摘要
目的 分析中药易混淆品快速鉴别方法。方法 选取2025年1月-2026年1月上海同济堂药业有限公司收集的6组临床高频中药易混淆品共120份样本为研究对象，分别采用传统性状鉴别、薄层色谱（TLC）快速鉴别、近红外光谱（NIRS）快速鉴别3种方法进行检测，以《中华人民共和国药典》2025年版标准复核结果为金标准，对比3种方法的鉴别准确率、检测时长与操作便捷性。结果 近红外光谱快速鉴别总准确率高于性状鉴别和TLC快速鉴别（P＜0.05）；近红外光谱平均检测时长短于TLC快速鉴别，仅略长于性状鉴别；近红外光谱对6组易混淆品的鉴别准确率均≥95.00%，稳定性最优。结论 近红外光谱快速鉴别法兼具高准确率、快速性与操作便捷性，可作为基层中药易混淆品现场快速筛查的核心方法，联合性状鉴别初筛可构建高效的中药质量管控体系，有效降低混淆品误用风险，保障临床用药安全。
关键词： 中药易混淆品；快速鉴别；近红外光谱；薄层色谱；性状鉴别；中药质量控制
Abstract
Objective To analyze the rapid identification methods for confusable Chinese medicines. Methods Six groups of frequently used clinical confusable Chinese medicines totaling 120 samples were selected from Shanghai Tongji Tang Pharmaceutical Co., Ltd. from January 2025 to January 2026 as the research objects. Three methods, namely traditional physical characteristics identification, thin-layer chromatography (TLC) rapid identification, and near-infrared spectroscopy (NIRS) rapid identification, were used for detection. The results of the 2025 edition of the "Chinese Pharmacopoeia" were used as the gold standard to compare the identification accuracy rate, detection time, and operational convenience of the three methods. Results The total accuracy rate of near-infrared spectroscopy rapid identification was higher than that of physical characteristics identification and TLC rapid identification (P < 0.05); the average detection time of near-infrared spectroscopy was shorter than that of TLC rapid identification, and only slightly longer than that of physical characteristics identification; the identification accuracy rate of all six groups of confusable medicines by near-infrared spectroscopy was ≥ 95.00%, and its stability was the best. Conclusion The near-infrared spectroscopy rapid identification method has high accuracy, rapidity, and operational convenience, and can be used as the core method for on-site rapid screening of confusable Chinese medicines at the grassroots level. Combined with physical characteristics identification for preliminary screening, an efficient quality control system for Chinese medicines can be constructed, effectively reducing the risk of incorrect use of confusable medicines and ensuring the safety of clinical medication.
Key words： Confusable Chinese medicines; Rapid identification; Near-infrared spectroscopy; Thin-layer chromatography; Physical characteristics identification; Quality control of traditional Chinese medicine
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