论文部分内容阅读
采用高效液相色谱法,以牛血清白蛋白为标准,对照品对生物提取法制备的药用胰岛素中高分子蛋白质杂质进行含量测定,高分子蛋白和胰岛素保留时间分别在7.2-9.2 min和12.0 min之间,能够达到基线分离,整个过程控制相对标准偏差RSD<10%,符合生产工艺要求.对后期生产工艺实施两种不同改进措施(1、2)得到的产品胰岛素含量>90%,符合国家生产标准.实验结果表明实施工艺改进措施2后能生产出符合国家标准的药用胰岛素.研究建立的测定方法适合原料药胰岛素企业对生产过程中高分子蛋白质杂质含量控制,并为生物提取法进行原料药胰岛素研究与开发提供相关技术信息.
High performance liquid chromatography (HPLC) with bovine serum albumin (BSA) as standard was used to determine the content of high molecular weight protein in medical insulin prepared by biological extraction. The retention time of high molecular weight protein and insulin was 7.2-9.2 min and 12.0 min , Can achieve the baseline separation, the relative standard deviation RSD <10% of the whole process control, in line with the requirements of the production process.Produce insulin content> 90% of the products obtained by the implementation of two different improvements (1, 2) Production standards.Experimental results show that after the implementation of process improvement measures to produce 2 in line with the national standard of medicinal insulin.Development of the determination method is suitable for the raw material of the insulin business in the production process of polymer protein impurity content control and biological extraction method for raw materials Drug insulin research and development to provide relevant technical information.