经皮给药制剂体外经皮渗透试验技术规范专家共识探讨

Discussion of Professional Consensus on the Technical Practice of the in Vitro Permeation Test for Topical and Transdermal Preparations

关键词:  体外经皮渗透试验  经皮给药制剂  处方筛选  一致性评价  专家共识

Key words:  in vitro permeation test  topical and transdermal preparations  prescription screening  consistency evaluation  professional consensus

摘要:

体外经皮渗透试验是评价经皮给药制剂的重要试验之一，试验结果对制剂的处方筛选、仿制药和参比制剂的一致性评价具有重要参考价值。该试验操作复杂，影响因素多，操作不当，可能会导致不同试验的结果无法比较，影响此类制剂的质量、有效性及安全性的评价。为此，亟需规范经皮给药制剂体外经皮渗透试验的操作。基于国际要求和国内实际，世界中医药学会联合会经皮给药专业委员会组织专家对形成经皮给药制剂体外经皮渗透试验技术规范进行多次研讨，形成初步共识，供业界同行及监管部门参考。

Abstract:

In vitro permeation test(IVPT) is one of the important tests for evaluating topical and transdermal preparations. The test results are critical to the prescription screening and consistency evaluation of generic drugs and reference products. The operations of IVPT are complicated and there are many influencing factors, which make unreliable results as well as affect the evaluation of quality, effectiveness and safety for topical and transdermal preparations. Therefore, it is necessary to standardize the IVPT method. Based on the international and domestic progress of this field, the Transdermal Drug Administration Committee of the World Federation of Chinese Medicine Societies organized the experts to discuss and finally formed this consensus for the reference of industry colleagues and supervision departments.