目的: 以市场上收集的37批玄参饮片为研究对象,初步建立基于量化的外观性状与内在质量相关联的玄参饮片质量等级评价方案。方法: 按传统质量评价方法将玄参饮片分别分为A、B两等,在量化A、B两等玄参饮片外观性状指标的同时,开展水分、灰分、浸出物和内在质量指标成分检测,并进行独立样本t检验分析、正交偏最小二乘判别分析（OPLS-DA）和Pearson相关性分析。结果: 在满足2020年版《中华人民共和国药典》 （简称《中国药典》）玄参质控标准的基础上,发现水溶性浸出物和醇溶性浸出物为玄参饮片分类的关键指标,并且玄参饮片色度值越小,密度（ρ）越大,则其水溶性浸出物含量越高,醇溶性浸出物含量越低。初步拟定玄参饮片“选货”和“统货”的等级划分标准：玄参饮片“选货”色泽（E*ab）≤5.5,ρ≥1.4 g · cm-3,水溶性浸出物含量≥77%;玄参饮片“统货”E*ab分布需在5.5~14,ρ大小应位于0.8~1.4 g · cm-3,水溶性浸出物含量≥60%。结论: 玄参饮片的外观性状与内在质量相关,且符合玄参“大而肉坚黑润者佳”的传统观点,便于从外观性状对玄参饮片的内在质量做出科学合理的判断。
Objective: To collect 37 batches of Scrophulariae Radix decoction pieces from the market as the research object, and to establish a quality grade standard of Scrophulariae Radix decoction pieces based on the correlation between quantitative appearance characteristics and intrinsic quality. Methods: According to the traditional quality evaluation method, 37 batches of Scrophulariae Radix decoction pieces were divided into two grades—A and B. Their appearance characteristics were quantified while their moisture, ash, leaching and intrinsic quality indexes were detected, respectively. Finally, the independent sample t test analysis, orthogonal partial least squares discriminant analysis (OPLS-DA) and Pearson correlation analysis were carried out to reveal the correlation between appearance characteristics and intrinsic quality. Results: On the basis of meeting the quality control standard of Scrophulariae Radix recorded in the 2020 edition of the Pharmacopoeia of the People's Republic of China （referred to as Chinese Pharmacopoeia,ChP）, it was found that water-soluble extractives and alcohol-soluble extractives were the key indexes for the grades classification of Scrophulariae Radix decoction pieces. In summary, the lower the chromatic value and the greater the density （ρ） of Scrophulariae Radix decoction pieces, the higher the water-soluble extractives and the lower the alcohol-soluble extractives. The grading quality standard of “selected goods” and “gradeless and uniformly priced goods” of Scrophulariae Radix decoction pieces were preliminarily drawn up: the chromatic value （E*ab）of “selected goods” of Scrophulariae Radix decoction pieces should be less than or equal to 5.5, the ρ of Scrophulariae Radix decoction pieces should be greater than or equal to 1.4 g · cm-3, and the content of water-soluble extractives should be greater than or equal to 77%, the value of E*ab of “gradeless and uniformly priced goods” of Scrophulariae Radix decoction pieces should be between 5.5 and 14, the value of ρ should be between 0.8 and 1.4 g · cm-3, and the content of water-soluble extractives should be greater than or equal to 60%. Conclusion: The appearance characteristics of Scrophulariae Radix decoction pieces are related with the internal quality, which is consistent with the traditional quality evaluation method, and it is convenient to scientifically judge the internal quality of Scrophulariae Radix decoction pieces from its appearance characteristics.
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