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基于机器感官技术的益气清肺颗粒安慰剂的制备及评价
滕婷婷1,2, 梁利鹏2, 骆利飞1,2, 丁辉3, 宋航宇4, 张艳斌4, 宋新波1,2
1.天津中医药大学现代中药创制全国重点实验室, 天津 301617;2.天津现代创新中药科技有限公司, 天津 300380;3.现代中医药海河实验室, 天津 301617;4.华润三九医药股份有限公司, 深圳 518110
摘要:
[目的] 基于机器感官技术制备益气清肺颗粒安慰剂并评价其效果。[方法] 利用机器感官技术,系统解析原药感官特征,对益气清肺颗粒进行安慰剂仿制。采用机器视觉、电子舌及电子鼻等客观评价手段,综合验证安慰剂模拟效果。[结果] 安慰剂与原药的色差 ΔE 为 2.236 1,颜色相似度 COS 值达 0.999 9,电子舌与电子鼻相似度分别为 0.931 6 和 0.999 3,表明两者在视觉、味觉、嗅觉及综合感官特性上高度一致,为益气清肺颗粒双盲临床试验提供了物质基础与方法学支持。[结论] 该研究突破了中药安慰剂感官属性模拟的技术瓶颈,为同类制剂的制备方法与质量控制提供了新思路,对于推动中药安慰剂标准化评价体系构建具有实践意义。
关键词:  益气清肺颗粒  安慰剂  相似性评价  机器感官技术
DOI:10.11656/j.issn.1672-1519.2026.10.09
分类号:R283
基金项目:现代中医药海河实验室自主立项项目(25HHZYSS00001);国家中医药管理局中医药科技专项课题(GZYKJS-2025-055);天津市科技计划项目(25ZYCGCG00390)。
Preparation and evaluation of Yiqi Qingfei Granules placebo based on machine sensory technology
TENG Tingting1,2, LIANG Lipeng2, LUO Lifei1,2, DING Hui3, SONG Hangyu4, ZHANG Yanbin4, SONG Xinbo1,2
1.National Key Laboratory of Modern Chinese Medicine Innovation and Manufacturing, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, China;2.Tianjin Modern Innovation Chinese Medicine Technology Co., Ltd., Tianjin 300380, China;3.Haihe Laboratory of Modern Chinese Medicine, Tianjin 301617, China;4.China Resources Sanjiu Medical & Pharmaceutical Co., Ltd., Shenzhen 518110, China
Abstract:
[Objective] To prepare a placebo of Yiqi Qingfei Granules based on machine sensory technology and evaluate its effect. [Methods] Using machine sensory technology and intelligent fitting models,the sensory characteristics of the original drug were systematically analyzed,and placebo imitation of Yiqi Qingfei Granules was carried out. Using objective evaluation methods such as machine vision,electronic tongue,and electronic nose,comprehensively verify the placebo simulation effect. [Results] The color difference ΔE between the placebo and the original drug was 2.236 1,and the color similarity COS value was 0.999 9. The similarity between electronic tongue and electronic nose was 0.931 6 and 0.999 3,respectively. This indicates that the two have highly consistent visual,gustatory,olfactory,and comprehensive sensory characteristics,providing material basis and methodological support for the double-blind clinical trial of Yiqi Qingfei Granules. [Conclusion] This study has broken through the technical bottleneck of sensory attribute simulation for traditional Chinese medicine placebos,providing new ideas for the preparation methods and quality control of similar formulations,and has practical significance for promoting the construction of a standardized evaluation system for traditional Chinese medicine placebos.
Key words:  Yiqi Qingfei Granule  placebo  similarity evaluation  machine sensory technology
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