| 注射用萘普生钠细菌内毒素检查法建立及方法学研究 |
| |
| 引用本文： | 刘用国,王江融,李鸣,温伟添.注射用萘普生钠细菌内毒素检查法建立及方法学研究[J].海峡药学,2005,17(5):40-42. |
| |
| 作者姓名： | 刘用国 王江融 李鸣 温伟添 |
| |
| 作者单位： | 福建省药品检验所,福州350001;福建医科大学药学系,福州,350004 |
| |
| 摘 要： | 目的建立注射用萘普生钠的细菌内毒素检查方法。方法参照中国药典2000年版附录中细菌内毒素检查法和细菌内毒素检查法应用指导原则要求进行试验,确定注射用萘普生钠的细菌内毒素限值,用不同厂家的鲎试剂对注射用萘普生钠进行干扰试验。结果注射用萘普生钠经稀释至0.5mg·mL-1浓度时可有效地排除其对鲎试验的干扰作用。结论注射用萘普生钠可用细菌内毒素检查法进行检测。
|
| 关 键 词： | 细菌内毒素检查 干扰试验 注射用萘普生钠 |
| 文章编号： | 1006-3765（2005）05-0040-03 |
Study on Bacterial Endotoxin Test Establishment and Methodology of Naproxen Sodium for Injection |
| |
| LIU Yong-guo,WANG Jiang-rong,LI Ming,WEN Wei-tian.Study on Bacterial Endotoxin Test Establishment and Methodology of Naproxen Sodium for Injection[J].Strait Pharmaceutical Journal,2005,17(5):40-42. |
| |
| Authors: | LIU Yong-guo WANG Jiang-rong LI Ming WEN Wei-tian |
| |
| Institution: | 1.Fujian Institute for Drug Control Fuzhou 350001 China;2.Fujian Medical Univercity Fuzhou 350004 China |
| |
| Abstract: | OBJECTIVE To establish a method of bacterial endotoxin test of Naproxen Sodium for Injection.METHODS The test was conducted according to bacterial endotoxin test method and application guide request of baterial endotoxin test method induced in the appendix of China Pharmacopeia 2000,make sure the bacterial endotoxin limitation of the sample use limulus reagent from different manufacturers to conduct the interferential test of naproxen sodium for injection.RESULTS when the sample was diluted to the concentration of 0.5% mg/ml,the interference of sample to limulus test was eliminated efficiently.CONCLUSION The sample can bechecked and measured by bacterial endotoxin test method |
| |
| Keywords: | Bacterial endotoxin test Interferential test Naproxen sodium for injection |
| 本文献已被 CNKI 万方数据 等数据库收录！ |
