| 盐酸瑞芬太尼细菌内毒素检查法的建立 |
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| 引用本文： | 付蓉,李莉娥,覃琨,程延军. 盐酸瑞芬太尼细菌内毒素检查法的建立[J]. 三峡大学学报(自然科学版), 2010, 32(6): 104-106 |
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| 作者姓名： | 付蓉 李莉娥 覃琨 程延军 |
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| 作者单位： | [1]武汉大学药学院,武汉430072 [2]宜昌人福药业有限责任公司,湖北宜昌443005 |
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| 摘 要： | 目的:建立盐酸瑞芬太尼的细菌内毒素检查法.方法:参照《中国药典》2005年版二部附录"细菌内毒素检查法",用不同厂家的鲎试剂对不同批号的盐酸瑞芬太尼分别进行干扰试验,考察确立盐酸瑞芬太尼的细菌内毒素检查法.结果:采用灵敏度为0.5 IU.mL-1的鲎试剂,将本品稀释到0.254 mg.mL-1以下,对鲎试剂的凝集反应无干扰.结论:本品可用细菌内毒素检查法来控制内毒素,其细菌内毒素限值可定为20 IU.mg-1.
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| 关 键 词： | 盐酸瑞芬太尼 细菌内毒素检查法 干扰试验 |
Establishment of Bacterial Endotoxin Test of Remifentanil Hydrochloride |
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| Fu Rong,Li Li-e,Qin Kun,Cheng Yanjun. Establishment of Bacterial Endotoxin Test of Remifentanil Hydrochloride[J]. Journal of China Three Gorges University(Natural Sciences), 2010, 32(6): 104-106 |
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| Authors: | Fu Rong Li Li-e Qin Kun Cheng Yanjun |
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| Affiliation: | Fu Rong Li Li-e Qin Kun Cheng Yanjun(1.College of Pharmacy,Wuhan Univ.,Wuhan 430072,China;2.Yichang Humanwell Pharmaceutical Co.,Ltd.,Yichang 443005,China) |
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| Abstract: | The purpose is to establish the bacterial endotoxin test of remifentanil hydrochloride.According to the ＂bacterial endotoxin test＂ of ChP2005,interference test is used to test the different batches remifentanil hydrochloride with different limulus factories to establish the bacterial endotoxin test of remifentanil hydrochloride.The substance is dissolved to be examined with limulus agent（the sensitivity is 0.5 IU per mL） to 0.254 mg per mL;then,there is no interference in the agglutinate reaction.The method can be used to control the bacterial endotoxin of remifentanil hydrochloride;the bacterial endotoxin limit is 20 IU per mg. |
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| Keywords: | remifentanil hydrochloride bacterial endotoxin test interference test |
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