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目的:优选康复新胃漂浮片的处方,为康复新的开发利用提供参考。方法:采用全粉末直接压片法制备康复新胃漂浮片,以体外漂浮性能与释药性能为综合评价指标,在单因素试验基础上,采用混料设计考察羟丙甲基纤维素(HPMC)、交联聚维酮(PVPP)及NaHCO3对康复新胃漂浮片处方的影响。利用HPLC测定氨基酸含量,流动相[0.1mol·L-1乙酸钠缓冲溶液(pH6.5)-乙腈(93∶7)]-[乙腈-水(80∶20)]梯度洗脱,检测波长254nm,柱温40℃。结果:最佳处方为25%康复新冻干粉,28.38%HPMCK4M,13.38% NaHCO3,18.24% PVPP,14%微晶纤维素,1%硬脂酸镁。康复新胃漂浮片的起漂时间(2±0.2)min,持漂时间>12h,体外释放符合零级动力学模型。结论:制备的康复新胃漂浮片具有良好的体外漂浮性能和释药性能,可增加康复新在胃部的滞留时间,对治疗消化性溃疡具有重要意义。
Objective: To optimize the prescription of new stomach floating tablets and provide reference for the new development and utilization of rehabilitation. Methods: The new floating tablets were prepared by all-powder direct tabletting method. The floating performance and drug release performance in vitro were evaluated comprehensively. On the basis of the single factor test, the mixture design was used to investigate the effects of HPMC, , Crospovidone (PVPP) and NaHCO3 on the prescription of rehabilitation stomach floating tablets. The content of amino acids was determined by HPLC. The mobile phase was eluted with a gradient of 0.1 mol·L-1 sodium acetate buffer (pH6.5) -acetonitrile (93: 7)] - [acetonitrile- water (80:20) The column temperature was 40 ℃. Results: The best prescription was 25% fresh lyophilized powder, 28.38% HPMCK4M, 13.38% NaHCO3, 18.24% PVPP, 14% microcrystalline cellulose and 1% magnesium stearate. The floating time of rehabilitated new gastric floating tablets was (2 ± 0.2) min and the holding time was> 12h. The release in vitro was in accordance with the zero-order kinetic model. CONCLUSION: The reconstituted neovascularization floating tablets have good floating properties and drug release properties in vitro, which can increase the retentive residence time in the stomach and is of great significance for the treatment of peptic ulcer.