莫达非尼肠溶片的制备

Preparation of Enteric-coated Modafinil Tablet

目的制备莫达非尼肠溶片。方法选用适宜的辅料压制莫达非尼片芯,选用Eudragit L100-55为肠溶包衣材料,采用薄膜包衣法制备莫达非尼肠溶片。以HPLC法测定莫达非尼含量,采用浆法测定肠溶片的释放度。结果包衣转速为20~30r/min,包衣增重为5%,热处理时间为2h,制备的肠溶片在HCl溶液中2h无裂片或崩解,在磷酸盐缓冲液中释放度符合2005版中国药典要求。结论薄膜包衣法工艺简单,重现性好,方法可行。制备的肠溶片在酸液中和磷酸盐缓冲液中释放度符合2005版中国药典标准。

Aim To prepare Enteric-coated Modafinil Tablet （EMT）. Methods The tablet core was compressed with suitable excipients, and the EMT was prepared using film coating technology with Eudragit L100-55. The concentration of Modafinil was detected by an HPLC-UV method, and the release degree of EMT was investigated. Resuits The pan rotation speed was 20 -30r/min;the coating level was about 5 %, and the heat-treatment time is 2h. The EMT did not splinter or disintegrate in HCl solution, and the release degree in phosphate buffer corresponds with ChP 2005. Conclusions Film coating technology is simple, repeatable and feasible for the preparation of EMT.