烟酸注射液细菌内毒素检查法研究

Study of Bacterial Endotoxin Test for Nicotinic Acid Injection

目的建立烟酸注射液细菌内毒素检查方法。方法参照中国药典2005年版(二部)附录收载的细菌内毒素检查法及其原则进行实验,用两个不同厂家的鲎试剂对3批烟酸注射液进行干扰试验。结果当烟酸注射液稀释至20倍(即浓度为0.5 mg.mL-1)时可消除对鲎试剂与细菌内毒素凝集反应的干扰。结论烟酸注射液可用细菌内毒素检查法进行安全性质量检查。

OBJECTIVE To establish the bacterial endotoxin test in nicotinic acid injection, METHODS According to China Pharmacopoeia 2005 version （ Ⅱ ） appendix,the interference test was studied using tachypleus amebocyte lysate from two factories and three batches of nicotinic acid injection, RESULTS The interference could be eliminated when nicotinic acid injection was diluted by 20 times （0.5 mg· mL^-1）, CONCLUSION Bacterial endotoxin test could be used for nicotinic acid injection.