甲硫酸新斯的明注射液细菌内毒素检查方法的研究  

Study on of Bacterial Endotoxin test for Neostigmine Methylsulfate injection

作　　者：高锦[1] 付聪[2] 嵇扬[1] 聂渝琼[1] 胡丹[1] 周苏萍[1] 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100071 [2]解放军第307医院药学部,北京100071

出　　处：《药物分析杂志》2008年第7期1141-1143,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立甲硫酸新斯的明注射液细菌内毒素的检查方法。方法:采用2005年版中国药典附录细菌内毒素检查法。结果:甲硫酸新斯的明注射液在0.5 mg·mL^(-1)及以下浓度时,用灵敏度为0.25 EU·mL^(-1)的鲎试剂检测细菌内毒素,无干扰因素影响。结论:甲硫酸新斯的明注射液细菌内毒素限值确定为50 Eu·mg^(-1),可应用鲎试剂进行细菌内毒素法检查。Objective ：To establish application of bacterial endotoxin test to neostigmine methylsulfate injection. Methotis： The method based on the bacterial endotoxin test in Chinese phamlacopoeia 2005 edition. Results： It was proved that the maximum noninterference concentration of neostigmine methylsulfate injection was 0. 5 mg · mL^-1and the sensitivity of TAL was 0. 25 EU · mL^-1. Conclusion：The results suggested that bacterial endotoxin test is suitable for the detection of endotoxin in neostigmine methylsulfate injection and the bacterial endotoxin limit is 50 EU · mg^-1.

关 键 词：甲硫酸新斯的明注射液 细菌内毒素 干扰试验 

分 类 号：R927.12[医药卫生—药学]