维生素C泡腾片的产业化研究

Study on Industrialization of Vitamin C Effervescent Tablets

根据参比制剂的原始处方进行剖析并结合泡腾片的特点,对已有的维生素C泡腾片开展生产工艺升级。选取适合直压工艺的物料,并对物料的流动性进行考察,进行处方优化,之后开展3个批次的工艺验证,考察自制试剂的稳定性存放能否满足2015版中国药典的要求。同时对自制制剂与参比制剂开展质量一致性评价,考察结果为自制制剂与参比制剂成功拟合,f2因子大于50。通过维生素C泡腾片的工艺开发降低了制粒、整粒过程,节省了成本。

According to the original prescription of reference preparation and the characteristics of effervescent tablets,the production process of existing vitamin C effervescent tablets was upgraded.The materials suitable for direct pressing process were selected,the fluidity of materials was investigated,and the prescription was optimized.Three batches of process verification was carried out to investigate whether the stable storage of self-made reagents can meet the requirements of Chinese Pharmacopoeia 2015.At the same time,the quality consistency of self-made preparation and reference preparation with process verification batch was evaluated.The results showed that the self-made preparation and reference preparation were successfully fitted,and the f2 factor was greater than 50.Through the development of vitamin C effervescent tablets,the process of granulation and grading was reduced,and the cost was saved.