包衣参数对推拉式渗透泵片半透膜包衣层透明度的影响  

Influences of Coating Parameters on Transparency of Semi-permeable Membrane Coating on Push-pull Osmotic Pump Tablets

作　　者：杨继荣 陈伟 朱颖 YANG Jirong;CHEN Wei;ZHU Ying(Shanghai Colorcon Coating Technology Limited,Shanghai 201108)

机构地区：[1]上海卡乐康包衣技术有限公司,上海201108

出　　处：《中国医药工业杂志》2020年第12期1564-1569,共6页Chinese Journal of Pharmaceuticals

摘　　要：推拉式渗透泵片半透膜包衣层的透明度对于激光打孔机对药物层和推动层的识别非常重要。然而在半透膜包衣过程中,衣膜变白的情况时有发生。本试验使用棕红色包衣的空白片芯为模型制备乙酸纤维素半透膜包衣片,并通过对半透膜包衣后片剂的色差分析,以色差(DE)值来量化半透膜的透明度。采用JMP 10.0软件随机定制设计了12次试验(包含1个中心点),用以考察影响半透膜包衣层透明度的不同包衣参数,如包衣时的进风风量、进风温度、喷液速度、包衣增重和实际环境相对湿度。结果表明,喷液速度、进风温度及二者的交互作用对半透膜包衣层透明度的影响显著;包衣时的片床温度及其与实际环境相对湿度的交互作用也是导致衣膜不透明的显著因素。The transparency of the semi-permeable membrane coating on the push-pull osmotic pump tablets is very important for the identification of the drug layer and the push layer in laser drilling machine.In the process of semi-permeable film coating,the phenomenon of whitening of semi-permeable membrane occurs from time to time.In this paper,the push-pull osmotic pump tablets coated with cellulose acetate as semi-permeable membrane with the brownish red tablet cores were prepared,and color difference analysis was adopted to evaluate the transparency of the semi-permeable membrane with delta E(DE)value as a quantitative indicator.The JMP 10.0 statistic software was used to carry out the random customized experimental design for 12 experiments,including one central point.The influences of the selected coating process parameters including inlet airflow volume,inlet temperature,liquid spraying rate,coating weight gain and relative humidity of actual environment on transparency of the semi-permeable membrane were investigated.The results showed that the influences of liquid spraying rate,inlet temperature and their interaction significantly influenced transparency of the semi-permeable membrane,and bed temperature and its interaction with relative humidity of actual environment were also significant factors leading to film opacity.

关 键 词：推拉式渗透泵片 半透膜包衣 透明度 色差分析 

分 类 号：R944.4[医药卫生—药剂学]