单硝酸异山梨酯缓释片的工艺研究  

Study on the Technology of Isosorbide Mononitrate Sustained Release Tablets

作　　者：王海民 李芬 王刚民[1] Wang Haimin;Li Fen;Wang Gangmin(Shandong Fangming Pharmaceutical Group Co.,Ltd.,Heze 274500,China;Taishan Medical College,Taian 271000,China)

机构地区：[1]山东方明药业集团股份有限公司,山东菏泽274500 [2]泰山医学院,山东泰安271000

出　　处：《山东化工》2023年第12期10-12,15,共4页Shandong Chemical Industry

摘　　要：目的:对单硝酸异山梨酯缓释片的工艺进行研究,试验出合格的药品。方法:分别将单硝酸异山梨酯与辅料过筛,称取工艺处方量的原辅料,经过干混、湿混制粒;干燥,整粒;混合,压片、包衣、铝塑包装。对制备的片剂质量项目含量、有关物质、释放度检测,并对缓释片置于40±2℃/75%±5%条件下进行加速稳定性考察。结果:按工艺处方生产的单硝酸异山梨酯缓释片含量、有关物质、释放度等各项检测和6个月的稳定性考察均符合规定。结论:研制的单硝酸异山梨酯缓释片工艺稳定,产品质量可控,可进行工业化批量生产。Objective:The technology of isosorbide monostearate sustained-release tablets was studied,and qualified drugs were tested.Methods:Sieve isosorbide mononitrate and excipients respectively,weigh the raw and excipients in the process prescription,and make granules by dry mixing and wet mixing;Dry,whole;Mixing,tablet pressing,coating,aluminum plastic packaging.The content of quality items,related substances and release rate of the prepared tablets were tested,and the accelerated stability of the sustained release tablets was investigated at 40℃±2℃/75%±5%.Results:The content,related substances,release rate,etc.of isosorbide mononitrate sustained-release tablets produced according to the process prescription and the 6-month stability inspection were in line with the requirements.Conclusions:The developed isosorbide mononitrate sustained-release tablets have stable process and controllable product quality,which can be used for industrial batch production.

关 键 词：单硝酸异山梨酯 缓释片 工艺研究 

分 类 号：TQ460[化学工程—制药化工]