盐酸赖氨酸(注射用)细菌内毒素检查法的研究  

Bacterial Endotoxin Test of Lysine Hydrochloride(for Injection)

作　　者：黄逯 谢鹏 HUANG Lu;XIE Peng(Guangxi Institute for Food and Drug Control,Nanning,Guangxi,China 530021)

机构地区：[1]广西壮族自治区食品药品检验所,广西南宁530021

出　　处：《中国药业》2024年第5期73-76,共4页China Pharmaceuticals

摘　　要：目的建立盐酸赖氨酸(注射用)细菌内毒素的检测方法。方法按2020年版《中国药典(四部)》通则1143细菌内毒素检查法,采用凝胶法对样品进行干扰试验和细菌内毒素检查,采用动态浊度法定量检测样品中细菌内毒素的含量。结果Tris缓冲液稀释供试品,调节pH值在6.0~8.0范围内,可有效消除盐酸赖氨酸(注射用)对细菌内毒素的干扰。凝胶法和动态浊度法试验均符合规定,动态浊度法的回收率为84.75%~96.12%,在50%~200%范围内。结论所建立的方法可行,可用于盐酸赖氨酸(注射用)细菌内毒素的检查。Objective To establish a bacterial endotoxin test method of Lysine Hydrochloride(for Injection).Methods According to the bacterial endotoxin test in the general rule 1143 of the Chinese Pharmacopoeia(Edition 2020,VolumeⅣ),the interference test and bacterial endotoxin test were carried out on the samples by the gel method,and the content of bacterial endotoxin in the sample was quantitatively detected by the dynamic turbidimetry.Results Diluting the test sample with Tris buffer and adjusting the pH value within the range of 6.0-8.0 could effectively eliminate the interference of Lysine Hydrochloride(for Injection)on bacterial endotoxins.The tests of the gel method and dynamic turbidimetry could meet the requirements.The recovery rate of dynamic turbidimetry was in the range of 84.75%-96.12%,which was in the range of 50%-200%.Conclusion The established method can be used for the bacterial endotoxin test of Lysine Hydrochloride(for Injection).

关 键 词：盐酸赖氨酸(注射用) 细菌内毒素 凝胶法 动态浊度法 

分 类 号：R917[医药卫生—药物分析学] R977.4[医药卫生—药学]