安徽科技学院学报2024,Vol.38Issue(4) :53-61.DOI:10.19608/j.cnki.1673-8772.2024.0408

复方参芪颗粒的制备工艺及其质量控制

Preparation process and quality control of FuFangShenQiKeLi

吴飞 李月侠 李昊 金传山
安徽科技学院学报2024,Vol.38Issue(4) :53-61.DOI:10.19608/j.cnki.1673-8772.2024.0408

复方参芪颗粒的制备工艺及其质量控制

Preparation process and quality control of FuFangShenQiKeLi

吴飞 1李月侠 1李昊 2金传山2
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作者信息

  • 1. 安徽省中医药科学院亳州中医药研究所,安徽亳州 236800;亳州职业技术学院,安徽亳州 236800
  • 2. 安徽中医药大学,安徽合肥 230012
  • 折叠

摘要

目的:优选复方参芪颗粒的最佳配方和制备工艺,并对其质量控制进行初步研究.方法:以颗粒的吸湿率、成型率、流动性和口感为评价指标,按不同权重综合评分,以综合得分为响应值,结合响应面法分析,优选配方和制备工艺;用高效液相色谱法测定黄芪甲苷的含量.结果:浸膏与辅料比例为1∶4,甘露醇与乳糖比例为4∶3,矫味剂用量为0.20%,成型率、吸湿率、休止角分别为96.86%、2.52%、27.60°,颗粒微甜,可接受;黄芪甲苷的线性回归方程为y=1.321 9x+1.113 3,R2=0.999 6.黄芪甲苷在1.994~7.976 µg范围内具有良好的线性关系.结论:此方法重现性好,优选的复方参芪颗粒制备工艺切实可行;黄芪甲苷含量测定方法线性关系良好,可用于其质量控制.

Abstract

Objective:To optimize the optimal prescription and preparation process of FuFangShenQiKeLi,to study its quality control.Methods:The moisture absorption rate,molding rate,fluidity,and taste of particles were used as evaluation indicators,and comprehensively scoring according to different weights,the comprehensive score as the response value,were combined with response surface methodology analysis,to optimize the prescription and preparation process.Determine The content of Astragaloside IV using high-performance liquid chromatography.Results:The ratio of extract to excipients was 1∶4,the ratio of mannitol to lactose was 4∶3,and the amount of flavor correction agent was 0.20%.The molding rate,moisture absorption rate,and angle of rest were 96.86%,2.52%,and 27.60°,respectively.The particles were slightly sweet and acceptable.The linear regression equation for astragaloside Ⅳ was y=1.321 9x+1.113 3,R2=0.999 6.Astragaloside Ⅳ exhibitsed a good linear relationship within the range of 1.994 to 7.976 μg.Conclusion:This method had good reproducibility and the optimal preparation process for FuFangShenQiKeLi is practical and feasible.The method for determining the content of Astragaloside Ⅳ has a good linear relationship and could be used for its quality control.

关键词

复方参芪颗粒/制备工艺/响应面法/高效液相色谱法/黄芪甲苷

Key words

FuFangShenQiKeLi/Preparation process/Response surface method/High performance liquid chromatography/Astragaloside Ⅳ

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基金项目

安徽省高校优秀青年人才支持计划项目(gxyq2020136)

安徽省高校自然科学研究项目(KJ2021ZD0163)

安徽省质量工程项目(2022cjrh034)

出版年

2024
安徽科技学院学报
安徽科技学院

安徽科技学院学报

影响因子:0.434
ISSN:1673-8772
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