基于崩解时限的牡蛎糖原片剂配方组合优化研究

Optimization research of the formulation of oyster glycogen tablets basing on disintegration time

为了确定牡蛎糖原片剂的制备工艺,以崩解时限为重要指标,利用单因素结合正交试验法筛选优化牡蛎糖原片剂配方组合。研究结果表明,以牡蛎糖原冻干粉添加量15%、微晶纤维素15%、麦芽糊精5%、羧甲基淀粉钠5%、硬脂酸镁0.02%、玉米淀粉59.98%为片剂处方,优选出的处方工艺简单可行,制备的片剂质量符合中国药典(2015版)的有关规定,稳定性好。

To develop the preparation technique of oyster glycogen tablets, the preparation technique of oyster glycogen tablets was optimized by single factor and orthogonal experiment, with the disintegration time as important quality indicators. Results showed that, the optimum ratio of oyster glycogen freeze - dried powder, MCC, mahodextrin, CMS -Na, magnesium stearate and corn starch were 15%, 15%, 5%, 5%, 0. 02% and 59. 98%, respectively. The optimal process was simple and feasible to conduct, and the quality of the optimized oyster glycogen tablets had a good stability, which met the criterion of Chinese Pharmacopoeia （2015）.