摘要
目的制备维生素C微丸 ,并评价其稳定性。方法采用悬浮包衣制剂技术 ,通过均匀设计试验筛选出制备维生素C微丸的处方工艺参数 ,并通过加速试验和长期试验考察其稳定性。结果以枸橼酸及微粉硅胶等为辅料制备维生素C丸芯 ,以丙烯酸树脂为包衣材料 ,包衣液浓度为 4 % ,在进风温度为 5 0℃ ,喷雾压力为 1 4 7× 1 0 5Pa,输液速度为 9 0mL/min的条件下进行悬浮包衣 ,可以制得稳定性良好的维生素C微丸。
Objective To prepare vitamin C pellets and evaluate their stabilities.Methods The optimal formulations and technical parameters of the pellets were found with the uniform experimental design.The stabilities of the pellets were investigated by accelerated experiments and shelf-life tests.Results The pellets prepared by the optimal formulations and technology showed good stabilities under various experimental conditions.The optimal formulations and technical parameters of the pellets were that we might use citric acid and colloidal silicon dioxide to make a bead core and use Eudragit E as the coating material to make coated-pellets by the suspension coating technology under optimal conditions,that is 4% for the concentration of the coating liquid,50 centigrade for the inlet air temperature, 1.47×10 5 Pa for the spraying air pressure and 9 mL/min for the spraying rate of the coating liquid.Conclusions The coated-pellets showed good stabilities under various experimental conditions and will play an important part in preventing the vitamin C pharmaceutical dosage from color change.
出处
《沈阳药科大学学报》
CAS
CSCD
2002年第4期244-248,共5页
Journal of Shenyang Pharmaceutical University
关键词
维生素C
微丸
悬浮包衣法
稳定性
均匀设计
vitamin C
pellets
suspension coating technology
stabilities
uniform design
