用切喷型流化床制备高含量的对乙酰氨基酚微粒

Granulation of High-Content Micro-Particles by a Fluid Bed Tangential Spray Rotogranulation Process

目的用切喷型流化床制备高药物含量的对乙酰氨基酚微粒。方法将对乙酰氨基酚原料、乳糖和微粉硅胶按6∶1∶0.012的比例搅拌混合,以3%HPMC T5为黏合剂,采用切喷型流化床制备微粒。结果在风机频率27 Hz,转盘转速480 r·min^-1,雾化压力0.2 MPa,流速5 g·min^-1,进风温度33℃工艺条件下,耗黏合剂300 mL,得到96～180μm的颗粒,收率约72%,Carr’s流动指数为90,脆碎度为1.38%。其中风量和风温决定了收率和粒径分布,雾化压力和转盘速度主要影响颗粒的硬度和表面形态。结论该方法制备的微粒药物含量高,较圆整,表面光滑,流动性好,粒径分布小,且微粒具有一定硬度,符合后续包衣的要求。

OBJECTIVE To prepare high-content paracetamol micro-particles by a fluid bed tangential spray rotogranulation process. METHODS Paracetamol powders mixed with lactose and silica gel at the ratio of 6：1 ： 0. 012 was granulated using 3% HPMC T5 as the binder with tangental-spay fluid-bed. RESULTS Micro-particles of 96 - 180 μm were gained at the conditions of air flow rate at 27 Hz, rotating speed at 480 r·min^-1 , atomizing air pressure at 0.2 MPa, spraying rate at 5 g·min^-1 and inlet temperature at 33 ℃. The yield was about 72%, Carr＇ s flow index was 90 and friability was 1.38%. CONCLUSION The micro-particles made by the method have high-content drug, high yield, suitable particle size, good flowability and low friability.