棓丙酯注射液细菌内毒素检查可行性探讨  

Discussion about Bacterial Endotoxins Test in Propylgallate Injection

作　　者：田光彩 

机构地区：[1]河南省濮阳市食品药品检验检测中心,濮阳457000

出　　处：《海峡药学》2018年第2期75-77,共3页Strait Pharmaceutical Journal

摘　　要：目的探讨用细菌内毒素检查法检查棓丙酯注射液的热原,提高内毒素的检出率。方法利用不同厂家生产的鲎试剂与同厂家和不同厂家生产的棓丙酯注射液进行干扰试验,全面考察棓丙酯注射液对细菌内毒素检查的干扰作用,以确定其最大不干扰浓度及最佳试验浓度。结果试验证明棓丙酯注射液最大不干扰浓度为稀释2倍,最佳试验浓度为稀释4倍。结论棓丙酯注射液内毒素限值按0.5EU·m L-1进行细菌内毒素检查安全可靠。OBJECTIVE To explore the bacterial endotoxin test in Propylgallate Injection instead of pyrogem examination. METHODS The interference test was conducted by using the TAL from the different factories and Propylgallate Injection produced from the same and different factories to investigate the interference effects of Propylgallate Injection on bacterial endotoxins tests,in order to determine a maximum interference concentration and the best testing concentration. RESULTS It was proved that the maximum noninterference concentration of Propylgallate Injection was 2 times of diluted liquid,the best testing concentration was 4 times of diluted liquid. CONCLUSION The most suitable limit of bacterial endotoxin in Propylgallate Injection was 0. 5 EU · m L^-1. This method for bacterial endotoxin test was accurate and reliable,and could be used for replacing the pyrogen test.

关 键 词：棓丙酯注射液 鲎试剂 细菌内毒素检查法 

分 类 号：R927.11[医药卫生—药学]