枸橼酸阿奇霉素注射液细菌内毒素检测法探讨
Detection of bacterial endotoxin in azithromycin citrate injection
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摘要: 目的 建立枸橼酸阿奇霉素注射液细菌内毒素的检测方法.方法 参照《中国药典》2000版细菌内毒素检查法进行干扰试验.结果 枸橼酸阿奇霉素注射液经1倍稀释后对细菌内毒素检查法无干扰作用.结论 对枸橼酸阿奇霉素注射液进行热源检查及细菌内毒素检查对比试验,两法符合率均为100%,细菌内毒素法可用于该制剂.
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关键词:
- 枸橼酸阿奇霉素注射液 /
- 细菌内毒素 /
- 干扰试验
Abstract: Objective To establish a detecting method for the bacterial endotoxin in the azithromycin citrate injection. Methods The interference test was conducted with reference to Chinese Pharmacopoeia(2000ed) on BET. Results There was no interfere effect in the detection for bacterial endotoxin in the azithromycin citrate injection which was dilated one time. Conclusion The according rate is 100%, which make the pyrogen detection to the azithromycin citrate injection and experimentize contrast to the bacterial endotoxin.-
Key words:
- azithromycin citrate injection /
- bacterial endotoxin /
- interfer experiment
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