| 尼扎替丁氯化钠注射液的细菌内毒素检查 |
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| 引用本文： | 李浩,李健和,叶清.尼扎替丁氯化钠注射液的细菌内毒素检查[J].中国药业,2009,18(4):38-39. |
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| 作者姓名： | 李浩 李健和 叶清 |
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| 作者单位： | 1. 湖南省岳阳市二人民医院药剂科,湖南,岳阳,414000
2. 中南大学湘雅二医院药剂科,湖南,长沙,410011 |
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| 摘 要： | 目的建立尼扎替丁氯化钠注射液细菌内毒素的检查方法。方法用不同厂家、不同批号、不同灵敏度的鲎试剂对尼扎替丁氯化钠注射液进行干扰试验。结果用标示灵敏度为0．25EU／mL的鲎试剂，将尼扎替丁氯化钠注射液稀释2倍后对细菌内毒素检查无干扰作用。结论可以用细菌内毒素检查法取代尼扎替丁氯化钠注射液的热原检查。
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| 关 键 词： | 尼扎替丁氯化钠注射液 鲎试剂 细菌内毒素 |
Bacterial Endotoxin Test for Nizatidine and Sodium Chloride Injection |
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| Li Hao,Li Jianhe,Ye Qing.Bacterial Endotoxin Test for Nizatidine and Sodium Chloride Injection[J].China Pharmaceuticals,2009,18(4):38-39. |
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| Authors: | Li Hao Li Jianhe Ye Qing |
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| Institution: | 1. Department of Pharmacy, Yueyang Municipal No. 2 People＇s Hospital, Yueyang, Hunan, China 414000; 2. Department of Pharmacy, Second Xiangya Hospital, Central South University, Changsha, Hunan, China 410011) |
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| Abstract: | Objective To establish the method of bacterial endotoxin test for Nizatidine and Sodium Chloride Injection using tachypleus amebocyte lysate. Methods The interferential test of Nizatidine and Sodium Chloride Injection was studied using tachypleus amebocyte lysate of different factories, different batch numbers and different sensitivities. Results When the taehypleus amebocyte lysate＇ sensitivity was 0.25 EU/mL and the maximum valid dilution was 2, the bacterial endotoxin test is not interferential. Conclusion The bacterial endotoxin test of Nizatidine and Sodium Chloride Injection can replace the pyrogen test. |
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| Keywords: | Nizatidine and Sodium Chloride Injection tachypleus amebocyte lysate bacterial endotoxin test |
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