目的 建立安宫牛黄丸（ANP）HPLC指纹图谱，测定其中6种有效成分的量并进行化学模式分析。方法 采用HPLC法，以乙腈-0.1%磷酸水溶液为流动相进行梯度洗脱，检测波长为230 nm，对4个不同厂家生产的12批ANP样品进行测定，并采用中药色谱指纹图谱相似度评价软件进行相似度分析。对主要有效成分栀子苷、京尼平苷酸、盐酸小檗碱、黄芩苷、汉黄芩苷、汉黄芩素进行了定量测定。并采用化学模式识别的方法对不同厂家产品进行分析。结果 4个不同厂家生产的12批ANP的指纹图谱相似度均在0.9以上。对6种有效成分定量测定结果发现不同厂家产品仍存在一定差异，尤其以黄芩所含成分差别较大，说明ANP中黄芩原料药材差异较大，其中C厂家产品中黄芩苷、汉黄芩苷及汉黄芩素的量较其他厂家更为稳定，并且其量普遍高于其他厂家。通过主成分分析中的F综合评分，进一步评价不同厂家样品质量的优劣。结果发现，C厂家产品在综合排名中排名较靠前，其结果与其定量测定结果基本吻合。结论 指纹图谱结合有效成分的化学模式分析能更全面地反映ANP的质量和优劣，所建立的方法对进一步合理控制ANP的质量提供了实验依据。

Objective To establish the HPLC fingerprint of Angong Niuhuang Pills (ANP) and determine the contents of six compounds with analysis of their quality by chemical pattern recognition. Methods The separation was performed with acetonitrile-0.1% phosphoric acid aqueous solution as the mobile phase, and the detection wavelength was set at 230 nm. Twelve batches of samples were collected from four different companies and analyzed using the evaluation system of traditional Chinese medicine chromatographic fingerprint similarity, and chemometric methods. The content of the main effective components of geniposidic acid, geniposide, berberine hydrochloride, baicalin, wogonosidc, and wogonin were determined. The samples of different companies were analyzed by chemical pattern recognition. Results The similarity of fingerprints was above 0.9, the content of six kinds of main effective components showed that there were some differences in the 12 batches of products, especially the composition of Scutellaria baicalensis. The results indicated that the quality of S. baicalensis was not stable. Among them, the contents of baicalin, wogonosidc and wogonin of company were more stable than other companies, and even higher than other companies. The samples can be sorted according to their quality through the F score of the PCA. The results showed that the samples of C company in the comprehensive ranking ranked more forward, which were consistent with the quantitative results. Conclusion Fingerprints combined with chemical pattern recognition can comprehensively response the quality of ANP, providing the experiments basis of reasonable controlling the quality of preparation.

江苏省“333高层次人才培养工程”项目（BRA2016506）