| 西咪替丁注射液的细菌内毒素检查方法研究 |
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| 引用本文： | 郭冬萍,李焕丹. 西咪替丁注射液的细菌内毒素检查方法研究[J]. 齐鲁药事, 2013, 0(2): 92-94 |
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| 作者姓名： | 郭冬萍 李焕丹 |
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| 作者单位： | 广东省中医院 |
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| 摘 要： | 目的建立西咪替丁注射液的细菌内毒素的检查方法。方法按照《中国药典》2010年版附录细菌内毒素检查法进行试验,用两个不同厂家的鲎试剂对西咪替丁注射液进行干扰试验。结果西咪替丁注射液在2.0mg.mL-1浓度时对细菌内毒素检查无干扰。其细菌内毒素限值定为0.5 EU.mg-1。结论本方法快速、灵敏,可以用于西咪替丁注射液的细菌内毒素限度检查。
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| 关 键 词： | 西咪替丁注射液 细菌内毒素 干扰试验 |
Study on the bacterial endotoxin inspection method of Cimetidine Injection |
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| GUO Dong-ping,LI Huan-dan. Study on the bacterial endotoxin inspection method of Cimetidine Injection[J]. qilu pharmaceutical affairs, 2013, 0(2): 92-94 |
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| Authors: | GUO Dong-ping LI Huan-dan |
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| Affiliation: | (Guangdong Hospital of Traditional Chinese Medicine,Guangzhou 510240,China) |
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| Abstract: | Objective To establish a bacterial endotoxin inspection method of Cimetidine Injection.Methods Interference tests of Cimetidine Injection were performed with TAL from two manufacturers according to bacterial endotoxin inspection test method in Appendix of Chinese Pharmacopoeia(2010 Edition).Results No interference was found when Cimetidine Injection with concentration of 2.0 mg· mL-1.The limit value of bacterial endotoxin was 0.5 EU·mg-1.Conclusion The method was rapid,sensitive,and it can be used for the bacterial endotoxin limit test of Cimetidine Injection. |
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| Keywords: | Cimetidine Injection Bacterial endotoxin Interference test |
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