摘要
目的:优选虎杖解毒无糖颗粒的成型工艺。方法:通过单因素实验,以颗粒的成型率、溶化性、吸湿率和流动性为评价指标,确定辅料种类;采用星点设计-效应面法和总评归一值法,优选虎杖解毒无糖颗粒的辅料总量、混合辅料的比例以及润湿剂乙醇的体积分数,并验证优化结果是否可靠。结果:最佳成型工艺条件为稠膏-辅料用量比(0.41∶1),糊精-乳糖(2.79∶1),润湿剂为60.9%乙醇;工艺试验验证结果与二项式拟合方程预测结果的偏差小于5%。结论:优选的成型工艺稳定可靠,实验方法简单直观,制得颗粒成型性、溶化性、抗湿性、流动性俱佳,为生产提供科学依据。
OBJECTIVE To optimize molding process of Polygonum cuspidatum antidote sugarless granules.METHODSBased on results of a single factor experiment,with pellet formability,dissolubility,hygroscopicity and liquidity as comprehensive indexes,excipient types were defined.Then technique of central composite design-response surface and overall desirability was used to optimize total necessities,ratio of mixed excipients and volume fraction of wetting agent ethanol,and it was validated whether the optimized results were reliable.RESULTS Optimal molding technology conditions were as follows：proportion of total necessities（0.41∶1）,proportion of dextrin-lactose（2.79∶1）,volume fraction of ethanol（60.9%）.Deviation between was less than 5% between results of the best technology verification test and the binomial fitting equation forecast.CONCLUSION This optimized molding process is stable and feasible.The test method is simple and intuitive,granules prepared by this method have a high qualified rate,good dissolubility,strong anti-hygroscopicity and good liquidity,and the experiment can provide a scientific basis for mass production of this preparation.
出处
《中国医院药学杂志》
CAS
CSCD
北大核心
2016年第20期1759-1763,共5页
Chinese Journal of Hospital Pharmacy
基金
四川省科研院所科技成果转化项目(编号:13010132)
关键词
虎杖解毒无糖颗粒
成型工艺
星点设计-效应面
Polygonum cuspidatum antidote sugarless granules
molding process
central composite design-response surface
