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目的优化酮咯酸氨丁三醇缓释片处方,并对其进行体外释放度考察。方法采用羟丙甲基纤维素(HPMC)为骨架材料制备酮咯酸氨丁三醇缓释片,通过测定体外释放度,对HPMC黏度和用量、填充剂种类、润滑剂用量、制粒方法等因素进行筛选,在此基础上,结合星点设计-效应面法进行处方优化,并对模型进行验证。结果最佳处方为每片含酮咯酸氨丁三醇20 mg、HPMC K15M 45 mg、微晶纤维素10 mg、Starch1500 25 mg、微粉硅胶1 mg、硬脂酸镁1 mg,制备工艺为粉末直接压片。释药动力学符合Higuchi方程。结论采用星点设计-效应面法优化酮咯酸氨丁三醇缓释片处方,所建模型预测性良好。
Objective To optimize the formulation of ketorolac tromethamine sustained-release tablets and investigate its in vitro release. Methods Hydroxymethylcellulose (HPMC) was used as the matrix material to prepare ketorolac tromethamine sustained-release tablets. The viscosity and amount of HPMC, the type of filler, the amount of lubricant, the granulation method and so on Factor screening, on this basis, combined with the star point design - response surface method for prescription optimization, and verify the model. Results The best prescription for each tablet containing ketorolac tromethamine 20 mg, HPMC K15M 45 mg, microcrystalline cellulose 10 mg, Starch1500 25 mg, silica powder 1 mg, magnesium stearate 1 mg, the preparation process for the powder Direct compression. Release kinetics fit Higuchi equation. Conclusion The method of star point design-response surface method was adopted to optimize the formulation of ketorolac tromethamine sustained-release tablets. The model was predictive.