文章摘要
王静,白亦昊,周长明,吕雯.乙型肝炎人免疫球蛋白抗-HBs效价酶联免疫方法的建立[J].中国药品标准,2017,18(6):439-442
乙型肝炎人免疫球蛋白抗-HBs效价酶联免疫方法的建立
Establishment of the ELISA Method to Test Anti –HBs Potency on Human Hepatitis B ImmunoglobulinWang Jing, Bai Yi-hao, Zhou Chang-ming, Lv Wen (Beijing Institute for Drug Control, Beijing 102206)
投稿时间:2017-07-24  修订日期:2017-12-06
DOI:
中文关键词: 量反应平行线法  酶联免疫法  抗-HBs效价  乙型肝炎人免疫球蛋白
英文关键词: quantity  response parallel  line analysis, ELISA, anti –HBs  potency, human  hepatitis B  immunoglobulin
基金项目:
作者单位E-mail
王静 北京市药品检验所 wj80914@163.com 
白亦昊 北京市药品检验所  
周长明 北京市药品检验所 ZCM.602@163.COM 
吕雯 北京市药品检验所  
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中文摘要:
      目的:建立酶联免疫法检测乙型肝炎人免疫球蛋白抗-HBs效价的测定方法。方法:依据2015年版中国药典的规定,乙型肝炎人免疫球蛋白抗-HBs效价采用酶联免疫法测定,并应用生物检定统计法中的量反应平行线法设计实验,检测实验可靠性,计算效价。结果:每次实验的可靠性均符合2015年版中国药典规定,可信限率在10 %以内,专属性强,试剂盒和仪器因素检测结果经F检验,差异统计学意义(P>0.05),重复性RSD为1.61%。当抗-HBs效价在0.0512 IU.mL-1~0.1 IU.mL-1范围内时,标准品和样品线性相关系数均大于0.99。7批样品与厂家放射免疫法的结果经F检验,统计学差异(P>0.05)。结论:乙型肝炎人免疫球蛋白抗-HBs效价采用酶联免疫法测定,量反应平行线法分析,测定结果稳定、可靠,操作安全、快速、污染,可用于乙型肝炎人免疫球蛋白抗-HBs效价检测。
英文摘要:
      Objective :To Establish the ELISA method to test the potency of anti –HBs on human hepatitis B immunoglobulin. Methods: According to the regulations of ChP. 2015,the ELISA was used for detecting the potency of anti –HBs on human hepatitis B immunoglobulin. Meanwhile, the quantity response parallel line analysis of bioassay-statistical was applied to design the experiment. The reliability was examined and the potency was calculated. Results: The reliable test of each experiment met the specification of ChP. 2015. The fiducial limit rate was within 10%. The specificity was good. The determination results by two different kits and instruments were analyzed by F test and showed no significant difference(P>0.05). The relative standard substance deviation (RSD) in reproducibility test was 1.61 %. While the anti –HBs potency of standard and samples were between 0.0512 IU.mL-1~0.1 IU.mL-1, the linear correlation coefficients (r values) were both more than 0.99.The result of 7 batches of samples showed no statistical difference (P>0.05) by F test with manufacturers radioimmunoassay. Conclusion: The testing results were stable and reliable. The operation was safe, rapid and without contamination. The anti –HBs potency on human hepatitis B immunoglobulin detected by the ELISA method and analyzed by the quantity response parallel line was validated.
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