氟班色林片的制备工艺研究

Study on the preparation process of Flubanserin Tablets

目的以国外上市的氟班色林为参比制剂,研究制备氟班色林片剂的最佳处方及工艺。方法采用单因素实验和正交实验确定最优工艺。结果最佳处方及工艺为一水乳糖17.10 g、微晶纤维素M-1013.33 g、羟丙甲基纤维素0.85 g、硬脂酸镁0.17 g,以体积分数为85%的乙醇溶液作为润湿剂,原料药粒径为80目,采用湿法制粒,微晶纤维素内加与外加比例为1.6∶1,片剂硬度为80 N·cm^(-2)。结论通过工艺优化所制备的氟班色林片剂的片形外观、制粒情况、崩解时限、溶出率等指标均达到了相应的质量要求。经优化的制备工艺合理、可行。

Objective To study the optimal prescription and process of Flibanserin Tablets,using flibanserin marketed abroad as a reference formulation.Methods Single factor experiments and orthogonal experiments were used to determine the optimal process.Results The optimum prescription and process is 17.10 g of lactose monohydrate,3.33 g of microcrystalline cellulose M-101,0.85 g of hydroxypropyl methyl cellulose and 0.17 g of magnesium stearate,with 85%by volume ethanol solution as wetting agent,80 mesh particle size of flibanserin,wet granulation,1.6∶1 ratio of microcrystalline cellulose inside and outside,and 80 N·cm^(-2) of tablet hardness.Conclusion The Flupanserin Tablets prepared by the process optimisation met the corresponding qua-lity requirements in terms of tablet appearance,granulation,disintegration time and dissolution rate.The optimized preparation process is reasonable and feasible.