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目的:采用星点设计-效应面法优选灯盏花素胃漂浮片的处方。方法:在单因素试验基础上,以羟丙基甲基纤维素K4M(HPMC K4M)和乳糖用量为考察因素,灯盏花素在第2,6,10 h释放度的综合评分为评价指标,通过星点试验优选灯盏花素胃漂浮片的处方,运用SAS软件对试验数据进行处理,选择最佳数学模型,采用Statistica 6.0软件绘制三维效应面图和等高线图,确定最优处方。结果:最佳处方为灯盏花素10 mg,HPMC K4M(亲水凝胶骨架)20 mg,乳糖(致孔剂)10 mg,碳酸氢钠(起泡剂)15 mg,十八醇(助漂剂)10 mg,微晶纤维素(填充剂)35 mg;HPMC K4M和乳糖用量分别为20%,10%。灯盏花素胃漂浮片在第2,6,10 h的释放度分别为19.2%,39.7%,81.5%,能在5 s内起漂,持续漂浮>10 h。结论:建立的数学模型预测性良好,可用于灯盏花素胃漂浮片处方的优化。制备的胃漂浮片释药要求符合规定,漂浮性能良好。
OBJECTIVE: To optimize the prescription of breviscapine gastric floating tablets by the method of star point design-response surface method. Methods: Based on the single factor test, taking the dosage of hydroxypropyl methylcellulose K4M (HPMC K4M) and lactose as examining factors, the comprehensive score of breviscapine release at the 2nd, 6th and 10th hour was used as the evaluation index, The star spot test was used to optimize the formulation of Breviscapine gastric floating tablets. SAS software was used to process the experimental data. The best mathematical model was selected. Statistica 6.0 software was used to draw the 3D effect surface and contour map to determine the optimal prescription. Results: The best prescription was breviscapine 10 mg, HPMC K4M (hydrophilic gel matrix) 20 mg, lactose (porogen) 10 mg, sodium bicarbonate (foaming agent) 15 mg, stearyl alcohol Agent) 10 mg, microcrystalline cellulose (filler) 35 mg; HPMC K4M and lactose were 20%, 10%. Breviscapine gastric floating tablets released in the first 2, 6, 10 h were 19.2%, 39.7%, 81.5%, can float within 5 s, sustained floating> 10 h. Conclusion: The established mathematical model has good predictability and can be used to optimize the formulation of breviscapine gastric floating tablets. Preparation of gastric floating tablets release requirements in line with the provisions of good floating performance.