摘要
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） method was applied to determine the impurities of macromolecular protein content in biological extracting medicinal insulin, and Bovine serum albumin as standard sample in the process. The retention time of macromolecular protein and insulin were from 7.2to 9.2 min and 12.0 min, and baseline separation can be achieved. In the whole controlling process, relative standard deviation RSD10% conformed to the requirements of production process. The quality of product through implement process improvement 1 and 2 was controlled by this approach, and the product of insulin content90% can according to the national production standards. The experimental results showed that the quality of the medical insulin product was conformed to the national drug standards, as implement process improvement 2 measures were adopted. In this study, the analysis method for the content of impurities macromolecular protein was established, and it is suitable for impurities of macromolecular protein control in the active pharmaceutical ingredients insulin production process. Relevant scientific and technical information can be provided, which worked on biological active pharmaceutical ingredients insulin research and development.
出处
《南开大学学报（自然科学版）》
CAS
CSCD
北大核心
2017年第1期72-78,共7页
Acta Scientiarum Naturalium Universitatis Nankaiensis
基金
安徽省高等学校省级优秀青年人才基金重点项目(2013SQRL051ZD)
安徽省高等教育振兴计划重大教学改革研究项目(2015zdjy101)
蚌埠市社会科学规划项目(BB16B019)
安徽省自然科学基金项目(1308085QB24)
国家级大学生创新创业训练计划项目(201410367014
201510367003)
蚌埠医学院教学研究项目(jyxm1506)
