硫酸沙丁胺醇注射液细菌内毒素检查方法的建立研究  

Investigation of Methodological Bacterial Endotoxin Test of Salbutamol Sulfate Injection

作　　者：李雪梅[1] 王瑶 胡宇驰[1] 曹春然[1] LI xuemei;WANG yao;HU yuchi;CAO chunran(Beijing Institute far Drug Control,NMPA Key Laboratory for Research and Evaluation of Generic Drugs,Beijing Key Laboratory of Analysis and Evaluation on Chinese Medicine,Beijing 102206,China)

机构地区：[1]北京市药品检验所,国家药品监督管理局仿制药研究与评价重点实验室,中药成分分析与生物评价北京市重点实验室,北京102206

出　　处：《生命科学仪器》2020年第3期88-91,共4页Life Science Instruments

摘　　要：目的:建立硫酸沙丁胺醇注射液细菌内毒素检查方法。方法:根据《中国药典》2015年版细菌内毒素检查法的规定,确定硫酸沙丁胺醇注射液细菌内毒素限值并使用鲎试剂对硫酸沙丁胺醇注射液进行干扰试验测定其非干扰浓度。结果:硫酸沙丁胺醇注射液在0.005mgml^-1及以下浓度时不对鲎试剂与内毒素的反应产生干扰。结论:硫酸沙丁胺醇注射液可以用细菌内毒素检查方法(凝胶法)进行质量控制。Objective:To establish the bacterial endotoxins test method for the Salbutamol Sulfate Injection Methods:According to bacterial endotoxin test in Chinese Pharmacopoeia 2015,setting the limit of bacterial endotoxin and using limulus amebocyte lysate reagent from two manufacturers to carry out the interference test of bacterial endotoxin interference test.Bacterial endotoxin test was also carried out on the Salbutamol Sulfate Injection.Results:When diluted to the final concentration of 0.005 mg·mL-1,the samples were no showed any disturbance to the reaction of tachypleus amebocyte lysate and endotoxin.Conclusion:the quality of the Salbutamol Sulfate Injection can be monitored by bacterial endotoxin test(gel method).

关 键 词：硫酸沙丁胺醇注射液 细菌内毒素检查法 干扰试验 

分 类 号：TQ460.7[化学工程—制药化工]