干法制粒压片制备马波沙星风味片的研究

The Study on Preparation of Maploxacin Flavour Tablets by Dry Granulation

为制备马波沙星风味片,通过颗粒一次成型率,适口性、脆碎度、溶出度、批间重复性进行质量评价,以单因素实验筛选处方,正交试验优化处方,得到马波沙星风味片最佳处方为:马波沙星10%、乳糖24%、微晶纤维素37.5%、预胶化淀粉12%、鸡肝粉7.5%、羟丙基纤维素5%、低取代羟丙基纤维素3%、硬脂酸镁1%,采用干法制粒压片工艺,避免了溶剂的使用,操作简单,产品质量稳定,处方成本低,更易推广使用,在临床应用中具有广阔前景。

To prepare mabloxacin flavour tablet in this study,quality evaluation was conducted based on primary particle formation rate,palatability,friability,dissolution,and inter-batch repeatability.The formulation was screened using a single-factor experiment,and optimized using an orthogonal experiment,with the acquisition of the optimal formula for marbofloxacin flavour tablet as follows:marbofloxacin 10%,lactose 24%,microcrystalline cellulose 37.5%,pregelatinized starch 12%,chicken liver powder 7.5%,hydroxypropyl cellulose 5%,hyposubstituted hydroxypropyl cellulose 3%,magnesium stearate 1%.Without the use of solvents,the dry granulation tabletting process has the advantages of simple operation,stable product quality,and low formulation cost,which is easier to promote and use.Findings in our study suggest that this process has broad prospects in clinical applications.