目的 建立疏风解毒颗粒（Shufeng Jiedu Granules，SJG）安慰剂的感官与物理参数的模拟与评价方法，研制其安慰剂并构建质量标准体系，开展稳定性考察。方法 基于感官指标（颜色、气味、味道）及物理参数（粒度分布、堆密度）等关键质量属性（CQAs）构建相似性评价模型，采用Pearson相关系数（Pearson correlation coefficient，PCC）量化安慰剂与模拟对象的属性相似度；建立HPLC法同步测定安慰剂中人工色素（柠檬黄、苋菜红、亮蓝）及蔗糖八醋酸酯的含量，用于质量控制。结果 安慰剂与SJG的人工感官相似性评分均＞3分（满分为5分），颜色与物理特性PCC＞0.998；电子舌/鼻分析显示味道与气味特征相似度与人工评价一致；HPLC方法学验证显示专属性与线性关系良好（R²≥0.999 4），精密度等方法学考察指标符合相关规定，稳定性试验6个月内含量变化率＜7.0%。结论 通过整合感官评价、物理表征与化学定量分析，首次构建中药安慰剂多维质量评价体系，阐明感官指标稳定性的化学基础，为双盲临床试验中SJG安慰剂的相似性控制提供方法学保障。

Objective To establish simulation and evaluation methods for sensory and physical parameters of Shufeng Jiedu Granules (SJG, 疏风解毒颗粒) placebo, develop its preparation process, construct a quality standard system, and conduct stability studies.Methods A similarity evaluation model was developed based on critical quality attributes (CQAs) including sensory indicators (color, odor, taste) and physical parameters (particle size distribution, bulk density), with the Pearson correlation coefficient (PCC) used to quantify attribute similarity between the placebo and SJG. HPLC methods were established for simultaneous determination of artificial pigments (tartrazine, amaranth, brilliant blue) and sucrose octaacetate for quality control.Results The placebo demonstrated human sensory similarity scores > 3 (maximum score: 5) compared with SJG. Color and physical characteristics showed PCC > 0.998. Electronic tongue/nose analysis revealed taste and odor profiles consistent with human sensory evaluation. HPLC method validation confirmed acceptable specificity and excellent linearity (R² ≥ 0.999 4), with precision and other methodological parameters complying with pharmacopeial requirements. Accelerated stability testing over six months exhibited content variation rates < 7.0%.Conclusion This study pioneered a multidimensional quality evaluation system for traditional Chinese medicine placebos by integrating sensory evaluation, physical characterization, and chemical quantification, elucidating the chemical basis of sensory stability. The methodology provides critical support for similarity assurance of SJG placebo in double-blind clinical trials.

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上海市卫健委临床研究专项（201940296）；上海市卫健委临床研究专项（202140347）；上海中医药慢性病防治与健康服务省部共建协同创新中心（A1-U24-308-01）；上海市科技计划项目“上海市健康辨识与评估重点实验室”（21DZ2271000）