摘要
皮肤外用半固体制剂包括乳膏剂、软膏剂、凝胶剂等剂型,含乳化剂、防腐剂、增稠剂或软化剂等多种辅料,可以是单相体系,也可以是包含连续相和分散相的多相体系,其处方设计、生产工艺复杂。流变学可以综合反映产品中物质分布、聚集状态等微观结构差别,是该剂型的关键质量属性,且与体外释放、体外渗透、稳定性、感官感受等其他项目存在关联性,是评价仿制药与原研药质量一致性最有效的手段之一。本文通过查阅国内外文献以及相应的政策法规要求,介绍流变学研究现状和测试方法,分析影响流变学特性的相关因素,探讨流变学参数所体现出的质量差别,指导制药厂家对处方和工艺进行改进,以期为该类制剂的开发和质量等同性研究提供帮助。
Topical semi-solid preparations include creams,ointments,gels and other dosage forms,which contain various excipients such as emulsifiers,preservatives,thickeners or emollient agents,etc.They can be single-phase system,or multiple system consisting of continuous phase and disperse phase thanks to its complex design of formulation and manufacturing process.Rheology properties are critical quality attributes of topical semi-solid preparations,which can comprehensively reflect the difference in microstructure such as the substance distribution and aggregation state of the product,and is related to other attributes such as in vitro release,in vitro penetration,stability and cutaneous sense.It is one of the most effective means to evaluate the quality equivalence between generic drugs and innovator drugs.After reviewing domestic,foreign literature and relative policies,this paper described the research status and test methods of rheology,analyzed the possible factors affecting rheological properties,discussed the quality differences reflected in rheological data,in order to guide pharmaceutical manufacturers to improve their formulations and processes and provide help for the development and quality equivalence research of such preparations.
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(School 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)
出处
《药学前沿》
CAS
2024年第10期300-309,共10页
China Pharmacist
基金
国家药品标准制定、修订研究课题项目(2023Y20)
湖北省药品监督检验研究院中青年科研基金项目(2022YN007)。
关键词
流变学
外用半固体制剂
处方设计
生产工艺
质量评价
流动曲线
屈服应力
Rheology
Topical semi-solid preparations
Design of formulation
Manufacturing process
Quality evaluation
Flow curve
Yield stress
