摘要
依据中国药典2000年版“细菌内毒素检查法”,通过鲎试剂的干扰试验,研究注射用氨基酸原料中细菌内毒素检查法的可行性。结果在2-16倍稀释级下,L-缬氨酸（c=2.5%）和L-异亮氨酸（c=2.5%）对鲎试剂无干扰,检测细菌内毒素的鲎试剂灵敏度≤5.0×10^2EU·L^-1,而在16倍稀释级范围内,L-脯氨酸（c=4.5%）和L-亮氨酸（c=2.0%）对鲎试剂检查法有抑制作用。结论为注射用L-异亮氨酸和L-缬氨酸用灵敏度为5.0×10^2EU·L^-1的鲎试剂检查其细菌内毒素方法可行,可以代替家兔法检查热原。
In studying the feasibility of the method for examination of bacterial endotoxin in amino acids in injection by tachypleus amebocytelysate（TAL） interference test, L - Valine （ c = 2.5% ） and L - isoleucine （ c = 2. 5% ） did not interfere with TAL reagent in 2 - 16 times diluted concentrations and it could be tested with TAL that sensitivity was 0.5EU·ml^-1. But L - proline （ c = 4.5% ） and L - leucine （ c = 2.0% ） had inhibition with TAL under 16 times diluted scales. The method of bacterial endotoxin test of L - valine and L - isoleucine in injection was feasible, and could replace the rabbit test for pyrogen.
出处
《氨基酸和生物资源》
CAS
2007年第2期70-72,共3页
Amino Acids & Biotic Resources
