| 注射用头孢哌酮钠他唑巴坦钠的细菌内毒素检查方法研究 |
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| 引用本文： | 韩克胜,曾志敏,孙发燕,史海丽,郝敬刚,陈俊贤.注射用头孢哌酮钠他唑巴坦钠的细菌内毒素检查方法研究[J].海南医学院学报,2009,15(12):1505-1507. |
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| 作者姓名： | 韩克胜 曾志敏 孙发燕 史海丽 郝敬刚 陈俊贤 |
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| 作者单位： | 海口奇力制药股份有限公司,海南,海口,570216 |
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| 基金项目： | 海南医学院科研基金资助学报项目 |
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| 摘 要： | 目的：建立注射用头孢哌酮钠他唑巴坦钠的细菌内毒素检查法。方法：按《中国药典》2005年版2部附录ⅪE细菌内毒素检查法进行实验和结果判断,并与热原检查法结果比较。结果：注射用头孢哌酮钠他唑巴坦钠对细菌内毒素检查不产生干扰,细菌内毒素的限量值可定为0.13EU/mg。结论：可用细菌内毒素检查法代替家兔热原检查法控制其热原。
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| 关 键 词： | 头孢哌酮钠他唑巴坦钠 细菌内毒素检查 干扰试验 |
Bacterial endotoxin test using cefoperazone sodium and sulbactam sodium for injection |
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| HAN Ke-sheng,ZENG Zhi-min,SUN Fa-yan,SHI Hai-li,HAO Jin-gang,CHEN Jun-xian.Bacterial endotoxin test using cefoperazone sodium and sulbactam sodium for injection[J].Journal of Hainan Medical College,2009,15(12):1505-1507. |
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| Authors: | HAN Ke-sheng ZENG Zhi-min SUN Fa-yan SHI Hai-li HAO Jin-gang CHEN Jun-xian |
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| Institution: | ( Haikou. Qili Pharmaceutical Co. , Ltd. , Haikou 570216, China) |
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| Abstract: | Objective:To establish method of bacterial endotoxin test with cefoperazone sodium and sulbactam sodium for injection. Methods: The test result of the above mentioned method were evaluated with the bacterial endotoxin test method that was described in the Appendix Ⅺ E of Chinese Pharmacopoeia,2005 edition. Compare the result with that of using pyrogen test method. Results: Bacterial endotoxin test method using cefoperazone sodium and sulbactam sodium for injection was interference free to the result,and the limit value can be defined as high as 0.13 EU/mg. Conclusion: The bacterial endotoxin test method using cefoperazone sodium and sulbactam sodium for injection can replace the rabbit pyrogen test to control the heat source. |
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| Keywords: | Cefoperazone sodium and sulbactam sodium for injection Bacterial endotoxin test Interference test |
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