首页|2类皮肤外用半固体制剂屈服应力测定方法的研究

2类皮肤外用半固体制剂屈服应力测定方法的研究

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

yield stresstransient viscosity methodcreep test methodrheological regression methodsimple yield stress fluidsthixotropic yield stress fluids

刘超逸、高旋、王林波、陈晓萍、秦峰、吴晓鸾

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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

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

2024

中国新药杂志
中国医药科技出版社 中国医药集团总公司 中国药学会

中国新药杂志

CSTPCD北大核心
影响因子:1.039
ISSN:1003-3734
年,卷(期):2024.33(14)
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