| 注射用红花黄色素细菌内毒素检查法 |
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| 引用本文： | 柯正方.注射用红花黄色素细菌内毒素检查法[J].海峡药学,2009,21(8):52-53. |
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| 作者姓名： | 柯正方 |
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| 作者单位： | 浙江省台州市食品药品检验所,台州,318000 |
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| 摘 要： | 目的对注射用红花黄色素进行凝胶法干扰试验，建立注射用红花黄色素细菌内毒素检查法的试验方法。方法采用中国药典2005年版二部附录细菌内毒素检查法。结果注射用红花黄色素稀释300倍（0．167mg·mL^-1）时对细菌内毒素检查法无干扰作用。结论使用细菌内毒素检查法检查注射用红花黄色素中的细菌内毒素是可行的，可用细菌内毒素检查法代替家兔热原检查法。
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| 关 键 词： | 注射用红花黄色素 细菌内毒素 凝胶法 干扰试验 |
Bacterial endotoxin test for Honghuahuangsesu injection |
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| KE Zhong-fang.Bacterial endotoxin test for Honghuahuangsesu injection[J].Strait Pharmaceutical Journal,2009,21(8):52-53. |
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| Authors: | KE Zhong-fang |
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| Institution: | KE Zheng-fang(Taizhou Institute for Food and Drug Control, Taizhou 318000, China) |
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| Abstract: | OBJECTIVE To establish a method for the determination of bacterial endotoxin for Honghuahuangsesu injection. METHODS According to the method of determination of bacterial endotoxin approved by Chinese Pharmacopoeia 2005 edition. RESULTS The interference on the determination of bacterial endotoxin can be excluded when Honghuahuangsesu injection was diluted 300 times. CONCLUSION It is feasible to detect the bacterial endotoxin for Honghuahuangsesu injection by the method of determination of bacterial endotoxin and the method may replace pyrogen test. |
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| Keywords: | Honghuahuangsesu injection Bacterial endotoxin Gel-clot Interference test |
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