| 帕米膦酸二钠葡萄糖注射液细菌内毒素检查法的实验研究 |
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| 引用本文： | 宗卫峰,居红枫,孟长虹,吴敏.帕米膦酸二钠葡萄糖注射液细菌内毒素检查法的实验研究[J].药品评价,2005,2(6):427-429. |
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| 作者姓名： | 宗卫峰 居红枫 孟长虹 吴敏 |
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| 作者单位： | 1. 江苏省药品检验所,南京,210008
2. 江苏省东台市人民医院,东台,224200 |
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| 摘 要： | 目的研究帕米膦酸二钠葡萄糖注射液对细菌内毒素检查实验的干扰情况,并建立其细菌内毒素检查的质量标准。方法参照《中国药典》2000年版二部附录ⅪE细菌内毒素检查法进行试验,用两个不同厂家的鲎试剂对帕米膦酸二钠葡萄糖注射液进行干扰试验研究。结果帕米膦酸二钠葡萄糖注射液对细菌内毒素检查有干扰作用,但通过稀释可消除其干扰。结论可以用细菌内毒素检查法(凝胶法)代替家兔热原检查法控制其产品质量。
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| 关 键 词： | 帕米膦酸二钠葡萄糖注射液 细菌内毒素 干扰试验 |
| 文章编号： | 1672-2809（2005）06-0427-03 |
| 收稿时间： | 2005-08-03 |
| 修稿时间： | 2005-11-10 |
Research of bacteririal endotoxin test in Pamidronate Disodium and Glucose Injection |
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| ZONG Wei-feng,JU Hong-feng,MENG Chang-hong,et al..Research of bacteririal endotoxin test in Pamidronate Disodium and Glucose Injection[J].Drug Evaluation,2005,2(6):427-429. |
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| Authors: | ZONG Wei-feng JU Hong-feng MENG Chang-hong |
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| Abstract: | Objective To study the interferential effect of Pamidronate Disodium and Glucose Injection on bacterial endotoxin test and to establish bacterial endotoxin test method for the sample.Method According to China Pharmacopoeia 2000,inhibition or enhancement test for bacterial endotoxin test was performed with Amebocyte Lysate manufactured by two different companies.Results The injection Pamidronate Disodium can interfere to the Bacterial Endotoxins test,but the inhibition effect can be eliminated by appropriate dilution.Conclusion The results suggest that bacterial endotoxins test(gel-clot method) can be used as an alternative method for the rabbit pyrogen test for Pamidronate Disodium and Glucose Injection. |
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| Keywords: | Pamidronate Disodium and Glucose Injection bacterial endotoxin interference test |
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