摘要
体外渗透试验(in vitro permeation test,IVPT)作为最关键的体外研究项目之一,已被广泛用于皮肤递药制剂的研发及其生物等效性(bioequivalency,BE)评价。IVPT通过模拟药品在生理条件下的透皮过程,反映药品的质量与临床治疗的有效性,但在实际操作中存在皮肤难以获得,皮肤受种属、年龄、状态、部位等多因素干扰的困难。为了完善规范IVPT,国内外药品监管机构已制定了不同的试验标准。因此,本文参考国内外相关IVPT法规,结合文献研究内容,对IVPT的关键设计因素进行总结归纳,并补充了其作为评价手段的典型应用以供业界人士参考。
In vitro permeation test(IVPT),as one of the most critical in vitro research projects,has been widely used in the development of dermal drug delivery products and bioequivalency(BE)evaluation.IVPT reflects the quality of drugs and the effectiveness of clinical treatment by simulating the transdermal process of drugs under the physiological conditions.However,in practical operation process,there are many interfering factors,such as difficulty in obtaining skin,interference of species,age,state of skin,difficulty in skin treatment and poor reproduc⁃ibility of methods.To improve and standardize the IVPT test,domestic and foreign drug regu⁃latory agencies have developed different test standards for industries to refer.Therefore,this paper refers to the relevant IVPT regulations in China and abroad,combines the literature research,summarizes the key design factors of IVPT,and supplements the typical application as an evaluation method for reference.
作者
毛可阳
崇小萌
罗华菲
宁保明
MAO Ke-yang;CHONG Xiao-meng;LUO Hua-fei;NING Bao-ming(National Advanced Medical Engineering Research Center,China State Institute of Pharma-ceutical Industry,Shanghai 201203,China;National Institutes for Food and Drug Control,Key Laboratory of National Medical Products Administration,Key laboratory of Research and Evaluation of Chemical Drug Quality,Beijing 102629,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2024年第1期42-54,共13页
Chinese Journal of New Drugs
基金
四川省药品监督管理局化学药品质量研究与控制重点实验室开放课题项目(2022HZKF-02)。
关键词
体外渗透试验
皮肤递药制剂
生物等效性
in vitro permeation test
dermal drug delivery products
bioequivalence
