北京生物醫(yī)學工程

精子梯度分離液的細菌內毒素測定

Study on the bacterial endotoxin test of sperm gradient separation solution

作者：陳鴻波孫聰慧陳丹丹

單位：中國食品藥品檢定研究院(北京 102629),<br />通信作者：陳丹丹。E-mail: [email protected]

關鍵詞：細菌內毒素；動態(tài)濁度法；動態(tài)顯色法；納米粒子；醫(yī)療器械

分類號：R318

出版年·卷·期（頁碼）：2022·41·4（417-419）

摘要：

目的檢測精子梯度分離液的細菌內毒素含量是否合格，以滿足臨床使用安全的需求。方法依據《中華人民共和國藥典》2015年版四部中的細菌內毒素檢查法，采用動態(tài)顯色和動態(tài)濁度法定量檢測樣品的細菌內毒素含量。結果樣品細菌內毒素含量用兩種方法檢測分別為0.195 EU/mL和0.269 EU/mL。結論該樣品細菌內毒素含量小于0.5 EU/mL，低于規(guī)定的限值，符合規(guī)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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