氯化钙注射液细菌内毒素检查法研究  

Study of Bacterical Endotoxins Test of Calcium Chloride Injection

作　　者：张红宇[1] 高菊珍[1] 王莉[1] 王璐[1] 

机构地区：[1]云南省药品检验所,云南昆明650011

出　　处：《中国药业》2005年第8期31-32,共2页China Pharmaceuticals

摘　　要：目的:建立氯化钙注射液的细菌内毒素检查方法。方法:采用2000年版《中国药典(二部)》附录ⅪE细菌内毒素检查法和附录ⅪⅩF细菌内毒素检查法应用指导原则。结果:氯化钙注射液在2.5mg/mL稀释浓度时对细菌内毒素检查法无干扰作用,其细菌内毒素限值L=0.2EU/mg。结论:可采用细菌内毒素检查法替代家兔热原法对氯化钙注射液进行细菌内毒素检查。Objective： To study the bacterical endotoxins test of calcium chloride injection. Methods： According to the bacterical endotoxins test and inhibition or enhancement test approved by Chinese pharmacopoeia of 2000 edition. Resulta：2. 5 mg/mL solution of calcium chloride injection don＇t inhibit or enhance the test, L =0. 2 EU/mg. Conclusion：These results suggest that the bacterical endotoxins test can be used for the detection of endotoxin in calcium chloride injection instead of pyrogen test.

关 键 词：氯化钙注射液 细菌内毒素检查法 干扰试验 

分 类 号：R927.12[医药卫生—药学] R976