加味玉屏风颗粒干法制粒工艺的优化  

Optimization of Dry Granulation Technology of Modified Yupingfeng Granules

作　　者：程佩佩 翟红伟 赵玉婷 龙林 胡辉 CHENG Peipei;ZHAI Hongwei;ZHAO Yuting;LONG Lin;HU Hui(Jing Brand Chizhengtang Pharmaceutical Co.,Ltd.,Huangshi 435100;Hubei Provincial Key Lab.for Quality and Safety of Traditional Chinese Medicine Health Food,Daye 435100;Hubei Engineering Technology Research Center of Chinese Medicine Granule,Huangshi 435100)

机构地区：[1]劲牌持正堂药业有限公司,湖北黄石435100 [2]中药保健食品质量与安全湖北省重点实验室,湖北大冶435100 [3]湖北省中药配方颗粒工程技术研究中心,湖北黄石435100

出　　处：《中国医药工业杂志》2023年第2期237-242,253,共7页Chinese Journal of Pharmaceuticals

基　　金：湖北省科技重大专项(2020ACA019)。

摘　　要：本研究对加味玉屏风颗粒的干法制粒工艺进行优选。将乳糖、糊精、二氧化硅分别与加味玉屏风浸膏粉混合后干法制粒。采用正交试验,以一次成型率、吸湿率、溶化率、休止角为考察指标,通过综合评价,并结合实际工业应用效果筛选得到优化的药辅配比为m(乳糖)∶m(糊精)∶m(二氧化硅)∶m(浸膏粉)=0.6∶0.4∶0.05∶1。在此药辅配比基础上,以压辊转速、压轮压力和输料转速为考察因素,以单次有效颗粒成型率、颗粒堆密度、颗粒脆碎度为考察指标,采用正交试验进行优选干法制粒的工艺参数。结果优选的干法制粒工艺参数为:压辊转速15 r/min,压轮压力20 MPa,输料转速80 r/min。优选后的加味玉屏风颗粒干法制粒工艺经中试放大试验,证明工艺稳定可行,可为工业生产提供参考。The aim of this paper was to optimize the dry granulation technology of modified Yupingfeng granules.Lactose,dextrin and silicon dioxide were respectively mixed with the modified Yupingfeng extract,followed by dry granulation.Then,an orthogonal test was employed to comprehensively evaluate the properties of the granules with the primary forming rate,moisture absorption rate,rate of dissolving and angle of repose as the indicators.Combined with actual industrial application,the optimal mass ratio of different excipients to the extract was selected as m(lactose)∶m(dextrin)∶m(silicon dioxide)∶m(the extract powder)=0.6∶0.4∶0.05∶1.On the basis of this ratio,the process parameters of dry granulation,namely the wheel speed,wheel rolling pressure and feeding speed,were optimized by the orthogonal test with the single effective particle forming rate,particle bulk density and fragility as indexes.The optimal dry granulation process parameters were as follows:wheel speed was 15 r/min,wheel rolling pressure was 20 MPa,and feeding speed was 80 r/min.The optimized dry granulation process of modified Yupingfeng granules was proved to be stable and feasible based on the pilot-scale test,which could provide a reference for industrial production.

关 键 词：加味玉屏风颗粒 正交试验 干法制粒 优化 处方 工艺 

分 类 号：R944.27[医药卫生—药剂学]