护肝片改薄膜包衣生产工艺研究

Research on Production Techology of Liver Protection Tablet Film Coating

为了解决糖衣片在临床使用中出现的问题,改变了包衣工艺,建立了护肝片薄膜包衣的最佳工艺条件并考察其稳定性。将护肝片的包衣工艺由糖衣改为薄膜衣,通过正交试验确定护肝片薄膜包衣的最佳包衣液浓度、喷量、喷雾风速温度,并用加速试验法和室温留样考察其稳定性。在包衣液浓度为13%、包衣液喷速为140 g/min、进风温度为75℃的条件下生产的薄膜衣片质量最佳,且按2010药典检验其稳定性合格。结果表明,此制备工艺稳定,可用于护肝薄膜衣片的工业生产。

In order to solve the problems caused by sugar coating in clinical applications of liver protection tablets,the coating process was changed,the best film coating process was established,and its stability was tested.Sugar coating was switched to film coating,the optimal concentration of the coating liquid,spray rate,and inlet air temperature were determined by orthogonal test,and its stability was tested using accelerated test method and room temperature sample test method.The best conditions of producing film coated tablets were keeping concentration at 13%,spray rate at 140 g/min,and inlet air temperature at 75 ℃. The film coated tablets were passed the stability test in accordance of the Pharmacopoeia of the People＇s Republic of China（2010 version）.The results showed that the film coating process was stable and suitable for mass production of film coated liver protection tablets.