离心制粒工艺制备微晶纤维素空白微丸的研究

目的：考察微日纤维素（MCC）以离心制粒工艺制备微丸时的颗粒形成机理和影响因素，优化工艺参数。方法：采用不同批次间颗粒性质比较的方法，考察并确定影响离心制粒工艺的处方和工艺因素，通过均匀设计，优化MCC处方成丸的工艺参数。以优化条件制备微丸，与市售空白丸芯进行颗粒物理性质比较。结果：粘合剂用量、主机转速、粘合剂加入速度和滚圆时间对MCC处方的颗粒结聚影响较大。经多元线性回归，获得了这些因素与微丸收率、均匀度、微丸粒径间的定量关系，颗粒增长主要受物料含水量的制约，以优化工艺参数制备的微丸颗粒物理性质，与市售MCC空白丸芯相比无较大差异。结论：水性辅料以离心制粒工艺制备微丸切实可靠。

Studies on Preparation of Microcrystalline Cellulose Pellets by Using Centrifugal Fluid-bed Equipment

Aim To study the mechanism for pellets formation and influences on preparation of pellets by using centrifugal fluid-bed equipment with microcrystalline cellulose(MCC) and to optimize the granulation conditions.Methods Granulations in different batches were investigated to compare the influences of variables such as formulation composition and technics.Uniform design was used to optimize the granulation conditions.The comparison was made between qualities of pellets produced in optimized conditions and that obtained in market.Results It is shown that the amount of wetting agent,the rotation speed of disk,the spray rate and spheronization time have significant influences on insoluble granulations in centrifugal fluid-bed equipment and a combination of variables was established.It is found that the enlargement of granules was ruled by the water content.There was no remarkable differences between pellets produced in optimized conditions and obtained in market.Conclusion It is reliable to produce pellets with insoluble granulations in centrifugal fluid-bed equipment.