经典名方易黄汤颗粒剂的制备工艺研究  

Study on Preparation Technology of Classic Famous Fang Yi Huang Decotion Granules

作　　者：王硕 郭勇 邹妍 李丹 姜国志 李响 Wang Shuo;Guo Yong;Zou Yan;Li Dan;Jiang Guozhi;Li Xiang(Shineway Pharmaceutical Group Co.,Ltd.,Shijiazhuang 051430,China;Hebei Provincial Key Laboratory of Quality Process Control of Classical Formulas and Modern Chinese Medicines,Shijiazhuang 051430,China)

机构地区：[1]神威药业集团有限公司,河北石家庄051430 [2]河北省经典名方与现代中药质量过程控制重点实验室,河北石家庄051430

出　　处：《广东化工》2024年第23期54-56,81,共4页Guangdong Chemical Industry

基　　金：经典名方产业技术创新战略联盟(232790492A)。

摘　　要：目的:探索易黄汤颗粒的制备工艺及工艺参数。方法:采用干法制粒对易黄汤颗粒进行制备,对颗粒的可压性、溶化性、吸湿性为指标,对其辅料种类进行筛选。对制粒过程中辅料的种类、矫味剂等参数进行优化,确认颗粒剂的最佳制备工艺,并进行处方验证试验。结果:优选的辅料为麦芽糊精,调整干法制粒机参数为:压制片厚为0.2 mm~1.0 mm,片厚范围为设定压制片厚的±0.3 mm,液压压力60 bar~160 bar,螺旋送料转速40~130转/分,挤压压辊转速5~30转/分、整粒转速80~190转/分。压辊温度不得超过35℃,压辊位移上下限0.1~4.0。粗粒和细粉重新制粒,过14/40目筛,制得硬度适宜、色泽一致的颗粒。三批工艺验证结果表明,采用优选的制粒方法制备的颗粒收率较高。结论:优选的易黄汤颗粒制备工艺稳定可靠,可用于后续易黄汤产业化生产研究中。Objective:To study the best preparation of Yihuang tang granules and process parameters.Methods:Yihuangn tang granules were prepared by dry granulation.By using the compressibility,solubility,and hygroscopicity of particles as indicators,the types of excipients are screened.Optimize the types of excipients and flavor correction agents used in the granulation process,confirm the optimal preparation process for granules,and conduct prescription validation experiments.Results:The preferred excipients were maltodextrin.The parameters of the dry granulator were as follows:the pressing thickness was 0.2 mm~1.0mm,the thickness range was±0.3mm,the hydraulic pressure was 60 bar~160 bar,the spiral feed speed was 40-130 rpm,the extrusion roller speed was 5 rpm~30 rpm,and the whole grain speed was 80 rpm~190 rpm.The roller temperature shall not exceed 35℃,and the upper and lower line was 0.1~4.0.Crude grain and fine powder re-treatment,over 14/40 mesh sieve,to make a suitable hardness,color consistent particles.The process validation results of 3 batches showed that the yield of the preferred granulation method were high.Conclusion:The preferred preparation process of Yihuang Tang granules were stable and reliable,and can be used in the subsequent industrial production of peach soup particles.

关 键 词：易黄汤 干法制粒 辅料筛选 工艺参数 

分 类 号：R283.6[医药卫生—中药学]