目的 对不同企业生产的金荞麦片进行质量评价。方法 分别收集18批次A企业和20批次B企业生产的金荞麦片，HPLC法测定所有38批次金荞麦片指纹图谱，标定共有峰，采用四级杆飞行时间质谱（quadrupole time-of-flight mass spectrometry，Q-TOF-MS/MS）对共有峰进行成分鉴定，以量化共有峰面积为变量，对指纹图谱进行层次聚类分析（hierarchical cluster analysis，HCA）、主成分分析（principal component analysis，PCA）、正交偏最小二乘法-判别分析（orthogonal partial least squares- discriminant analysis，OPLS-DA）等模式识别分析，对样品中采用对照品比对确认且分离度较好的9个成分进行定量测定。结果 38批次金荞麦片指纹图谱标定共有峰33个；Q-TOF-MS/MS共鉴定成分53个，包括21个鞣质类成分、12个酚类成分、7个黄酮类成分、7个苯丙素苷类成分、2个氨基酸类成分、2个有机酸类成分、1个生物碱类成分及1个萜类成分，其中3个酚类成分（没食子酸、原儿茶酸和原儿茶醛）、5个鞣质类成分（原花青素B1、B2、B3、C1、C2）、4个黄酮类成分（儿茶素、表儿茶素、表儿茶素没食子酸酯和芦丁）采用对照品比对确认，除原花青素C2、B2和芦丁外的9个成分分离度较好，B企业生产的金荞麦片中这9个成分的平均含量均明显高于A企业（P＜0.01）。HCA、PCA和OPLS-DA结果一致，均明显将A企业和B企业生产的金荞麦片区分为2类。共有峰30、29、16、17、2、21、10、11、18、20、27对应的成分（如原花青素C2、B2、C1、B1、B3、没食子酸、表儿茶素等）是引起2家企业生产的金荞麦片质量差异的标志性成分。结论 2家企业生产的金荞麦片存在明显质量差异。

Objective To evaluate the quality of Fagopyri Dibotryis Rhizoma Tablets (FDRT) produced by different companies. Methods A total of 18 batches of FDRT produced by company A and 20 batches of FDRT produced by company B were collected, respectively. The fingerprints of 38 batches FDRT were determined using HPLC, the common peaks were assigned and the constituents of these peaks were identified by quadrupole time-of-flight mass spectrometry (Q-TOF-MS/MS). Using quantitative common peak areas as variables, pattern recognition analysis of the fingerprint was conducted using hierarchical cluster analysis (HCA), principal component analysis (PCA), and orthogonal partial least squares discriminant analysis (OPLS-DA). The content of the nine constituents confirmed by comparison with reference substances and have good separation in samples were determined. Results There were 33 common peaks in the fingerprint of 38 batches of FDRT, and a total of 53 constituents were identified by Q-TOF-MS/MS, including 21 tannins, 12 phenolics, seven flavonoids, seven phenylpropanoid glycosides, two amino acids, two organic acids, one alkaloid, and one terpenoid, among them, three phenolics (gallic acid, protocatechuic acid, and protocatechualdehyde), five tannins (procyanidin B1, B2, B3, C1, C2), four flavonoids (catechin, epicatechin, epicatechin gallate, and rutin) were confirmed by reference substance. The separation degree of nine constituents except for procyanidin C2, B2, and rutin was relatively good. The average content of these nine constituents in FDRT produced by company B was significantly higher than that in FDRT produced by company A (P < 0.01). The results of HCA, PCA, and OPLS-DA were consistent, clearly distinguished the FDRT produced by company A and company B into two categories. The constituents corresponding to common peaks 30, 29, 16, 17, 2, 21, 10, 11, 18, 20, and 27, such as procyanidin C2, B2, C1, B1, B3, gallic acid, epicatechin, etc., are the marker constituents responsible for the quality differences in FDRT produced by two enterprises. Conclusion There is a significant quality difference in FDRT produced by two companies.

R283.6

江苏省南通市科技计划社会民生重点项目（MS12022012）；江苏省药学会正大天晴医院药学科研基金重点项目（Q202205）；江苏省南通市卫生健康委员会科研课题（WSZ2022034）；南通市药学会常州四药医院药学科研基金项目（ntyx2201）