阴道环体外理化评价方法研究进展  

Research Progress on in vitro Physical-chemical Evaluation Methods for Intravaginal Rings

作　　者：李莉[1] 黄元礼[1] 赵丹妹[1] 柯林楠[1] Li Li;Huang Yuanli;Zhao Danmei;Ke Linnan(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2024年第10期1213-1221,共9页Chinese Pharmaceutical Affairs

基　　金：国家药品监督管理局药品监管科学体系建设重点项目(编号RS2024X010)。

摘　　要：目的:研究分析阴道环体外理化评价方法的研究进展和应用情况,并对存在的问题进行探讨,为我国该类产品的质量控制和科学监管提供参考。方法:梳理国内外阴道环研发和上市产品现状,对体外理化评价方法如药物释放测试、机械性能测试等进行总结和分析。结果:阴道环作为一种新型药械组合产品,目前国内外缺乏该类产品体外理化评价的标准方法。结论:阴道环在艾滋病预防及妇科疾病的治疗方面展现出巨大的应用前景,由于其具备药品和器械双重特点,决定了其质量控制和评价手段不能单纯地按照药品的相关要求来进行,亟需开展阴道环体外评价试验方法标准化的相关研究。Objective:To study and analyze the research progress and application of in vitro physical-chemical evaluation methods for Intravaginal Rings(IVRs),discuss the existing problems,and to provide reference for the quality control and scientific supervision of such products in China.Methods:The current status of IVRs development and marketed products at home and abroad was investigated,and in vitro physical-chemical evaluation methods,such as drug release tests and mechanical property tests,were summarized and analyzed.Results:As a new type of drug-device combination product,there was currently a lack of standardized methods for in vitro physical-chemical evaluation of IVRs at home and abroad.Conclusion:IVRs have a broad application prospect in the prevention of AIDS and the treatment of gynaecological diseases.Due to the dual characteristics of drug and device,their quality control and evaluation methods cannot be carried out solely in accordance with the relevant requirements of drugs,and there is an urgent need to carry out research on the standardization of IVRs in vitro evaluation test methods.

关 键 词：阴道环 药械组合产品 体外理化评价方法 药物释放 

分 类 号：R917[医药卫生—药物分析学]