阿达帕林凝胶原研药与仿制药的流变学特性一致性考察  

Consistency investigation on rheological properties of adapalene gel original drug and generic drugs

作　　者：王经纬 陈晓颙 袁怡 刘晨曦 胡敏 WANG Jingwei;CHEN Xiaoyong;YUAN Yi;LIU Chenxi;HU Min(College of Pharmacy,Hubei University of Chinese Medicine,Wuhan 430065,China;Hubei Institute for Drug Control,Wuhan 430075,China;Hubei Engineering Research Center for Drug Quality Control,Wuhan 430075,China)

机构地区：[1]湖北中医药大学药学院,武汉430065 [2]湖北省药品监督检验研究院,武汉430075 [3]湖北省药品质量检测与控制工程技术研究中心,武汉430075

出　　处：《药学前沿》2025年第1期33-39,共7页China Pharmacist

基　　金：国家药品标准制修订研究课题(2023Y20);国家药品标准制修订研究课题(2024Y02);中青年科研基金项目(2022YN007)。

摘　　要：目的建立阿达帕林凝胶合理、有效的流变学评价方法,并考察原研药与国内几家不同企业生产的阿达帕林凝胶仿制药之间的流变学特性一致性。方法采用流变仪对阿达帕林凝胶原研药与仿制药进行流动曲线、固定剪切速率测定黏度、应变振幅扫描、频率振幅扫描、三阶段触变性测试等检测,并对其差异进行分析比较。结果阿达帕林凝胶原研药与仿制药均为假塑性流体(剪切变稀的非牛顿流体),并具有一定的屈服应力,应变振幅扫描显示所测样品弹性模量均大于黏性模量,具有一定的抗形变能力。其中仿制药4与原研药以及其他仿制药之间差距较大,黏度最低,抗形变能力较差。结论建立的方法重复性良好,可用于比较阿达帕林凝胶原研药与仿制药的流变学差异。不同厂家生产的阿达帕林凝胶仿制药与原研药流变学特性存在一定差异。Objective To establish reasonable and effective rheological methods for evaluating adapalene gel,and to investigate the consistency of rheological properties between the original drug and domestic generic drugs from several different domestic enterprises.Methods A rheometer was used to conduct shear flow test,viscosity test,strain sweep test,frequency sweep test,3 interval thixotropy test,etc,and the differences between the original drug and generic drugs were analyzed.Results The original drug and the generic drugs were all pseudoplastic fluids(shear-thinning non-Newtonian fluids).All of them had certain yield stress,and all strain sweep tests showed that the elastic modulus of the samples was higher than the viscous modulus,and could resist deformation to some extent.Among all samples,there was a large gap between generic drug 4 and the original drug and other generic drugs,with the lowest viscosity and poor deformation resistance.Conclusion The established method has good reproducibility and can be used to compare the rheological difference between the original drug and generic drugs.There are certain differences in the rheological properties of adapalene gel generic drugs produced by different manufacturers and the original drug.

关 键 词：阿达帕林凝胶 流变学 假塑性流体 仿制药 原研药 一致性评价 黏度 

分 类 号：R943[医药卫生—药剂学]