基于体外溶出和体内吸收模拟技术的法罗培南钠片的有效性评价  

Bioequivalent evaluation of faropenem sodium tablets based on in vitro dissolution and in vivo absorption simulation technology

作　　者：刘广桢 赵海云 于明艳 牛冲 陈涛 凌霄 胡昌勤[3] Liu Guang-zhen;Zhao Hai-yun;Yu Ming-yan;Niu Chong;Chen Tao;Ling Xiao;Hu Chang-qin(Shandong Institute for Food and Drug Control,Jinan 250101;National Institute for Food and Drug Control,Beijing 102629;Shanghai PharmoGo Co.,Ltd,Shanghai 200122)

机构地区：[1]山东省食品药品检验研究院,济南250101 [2]上海凡默谷信息技术有限公司,上海200122 [3]中国食品药品检定研究院,北京102629

出　　处：《中国抗生素杂志》2018年第10期1222-1226,共5页Chinese Journal of Antibiotics

基　　金：国家重大新药创制专项项目(No.2015ZX09303001001);山东省重点研发计划项目(No.2016ZDJS07A04);山东省食品药品检验研究院发展类项目(No.FZL2017-02)

摘　　要：目的评价国产法罗培南钠片的有效性。方法利用溶出度技术考察国产法罗培南钠片在不同溶出介质中的体外溶出行为,并与参比制剂进行比较;同时采用GastroPlus软件建立体内外相关性模型,将体外溶出曲线导入模型获得体内药时曲线数据,模拟其在体内的吸收情况。结果溶出度实验结果显示仿制药和参比制剂体外溶出曲线与参比制剂不相似或部分相似,但计算机模拟结果显示其体内的药时曲线与参比制剂基本一致。结论国产法罗培南钠片与参比制剂具有生物等效性,均为有效制剂。Objective To evaluate the bioequivalence of domestic faropenem sodium tablets. Methods The dissolution test technology was used to investigate the dissolution profiles of generic faropenem sodium tablets in different dissolution media to compare with the reference formulation. The in vitro-in vivo correlation module was built with GastroPlus software. When the dissolution profiles were loaded into the in vitro-in vivo correlation module, the absorption behavior of drugs was obtained to compare the reference formulation with the test formulation on the plasma concentration-time data. Results The dissolution results indicated that dissolution profiles of the generic formulation were not or partially similar to the reference formulation. It was close between the reference formulation and the test formulation on the plasma concentration-time data with computer simulation. Conclusion The domestic faropenem sodium tablets were bioequivalent with the reference formulation.

关 键 词：法罗培南钠片 计算机模拟 溶出度 体内外相关性 生物等效性 

分 类 号：R978.1[医药卫生—药品]