基于活性成分优化清肝凉血颗粒制备工艺研究  

Optimization of the preparation process for Qinggan Liangxue Granules based on active components

作　　者：陈燕 严文利 周德勇 李拓新 范赫名 刘冬平 Chen Yan;Yan Wenli;Zhou Deyong;Li Tuoxin;Fan Heming;Liu Dongping(New Drug Formulation Research and Development Center,Beijing Institute of Traditional Chinese Medicine,Beijing Hospital of Traditional Chinese Medicine,Capital Medical University,Beijing 100010,China)

机构地区：[1]北京市中医药研究所中药新药制剂研发中心、首都医科大学附属北京中医医院,北京100010

出　　处：《国际中医中药杂志》2024年第11期1475-1479,共5页International Journal of Traditional Chinese Medicine

基　　金：北京市中医药研究所市财政专项(YJS-2023-11)。

摘　　要：目的优化清肝凉血颗粒的制备工艺。方法采用L^(9)(3^(4))正交试验设计,以落新妇苷和芍药苷转移率为指标,考察加水倍量、提取时间和提取次数对清肝凉血颗粒提取工艺的影响,筛选最佳提取工艺。以颗粒成型率、含水量、溶化性和流动性为评价指标,比较不同辅料比例和制粒条件下的成品效果。结果清肝凉血颗粒的最佳提取工艺为:加10倍量水,回流提取2次,1.5 h/次;采用湿法制粒,干浸膏粉与底料比例为4∶1(m/m),润湿剂为95%乙醇。结论清肝凉血颗粒制剂工艺稳定可行,为进一步研发和质量控制奠定了基础。Objective To optimize the preparation process of Qinggan Liangxue Granules.Methods The L^(9)(3^(4))orthogonal experimental design was used to investigate the effects of water addition,extraction time and extraction times on the extraction process of Qinggan Liangxue Granules by taking the transfer rate of astilbin and paeoniflorin as the indexes,so as to screen the optimal extraction process.The evaluation indexes of granule molding rate,water content,solubility and fluidity were used to compare the effect of finished products under different ratios of excipients and granulation conditions.Results The optimal extraction process was to add 10 times the amount of water reflux extraction twice,each time 1.5 h;using wet granulation,the ratio of dry paste powder to base material was 4:1(m/m),and the wetting agent was 95%ethanol.Conclusion The preparation process of Qinggan Liangxue Granules is stable and feasible,which lays a foundation for further research and development and quality control.

关 键 词：银屑病 清肝凉血颗粒 落新妇苷 芍药苷 正交试验 中药工艺改进 

分 类 号：R283.6[医药卫生—中药学]