【摘要】 医药行业在中国属于特殊的行业,涉及到国民健康、经济发展以及社会稳定,药品研发中质量管理体系起到保证药品质量的作用。建立合理药品研发质量管理体系,逐步强化药品质量管理,为药品研发的成功奠定良好的基础。文章以研究实例为背景,引入化学合成、气相色谱、液相色谱的相关内容,重点介绍索利那新原料药的相关质量控制措施。更多还原

【Abstract】 The pharmaceutical industry is a special industry in our country,which involves the health of the people and the economic development and stability of the society,and is related to the people’s life.The quality management system in drug research and development plays a role in ensuring the quality of drugs.Establish a reasonable quality management system for drug research and development,gradually strengthen drug quality management,and lay a good foundation for the success of drug research and development.Based on the research examples,this paper introduces the contents of chemical synthesis,gas chromatography and liquid chromatography,with emphasis on the quality control of Solifenacin Succinate API.更多还原