羟乙基淀粉130/0.4氯化钠注射液细菌内毒素标准研究

Study on the bacterial endotoxin standard of Hemohes

目的:建立适合我国国情的羟乙基淀粉130/0.4氯化钠注射液(Hemohes)细菌内毒素检查方法。方法:按所附企业标准的细菌内毒素限值,依《中国药典》(2005版)二部细菌内毒素检查方法中凝胶法进行检验,并对其进行干扰试验。结果:本品原液稀释2倍时,对试验无干扰影响。结论:该进口品种,采用凝胶法进行内毒素检查是可行的。

Object： To establish a bacterial endotoxins test of Hemohes injection （hydroxyethyl starch（HKS） ：sodium chloride = 130： 0.4）. Methods： The tests containing the interference tests were conducted according to the Pharmacopoeia of the People＇s Republic of China （Part 11 , 2005 Edition）. Results： The interference effect could be excluded by diluting hemohes to 2 times. Conclusion： The established method is apphcable in bacterial endotoxins test for the imported product.