| 肖婧薇,何华红,李薇.唑来膦酸细菌内毒素检查方法的研究[J].中国药品标准,2017,18(3):194-198 |
| 唑来膦酸细菌内毒素检查方法的研究 |
| Study on the method of bacterial endotoxin test in Zoledronic Acid |
| 投稿时间：2017-03-14 修订日期：2017-06-07 |
| DOI： |
| 中文关键词: 唑来膦酸 细菌内毒素检查 干扰试验 |
| 英文关键词: Zoledronic Acid Bacterial endotoxin test Interference experiment |
| 基金项目: |
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| 摘要点击次数: 449 |
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| 中文摘要: |
| 目的：改进并提高唑来膦酸质量标准的细菌内毒素检查项。方法：按2015年版《中国药典》(四部)通则细菌内毒素检查法,用不同厂家的鲎试剂对唑来膦酸注射液和注射用唑来膦酸分别进行干扰试验。结果：不同厂家生产的唑来膦酸注射液和注射用唑来膦酸均在0.05mg﹒ml-1及以下浓度对细菌内毒素检查法无干扰作用。结论：可将唑来膦酸注射液和注射用唑来膦酸的细菌内毒素检查法统一限值为：每1mg唑来膦酸含细菌内毒素的量应不高于5.0EU。 |
| 英文摘要: |
| Objetive: To improve the bacterial endotoxin test of the quality standard in Zoledronic Acid. Methods: According to the bacterial endotoxin test in Chinese Pharmacopoeia 2015 version (Vol. Ⅳ) general rules, the interference tests for Zoledronic Acid Injection and Zoledronic Acid for Injection with different TAL manufacturers were carried on. Results: There was no interference in the bacterial endotoxins test when the concentration of Zoledronic Acid Injection and Zoledronic Acid for Injection from different manufacturers was at or less than 0.05mg/ml. Conclusion: The unified limit of bacterial endotoxin test for Zoledronic Acid Injection and Zoledronic Acid for Injection is reasonable at no more than 5.0Eu/mg. |
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