医用透明质酸钠细菌内毒素检查方法的研究

本实验是为研究透明质酸钠的细菌内毒素检查方法。方法：实验中使用鲎试剂的灵敏度 为０．０３ＥＵ／ｍｌ，进行干扰试验和抗干扰试验，并对其进行了热原检查。结果：在干扰试验中，样品 表现为增强性干扰，增大样品稀释倍数不能排除干扰。添加抗增液则可有效排除干扰。根据参考 文献和热原检查的兔剂量，我们认为透明质酸钠的细菌内毒素限值应定为５ＥＵ／ｍｌ以内。

Study on Bacterial Endotoxin Test for Sodium Hyaluronate

The experiment on the testing for bacterial endotoxins in sodium hyaluronate(SH) was reported in this paper. The sensitivity of the adopted reagent, Thachypleus Amebocyte Lysate, was 0.03EU/ml. The interference, anti-interference and pyrogen tests were performed. It showed that the interference could not be excluded in increasing the sample dilution, but could be effectively excluded when adding anti- enchancing solution. According to the references and the pyrogen test data, we considered that the maximum value of bacterial endotoxin in sodium hyaluronate should be defined at 5EU/ml.