两种制粒方法制备口腔速溶片的工艺比较

目的制备盐酸羟考酮口腔速溶片，并初步探讨其速溶机理。方法分别采用流化床一步制粒法和手工湿法制粒两种工艺制备颗粒，比铰颗粒外观、流动性、粒径分布、孔隙结构的差异；颗粒压片后，比较所得片剂在崩解时间上的差异。结果以流动性指数为考察标准，发现采用流化床制得的颗粒均一性、可压缩性、流动性明显好于手工湿法颗粒，前者所得片剂的崩解时间明显快于后者。结论用流化床制粒可获得较为理想的盐酸羟考酮口腔速溶片，其高孔隙颗粒结构与其速溶机理密切相关。

A Comparison of two Methods of Preparing the Rapidly Dissolving Tablets of Oxycodone Hydrochloride

Aim To prepare rapidly-dssolving tablets of Oxycodone Hydrochloride. Methods Two kinds of granules were obtained by the fluidiz-bed granulation and traditional wet granulation. The appearance, flow ability, diameter distribution and pore structure of the two kinds of granules were compared.The granule was compressed to get rapidly dissolving tablets,and the disintegration time of the tablets was compared. Results Flow index was investigated, the uniformity, compressibility and flow ability of the granule made by the fluid-bed granulation were better than those of the traditional wet granulation.The rapidly dissolving tablets made by fluid-bed distintegrated faster than traditional wet granulation.Conclusion It was an ideal method to prepare rapidly-dissolving tablets of Oxycodone Hydrochloride by fluid-bed granulation.The high porosity of the granule might account for the fast dissolving effect.