以红花为例的中药材饮片掺杂增重“五位一体”综合鉴别体系的构建与应用研究

Construction and Application of a "Five-in-One" Integrated Identification System for Detecting Adulteration and Weight Gain in Chinese medicines and decoction pieces: A Case Study on Carthami Flos

关键词:  掺杂增重  综合鉴别  五位一体  质量标准  补充检验方法

Key words:  adulteration and weight gain  integrated identification  five-in-one system  quality standard  supplementary testing method

摘要:

针对中药材饮片掺杂增重现象日趋复杂、现有标准与检验方法难以有效识别与判定的问题,本研究以红花为范例,构建了一套“性状初筛—显微鉴别—理化验证—仪器确认—标准响应”的“五位一体”综合鉴别体系。通过系统整合传统经验鉴别与现代分析技术,该体系实现了对掺入油脂、无机盐、淀粉及糖类等常见增重物的快速筛查、形态学观察、理化验证和精准定性。应用该体系对296批国家药品抽检红花样品进行分析,不合格检出率从现行标准检验的9.8%提升至29.7%,揭示了被掩盖的质量问题。研究进一步基于检测数据,提出了修订红花总灰分、酸不溶性灰分限度及建立专项补充检验方法的建议。该体系为提升中药材饮片掺杂增重监管的准确性与效率提供了系统的技术方案,并对其它药材的质量控制具有借鉴意义。

Abstract:

In response to the increasingly complex phenomenon of adulteration and weight gain in Chinese medicines and decoction pieces, which existing standards and testing methods fail to effectively identify, this study established a comprehensive "five-in-one" identification system using Carthami Flos as a model. The system integrates five sequential approaches: preliminary screening by macroscopic characteristics, microscopic identification, physicochemical verification, instrumental confirmation, and standard response. By systematically combining traditional empirical identification with modern analytical technologies, this system achieves rapid screening, morphological observation, physicochemical verification, and accurate qualitative identification of common weight-gaining adulterants such as oils, inorganic salts, starches, and sugars. Application of this system to 296 batches of nationally sampled safflower revealed that the detection rate of substandard samples increased from 9.8% with current standard testing to 29.7%, exposing previously concealed quality issues. Based on the analytical data, recommendations were proposed for revising the limits of total ash and acid-insoluble ash in safflower, as well as establishing specialized supplementary testing methods. This system provides a systematic technical solution to enhance the accuracy and efficiency of regulatory oversight for adulteration and weight gain in Chinese medicines and decoction pieces, with reference value for quality control of other medicinal materials.