CAJ | 학술논문

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。
목적채용응효법화동태탁도법검측주사용중조인첩상신경영양인자（ CNTF ）중세균내독소함량，공제제품질량，소제림상열원반응적발생。방법공시품삼조《중화인민공화국약전》（2010년판）삼부부록ⅫE세균내독소검사법중적응효법화동태탁도법요구진행검사。결과주사용중조인첩상신경영양인자용액재100μg/mL질량농도하，학정내독소한치위10 EU/mL。응효법화동태탁도법검사후，주사용중조인첩상신경영양인자내독소함량균부합규정。결론응효법화동태탁도법가용우주사용중조인첩상신경영양인자적세균내독소검사。
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 pre-vention of pyroten reaction in clinical practice .Methods the experiment was conducted according to BET in China Phar-macopoeia 2010 , third section .Results The protein concentration was 100 μg/mL, the detection limit for acterial endo-toxin as defined 10 EU/mL.With the gel-clot test and the kinetic turbidimetric test , results of the tested samples were vali-dated.Conclusion Both the gel-clot test and the kinetic turbidimetric test are suitable for bacterial endotoxin test of re-combinant human ciliary neurotrophic factor for injection .