凝胶法和动态浊度法检测注射用重组人睫状神经营养因子中细菌内毒素含量

Development of bacterial endotoxin test for recombinant human ciliary neurotrophic factor for injection

目的采用凝胶法和动态浊度法检测注射用重组人睫状神经营养因子(CNTF)中细菌内毒素含量,控制制品质量,消除临床热原反应的发生。方法供试品参照《中华人民共和国药典》(2010年版)三部附录ⅫE细菌内毒素检查法中的凝胶法和动态浊度法要求进行检查。结果注射用重组人睫状神经营养因子溶液在100μg/mL质量浓度下,确定内毒素限值为10 EU/mL。凝胶法和动态浊度法检查后,注射用重组人睫状神经营养因子内毒素含量均符合规定。结论凝胶法和动态浊度法可用于注射用重组人睫状神经营养因子的细菌内毒素检查。

Objective To develop a method in detection of bacteria endotoxin for recombinant human ciliary neurotrophic factor for injection with the gel-clot test and the kinetic turbidimetric test for the control of the quality of the drug and prevention of pyroten reaction in clinical practice.Methods the experiment was conducted according to BET in China Pharmacopoeia 2010,third section.Results The protein concentration was 100 μg / mL,the detection limit for acterial endotoxin as defined 10 EU / mL.With the gel-clot test and the kinetic turbidimetric test,results of the tested samples were validated.Conclusion Both the gel-clot test and the kinetic turbidimetric test are suitable for bacterial endotoxin test of recombinant human ciliary neurotrophic factor for injection.