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卡介苗溶菌粘膜免疫调理剂浓度检测方法的建立

Establishment of a Method for Determining the Concentration of Broken BCG Mucous Membrane Immune Modifier

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【作者】 邹宇玲贾淑珍寇丽杰乔莱艳黄建王国治

【Author】 Zou Yuling, Jia Shuzhen, Kou Lijie, Qiao laiyan, Huang jian and Wang guozhi (National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100050)

【机构】 中国药品生物制品检定所

【摘要】 采用分光光度法检测卡介苗溶菌粘膜免疫调理剂(简称调理剂或BCG-b)浓度。405nm为最适检测波长。经测定,调理剂浓度重量(或单位)与OD值的相关系数r=0.97,自由度n’=4(P<0.01)。调理剂10mg·mL-1浓度的OD值(405nm)为1.318±0.088。用该方法测定了3批调理剂成品(试制)的浓度。结果表明,分光光度法具有良好的重复性和可靠性,适用于调理剂浓度的测定。

【Abstract】 Broken BCG mucous membrane immune modifier(BCG-b)would be intended to therapy tumors with type of the mucous membrane. We determined the concentration of BCG-b by spectrometry. Firstly, the OD value was highly correlated with the concentration of BCG-b at 405nm (r=0.97,P<0.01). And then, six batches of final bulk (10mg·mL-1) were measured at 405nm. The average of OD value was 1.318±0.088 at 405nm in final bulk. These OD values of six batches appeared normal distribution. Finally, the concentration of three final products was determined. The error was 0.05-3.77%. The concentration of BCG-b in final product equals to OD value/1.318×10×6±20% (U/container). The results proved that spectrometry possesses the fine repeatability and reliability to determine the concentration of BCG-b.

  • 【文献出处】 中国药事 ,Chinese Pharmaceutical Affairs , 编辑部邮箱 ,2008年08期
  • 【分类号】R927
  • 【被引频次】4
  • 【下载频次】49
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