| 复方乳酸钠注射液3号细菌内毒素检查方法的研究 |
| 投稿时间：2010-12-22 修订日期：2011-01-18 点此下载全文 |
| 引用本文：付聪,高锦,嵇杨,聂渝琼,程洋,付晓菲.复方乳酸钠注射液3号细菌内毒素检查方法的研究[J].药学实践杂志,2011,29(2):120~121,148 |
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| 中文摘要:目的 建立军队医院制剂复方乳酸钠注射液3号细菌内毒素检查方法。 方法 采用2005年版中国药典附录细菌内毒素检查法,以不同厂家的鲎试剂对2批复方乳酸钠注射液3号分别进行干扰试验。 结果 将复方乳酸钠注射液3号稀释为2倍稀释液后,用灵敏度为0.25 EU/ml的鲎试剂进行干扰试验,结果对鲎试剂与细菌内毒素的凝胶反应无增强、抑制干扰。 结论 内毒素限值确定为 0.5 EU/ml时,可应用鲎试剂进行细菌内毒素法检查。该方法准确、可靠,可代替家免法检查该注射剂的热原。建议《中国人民解放军医疗机构制剂规范》再版时将家兔法改为细菌内毒素法。 |
| 中文关键词:复方乳酸钠注射液3号 细菌内毒素 干扰试验 |
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| Research on bacterial endotoxin test for compound sodium lactate injection No.3 |
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| Abstract:Objective To establish the method of bacterial endotoxin test for compound sodium lactate injection No.3. Methods The method based on the bacterial endotoxin test in Chinese pharmacopoeia 2005 edition was used. Results Neither inhibition nor enhancement was found in the bacterial eddotoxin interfere factors test after the drug was diluted and the sensitivity of TAL was 0.25 EU/ml. Conclusion The results suggested that bacterial endotoxin test was suitable for the detection of endotoxin in compound sodium lactate injection No.3 and the bacterial endotoxin limit is 0.5 EU/ml. |
| keywords:compound sodium lactate injection No.3 bacterial endotoxin test interfere factors test |
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