维生素C包衣微丸的制备及稳定性研究Preparations and stabilities of vitamin C pellets
曾环想,肖全英,潘卫三,陈济民
ZENG Huan-xiang 1; XIAO Quan-ying 1; PAN Wei-san 2; CHEN Ji-min 2 (1. Shenzhen Pharmaceutical Factory;
摘要(Abstract)：
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。结论本文研制的包衣微丸为解决维生素C制剂的变色问题作了有益的探索
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.
关键词(KeyWords)：
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
基金项目(Foundation):
作者(Authors):
曾环想,肖全英,潘卫三,陈济民
ZENG Huan-xiang 1; XIAO Quan-ying 1; PAN Wei-san 2; CHEN Ji-min 2 (1. Shenzhen Pharmaceutical Factory;
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