摘要
目的通过比较国产非那雄胺片与原研制剂的体外溶出行为,评价仿制药与参比制剂的质量一致性,利用计算机模拟技术分析体内外相关性。方法参照《中国药典》2015年版方法(2020年版《中国药典》该项目没有变化),分别考察国产制剂与原研制剂在4种不同溶出介质(pH 1.2盐酸溶液、pH 4.5醋酸盐溶液、pH 6.8磷酸盐溶液、水)中的体外溶出行为。同时借助GastroPlus^(TM)软件结合体外溶出试验结果,建立非那雄胺片体内外相关性模型。结果在选定条件下,国内15家制药公司中有3家公司产品在4种溶出介质中的溶出曲线均与原研制剂相似。软件分析结果提示,体外溶出曲线与软件模拟的体内行为不相似。结论大部分非那雄胺片仿制制剂在体外的溶出曲线与原研制剂存在一定的差异,国产非那雄胺片工艺水平及处方有待提高,反映体内释放行为的生物体相关溶出条件有待进一步研究。
OBJECTIVE To evaluate the quality consistency of generic and original finasteride tablets by comparing in vitro dissolution behaviors,and investigate the in vivo-in vitro correlation.METHODS According to Chinese Pharmacopeia 2015,the dissolution curves of the generic preparations and the original preparation in four different dissolution media(pH 1.2 hydrochloric acid solution,pH 4.0 sodium acetate solution,pH 6.8 phosphate solution,water)were determined.The GastroPlus^(TM) software was used to analyze the in vitro-in vivo correlation.RESULTS The products from three domestic pharmaceutical companies were all in line with the original tablets in the dissolution curve similarities.The analysis results by Gastroplus software indicated that the dissolution behaviors of finasteride tablets in vitro and in vivo were not similar.CONCLUSION There have differences in the similarity of the dissolution curves between most of the domestic generic finasteride tablets and the original drug.The prescription and process of domestic finasteride tablets need to be improved,and the evaluation method of dissolution in vitro needs to be further studied.
作者
曾庆花
邓鸣
杨娜
朱健萍
卢日刚
ZENG Qing-hua;DENG Ming;YANG Na;ZHU Jian-ping;LU Ri-gang(Guangxi Institute for Food and Drug Control,Nanning 530021,China)
出处
《中国药学杂志》
CAS
CSCD
北大核心
2022年第13期1118-1121,共4页
Chinese Pharmaceutical Journal
基金
十三五国家科技专项“重大新药创制”课题资助(2017ZX09101001)
广西重点研发计划资助(桂科AB17292049,桂科AB18221125)。
关键词
非那雄胺片
溶出度
一致性评价
计算机模拟技术
finasteride tablet
dissolution
consistency evaluation
computer simulation
