皮肤科药物研发中的若干问题解析

Key points in the development of dermatology drugs

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。

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.