| 矫建,鲁军,张婷婷,刘进朋.专利蓝Ⅴ号钠盐注射液细菌内毒素检查法的研究[J].中国药事,2017,(7):785-788 |
| 专利蓝Ⅴ号钠盐注射液细菌内毒素检查法的研究 |
| Study on Bacterial Endotoxin Test for Patent Blue V Sodium Salt Injection |
| 投稿时间：2016-12-05 |
| DOI：10.16153/j.1002-7777.2017.07.013 |
| 中文关键词: 食品染色剂 肿瘤检测药物 专利蓝V号钠盐 细菌内毒素 鲎试剂 干扰试验 |
| 英文关键词: food stain tumors-detected drugs PB Ⅴ sodium salt injection bacterial endotoxin TAL interference test |
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| 中文摘要: |
| 目的：建立肿瘤检测用药物专利蓝Ⅴ号钠盐注射液细菌内毒素检查方法。方法：按《中国药典》2015年版细菌内毒素检查法，对不同批号的样品进行干扰试验和细菌内毒素检查。结果：高浓度专利蓝Ⅴ号钠盐注射液对鲎试剂与细菌内毒素的凝集反应有干扰作用，在稀释120倍时可排除干扰。结论：本试验建立的细菌内毒素检查方法可用于专利蓝Ⅴ号钠盐注射液的细菌内毒素检查，控制其产品质量。 |
| 英文摘要: |
| Objective: To establish a method of bacterial endotoxin test for tumors-detected drugs patent blueⅤ(PBⅤ) sodium salt injection. Methods: Interference test and bacterial endotoxin test of different batches of samples were carried out according to Chinese Pharmacopoeia (2015 edition). Results: Agglutination interference to tachypleus amebocyte lysate (TAL) and bacterial endotoxin occurred at a high concentration of PB V sodium salt injection which was eliminated after being diluted to 120 times. Conclusion: The bacterial endotoxin test may be suitable for PBⅤ sodium salt injection to control its quality effectively. |
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