摘要
针对羚珠散制剂缺陷,以期导入粒子设计技术提高其质量。以粉体粒子设计机制为基础结合溶剂挥发法的特点制备琥珀-朱砂-人工牛黄复合粒子,并分别对复合粒子、物理混合物的粉体学性质及毒效成分的含量均匀度进行考察,探讨粒子设计技术在羚珠散质量方面的技术优势。结果表明,溶剂挥发法-粒子设计技术制备的复合粒子属于微粉粒子,在SEM中可以观察到稳定的复合粒子团块结构。复合粒子比物理混合物具有更好的流动性及口服顺应性。复合粒子的色差、堆密度、含量均匀度的差值均比物理混合物小,同时具有较小的RSD,分别为4.8%、1.8%、3.4%(胆红素)、0.63%(硫化汞HgS)。溶剂挥发法-粒子设计技术可用于提升羚珠散的制剂质量,相关研究为中药散剂质量的优化提供了新思路。
Targeting the deficiencies of Lingzhu Powder,this study introduced the particle design technology to improve its quality.Based on the mechanism of particle design for powder and the characteristics of solvent evaporation method,composite particles consisting of Succinum,Cinnabaris,and artificial Bovis Calculus were prepared.And the powder properties of composite particles and physical mixtures as well as the content uniformity of toxic components were investigated for exploring the technological advantages of particle design in improving the quality of Lingzhu Powder.The results showed that the composite particles prepared using solvent evaporation method and particle design technology were micro-particles,and the stable agglomerate structure could be observed under SEM.Composite particles exhibited better fluidity and compliance in oral intake than physical mixtures.The differences in chromatism,bulk density,and content uniformity of the composite particles were smaller than those of physical mixtures,and the corresponding RSD values[4.8%,1.8%,3.4%(bilirubin),and 0.63%(HgS),respectively]were smaller.The solvent evaporation combined with particle design technology can be utilized to significantly improve the quality of Lingzhu Powder,which has provided new ideas for the optimization of the quality of traditional Chinese medicinal powder.
作者
周晓
封亮
张小飞
杨艳君
贾晓斌
邹俊波
史亚军
ZHOU Xiao;FENG Liang;ZHANG Xiao-fei;YANG Yan-jun;JIA Xiao-bin;ZOU Jun-bo;SHI Ya-jun(Shaanxi Province Key Laboratory of New Drugs and Chinese Medicine Foundation Research,College of Pharmacy,Shaanxi University of Chinese Medicine,Xianyang 712046,China;School of Traditional Chinese Pharmacy,China Pharmaceutical University,Nanjing 211198,China)
出处
《中国中药杂志》
CAS
CSCD
北大核心
2021年第23期6028-6034,共7页
China Journal of Chinese Materia Medica
基金
国家重点研发计划项目(2018YFC1706904)
陕西省中医药管理局中药制药工程重点学科项目(2017001)
陕西中医药大学学科创新团队项目(2019-YL11)。
关键词
粒子设计技术
溶剂挥发法
羚珠散
复合粒子
粉体学性质
particle design technology
solvent evaporation method
Lingzhu Powder
composite particles
powder properties
