己酮可可碱葡萄糖注射液内毒素检测法探讨
Study on BET in pentoxifylline glucose injection
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摘要: 目的 探讨细菌内毒素法对己酮可可碱葡萄糖注射液进行检测的可行性。方法 按照《中国药典》2000版收载的细菌内毒素检查法的要求进行干扰试验。结果 将己酮可可碱葡萄糖注射液稀释2倍后对鲎试剂凝集反应没有干扰作用,用标示灵敏度为0.25EU/mL的鲎试剂检测细菌内毒素是有效的。结论 细菌内毒素法可用于己酮可可碱葡萄糖注射液的检测,控制其质量。
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关键词:
- 己酮可可碱葡萄糖注射液 /
- 细菌内毒素检查法 /
- 鲎试剂
Abstract: Objective To study the feasibility of bacterial endotoxin test(BET) for the pentoxifylline glucose injection.Methods The interference test was conducted with reference to Chinese Pharmacopoeia(2000ed) on BET.Results The tachypleus amebocyte lysate has no interfered by the pentoxifylline glucose injection diluted 2 times in the coagulate reaction, so it is valid to use the sensitivity of TAL 0.25EU/mL to test bacterial endotoxin. Conclusion The bacterial endotoxin test(BET) can be used as quality control of the pentoxifylline glucose injection. -
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