中国药房2011，Vol.22Issue(45)：4287-4288,2.
氯解磷定注射液细菌内毒素检查法的建立
Establishment of Bacterial Endotoxin Test for Pralidoxime Chloride Injection
摘要
Abstract
OBJECTIVE: To establish a method to test bacterial endotoxin in Pralidoxime chloride injection. METHODS: The experiment was carried out in accordance to the bacterial endotoxin test in Chinese Pharmacopoeia (2010 edition). The limit and dilute concentration of bacterial endotoxin were determined. Preliminary interference test, interference test and bacterial endotoxin test of four batches of Pralidoxime chloride injection were performed with tachypleus amebcyte lysate (TAL) manufactured by 2 companies. RESULTS: The limit of bacterial endotoxin was 0.2 EU·mg-1. The bacterial endotoxin was detected with TAL 0.25 EU·mL-1 when the maximum concentration of pralidoxime chloride was 10 mg·rnL-1 without interference. The bacterial endotoxin test of 4 batches of samples was all up to the regulations. CONCLUSION: The results suggest that TAL can be used for the bacterial endotoxin test of Pralidoxime chloride injection.关键词
氯解磷定注射液/细菌内毒素检查/鲎试剂/干扰试验Key words
Pralidoxime chloride injection/ Bacterial endotoxin test/ Tachypleus amebcyte lysate/ Interference test分类
医药卫生引用本文复制引用
王贵英..氯解磷定注射液细菌内毒素检查法的建立[J].中国药房,2011,22(45):4287-4288,2.
