降低双氯芬酸钾片杂质的工艺研究  

Technical Study of Reducing Impurity in Diclofenac Potassium Tablets

作　　者：王娟 李静[3] 刘阿钻 吴晓静 WANG Juan;LI Jing;LIU A-zuan;WU Xiao-jing(School of Chemistry and Chemical Engineering,Hefei University of Technology,Hefei 230009,China;Anhui Shengying Pharmaceutical Limited Liability Company,Hefei 230009,China;Institute for Geoanalysis of Anhui Province,Hefei 230001,China)

机构地区：[1]合肥工业大学化学与化工学院,安徽合肥230009 [2]安徽圣鹰药业有限公司,安徽合肥230088 [3]安徽省地质实验研究所,安徽合肥230001

出　　处：《安徽化工》2018年第5期63-65,69,共4页Anhui Chemical Industry

摘　　要：双氯芬酸钾片的常规生产工艺是将原辅料按照工艺处方配比混合,制粒后进行压片、包衣。在储存过程中,发现按照该工艺生产的双氯芬酸钾片中杂质Ⅲ [2-(2, 6-二氯苯氨基)苯甲醛]的含量会随着储存时间的延长显著升高。通过改变生产过程中工艺参数及制粒方式,并对各个环节的生产条件进行优化,将生产中的辅料制粒烘干后与原料混合压片,避免制粒过程中双氯芬酸钾与水和乙醇接触,能有效降低双氯芬酸钾片的杂质。The conventional production of diclofenac potassium tablets is to mix the raw and auxiliary materials according tothe ratio of the technical prescription, and then to press the tablets and coat them after granulation. During the storage process,it was found that the content of impurity III in potassium diclofenac tablets produced by this process had increasedsignificantly with the prolongation of storage time. The optimal production conditions are obtained by changing the processparameters and granulation methods. Avoiding the contact of diclofenac potassium with water and ethanol during granulationprocess, the impurity of diclofenac potassium tablets can be effectively reduced by mixing auxiliary materials with rawmaterials after drying and granulating the excipients in the production.

关 键 词：双氯芬酸 杂质Ⅲ 生产工艺 

分 类 号：TQ463.6[化学工程—制药化工] O657.72[理学—分析化学]