细辛脑注射剂细菌内毒素检查法研究

Study on Bacterial Endotoxin Test for Asarone Injection

摘要: 目的建立细辛脑注射剂的细菌内毒素检查法。方法按中国药典2010年版二部附录ⅪE细菌内毒素检查法进行实验和结果判断。对不同厂家生产的供试品进行干扰试验和细菌内毒素检查。结果浓度为0.1 mg·mL^-1细辛脑注射剂溶液对鲎试剂与细菌内毒素的凝集反应有干扰作用，经稀释后可排除干扰。结论本品最大不干扰浓度为0.05 mg·mL^-1，可采用细菌内毒素检查法进行质量控制。

Abstract: OBJECTIVE To establish a bacterial endotoxin test(BET) for asarone injection. METHODS According to Ch.P 2010 Vol Ⅱ Appendix ⅪE, the interference test and bacterial endotoxin test of different manufacture factory of samples were carried out. RESULTS There was interference in the agglutinate reaction beteeen the sample and relative TAL with the concentration of 0.1 mg·mL^-1 asarone injection solution, and the interference was eliminated after diluted. CONCLUSION The nointerference concentration of asarone injection is 0.05 mg·mL^-1. The bacterial endotoxin test can be used for the quality control of asarone injection.