复方钾钙镁液中细菌内毒素检查法的可行性研究

目的:建立心脏跳停液——复方钾钙镁液的细菌内毒素检查法。方法:利用鲎试剂,依据《中国药典》2005年版二部附录细菌内毒素检查法中的凝胶半定量试验方法对3批复方钾钙镁液进行检查。结果:复方钾钙镁液经6倍以上稀释后进行试验可排除干扰因素,用半定量法估算3批样品中细菌内毒素的含量分别为0.36、0.36、0.255EU·mL-1,均小于规定限值1.5EU·mL-1。结论:所建立的半定量分析方法检查复方钾钙镁液中的细菌内毒素是可行的。

Research on the Feasibility of Bacterial Endotoxin Test for Compound Jiagaimei Solution

OBJECTIVE： To establish bacterial endotoxin test for cardioplegic solution （compound jiagaimei solution）.METHODS： Semi-quantitative analysis stated in volume Ⅱ of Chinese Pharmacopoiea （2005 edition） was used to detect 3 batches of compound jiagaimei solution with tachypleus amebocyte lysate （TAL）.RESULTS： The interference factors of bacterial endotoxin test could be overcome through 6-fold dilution of cardioplegic solution.The content of bacterial endotoxin in 3 batches of samples were 0.36,0.36 and 0.255 EU·mL-1,respectively.They were all lower than the limitation of bacteria endotoxin of 1.5 EU·mL-1.CONCLUSION： It is feasible to detect bacterial endotoxin of compound jiagaimei solution using semi-quantitative analysis.