文章摘要
陈卫,陈莉,刘小艳,杜鹏飞,季文君,程继业,戴国英,陶渊达.纳米胶束载体聚乙二醇单甲醚聚乳酸嵌段共聚物中细菌内毒素动态显色定量方法的建立[J].中国药品标准,2019,(3):231-236
纳米胶束载体聚乙二醇单甲醚聚乳酸嵌段共聚物中细菌内毒素动态显色定量方法的建立
Content Determination of Bacterial Endotoxin in mPEG-PLA polymeric micelles by kinetic chromogenic method
投稿时间:2018-11-26  修订日期:2019-05-21
DOI:
中文关键词: 动态显色法  纳米胶束载体聚乙二醇单甲醚聚乳酸嵌段共聚物  细菌内毒素  定量
英文关键词: Kinetic chromogenic method  mPEG-PLA polymeric micelles  Endotoxin  Quantitative
基金项目:
作者单位E-mail
陈卫 苏州市药品检验检测研究中心 flone_chen@126.com 
陈莉 苏州市药品检验检测研究中心  
刘小艳 苏州海特比奥生物技术有限公司  
杜鹏飞 苏州海特比奥生物技术有限公司  
季文君 苏州市药品检验检测研究中心  
程继业 苏州市药品检验检测研究中心  
戴国英 苏州市药品检验检测研究中心  
陶渊达 苏州市药品检验检测研究中心  
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中文摘要:
      目的: 建立纳米胶束载体聚乙二醇单甲醚聚乳酸嵌段共聚物细菌内毒素动态显色定量方法。 方法: 首先建立动态显色法测定细菌内毒素的标准曲线,并验证标准曲线的可靠性,考察样品对细菌内毒素检查的干扰情况,确定样品的最大无干扰浓度,随后验证方法的精密性和准确性,并进行初步应用。 结果: 标准曲线可靠性验证中,相关系数r>0.99,标准曲线可靠。供试品用水稀释并添加内毒素标准品至供试品终浓度0.625mg.ml-1(稀释40倍)及内毒素终浓度为0.25 Eu.ml-1时,测定其回收率接近100%,供试品在该浓度对内毒素实验的干扰作用较小。方法的精密度和准确度验证中,标准曲线各浓度点测量结果的变异系数均<7%,加入各浓度的内毒素标准品的测定结果的变异系数均<5%,回收率在94%-112%之间。另外,日常检测3批供试品的内毒素含量均小于限值,回收率在97%-105%之间。结论: 动态显色法可用于定量检测纳米胶束载体聚乙二醇单甲醚聚乳酸嵌段共聚物的细菌内毒素。
英文摘要:
      Objective: To establish the quality control method of quantitative testing of endotoxin in mPEG-PLA polymeric micelles. Methods: The standard curve for determination of bacterial endotoxin by kinetic chromogenic assay was plotted and verfieid for reliability. The interference of samples to determination of bacterial endotoxin was investigated to determine the maximum sample concentration without interference. The method was verified for precision and accuracy, and preliminarily applied. Results: In the reliability experiment of standard curve, r values of the curve were all above 0.99, which indicated the validity of the standard curve. In the interference experiment, the sample was redissolved and diluted to 0.625 mg.ml-1 after 0.25 Eu.ml-1 (final) of standard endotoxin was added into the sample as recovered solution. The recovery rates of endotoxin were all close to 100%. The Coefficient of Variance of determination results of standard endotoxin were less than 7%,while those of test samples added with standard endotoxin were less than 5%,with recovery rates of 94%-112%. In addition, the contents of endotoxin in three batches of samples were all lower than the limited value through routine testing, with recovery rates of 97%-105%. Conclusion: The kinetic chromogenic method is applicable to the quantitative testing of endotoxin in mPEG-PLA polymeric micelles.
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