生脉注射液含残留蛋白质的检测

Sheng Mai injection with residual protein detection

目的:检测生脉注射液不同制备工艺中间体残留蛋白质含量。方法:以残留蛋白质为检测目标,采用透析法获取生脉注射液不同制备工艺中间体中大分子杂质,Bradford法测定各大分子杂质中残留蛋白质含量,结合SDS-PAGE电泳分析各残留蛋白质分子量。结果:在0-8μg线性范围内,牛血清白蛋白标准品回归方程为:Y=0.0474X-0.003(r=0.9974);不同工艺对提取液中残留蛋白的影响较大,红参提取液含残留蛋白浓度较高;麦冬、五味子提取液残留蛋白含量相对较低;经对SDS-PAGE电泳结果分析,各不同工艺提取液中间体含蛋白质分子量主要集中于6-11万。结论:生脉注射液中间体提取工艺工程中可能有蛋白质残留,应加强残留蛋白质检测及生脉注射液的工艺改进;Bradford法结合SDS-PAGE电泳分析生脉注射液中的残留蛋白质,快速、准确、敏感性及检测结果均较好,可为工业生产提供科学数据参考。

Objective：Shengmai injection intermediate of different processes residual protein content.Methods：The target for the detection of residual protein,using dialysis for Health and Injection Preparation of intermediates in the macromolecules of different impurities,Bradford Determination of major elements in the residual protein content of impurities,combined with SDS-PAGE electrophoresis analysis of the residues in the protein molecular weight.Results：The linear range of 0-8 μg,bovine serum albumin standard regression equation：Y=0.0474X-0.003（r=0.9974）;different process on the extraction of residual protein in a larger,red ginseng extract liquid containing a high concentration of residual protein;Ophiopogon,Schisandra extract residual protein content is relatively low;by electrophoresis on SDS-PAGE analysis of extracts from the different intermediate processes including protein molecular weight mainly in the 6-11 million.Conclusion：Shengmai injection intermediate extraction residue protein engineering may be to enhance detection of residual protein and Shengmai injection process improvement;Bradford method with SDS-PAGE electrophoresis Shengmai Injection residue protein,fast,accuracy,sensitivity,and test results are good,can provide scientific data for industrial production of reference.