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目的利用泡腾剂提供稳定持续的释药动力,制备葛根素(PU)泡腾性渗透泵控释片,并考察其体外释药机制。方法以碳酸氢钠和柠檬酸为泡腾剂,聚氧乙烯N80为助悬剂制备片芯;以醋酸纤维素为包衣材料,邻苯二甲酸二乙酯为增塑剂,聚乙二醇-400为致孔剂制备PU单层渗透泵片;以体外释放度为评价指标,单因素考察确定最佳处方。结果泡腾剂种类和用量、助悬剂的种类和用量、促渗剂的种类及剂量、包衣增重对累积释放度均有显著影响,增塑剂、释放介质及转速对累积释放度无显著影响。考察工艺的重现性,并对其释药曲线进行模型拟合,结果表明工艺可重现。结论成功制备了PU泡腾性渗透泵控释片,其在12 h内呈现零级释放(r>0.999 0),药物释放比较完全(累积释放度>85%),工艺简单。
OBJECTIVE: To provide a stable and sustained release kinetics of effervescent preparation of Puerarin (PU) effervescent osmotic pump controlled release tablets and study its in vitro drug release mechanism. Methods Sodium bicarbonate and citric acid were used as effervescent agents. Polyoxyethylene N80 was used as suspending agent to prepare the core. With cellulose acetate as coating material and diethyl phthalate as plasticizer, polyethylene glycol -400 as a porogen to prepare PU monolayer osmotic pump tablets; in vitro release as the evaluation index, single factor study to determine the best prescription. Results The types and amount of effervescent agent, the type and amount of suspending agent, the type and dosage of penetration enhancer, and the weight gain of coating had a significant effect on the cumulative release. The release of plasticizer, Significantly affected. The reproducibility of the process was investigated, and the model of the release curve was fitted. The results showed that the process was reproducible. Conclusion PU effervescent osmotic pump controlled release tablets were successfully prepared, which showed zero-order release (r> 0.999 0) within 12 h and complete drug release (cumulative release> 85%). The process was simple.