挤出滚圆法制备中药微丸过程中,同时具有润滑作用和黏合作用的润湿剂,其用量直接影响软材、挤出物的性质,进而影响微丸的成型质量。本研究选择具有代表性的25种单味中药作为模型药物,以MCC为成球剂,设定20%,30%,40%3个载药量,共75种制剂原料,测定转矩流变曲线,获得最大转矩(T_(max))及对应的加水量(WT_(max)),并在其指导的加水量条件下挤出、滚圆。结果表明,对于75种含中药的制剂原料,在转矩流变性曲线第2个最大转矩力所对应的加水量(WT_(max-2))条件下得到圆球的制剂原料共有74个,提示MTR可用于指导中药微丸最佳润湿剂用量的优选。转矩流变仪不仅可用于指导挤出滚圆法制备纯MCC微丸的最佳润湿剂用量筛选,也可用于指导含中药提取物微丸的最佳润湿剂用量筛选,在制备中药微丸时,可减少大量的预实验。
With lubricant and bonding effect simultaneously,wetting agent has direct effect on properties of wet mass and extrudate,thus affecting the forming quality of pellets in extrusion-spheronization process. In this research,25 representative kinds of traditional Chinese medicine( TCM) were selected as model drugs and 20 %,30 % and 40 % drug loading were set with MCC as their balling agent. The torque rheological curves were measured to get parameters such as maximum torque( T_(max)) and corresponding water addition( WT_(max)) for these 75 raw materials by a mixer torque rheometer( MTR). The results showed that among 75 representative raw materials,74 ones could be obtained for spherical pellets under the water addition of WT_(max-2). corresponding to the second largest torque in torque rheological curve,suggesting that MTR could be used to select the optimal wetting agent dosage of TCM pellets. So the tedious and expensive pre-production work could be considerably reduced when TCM pellets were prepared.