酚磺乙胺注射液细菌内毒素检查法的研究

通过计算确定Ｅｔａｍｓ的细菌内毒限值，并以稀释的方法排除Ｅｔａｍｓ对细菌毒试验的干扰。确定其最大非抑制浓度及宜选用的鲎试剂灵敏度。结果Ｅｔａｍｓ的细菌内毒限值为１０ＥＵ．ｍｌ＾－１，最大无抑制浓度为１２．５ｍｇ．ｍｌ＾－１，宜选用小于或等于０．５ＥＵ．ｍｌ＾－１ｔｘ

A Study on Bacterial Endotoxin Test of Etamsylate Injection

A study on bacterial endotoxin test of Etamsylate Injection(Etams)was reported.To determine the bacterial endotoxin limit of Etams.The method of dilution was used to prevent the interference of Etams to the bacterial endotoxin test.To determine the maximum uninhibited concentration of Etams and the labeled TAL Reagent sensitivity which should be chosen.The resutls showed that the bacterial endotoxin limit of Etams was 10 EU.ml\ \{-1\},and the maximum uninhibited concentration of Etams was 12.5 mg.ml\ \{-1\}.We should use less than or equal to 0.5 EU.ml\ \{-1\} labeled TAL Regent sensitivity for the bacterial endotoxin test.The bacterial endotoxin test can be used for the controlling of pyrogen of Etams.