文章摘要
王尧尧,顾德周,王贺,杨晨,何跃芳,王林.动态浊度法定量检测依地酸二钠中细菌内毒素的含量[J].中国药品标准,2019,20(6):495-499
动态浊度法定量检测依地酸二钠中细菌内毒素的含量
Quantitative Determine of Bacterial Endotoxin in Disodium Edetate by Kinetic Turbidimetric Assay
投稿时间:2019-07-26  修订日期:2019-11-20
DOI:
中文关键词: 依地酸二钠  细菌内毒素  动态浊度法
英文关键词: SDisodium edetate  Bacterial endotoxin  Dynamic turbidimetric method.
基金项目:
作者单位E-mail
王尧尧 扬子江药业集团有限公司 wangyaoyao@yangzijiang.com 
顾德周 扬子江药业集团有限公司  
王贺 扬子江药业集团有限公司  
杨晨 扬子江药业集团有限公司  
何跃芳 扬子江药业集团有限公司  
王林 扬子江药业集团有限公司  
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中文摘要:
      目的 建立依地酸二钠细菌内毒素的常规检测方法。方法 根据2015年版《中国药典》四部通则1143细菌内毒素检查法,采用动态浊度法对依地酸二钠进行干扰预试验和正式干扰试验,确定依地酸二钠的不干扰稀释倍数或不干扰稀释浓度。结果 用BET水溶解配制成初始浓度为50 mg?mL-1的供试品溶液,采用钙离子缓冲液稀释50倍,再用BET水稀释2倍进行定量检测。结果无干扰因素影响,内毒素回收率在50%-200%范围内。 结论 动态浊度法可用于检测依地酸二钠中的细菌内毒素含量。
英文摘要:
      ABSTRACT Objective: A routine method of detecting bacterial endotoxin for disodium edetate.Methods: The bacterial endotoxin test was carried out according to the methods by the general rule 1143 of Chinese Pharmacopoeia 2015 edition,dynamic turbidimetric method was used to conduct pre-interference test and interference test on disodium edetate to determine the non-interference dilution ratio or non-interference dilution concentration of the sample. Results: The test solution with initial concentration of 50 mg?mL-1 was prepared by dissolving BET water. The solution was diluted 50 times with special diluent for calcium ion buffer, and then diluted 2 times with BET water for quantitative detection. Results the recovery rate of endotoxin was in the range of 50%-200%.Conclusion: Kinetic turbidimetric method can be used in the detection of disodium edetate of bacterial endotoxin.
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