流变学评价在皮肤局部外用半固体制剂处方开发中的应用进展  

Progress in Application of Rheological Evaluation in Formulation Development of Semisolid Preparations for Topical Skin Use

作　　者：黄乐乐[1] 马晋隆[1] 王嘉明 徐驿 徐盛超 朱慧勇[1] 史家骏[1] 倪睿[1] 罗华菲[1] HUANG Lele;MA Jinlong;WANG Jiaming;XU Yi;XU Shengchao;ZHU Huiyong;SHI Jiajun;NI Rui;LUO Huafei(National Pharmaceutical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203)

机构地区：[1]中国医药工业研究总院药物制剂国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2022年第5期611-620,共10页Chinese Journal of Pharmaceuticals

摘　　要：皮肤局部外用半固体制剂的微观结构决定了制剂的流变学特性,流变行为可能会影响产品的生产制造、外观性状、稳定性、感官特性和体内性能等。通过流变学评价可表征皮肤局部外用半固体制剂的微观结构特征,对制剂处方开发具有较高的应用价值。流变学参数可作为皮肤局部半固体制剂的关键质量属性,并可用于预测产品稳定性和患者顺应性。本研究介绍了皮肤局部外用半固体制剂常用的流变学测试方法,及其在处方工艺开发、提高产品稳定性和改善患者顺应性方面的应用情况。Rheological properties of semisolid preparations for topical skin use depend on the microstructures.Rheological behaviors may affect the manufacturing,appearance,stability,skin sensory properties,and in vivo performance of the semisolid preparations.The microstructure features of topical semisolid preparations can be characterized by rheological evaluation,which has a high application value in formulation development.The rheological parameters can serve as critical quality attributes of semisolid preparations for topical skin use,and can be used to predict storage stability and patient compliance.The general methods used for rheological evaluation are introduced and their applications in terms of formulation development,improvement in stability and patient compliance are reviewed in this paper.

关 键 词：局部半固体制剂 流变学特性 稳定性 皮肤感官特性 顺应性 

分 类 号：R944.9[医药卫生—药剂学]