辅助生殖培养用液中庆大霉素临床前安全评价思考  

Consideration on Preclinical Safety Evaluation of Gentamicin in Assisted Reproductive Culture Medium

作　　者：管瑞芹 王召旭[2] 姜爱莉[1] 柯林楠[2] Guan Ruiqin;Wang Zhaoxu;Jiang Aili;Ke Linnan(Yantai University,Yantai 264005,China;National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]烟台大学,烟台264005 [2]中国食品药品检定研究院,北京102629

出　　处：《中国药事》2022年第12期1377-1382,共6页Chinese Pharmaceutical Affairs

基　　金：国家重点研发计划(编号2020YFC1107901)。

摘　　要：目的:归纳总结庆大霉素对配子和胚胎的影响,并对辅助生殖培养用液临床前评价需要考虑的问题进行分析,为辅助生殖培养用液产品中庆大霉素的临床前安全评价提供参考。方法:以辅助生殖培养用液中添加的药物庆大霉素为研究对象,结合庆大霉素在产品中的应用,采用文献调研法总结归纳了庆大霉素对生殖细胞、胚胎以及胚胎干细胞产生的影响,并根据辅助生殖用液产品监管现状,提出临床前安全评价思考。结果与结论:庆大霉素被广泛应用在辅助生殖培养用液中,安全、规范地使用庆大霉素在辅助生殖技术中具有重要意义。目前有关庆大霉素对配子及胚胎毒性的研究较少,已知的结论都是基于鼠胚试验及其他动物试验得出的结果扩展到人类胚胎,有必要关注庆大霉素对人类配子及胚胎发育的影响。其次,对于辅助生殖用液产品中庆大霉素添加量的确定、原料质量控制以及检测方法等方面存在的问题提出有针对性的建议,为加强辅助生殖用液的质量控制和产业监管提供思路,从而促进辅助生殖技术的发展。Objective:To summarize the effects of gentamicin on gametes and embryos,and analyze the problems needed to be considered in the preclinical evaluation of gentamicin in liquid products for assisted reproductive culture,so as to provide references for the preclinical safety evaluation of gentamicin in assisted reproductive culture liquid products.Methods:The drug gentamicin added in the assisted reproductive culture medium was taken as the research object,combined with application of gentamicin in the product,the ef fects of gentamicin on germ cells,embryo and embryonic stem cells were summarized by literature research method,according to regulatory status of liquid products for assisted reproduction,preclinical safety evaluation thinking was put forward.Results and Conclusion:Gentamicin is widely used in assisted reproductive culture medium.Safe and standard use of gentamicin is of great significance in assisted reproductive technology.At present,there are few studies on the toxicity of gentamicin to gametes and embryos.The known conclusions are based on the results of mouse embryo test and other animal tests and extended to human embryos.It is necessary to pay attention to the ef fects of gentamicin on human gametes and embryos development.Secondly,for the problems in the determination of gentamicin dosage,quality control of raw materials and detection methods in assisted reproductive liquid products,targeted suggestions were put forward to provide ideas for strengthening the quality control and industrial supervision of assisted reproductive liquid products,so as to promote the development of assisted reproductive technology.

关 键 词：人类辅助生殖技术 培养用液 庆大霉素 配子 胚胎 临床前评价 质量监管 

分 类 号：R95[医药卫生—药学] R912