曲克芦丁注射液细菌内毒素检查方法研究

Study on bacterial endotoxin test methods of Troxerutin Injection

目的建立曲克芦丁注射液细菌内毒素检查法。方法参照《中国药典》2005年版二部附录"细菌内毒素检查法"进行干扰试验和结果判断。结果样品的最大不干扰浓度为2.5mg·mL-1。结论曲克芦丁注射液采用细菌内毒素检查法,方法可行。

OBJECTIVE To establish the bacterial endotoxin test method of Troxerutin Injection.METHODS Through the test for interfering fantors and the result judgment according to the Chinese Pharmacopoeia in 2005.RESULTS The sample＇s biggest disturbance density was 2.5mg·mL-1.CONCLUSION The results suggest that the bacterial endotoxins test is suitable for the detection of endotoxin in Troxerutin Injection.