摘要
目的:建立甲氧苄啶注射液的细菌内毒素检查法。方法:根据《中华人民共和国药典》2010年版细菌内毒素检查法,用鲎试剂对不同批号的甲氧苄啶注射液进行了干扰实验和细菌内毒素检查。结果:甲氧苄啶注射液浓度为0.16mg/ml时,对细菌内毒素检查无干扰。该品种4批样品的检查结果均符合规定。结论:甲氧苄啶注射液可应用鲎试剂进行细菌内毒素检查。
Objective：To establish a bacterial endotoxin test for trimethoprim injection. Methods：According to the bacterial endotoxin test in Pharmacopoeia of the People＇s Republic of China （2010 edition）, interference experiment and bacterial endotoxin test were performed on different batches of trimethoprim injection produced by different manufactures with tachypleus amebocyte lysate. Results：Trimethoprim injection with the concentration of 0.16 mg/ml didn＇t interfere with bacterial endotoxin test. The test results of four batches of trimethoprim injection met the requirement. Conclusion：Endotoxin in trimethoprim injec tion can be determined by bacterial endotoxin test with tachypleus amebocyte lysate.
出处
《药学服务与研究》
CAS
CSCD
2011年第6期453-455,共3页
Pharmaceutical Care and Research
关键词
甲氧苄啶注射液
细菌内毒素检查
干扰实验
鲎试剂
trimethoprim injection
bacterial endotoxin test
interference experiment
tachypleus amebocyte lysate
