中国药业2024，Vol.33Issue(16)：52-55,4.DOI:10.3969/j.issn.1006-4931.2024.16.012
正交试验法优选芪石升降归元颗粒一步制粒工艺
Optimization of One-Step Granulation Process of Qishi Shengjiang Guiyuan Granules by Orthogonal Test
摘要
Abstract
Objective To optimize the one-step granulation process of Qishi Shengjiang Guiyuan Granules.Methods The type,proportion,dosage of excipients,air-inlet temperature and fan frequency were investigated by the single factor test,with the granule property,granule yield,qualification rate,and solubility as evaluation indicators.The one-step granulation process was optimized by the L9(34)orthogonal test,with the material temperature,liquid feeding rate and atomization pressure as the investigation factors,and with the comprehensive score of granule molding rate,moisture,and granule qualification rate as the evaluation indicator.Then the verification test was carried out.Results The single factor test showed that the ratio of extract(with density in the range of 1.20-1.25 g/mL)to excipient dosage was 1∶1(m/m),and the excipient was a mixture of lactose and soluble starch(accounting for 60%and 40%respectively),the air-inlet temperature was in the range of 100-110℃,and the fan frequency was in the range of 35-45 Hz.The optimal one-step granulation process by the orthogonal test was as follows:the material temperature was in the range of 65-75℃,the liquid feeding rate was 10 r/min,and the atomization pressure was 0.20 MPa.The granules prepared by the optimal process had uniform size,high molding rate(about 95%),little moisture(<2%),and qualified solubility.The granules were not hygroscopic and were easy to store at the production environment temperature of 25℃and the relative humidity below 63.9%.Conclusion The optimal one-step granulation process has improved the production level and product quality of the preparation,which can be used for the industrial production of Qishi Shengjiang Guiyuan Granules.关键词
芪石升降归元颗粒/成型工艺/一步制粒/正交试验法Key words
Qishi Shengjiang Guiyuan Granules/molding process/one-step granulation/orthogonal test分类
医药卫生引用本文复制引用
吕建伟,黄庆,黎丽群,韦旭日,谢胜..正交试验法优选芪石升降归元颗粒一步制粒工艺[J].中国药业,2024,33(16):52-55,4.基金项目
国家中医临床研究基地建设项目[国中医药科技函[2018]131号] （）
国家中医药传承创新中心项目[发改办社会[2022]366号] （）
广西壮族自治区中医药管理局自筹经费科研课题[GXZYZ20210560]. （）
