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| 阴道环体外理化评价方法研究进展 |
| Research Progress of in vitro physical-chemical evaluation methods for intravaginal rings |
| 投稿时间：2024-04-20 修订日期：2024-09-26 |
| DOI： |
| 中文关键词: 阴道环 药械组合产品 体外评价方法 药物释放 |
| 英文关键词: intravaginal rings pharmaceutical and mechanical combination products in vitro evaluation methods drug release |
| 基金项目:国家药品监督管理局药品监管科学体系建设重点项目(RS2024X010) |
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| 中文摘要: |
| 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的按照药品的相关要求来进行，亟需开展IVRs体外评价试验方法标准化的相关研究。 |
| 英文摘要: |
| Abstract Objective: To study and analyze the research progress and application of in vitro physical and chemical evaluation methods of vaginal rings, discuss the existing problems, and provide reference for the quality control and scientific supervision of vaginal ring products in China. Methods: The current status of vaginal ring development and marketed products at home and abroad was investigated, and in vitro physicochemical evaluation methods, such as drug release tests and mechanical property tests, were summarised and analysed. Results: The vaginal ring was a new type of drug-device combination preparation, and there was a lack of standardized methods for in vitro physicochemical evaluation of vaginal rings at home and abroad. Conclusion: The vaginal ring has a broad application prospect in the prevention of AIDS and the treatment of gynaecological diseases. As the vaginal ring has the dual characteristics of drug and device, its quality control and evaluation methods cannot be carried out purely in accordance with the relevant requirements of drugs, and there is an urgent need to carry out research related to the standardisation of test methods for the in vitro evaluation of the vaginal ring. |
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