硝酸异山梨酯制剂释放NO的质量控制分析  

Quality Control of Releasing NO via Isosorbide Dinitrate

作　　者：苏彦文[1] 张凤荣[2] 苏彦斌[3] 

机构地区：[1]吉林化工学院教务处,吉林吉林132022 [2]吉林省药品检验所化学研究室,吉林长春130033 [3]吉林化工学院化学与制药工程学院,吉林吉林132022

出　　处：《吉林化工学院学报》2015年第6期22-27,共6页Journal of Jilin Institute of Chemical Technology

基　　金：吉林省科技发展支撑计划中药和生物药重点项目(No.20120946);吉林化工学院博士基金项目(No.20120121)资助

摘　　要：分析机体内一氧化氮(NO)来源、作用和双向性,探索了硝酸异山梨酯释放NO基本过程、生产工艺和质量控制对策,归纳整理了硝酸异山梨酯制剂质量控制的发展趋势;研究采用文献分析和生产企业调查结合方法;研究获得了硝酸异山梨酯释放NO的质量状况与溶出度、亚硝酸盐与硝酸盐含量、渗透压、原料纯度、有关物质控制、辅料、残留溶剂、储运条件和违法添加密切相关信息,提出了提高药品质量标准,优化处方、改进工艺,严格储运管理,加强生产监管理和开展专项检查的防治对策;研究结论认为硝酸异山梨酯释放NO质量控制点是生产过程,控制对策源于质量分析.This paper analyses source,function and double-edged sword of NO in vivo; explores the basic process,production engineering and quality control measures,and summarizes the development trend of quality control for releasing NO via isosorbide dinitrate by means of literature analysis and survey methods for production enterprises. The quality of releasing NO viaisosorbide dinitrate was related to dissolution rate,nitrite and nitrate content,osmotic pressure,purity of raw materials,auxiliary materials,related substances ontrol,residual solvents,storageconditions,and illegal addition. Some prevention and control measures are put forward to improve the uality standard of drugs. They are the optimization of prescription,improving process,strict supervision for storage and transportation,and carried out special inspections. The conclusions of this study are that the quality control of releasing NO via isosorbide dinitrate is the production process and the control measures derives from quality analysis.

关 键 词：硝酸异山梨脂 NO 释放 控制对策 

分 类 号：R927.2[医药卫生—药学]