摘要
目的:对葡萄糖酸钙注射液进行细菌内毒素检查法研究,建立其细菌内毒素检查方法。方法:按《中国药典》2005年版二部附录XIE细菌内毒素检查法进行。结果:葡萄糖酸钙注射液在2.5mg/ml稀释浓度对细菌内毒素检查法无干扰作用,其细菌内毒素限值L为0.1Eu/mg。结论:可采用细菌内毒素检查法替代家兔热原法对葡萄糖酸钙注射液进行细菌内毒素检查。
Objective：To study the Bacterial Endotoxins Test of Calcium Gluconate Injection. Methods：According to the Bacterial Endotoxins Test and inhibition or enhancement test approved by Chinese pharmacopoeia 2005 edition. Results： 2. 5mg/ml solution of Calcium Gluconate Injection don＇t inhibit or enhance the test, L = 0. 1 Eu/mg. Conclusion ： These results suggest that the Bacterial Endotoxins Test can be used for the detection of endotoxin in Calcium Glueonate Injection instead of pyrogen test.
出处
《中国药品标准》
CAS
2007年第3期55-58,共4页
Drug Standards of China
关键词
葡萄糖酸钙注射液
细菌内毒素检查法
干扰试验
Calcium Glueonate Injection
Bacterial Endotoxins Test
inhibition and enhancement test
