摘要
目的：改进残黄片的粉碎工艺,提升其质量稳定性。方法：借鉴中药复合粒子制备方法,设计3种超微粉碎工艺制备残黄片超微粉,利用扫描电镜观察粉体形态,差示扫描量热法评价各粉体的热稳定性,考察所得超微粉的粉体特性;通过高温、高湿、强光试验评价不同工艺所得残黄片的质量稳定性。结果：工艺1为残黄片中4味药材粗粉按比例混合后超微粉碎20 min。工艺2为将黄连与郁金一同超微粉碎25 min,青黛与白矾一同超微粉碎10 min,再将2种粉体混合均匀。工艺3为将黄连与郁金一同超微粉碎25 min,加入青黛继续粉碎10 min,再加入白矾粉碎5 min。3种工艺所得超微粉形态及粉体学性质差异明显,各粉体比热容依次为262.1,242.7,295.9 J·g^-1。高温、高湿、强光试验结果显示只有工艺3所得残黄片各项检测指标均合格,稳定性较好。结论：粒子设计理念下的超微粉碎工艺3提升了残黄片的粉体特性和压片可塑性,所得残黄片质量稳定性有较大改善。
Objective： To improve pulverizing process of Canhuang tablets for promoting its quality stability. Method： Based on the preparation method of composite particles of Chinese medicine,3 kinds of ultrafine grinding process was used to prepare Canhuang tablets. The powder characteristics were investigated parallel with morphology and thermal stability evaluation by scanning electron microscopy and differential scanning calorimetry. Quality stability of Canhuang tablets with different ultrafine grinding processes were evaluated under high temperature, high humidity and strong light conditions. Result： Process 1： Coptidis Rhizoma, Indigo Naturalis,Alumen and Curcumae Radix were mixed in proportion and pulverized 20 min. Process 2： Coptidis Rhizoma and Curcumae Radix were pulverized 25 min together; Indigo Naturalis and Alumen pulverized 10 min together,then 2 kinds of powder mixed evenly. Process 3： Coptidis Rhizoma and Curcumae Radix were ultrafine grinded for 25 min together,added Indigo Naturalis continue to pulverize 10 min,then added Alumen keep on pulverizing for 5 min. The morphology and powder properties of ultrafine powders with 3 kinds of processes were obviously different, specific heat capacities of them were 262. 1,242. 7,295. 9 J·g^-1. The results of high temperature,high humidity and strong light test showed that only Canhuang tablets with process 3 was qualified with good stability. Conclusion： The ultrafine grinding process 3 under composite particles design concept can improve the powder characteristics and plasticity of tableting,and the quality stability of Canhuang tablets under this process is greatly improved.
作者
吉日木巴图
张诗龙
范娜
宋杨
王啸洋
韩晋
JIRIMU Ba-tu;ZHANG Shi-long;FAN Na;SONG Yang;WANG Xiao-yang;HAN Jin(School of Pharmacy, Jiangxi University of Traditional Chinese Medicine, Nanchang 330004, China;302 Military Hospital of China, Beijing 100039, China;Academy of Mongolian Medicine, Inner Mongolia Medical University, Hohhot 010110, China)
出处
《中国实验方剂学杂志》
CAS
CSCD
北大核心
2018年第12期9-13,共5页
Chinese Journal of Experimental Traditional Medical Formulae
基金
北京市科技计划“十病十药”研发专项(Z171100001717002)
国家“重大新药创制”科技重大专项(2014ZX09J14106-01A)
关键词
超微粉碎
粉体
残黄片
质量
稳定性
影响因素试验
差示扫描量热法
ultrafine grinding
powder
Canhuang tablets
quality
stability
influencing factors test
differential scanning calorimetry
