摘要
目的 授权应用已获专利的能有效消除供试品干扰的定量内毒素检查方法——同体系模型（专利号：03126794．7）动态比浊法定量检查血液透析酸性浓缩液（A液）中的细菌内毒素含量。方法 对A液中定量添加标准内毒素进行干扰预试验，将A液稀释成30，40，50，60倍，定量添加标准内毒素，其回收率分别为76．12％。112．4％，173．6％，141．8％；从中筛选出最佳的稀释倍数为40倍，对3个批号（GH0504003，GH0504009，GH0504012）A液进行干扰试验，其回收率分别为116．7％，90．42％，113．8％。结果 标准内毒素使用0．0156，0．125，1．00Eu／mL，将A液稀释成40倍，定量添加标准内毒素，回收率均在50％～200％之间，认为A液对动态比浊法无干扰作用。可用于A液供试品检查。结论 应用同体系模型动态比浊法可以定量检测A液中的细菌内毒素。
Purpose To apply the homologous system model （having got the patent） in determining the concentrated solution of hemodialysis （ A solution）. Methods The interference test was fulfilled in A solution, which was diluted to 1/30,1/40,1/50,1/60, and the rates of recovery were and 76.12 %, 112.4 %, 173.6 % and 141.8 % respectively, but when the amount of endotoxin was addedto sample （ GH0504003, GH0504009, GH0504012） diluted to 1/40, the rates of recovery were 116.7%, 90.42% and 13.8% respectively. Results A solution diluted to 1/40 was added to the endotoxin standard and the concentrations in working curve were 0.015 6,0. 125 and, 1.00 Eu/mL. It is considered that the A solution was effective to eliminate the interference on turbidimetric method. Conclusion The kinetic turbidimetric method for homologous system model provides a new way to the detection of endotoxin in the concentrated solution of hemodialysis.
出处
《中国生化药物杂志》
CAS
CSCD
2006年第4期218-221,共4页
Chinese Journal of Biochemical Pharmaceutics
基金
2003年广东省科技计划项目(No.2003C33704)
关键词
同体系模型
动态比浊法
血液透析酸性浓缩液
细菌内毒素
干扰试验
homologous system model
kinetic turbidimetric method
the concentrated solution hemodialysis
bactrial endotoxin
interference test
