目的制备肠溶性包衣膜,考察混合膜材以及添加剂对膜材性质的影响。方法采用平面铸膜法制备Eudragit NE30D/L 30D-55及Eudragit FS 30D/L 30D-55游离膜,并以膜的透湿性、机械性能为指标,考察膜材比例及添加剂[增塑剂柠檬酸三乙酯(TEC)、抗黏剂单硬脂酸甘油酯(GMS)、乳化剂吐温80(Tween-80)]对游离膜的影响。结果 Eudragit NE 30D及Eudragit FS 30D的加入能够增加Eudragit L 30D-55膜材的延展性、弹性和耐撞击负载的能力,同时也会减小膜材的强度、增加其透湿性。Eudragit L 30D-55与Eudragit NE 30D的混合膜材透湿性较大,对于湿度敏感性药物,应尽量避免选择透湿性大的包衣膜材。TEC和Tween-80的加入可改善膜材的柔韧性和弹性,降低膜材的强度,同时,TEC的加入可以增加膜材的透湿性,而GMS对膜材各项机械性质和透湿性影响不大。结论通过简单的调节混合膜材的种类、比例、添加剂的用量可以制得符合要求的肠溶游离膜。
Film coating is an important unit operation to produce solid dosage forms,thereby,the monitoring of this process is helpful to find problems in time and improve the quality of coated products.Traditional methods adopted to monitor this process include measurement of coating weight gain,performance of disintegration and dissolution test,etc.However,not only do these methods cause destruction to the samples,but also consume time and energy.There have recently emerged the applications of process analytical technologies(PAT)on film coating,especially some novel spectroscopic and imaging technologies,which have the potential to real-time track the progress in film coating and optimize production efficiency.This article gives an overview on the application of such technologies for film coating,with the goal to provide a reference for the further researches.
