摘要
目的优化法罗培南钠片的制备工艺。方法采用湿法制粒工艺制备法罗培南钠片,以自制片与原研制剂体外溶出的相似因子(f2)为考察指标,用正交设计进行处方优化。结果按优化后工艺制备的法罗培南钠片在4种溶出介质中与原研制剂溶出相似因子分别为86,76,74,81。结论自制片与原研制剂在不同溶出介质中的溶出行为相似。
Objective To optimize the formulation ot Sodmm ~aropenem xaol^t~. ~,l~ w*-.---- Tablets were prepared by wet granulation method, and the formulation was optimized by an orthogonal design, using dissolution similarity factors (f2) between self-made preparation and branded drug as assess index. Results In different dissolution media, the dissolution curves of self-made preparation were compared with those of branded drug and the similarity factors (f2) were 86, 76, 74, 81, respectively. Conclusion In different dissolution media, the dissolution behavior of self-made preparation and branded drug is similar.
出处
《食品与药品》
CAS
2014年第4期233-235,共3页
Food and Drug
基金
国家科技支撑计划(项目编号:2014BAI16B00):手性药物大品种质量升级
关键词
法罗培南钠片
溶出
相似因子
Sodium Faropenem Tablets
dissolution
similarity factor