苯磺顺阿曲库铵细菌内毒素检查法研究

Investigation on bacterial endotoxin test of cisatracurium besilate

目的:建立苯磺顺阿曲库铵细菌内毒素的常规检测方法。方法:按《中国药典》2015年版通则1143细菌内毒素检查法进行,采用不同厂家的鲎试剂对不同批号的苯磺顺阿曲库铵分别进行干扰试验。结果:在验证条件下,供试品用稀释剂Ⅰ溶解制备成5 mg·mL^-1,并用稀释剂Ⅰ稀释40倍至0.125 mg·mL^-1后再用BET水稀释2倍至0.0625 mg·mL^-1,对细菌内毒素检查法无干扰作用。结论:建立的方法用于检查苯磺顺阿曲库铵的细菌内毒素可行。

Objective:To establish a bacterial endotoxin test method for cisatracurium besilate.Methods:The bacterial endotoxin test was carried out according to general notice 1143 of Chinese Pharmacopoeia 2015.The Tachypieus Amebocyte Lysates(TALs)from the different manufacturers were used to perform the interference tests on different batches of cisatracurium besilate.Results:The sample was dissolved to 5mg·mL^-1 with thinnerⅠ,and the solution was diluted for 40 times to 0.125 mg·mL^-1 with thinnerⅠ,then the solution was diluted for 2 times to 0.0625 mg·mL^-1 with water for BET under the validated condition.There was no interference on the concentration of 0.0625 mg·mL^-1.Conclusion:The established method can be used for bacterial endotoxin test of cisatracurium besilate.