【摘要】 目的研制盐酸胺碘酮包衣脉冲片,并考查体外释放特性。方法以盐酸胺碘酮为模型药物,制备合适的片芯;以乙基纤维素和丙烯酸树脂L100的乙醇溶液包衣,滚转包衣技术制备盐酸胺碘酮脉冲释放片,采用正交实验优化其制剂工艺,并进行体外溶出度测定。结果片芯崩解剂的用量为8%,包衣增重量为12%,包衣组成Eud-ragit L100-EC=2∶1即能达到设计要求,按照优化后处方制备的脉冲片的体外释药时滞为(6.11±0.18)h。结论本脉冲片处方设计和工艺方法可行,体外试验满足脉冲释药时滞效果。更多还原

【Abstract】 Objective To prepare the pulsatile-release tablets of amiodarone hydrocholride and investigate the dissolution prorperties in vitro.Methods Amiodarone hydrocholride was used as the model drug.The core was prepared and was pan-coated by ethylcellulose/eudragit L100,which dissolved in anhydrous alcohol.The orthogonal experiment was used to optimize the production technology,and the release degree of pulsatile tablet was determined.Results The technology was as follows:8%CMC-Na was selected as the disintegrant,the weight of coating in creased by 12% and coating composition eudragit L100-EC was 2∶1.The release of pulsatile tablet lasted(6.11±0.18)h in vitro.Conclusion The design and preparation of pulsatile-release tablets are feasible.In vitro test shows pulsatile-release delay effect.更多还原