清热舒通胶囊的成型工艺及稳定性考察

目的：优选清热舒通胶囊辅料的种类，及流化喷雾制粒的工艺参数，并考察成品的稳定性。方法：以颗粒的成型率、休止角为考察指标，优选合适的辅料；采用正交试验设计法优选流化喷雾制粒的工艺参数；通过影响因素试验、加速试验、长期试验考察制剂的稳定性。结果：采用微晶纤维素为辅料，流化喷雾制粒法制粒，进料速度30g·min^-1，物料温度60℃，物料比为1：1．5，雾化压力0．20MPa，颗粒成型率高。稳定性研究中，除高湿试验样品吸湿导致水分超标，崩解时间延长，药品性状发生改变外，在其他试验中，样品的各项考察指标均符合规定。结论：清热舒通胶囊工艺合理，可行；为避免吸潮，包装材料必须具有良好的防潮性能；清热舒通胶囊中试样品稳定性良好。

Preparation Process and Stability of Qingreshutong Capsules

Objective ： To study the preparation techniques and stability of Qingreshutong capsules. Method ： L9 （3^4 ） orthogonal experiment designs was adopted to choose the best technology of spraying granulation according to the rate of qualified granules, the stability of Qingreshutong capsules was investigated by influencing factor test, acceleration test and longterm test. Result： The optimum conditions was to added material at the speed of 30g per minute, to raise the material temperature to 60 ℃ at atomization pressure of 0.20 M Pa, and the rate of materials was 1 ： 1.5. Under conditions of high humidity experiment the preparation was unstable. In other stability experiment the preparation was stable. Conclusion： The optimal conditions is suitable for the preparation of Qingreshutong cap- sule. the stability of Qingreshutong capsules is good.