目的 提高方儿茶Uncaria gambier的质量标准。方法 收集16批进口方儿茶中药材，按照国家食品药品监督管理局颁布的《儿茶等43种进口药材质量标准》项下方法进行系统的性状、理化鉴别以及水分、总灰分测定；对原有的薄层鉴别方法进行优化，建立薄层鉴别（thin layer chromatography，TLC）的评价指标；增加了酸不溶性灰分、浸出物以及表儿茶素的含量测定方法，采用高效液相色谱测定方儿茶样品中儿茶素及表儿茶素的含量并进行方法验证，色谱柱为Welch Ultimate LP-C₁₈（250 mm×4.6 mm，5 μm），流动相为甲醇（A）-0.02%磷酸水溶液（B），梯度洗脱：0～5 min，15% A；5～20 min，15%～25% A；20～30 min，25% A；30～32 min，25%～40% A；32～35 min，40% A；35～36 min，40%～15% A；36～41 min，15% A；体积流量为1.0 mL/min，检测波长为280 nm，柱温为35 ℃，进样量为5μL。建立方儿茶HPLC指纹图谱，以S6峰为参照，采用《中药色谱指纹图谱相似度评价系统（2012版）》进行相似度评价，结合聚类分析（cluster analysis，CA）、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）对方儿茶进行质量评价。结果 方儿茶药材性状符合规定；薄层色谱图中特征斑点显色清晰，分离度好。16批样品中的水分为12.72%～14.15%，总灰分为2.94%～3.89%，酸不溶性灰分为0.21%～0.67%，浸出物为81.39%～86.83%。针对儿茶素和表儿茶素的含量测定方法，儿茶素的质量浓度在15～180 μg/mL内线性关系良好（r＝0.999 4），表儿茶素的质量浓度在10～120 μg/mL内线性关系良好（r＝1.000 0）；精密度、稳定性、重复性试验结果的RSD均低于2.00%；儿茶素平均加样回收率为100.83%，RSD为2.17%，表儿茶素平均加样回收率为99.90%，RSD为1.20%。16批样品中儿茶素质量分数为19.38%～24.74%，表儿茶素质量分数为3.49%～5.66%。HPLC特征指纹图谱共标定6个共有峰，指认其中2个成分，其中峰2为儿茶素、峰6为表儿茶素。16批饮片相似度均大于0.99；相对保留时间的RSD在0.16%～0.31%，表明不同批次间样品共有成分的重现性较好。CA将16批样品分为3类，PCA提取了3个主成分，OPLS-DA筛选出3个差异性标志物，方儿茶药材中共有成分在含量积累上受原产地生长环境的影响不大，但存在组间差距。初步拟定方儿茶药材质量标准为水分不得过16.00%，总灰分不得过5.00%，酸不溶性灰分不得过1.50%，醇溶性浸出物不得少于70.00%，儿茶素量不得少于21.00%；表儿茶素量不得少于3.00%。指纹图谱相似度不得低于0.90。结论 HPLC指纹图谱结合化学模式识别和多指标成分含量测定进行进一步研究，可为方儿茶药材质量的综合评价提供参考。

Objective Improvement of quality standards of imported medicinal herbs, Un-caria gambier Roxbs. Methods Sixteen batches of imported Chinese herbal medicines of Uncaria gambier were collected and systematically characterized, physicochemically and chemically identified as well as moisture and total ash were determined according to the methods under the Quality Standard for Catechu and 43 Other Imported Medicinal Herbs issued by the State Food and Drug Administration. The original thin-layer identification method was optimized, and the evaluation index of thin layer chromatograph (TLC) was established, the methods for the determination of acid-insoluble ash, leachate and epicatechin were added, and the con-tents of catechins and epicatechins in the samples of U. gambier were deter-mined by high-performance liquid chromatography (HPLC), and the method validation was carried out.The column was Welch Ultimate LP-C₁₈ (250 mm × 4.6 mm, 5 μm), and the mo-bile phase was methanol (A)-0.02% aqueous phosphoric acid (B) (0—5 min, 15% A, 5—20 min, 15%—25% A, 20—30 min, 25% A, 30—32 min, 25%—40% A, 32—35 min, 40% A, 35—36 min, 40%—15% A, 36—41 min, 15% A) at a flow rate of 1.0 mL/min, with the detection wavelength of 280 nm, the column temperature of 35 ℃ and the injection volume of 5 μL.The HPLC fingerprints of U. gambier were established, and the S6 peak was used as the reference, and the similarity evaluation was carried out by using the “Similarity Evaluation System of Chinese Medicine Chromatographic Fingerprints (2012 Edition)”, which was combined with the cluster analysis, principal component analysis, and orthogo-nal partial least squares discriminant analysis to evaluate the quality of U. gambier. Results The traits of U. gambier herbs were in accordance with the regulations, the characteristic spots in the thin-layer chromatograms showed clear colora-tion and good separation. 12.72%—14.15% of moisture, 2.94%—3.89% of total ash, 0.21%—0.67% of acid-insoluble ash, and 81.39%—86.83% of leachate were found in 16 batches of samplesFor the determination of catechin and epicatechin, the linearity of the mass concen-tration of catechin was good in the concentration range of 15—180 μg/mL (r = 0.999 4), and that of epicatechin was good in the concentration range of 10—120 μg/mL (r = 1.000 0), the RSDs of the results of the precision, stability, and reproducibility tests were all lower than 2.00%, the average spiked recovery of catechin was 100.83% with RSD of 2.17 (n = 6), and the average spiked recovery of epicatechin was 99.90% with RSD of 1.20% (n = 9).The catechin content of the 16 batches of samples ranged from 19.38% to 24.74%, and the epicatechin content ranged from 3.49% to 5.66%. A total of six common peaks were identified on the HPLC fingerprints, and two of them were identified as constituents, of which peak 2 was catechin and peak 6 was epicatechin. The similarity of the 16 batches of samples was greater than 0.99. The RSDs of the relative retention times were in the range of 0.16%—0.31%, which indicated that the reproducibility of the common components of the samples among different batches was good. Cluster analysis (CA) divided the 16 batches of samples into three categories, principal component analysis (PCA) extracted three principal components, and orthogonal partial least squares discriminant analysis (OPLS-DA) screened three differential markers. The components common to U. gambier herbs were not significantly affected by the growing environment of origin in terms of content accumulation, but there was a gap between groups. Conclusion The preliminary quality standards of U. gambier were: moisture not more than 16.00%, total ash not more than 5.00%, acid-insoluble ash not more than 1.50%, alcohol-soluble leachate not less than 70.00%, catechin not less than 21.00%, and epigallocatechin not less than 3.00%. The similarity of the fingerprints should not be less than 0.90, and the HPLC fingerprints combined with chemical pattern recognition and multi-indicator content determination should be further investigated, which can provide a reference for the comprehensive evaluation of the quality of U. gambier.

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