新型阴道用半固体制剂的质量表征与体外特性评价概述  

An Overview of Quality Characterization and in vitro Characteristics Evaluation of New Semi-solid Vaginal Preparations

作　　者：李祥梅 叶勇[1] 罗华菲[2] LI Xiangmei;YE Yong;LUO Huafei(School of Pharmacy,Guangxi Medical University,Nanning 530021;National Advanced Medical Engineering Research Center,China State Institute of Pharmaceutical Industry,Shanghai 201203)

机构地区：[1]广西医科大学药学院,广西南宁530021 [2]中国医药工业研究总院医药先进制造国家工程研究中心,上海201203

出　　处：《中国医药工业杂志》2023年第5期646-653,共8页Chinese Journal of Pharmaceuticals

摘　　要：阴道因具有血流丰富、给药面积大和无肝脏首过效应等优势,有利于药物发挥疗效。在阴道药物递送系统中,半固体制剂具有一定的流动性,在阴道中的铺展面积比固体制剂大,增加了阴道黏膜对药物的吸收效率。阴道用温敏凝胶可响应温度的变化,从液体转为半固体,因而兼具易于铺展和抵抗阴道液冲刷的效果。该研究通过检索文献,综述了阴道用半固体制剂的质量表征和体外评价方法,以期为半固体制剂的进一步开发提供参考。Vagina has the advantages of rich blood supply,large surface area and avoidance of liver first-pass effect,which is beneficial for the drug to exert its pharmacological effect.Among vaginal drug delivery systems,semisolid formulations have a certain fluidity and a larger spreading area in the vagina compared with solid formulations,which increases the absorption of drugs by the vaginal mucosa.The temperature-responsive gel for vaginal use can respond to the change of temperature and transform to a semi-solid from a liquid,so it is easy to spread and resist the clearance effect of vaginal fluid.This paper reviews the quality characterization and in vitro evaluation methods of semisolid preparations for vaginal use through literature search,hoping to provide some references for the further development of semi-solid preparations.

关 键 词：阴道药物递送系统 半固体制剂 温敏凝胶 质量表征 体外评价 

分 类 号：R944.9[医药卫生—药剂学]