薄膜包衣法制备中药复方结肠定位定时片

目的应用薄膜包衣法制备复方盐酸小檗碱结肠定位定时片。方法以肠溶丙烯酸树脂Eudragit L100与Eudragit S100为pH敏感层材料,以乙基纤维素水分散体(Surelease)为时滞层包衣材料,采用包衣锅包衣法制成结肠定位定时片;以体外释放度为考察指标,使包衣片释药特性基本符合设计要求。结果体外释放度试验表明,当pH敏感层增重4%、时滞层增重6%时,可控制药物在到达小肠后3h释药,且不受胃排空的影响。结论通过调整时滞层、肠溶层包衣厚度,包衣片可基本达到结肠定位释药的预期效果。

Colon-positioning-timing tablets of Chinese medicine prepared by film coating technique

Objective To prepare the colon-positioning-timing tablets of berberine from Chinese compound formula by using film coating technique.Method The colon-positioning-timing tablets were prepared with enteric-coated acrylic resin Eudragit L100 and Eudragit S100 as pH-sensitive layer material,and aqueous ethylcellulose dispersion(Surelease)as time-lag layer material by using film coating technique.The in vitro release percent was taken as the test indexes so the characteristics of the colon-positioning-timing tablets would be in the agreement with design requirement basically.Result The test of in vitro release percent showed that berberine released 3 hours after reaching the small intestines when the pH-sensitive layer was weighted by 4% and that of time-lag layer by 6%.The release was not influenced by gastric emptying.Conclusion The colon-positioning-timing tablets can achieve expected effect of positioning release in the colon through regulating the coating thickness of the time-lag layer and enteric layer.