祛痘类化妆品研发与备案功效评价的医学分析

Medical Analyses of Efficacy Evaluation for Anti-acne Cosmetics in R&D and Registration

基于医学理论分析祛痘类护肤品在研发与备案中的功效评价的方法。根据痤疮的医学治疗理论,针对祛痘类护肤品在实际研发和备案过程中所使用到的清洁、去角质、抗菌、抗炎、修复和预防复发的各种功效评价方法进行综述比较。人体功效评价方法具有直观、科学、准确、可靠的优势,但仅针对表观结果,不利于横向对比,对受试者存在一定的安全风险,且周期长,投入大;实验室评价方法医学理论的针对性更强,安全性高,周期短,但是却不能直观反映真实使用状态下的对人体皮肤的改善情况。实验室评价方法适用于化妆品新原料的开发与备案,以及化妆品研发过程中的配方、工艺筛选;人体功效评价适用于化妆品新品市场准入前的备案。

The efficacy evaluation methods of anti-acne cosmetics in R&D and registration was analyzed by medical theories.According to the medical treatment theory of acne, the efficacy evaluation methods of cleaning, exfoliating, anti-bacterial,anti-inflammatory, repairing and recurrence prevention of anti-acne cosmetics used in R&D and registration were reviewed and compared. Human efficacy evaluation method has the advantages of intuitive, scientific, accurate and reliable, but there are still some disadvantages, such as only for apparent results, not conducive to the comparison between products, certain safety risks for subjects, long cycle, and high cost. Laboratory evaluation method has stronger pertinence, high safety and short cycle,but it cannot directly reflect the improvement of human skin under the real use condition. The laboratory evaluation method is suitable for the development and registration of new raw materials for cosmetics, as well as the formulation and process selection in the process of cosmetics research and development. Human efficacy evaluation is applicable to registration of new cosmetics before market access.