| 右旋糖酐20葡萄糖注射液中细菌内毒素定量检查研究 |
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| 引用本文： | 苑庆华,赵海山,等.右旋糖酐20葡萄糖注射液中细菌内毒素定量检查研究[J].药物分析杂志,2001,21(4):293-295. |
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| 作者姓名： | 苑庆华 赵海山 |
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| 作者单位： | [1]天津市药品检验所300070 [2]天津大学无线电厂300072 |
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| 摘 要： | 目的：对右旋糖酐20葡萄糖注射液进行细菌内毒素回收干扰试验，建立定量检测右旋糖酐20葡萄糖注射液中污染内毒素试验方法。方法：采用中国药典2000年版附录检测细菌内毒素的动态浊度法。结果：右旋糖酐20葡萄糖注射液用细菌内毒素定量检测无干扰因素影响，内毒素回收率在50％－200％范围内。结论：使用内毒素动态浊度法定量检测右旋糖酐20葡萄糖注射液的污染内毒素是可行的，可用细菌内毒素定量检查法代替家兔热原检查法。
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| 关 键 词： | 右旋糖酐20葡萄糖注射液 细菌内毒素 动态浊度法 干扰试验 定量检查 |
Application of the Turbidimetric-kinetic Method for the Measurement of Endotoxin in Dextran 20 Glucose Injection |
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| YUAN Qing,hua and TANG Yuan,tai.Application of the Turbidimetric-kinetic Method for the Measurement of Endotoxin in Dextran 20 Glucose Injection[J].Chinese Journal of Pharmaceutical Analysis,2001,21(4):293-295. |
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| Authors: | YUAN Qing hua and TANG Yuan tai |
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| Abstract: | Objective:Application of the turbidimetric-kinetic method for practical quality control on endotoxin content in dextran 20 glucose injection.Methods:Accoding to the turbidimetric-kinetic method and eliminated interfere factors approved by Chinese pharmacopoeia 2000 edition.Results and Conclusions:Endotoxin added to dextran 20 glucose injection was recovered in a quantitative manner showing neither inhibition nor enhancement,the endotoxin recovery is more than 50 per cent and less than 200 per cent.These results suggest that the LAL-test could be used as an alternative method for the rabbit pyrogen test to dextran 20 glucose injection. |
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| Keywords: | dextran 20 glucose injection bacterial endotoxin turbidimetric-kinetic method interfere factors test |
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