| 甲磺酸罗哌卡因注射液细菌内毒素检查法的可行性研究 |
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| 引用本文： | 沈伟,王志德,肖珍,赵玉珍. 甲磺酸罗哌卡因注射液细菌内毒素检查法的可行性研究[J]. 中国药品标准, 2004, 5(3): 37-39 |
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| 作者姓名： | 沈伟 王志德 肖珍 赵玉珍 |
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| 作者单位： | 1. 陕西省药品检验所,西安,710061
2. 陕西关爱制药有限公司,咸阳,712000 |
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| 摘 要： | 目的:建立甲磺酸罗哌卡因注射液细菌内毒素检查法.方法:按<中国药典>(二部)2000年版附录细菌内毒素检查法.结果:将甲磺酸罗哌卡因注射液稀释至1.6mg/ml,可消除干扰,选用标示灵敏度为0.25EU/ml的鲎试剂检查细菌内毒素的方法可行、有效.结论:可以用细菌内毒素法替代家兔法作为日常检测甲磺酸罗哌卡因注射液的热原检查.
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| 关 键 词： | 甲磺酸罗哌卡因注射液 细菌内毒素 鲎试剂 干扰试验 |
The researches on the feasibility for the bacterial endotoxin inspection method of Ropivacaine Mesylate Injection |
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| Shen Wei,Wang Zhide,Xiao Zhen and Zhao Yuzhen. The researches on the feasibility for the bacterial endotoxin inspection method of Ropivacaine Mesylate Injection[J]. , 2004, 5(3): 37-39 |
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| Authors: | Shen Wei Wang Zhide Xiao Zhen Zhao Yuzhen |
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| Abstract: | Objective:To establish the endotoxin test method of Ropivacaine Mesylate Injection. Method To inspect bacterial endotoxin according to the method in addenda of China Pharmacopoeia (second part, 2000 edition). Results 1. 6mg/ml of Ropivacaine Mesylate Injection was effective to eliminate the interference in limulus test,so,the method of choosing tachy-pleus amebocyte lysate which sensitivity was labelled as 0. 25EU/ml to exdotoxin is capable and efficient. Conclusions For routine pyrogen test of Ropivacaine Mesylate Injection,the domestic rabbit method can be replaced by the bacterial endotoxin inspection method. |
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| Keywords: | Ropivacaine Mesylate Injection bacterial endotoxin tachypleus amebocyte lysate interference experiment |
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