夫西地酸乳膏流变学性质的一致性评价研究  

Research on Consistency Evaluation of Fusidic Acid Cream's Rheological Property

作　　者：高旋 刘超逸 王林波 陈晓萍 吴晓鸾 GAO Xuan;LIU Chaoyi;WANG Linbo;CHEN Xiaoping;WU Xiaoluan(Shanghai Institute for Food and Drug Control,NMPA Key Laboratory for Quality Analysis of Chemical Drug Preparations,Shanghai 201203,China)

机构地区：[1]上海市食品药品检验研究院,国家药品监督管理局化学药品制剂质量分析重点实验室,上海201203

出　　处：《药品评价》2023年第2期135-138,共4页Drug Evaluation

摘　　要：目的 对夫西地酸乳膏参比制剂及仿制制剂进行流变学性质的一致性评价研究。方法 采用马尔文流变仪对夫西地酸乳膏参比制剂及仿制药进行流动曲线、屈服应力、线性黏弹性、蠕变恢复、黏度测定等几个方面的对比研究。结果 参比制剂及仿制药均为剪切变稀型非牛顿流体;屈服应力大小相当;公共线性黏弹区为0.01~1 Pa,且在该范围内,两者弹性模量均大于黏性模量;蠕变恢复曲线可知两者均为黏弹性体;在不同剪切速率条件下,两者动力黏度大小相当。结论 该仿制夫西地酸乳膏与参比制剂的流变学性质基本一致。Objective To research the consistency of rheological properties between original and generic fusidic acid cream.Methods Comparative studies on the rheological curves,yield stress,linear viscoelasticity,creep recovery,and viscosity measurement of original and generic fusidic acid cream were carried out by using Malvern rheometer.Results The results showed that the original and generic fusidic acid cream were both non-Newtonian fluid with shear thinning,and have equivalent yield stress.The zones of linear viscoelastic are both 0.01-1 Pa,and in this zone the elastic moduli are greater than the viscosity moduli.It can be seen from the creep recovery curve that they both are viscoelastic material.Under different shear rates,the dynamic viscosity of them is equivalent.Conclusion The rheological properties of original and generic fusidic acid cream are basically consistent.

关 键 词：夫西地酸乳膏 流变学 参比制剂 仿制药 一致性评价 

分 类 号：R943[医药卫生—药剂学]