人类辅助生殖技术用液类产品生产用水的胚胎毒性研究

The Embryo Toxicity Research of Manufacturing Water of Medical Device of in Vitro Fertilization Technology

人类辅助生殖技术用液类医疗器械产品中,水是重要的组成成分。水的性状、电导率、微生物限度、总有机碳、易氧化物、重金属含量、细菌内毒素等指标对精子、卵子及胚胎体外发育有着重要的影响,所以对于此类产品而言,水的质量控制极其重要。生产用水的质量控制指标也在摸索。该研究选取通过Milli Q系统制备的三种纯化水,包括去离子反渗透水、超纯化水及无内毒素无核酸的超纯化水,并对比自来水,通过鼠胚试验测试了它们的胚胎毒性。结果证明使用无内毒素无核酸的超纯化水制备的辅助生殖用液产品的鼠胚发育效果最好,囊胚总细胞数和内细胞团数显著高于其他三组。该研究证明了用于制备辅助生殖用液类产品的水,去除其中内毒素和核酸成分的重要性,为辅助生殖用液的水质选择提供依据。

Water is an important component in liquid medical device products for human assisted reproductive technology.Water traits,conductivity,microbial limits,total organic carbon,easy oxides,heavy metal content,bacterial endotoxin and other indicators have an important impact on sperm,egg and embryo development in vitro,so for such products,the quality of water control is extremely important.The production water for producing such products is generally prepared by MilliQ purification system.In this research,we used four different types of water to fabricate the IVF liquids.It included deionized reverse osmosis water,ultra purified water and ultra purified water without endotoxin or nucleic acid,and compared with tap water.The in vitro rat embryo test system was used to study the embryotoxicity of this four different culture liquid production waters.From the result,the group of the super purified water without endotoxin and nucleic acid has the best result of the embryo formation rate,the number of total cell number and the inner cell number.This study proved the importance of removing endotoxin and nucleic acid from the water used for the preparation of the liquid products for assisted reproduction,and provided the basis for the selection of water quality for the liquid products for assisted reproduction.