摘要
目的运用JMP软件的试验设计对甲钴胺片处方进行研究。方法采用粉末直压工艺,通过试验设计筛选辅料种类、型号及用量,以流动性、含量均匀度、溶出度为指标,确定最佳处方组成。结果试验设计所得处方简单,预测结果与实测结果相似,流动性较好,含量均匀度达到《中国药典》2015年版四部要求,溶出与参比制剂相似。结论通过JMP软件的试验设计进行处方研究简单方便,最终得出的处方组成有望应用于工业化生产。
Objective To determine the formula of mecobalamin tablets with the experimental design function of JMP software.Methods Mecobalamin tablets were prepared by direct powder compression technique.With the aid of experimental design function of JMP,the types,models and dosage of the excipients were selected to optimize the formula with fluidity,content uniformity and dissolution as the evaluation indexes.Results The software designed formula was simple.The predicted results were similar to the measured results,with good fluidity.The content uniformity met the requirements of the fourth part of Chinese Pharmacopoeia 2015,and the dissolution was similar to that of the reference preparation.Conclusion It is simple and convenient to conduct formula research by JMP software experiment design.The final formula is expected to be used in industrial production.
作者
苏颖
白杰
蔡正军
肖学菊
张正全
韩雅慧
SU Ying;BAI Jie;CAI Zheng-jun;XIAO Xue-ju;ZHANG Zheng-quan;HAN Ya-hui(Beijing Scrianen Pharmaceutical Co.Ltd.,Beijing 102600)
出处
《中南药学》
CAS
2020年第5期781-784,共4页
Central South Pharmacy
关键词
甲钴胺片
JMP软件
试验设计
处方研究
mecobalamin tablet
JMP software
experiment design
formula research
