人类辅助生殖培养液的质量控制和安全性评价  

Quality Control and Safety Evaluation of Culture Medium for Human Assisted Reproduction

作　　者：赵丹妹[1] 黄元礼[1] 王春仁[1] 柯林楠[1] 韩倩倩[1] ZHAO Danmei;HUANG Yuanli;WANG Chunren;KE Linnan;HAN Qianqian(National Institutes for Food and Drug Control,Beijing,102629)

机构地区：[1]中国食品药品检定研究院,北京市102629

出　　处：《中国医疗器械杂志》2021年第6期599-603,共5页Chinese Journal of Medical Instrumentation

基　　金：中国科学院“器官重建与制造”战略性先导专项(XDA16040602)。

摘　　要：目的概述了人类辅助生殖培养液在质量控制与安全性评价上的关键点,为其在后续相关标准建立与质量控制提供参考。方法通过文献研究,总结归纳了人类辅助生殖培养液在质量控制和风险控制上的关键要素,探讨其在临床转化上的问题所在。结果人类辅助生殖培养液中有效成分及其有害降解产物、药物等成分研究对辅助生殖技术的展开至关重要。结论目前面临最大的挑战即是对人类辅助生殖培养液进行有效的质量控制,对其中的关键成分建立相应的检验方法和质量标准,确保在产品货架期内的安全性和有效性,进而提高辅助生殖技术的成功率。Objective In this paper,the key points of quality control and safety evaluation of human assisted reproductive medium were summarized to provide reference for the establishment of relevant standards and quality control in the future.Methods Through literature research,the key factors of quality control and risk control of human assisted reproductive medium were summarized,and the problems in clinical transformation were discussed.Results It is very important for the development of human assisted reproduction technology to study the active ingredients and their harmful degradation products and drugs in the culture medium of assisted reproduction.Conclusion At present,the biggest challenge is to effectively control the quality of the culture medium for human assisted reproduction,establish corresponding inspection methods and quality standards for the key components,ensure the safety and effectiveness during the product shelf life,and thus improve the success rate of human assisted reproduction technology.

关 键 词：人类辅助生殖培养液 成分稳定性 降解产物与杂质 添加药物 质量控制 

分 类 号：F203[经济管理—国民经济] R318[医药卫生—生物医学工程]