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

作　　者：吕建伟 黄庆 黎丽群 韦旭日 谢胜[1] LYU Jianwei;HUANG Qing;LI Liqun;WEI Xuri;XIE Sheng(The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning,Guangxi,China 530000)

机构地区：[1]广西中医药大学第一附属医院,广西南宁530000

出　　处：《中国药业》2024年第16期52-55,共4页China Pharmaceuticals

基　　金：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]。

摘　　要：目的优选芪石升降归元颗粒一步制粒成型工艺。方法以颗粒性状、颗粒收率、合格率和溶化性为评价指标,对辅料种类、占比及用量,进风温度,风机频率进行单因素考察;以物料温度、进液速率、雾化压力为考察因素,颗粒成型率、水分、颗粒合格率的综合评分为评价指标,采用L_(9)(3^(4))正交试验优选一步制粒工艺并验证。结果单因素考察结果显示,浸膏(密度1.20~1.25 g/mL)与辅料用量的比例宜为1∶1(m/m),辅料宜选择乳糖和可溶性淀粉混合(占比分别为60%和40%),进风温度100~110℃,风机频率35~45 Hz;正交试验所得最佳成型工艺为物料温度65~75℃,进液速率10 r/min,雾化压力0.20 MPa。以最佳工艺所制样品颗粒均匀、成型率高(约为95%)、水分较低(<2%)、溶化性合格,且生产环境温度25℃,相对湿度低于63.9%,可使颗粒不易吸湿,易于保存。结论优选的一步制粒成型工艺提高了制剂的生产水平和产品质量,可用于芪石升降归元颗粒的工业化大生产。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 L_(9)(3^(4))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 

分 类 号：R94[医药卫生—药剂学]