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

作　　者：邹宇玲[1] 贾淑珍[1] 寇丽杰[1] 乔莱艳[1] 黄建[1] 王国治[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《中国药事》2008年第8期672-674,共3页Chinese Pharmaceutical Affairs

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。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.

关 键 词：卡介苗溶菌粘膜免疫调理剂 浓度 分光光度法 

分 类 号：R917[医药卫生—药物分析学]