2类皮肤外用半固体制剂屈服应力测定方法的研究  

Study on the yield stress measurement methods of two kinds of semi-solid preparations for external skin use

作　　者：刘超逸 高旋 王林波 陈晓萍 秦峰 吴晓鸾 LIU Chao-yi;GAO Xuan;WANG Lin-bo;CHEN Xiao-ping;QIN feng;WU Xiao-luan(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：《中国新药杂志》2024年第14期1489-1495,共7页Chinese Journal of New Drugs

摘　　要：目的:探讨3种方法的特点及应用范围,为半固体制剂屈服应力的测定方法的选择提供了依据。方法:采用瞬态黏度法、蠕变测试法和流变曲线回归法对2类6种皮肤外用半固体制剂的屈服应力进行测定,结合触变性特点,对结果进行比对分析。结果:3种凝胶剂作为简单屈服应力流体,3种屈服应力测定方法均适用;3种乳/软膏剂属于触变性屈服应力流体,流变曲线回归法不适用,瞬态黏度法重复性较差。蠕变测试法能较为准确地测定上述2类皮肤外用半固体制剂的屈服应力。结论:对半固体制剂屈服应力测定方法进行选择时,可根据制剂性质、方法特点以及应用场景进行综合考量。Objective:To investigate the characteristics and application scopes of three yield stress measurement methods of semi-solid preparations for external skin use to provide basis for the selection of methods for such determination.Methods:The yield stress of two kinds of semi-solid preparations for external skin use was measured by transient viscosity method,creep test method and the rheological regression method.The results were compared and analyzed by combining thixotropy characteristics,and the characteristics and application scopes of the three methods were discussed.Results:It was shown that the three gelling agents were used as simple yield stress fluids,and all three yield stress determination methods were applicable.For the three emulsions/ointments which belong to thixotropic yield stress fluids,the rheological regression method is not applicable,and the transient viscosity method has poor repeatability.The creep test method can accurately measure the yield stress of the above two kinds of semi-solid preparations for external skin use.Conclusion:The yield stress measurement method for semi-solid preparations can be selected based on the preparation properties,method characteristics and application scenarios.

关 键 词：屈服应力 瞬态黏度法 蠕变测试法 流变曲线回归法 简单屈服应力流体 触变性屈服应力流体 

分 类 号：R943[医药卫生—药剂学]