目的:优化甘草黄酮胃内漂浮片的处方,改善甘草黄酮体外释放情况.方法:以均匀设计法优化甘草黄酮胃内漂浮片的处方与工艺,以体外漂浮性及释放度作为优化的考察指标.结果:通过优化,载药层处方各辅料用量比:HPMC K4M 45%、CMC-Na 12%、PEG600016%、乳糖7%;混合辅料与甘草黄酮按1:1配比;硬脂酸镁为润滑剂,全粉末压片,硬度为4.5~6.0 kg,片重300 mg.片剂外观光洁,漂浮性能好,体外溶出释放度符合零级速率方程.结论:本方法所制备的甘草黄酮胃内漂浮片外观及可压性好,体外8h释药性良好,工艺简单易行,生产成本低.%Objective: To optimize the prescription and preparation of gastric floating tablets of licorice flavonoids for improving the in vitro release rate. Methods: The prescription and preparation was optimized using the uniform design, the floating properties and release rate in vitro were investigated to determine the best preparation process. Results: The ratio of excipients used in the prescription of drug-loading layer for HPMC K4M, CMC-Na, octodecanol, PEG6000 and lactose was 45%, 12%, 20%, 16% and 7%, respectively. The mixing ration of excipients and licorice flavonoids was 1:1. Magnesium stearate was used as lubricant and the technology of direct powder compression was adopted. The hardness of the dry tablet was 4.5-6.0 kg, and the weight was 300 mg. The tablets had smooth appearance and good flotation property. Moreover, the drug release rate in vitro was accordant with the zero order rate equation. Conclusions: The gastric float-ing tablets of licorice flavonoids prepared through the optimized method had outstanding appearance and pressure resistance. Moreover, the modified tablets had good drug release rate in vitro within 8 h and low production cost because of the simple preparation process.
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