火把花根片薄膜包衣工艺及质量研究  

Research on the Film-coating Process and Quality of Colquhounia Root Tablets

作　　者：王帆 曹纬国 李杨红 乔志强 赵建权 王江瑞 WANG Fan;CAO Weiguo;LI Yanghong;QIAO Zhiqiang;ZHAO Jianquan;WANG Jiangrui(Department of Traditional Chinese Medicine,Chongqing College of Traditional Chinese Medicine,Chongqing 402760,China;Chongqing Hospital of Traditional Chinese Medicine,Chongqing 400011,China;Pharmaceutical Factory of the Chongqing Academy of Chinese Materia Medica,Chongqing 400800,China;Sinomune Pharmaceutical Co.,Ltd.,Wuxi 214194,China)

机构地区：[1]重庆中医药学院中药学院,重庆402760 [2]重庆市中医院,重庆400011 [3]重庆市药研院制药有限公司,重庆400800 [4]江苏知原药业股份有限公司,江苏无锡214194

出　　处：《现代中药研究与实践》2024年第6期61-65,共5页Research and Practice on Chinese Medicines

基　　金：重庆市长寿区科技计划项目(CSKJ2024007)

摘　　要：目的研究火把花根素片的薄膜包衣工艺。方法采用单因素考察法和正交实验进行包衣工艺优化,以包衣温度、包衣增重、锅体转速、雾化压力、喷液流速为考察因素,以包衣合格率、崩解时限为考察指标,确定包衣最佳工艺参数。结果包衣工艺的最佳参数为包衣锅进风温度为70.0℃(物料温度45.0~55.0℃左右)、包衣增重4.0%、锅体转速为9~15 r/min、雾化压力为0.70 MPa、喷液流速为0.30 mL/min。在此条件下,经过三批小试放大,火把花根薄膜包衣片各项质量指标均符合要求。结论本研究开发的包衣工艺操作简便实用,制得的产品质量可靠,适用于火把花根薄膜包衣片的生产。Objective To research on the film-coating process of Colquhounia Root tables.Methods The coating acceptance rate,disintegration time were used as index,single factor(air inlet temperature,coating weight gain,pan body speed,atomization pressure and spray flow rate)combined with orthogonal test were used to explore the best technological parameters of the film coating of Colquhounia Root tablets.Results The optimal proces parameters of Colquhounia Root film-coating tablets were as folows:air inlet temperature 70.0℃(material temperature 45.0~55.0℃),coating weight gain of 4.0%,pan body speed 9~15 r/min,atomization pressure 0.70 MPa and spray flow rate 0.30 mL/min.In this condition,the quality of film-coating tables were accord with quality standard after 3 batches of amplification.Conclusion The preparation process is stable and the quality is controllable,which can lay a foundation for the industrial production of the film coating of Colquhounia Root tables.

关 键 词：火把花根片 薄膜包衣 正交试验 工艺研究 

分 类 号：R284.1[医药卫生—中药学]