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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。
OBJECTIVE To prepare compound colonic parotid colonic timing tablets by film coating method. Methods Enteric-coated acrylic resin Eudragit L100 and Eudragit S100 were used as pH-sensitive layer materials and Surelease as the shelled coating material, In vitro release as an indicator, the release characteristics of coated tablets basically meet the design requirements. Results In vitro release test showed that when the pH-sensitive layer gained 4% weight gain and delayed layer weight gain 6%, the drug release could be controlled 3 hours after reaching the small intestine without being affected by gastric emptying. Conclusion By adjusting the thickness of lag layer and enteric coating, the coated tablets can basically achieve the expected results of colon-specific drug release.