枸橼酸钠细菌内毒素检查法的实验研究

Study on bacterial endotoxin test method for sodium citrate

目的研究枸橼酸钠对细菌内毒素检查试验的干扰情况,建立其细菌内毒素的限量检查方法。方法参照《中国药典》2010年版二部附录细菌内毒素凝胶限量检查法进行实验,以不同生产厂家、不同批号的鲎试剂对多批供试品进行干扰试验研究。结果枸橼酸钠经稀释为0.6mg/mL后对检测无干扰作用。结论该制剂可用细菌内毒素检查法控制产品质量,其内毒素限值为每毫克含内毒素量应小于0.25EU。

Objective To study the interference of sodium citrate in bacterial endotoxin test,and to establish a method of endotoxin limit test for the preparation. Methods The bacterial endotoxin test is performed according to the bacterial endotoxin determination method in China pharmacopoeia 2010,using different tachypleus a mebocyte lysate made in more manufacturers. Results In 0.6 mg/mL diluted concentration,the sodium citrate did not interfere in the result of the test. Conclusion The gel-clot test of bacterial endotoxin could be used for control the quality of sodium citrate,in which the bacterial endotoxin limit should be less than 0.25 EU/mg.