当前位置:
首页
网刊
皮肤科药物研发中的若干问题解析
皮肤科药物研发中的若干问题解析
张星一,田 娜

国家食品药品监督管理总局药品审评中心,北京 100038
Key points in the development of dermatology drugs
(Center for Drug Evaluation, China Food and Drug Administration, Beijing 100038,China)

摘要参考文献相关文章

起始页:2171

摘要:[摘要] 皮肤外用制剂多为半固体制剂,具有多相、热力学不稳定等特点,辅料多样且筛选过程复杂,多需进行体外透皮吸收试验加以评价,与常规注射、固体制剂的评价有显著差异。本文结合实际审评经验,对局部外用皮肤科药物的科学处方开发、原辅料的来源和控制、杂质分析的特点和技术要求、透皮吸收试验的设计与评价、稳定性研究的特点等技术关键点进行汇总和分析,希望有助于当前皮肤科药物的研发和评价。

关键词:[关键词] 皮肤科;外用药物;透皮吸收

通讯作者:

基金项目:

作者简介:

Abstract:[Abstract] Most of the external-use dermatology drugs are half-solid preparations, which have the features such as multiphase, thermodymatic-unstability, numerous excipients and were developed through a complex optimization procedure. Some of them need a transdermal test to reveal their effects on the whole body, thus the evaluation method of dermatology drugs is quite different from the normal solid dosage forms and injectable medicines. In this article, the key points of the scientific development of dermatology dosage forms, the legal resource of excipients, the control of the impurities, the design and assessment of transdermal test, and the particularity of the stability test were summarized, interpreted and analyzed.

Key words:[Key words] dermatology; external drugs; transdermal test

    [1] 国家食品药品监督管理局. 化学药物制剂研究基本技术指导原则

    [S]. 2005.


    [2] 崔德福. 药剂学

    [M].北京:人民卫生出版社,2007:177-187.


    [3] 国家食品药品监督管理局.化学药物杂质研究技术指导原则

    [S].2005.


    [4] 徐维黎,苏习刚,李克娜.药物透皮吸收及临床应用

    [J].中国医药指南,2009,7(4):86-87.


    [5] 罗世英,陈华萍.透皮吸收常用的几种实验动物

    [J].中国药业,2004,13(4):74-75.


    [6] BIMON AS, SCOTT RC. In-vitro percutaneous absorption: pig epidermal memberame as a model for human skin

    [J]. Pharm Pharmacol, 1998,40(9):249-252.


    [7] SIMON GA, MAIBACH HI. Thepig as an experimental animal model of percutaneous permeation in man:qualitative and quantitative observations

    [J]. Skin Pharmacol Appl Physiol, 2000, 13(5):229-234.


    [8] 国家食品药品监督管理总局. 化学药物(原料药和制剂)稳定性研究技术指导原则

    [S]. 2015.


    [9] 国家药典委员会.原料药物与制剂稳定性试验指导原则

    [S]. 2015.