摘要
目的优选辛白鼻渊颗粒喷雾制粒的最佳工艺。方法采用正交试验法,以喷雾干燥后药粉产量为考察指标优选工艺条件,并进行验证试验和成品质量考察。结果最佳工艺参数为进风温度90℃,喷液转速6 r/min,风机频率45 Hz;薄层鉴别结果显示,供试品溶液色谱中,在与黄芩苷和栀子苷对照品溶液色谱相应位置上显相同颜色的斑点;成品颗粒的主要成分、流动性、粒度、水分、干燥失重和溶化性检查均符合2015年版《中国药典(四部)》规定。结论优选制备工艺所制得的颗粒质量稳定,产品收率高,适宜于工业化生产。
Objective To optimize the optimum conditions for the spray granulation process of Xinbai Biyuan Granules.Methods The spray granulation process was optimized by the orthogonal test with the yield of powder after spray drying as evaluation indexes,the validation test and the quality of finished products were carried out.Results The optimum process parameters were as follows:the inlet air temperature was 90℃,the jet speed was 6 r/min,the fan frequency was 45 Hz.Thin-layer chromatography(TLC)identification results showed that the TLC chromatogram of the test solution had the same color spots on the corresponding positions of the TLC chromatogram of baicalin and mastoside reference solution.The main components,fluidity,particle size,moisture content,loss on drying and dissolution test of the produced granules could meet the requirements of the Chinese Pharmacopoeia(volumeⅣ,2015 edition).Conclusion The granules produced by the optimized preparation process have stable quality and high yield,which is suitable for industrial production.
作者
刘光先
陈文飞
林兆福
王德珍
LIU Guangxian;CHEN Wenfei;LIN Zhaofu;WANG Dezhen(Afiliated Hospital of Panzhihua UInitersity,Panzhihua,Sichuan,China 617000)
出处
《中国药业》
CAS
2021年第5期26-29,共4页
China Pharmaceuticals
基金
2018年四川省中医药管理局科研项目[2018YY015]。
关键词
辛白鼻渊颗粒
喷雾制粒
正交试验
成品颗粒
质量
工艺优选
Xinbai Biyuan Granules
spray granulation
orthogonal test
produced granules
quality
process optimization
