.1 mol/L盐酸溶液和磷酸盐缓冲液(pH6.8)对制剂质量具有更好的分辨能力,建议修订该溶出度检验方法的溶出介质,与原研药溶出曲线不一致的厂家,建议研究晶型或改进处方工艺。
Objective To compare the dissolution profiles of fluconazole capsules from copy and original manufacturers in 3 dissolution medium,so as to provide basis for comprehensive evaluation of the quality of fluconazole capsules.Methods The dissolution profiles of fluconazole capsules from 3 manufacturers in 0.1 mol/L hydrochloric acid solution,water and phosphoric acid buffer(pH6.8) were determined by the method 1 in appendix X C of Chinese Pharmacopeia 2010,and comparatively analyzed by the f2 similarity factor.Results In 0.1 mol/L hydrochloric acid solution and phosphoric acid buffer(pH6.8),the dissolution profiles of C manufacturer were similar to that of original manufacturer,but B was different from original manufacturer.In water,the dissolution profiles of fluconazole capsules from 2 copy manufacturers were significant different from that of the original manufacturer.Conclusion As the dissolution medium,water are more suitable for fluconazole capsules than 0.1 mol/L hydrochloric acid solution and phosphoric acid buffer(pH6.8).It is advisable for manufacturers that the dissolution profiles are different from that the original drug to improve their formulation and process of preparation.

关键词(KeyWords): 氟康唑胶囊;溶出曲线;相似因子
Fluconazole capsules;dissolution profiles;similarity factor

Abstract:

Keywords:

基金项目(Foundation): 国家科技攻关课题(编号:2004BA720A34)氟康唑胶囊药学试验验证

作者(Authors): 严小红;陈安丽;丘文嘉;江英桥;霍秀敏;邵颖;
YAN Xiao-hong1,CHEN An-li1,QIU Wen-jia1,JIANG Ying-qiao1,HUO Xiu-min2,SHAO Ying2(1.Guangzhou Institute for Drug Control,Guangzhou,Guangdong 510160,China; 2.Center for Drug Evaluation,SFDA,Beijing 100038,China)

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