| 高浓度维生素B6注射液细菌内毒素检查方法学验证 |
| 投稿时间：2019-09-25 修订日期：2019-11-08 点此下载全文 |
| 引用本文：沈娟,芦佳月,罗晓茹,王习文.高浓度维生素B6注射液细菌内毒素检查方法学验证[J].药学实践杂志,2020,38(1):67~70 |
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| 中文摘要:目的 建立高浓度维生素B6注射液的细菌内毒素检查方法。方法 采用《中国药典》2015年版四部通则1143细菌内毒素检查法进行检测。结果 用pH6.5～7.5的缓冲液将高浓度维生素B6注射液稀释至1.04 mg/ml，用λ为0.06 EU/ml的鲎试剂可以有效去除干扰。结论 该方法可行，可用于高浓度维生素B6注射液的细菌内毒素检查。细菌内毒素的限值确定为0.06 EU/mg。 |
| 中文关键词:高浓度维生素B6注射液 细菌内毒素 凝胶法 干扰试验 |
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| Validation of endotoxin test for high concentration vitamin B6 injection |
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| Abstract:Objective To establish a bacterial endotoxin test method for high concentration vitamin B6 injection.Method The test was taken according to the bacterial endotoxin test in Chinese pharmacopoeia 2015 edition.Result By diluting the sample concentration to 1.04 mg/ml with the buffer of pH6.5-7.5, and using λ=0.06 EU/ml of TAL reagent, the interference could be effectively avoided.Conclusion The method was useful, which could be used to test the bacterial endotoxin in high concentration vitamin B6 injection. The bacterial endotoxin limit was defined as 0.06 EU/mg. |
| keywords:high concentration vitamin B6 injection. endotoxin gel-clot test method interference test |
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