| 盐酸法舒地尔注射液细菌内毒素检查方法学研究 |
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| 引用本文： | 何忠平,张辉,裘颖儿.盐酸法舒地尔注射液细菌内毒素检查方法学研究[J].北方药学,2011,8(12):1-2. |
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| 作者姓名： | 何忠平 张辉 裘颖儿 |
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| 作者单位： | 浙江省金华市食品药品检验所,金华,321000;浙江省金华市食品药品检验所,金华,321000;浙江省金华市食品药品检验所,金华,321000 |
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| 摘 要： | 目的：建立盐酸法舒地尔注射液细菌内毒素检查方法。方法：参照2005年版《中国药典（二部）》细菌内毒素检查法进行试验。结果：样品原液对鲎试剂的凝聚反应有抑制作用,经2倍稀释可消除干扰,将细菌内毒素限值定为1EU/mg,可用灵敏度为0.25EU/ml的鲎试剂进行内毒素检查。结论：可用细菌内毒素检查法（凝胶法）替代家兔热原检查法控制产品热原。
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| 关 键 词： | 盐酸法舒地尔注射液 细菌内毒素检查法 干扰试验 |
Study on Bacterial Endotoxin Test of Fasudil Hydrochloride Injection |
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| He Zhongping,Zhang Hui,Qiu Yinger.Study on Bacterial Endotoxin Test of Fasudil Hydrochloride Injection[J].BEIFANG YAOXUE,2011,8(12):1-2. |
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| Authors: | He Zhongping Zhang Hui Qiu Yinger |
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| Institution: | He Zhongping Zhang Hui Qiu Yinger(Jinhua Institute for Food and Drug Control,Jinhua,Zhejiang,Ching 321000) |
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| Abstract: | Objective： To establish a method for bacterial endotoxin test of Fasudil Hydrochloride Injection.Methods：According to the method for bacterial endotoxin test in Chinese Pharmacopeia（edition 2005,Volume Ⅱ）,the study was performed.Results：The original sample solution had inhibitory effect on agglutination reaction of TAL.Dilution by 2 times could eliminate the interference factors. The limit value of endotoxin was set as1EU /mL and TAL with sensitivity of 0.25 EU /mL could be used for endotoxin test.Conclusion：The bacterial endotoxin test（gel - clot method）can be used as an alternative method for the rabbit pyrogen test to control pyrogen of products. |
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| Keywords: | Fasudil Hydrochloride Injection Method for bacteria endotoxin test Interference test |
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