北京生物医学工程

精子梯度分离液的细菌内毒素测定

Study on the bacterial endotoxin test of sperm gradient separation solution

作者：陈鸿波孙聪慧陈丹丹

单位：中国食品药品检定研究院(北京 102629),<br />通信作者：陈丹丹。E-mail: chendandan0506@126.com

分类号：R318

出版年·卷·期（页码）：2022·41·4（417-419）

摘要：

目的检测精子梯度分离液的细菌内毒素含量是否合格，以满足临床使用安全的需求。方法依据《中华人民共和国药典》2015年版四部中的细菌内毒素检查法，采用动态显色和动态浊度法定量检测样品的细菌内毒素含量。结果样品细菌内毒素含量用两种方法检测分别为0.195 EU/mL和0.269 EU/mL。结论该样品细菌内毒素含量小于0.5 EU/mL，低于规定的限值，符合规定。

Objective To meet the safety requirements for clinical use by determine whether the bacterial endotoxin content of the sperm gradient separation solution is qualified. Methods According to the bacterial endotoxin test method in Pharmacopoeia of the people's Republic of China (2015 Edition), the bacterial endotoxin content of quantitative test samples was detected by dynamic chromogenic method and dynamic turbidy method. Results the bacterial endotoxin contents of the samples were 0.195 EU/ml and 0.269 EU/ml, respectively. Conclusions the bacterial endotoxin content of the sample is less than 0.5 EU/ml, which is lower than the prescribed limit value and meets the requirements.

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