目的 建立冠心舒通胶囊的HPLC指纹图谱,为其质量评价提供依据。方法 采用Agilent TC-C₁₈(250 mm×4.6 mm,5μm)色谱柱,在280 nm波长下,以0.05%磷酸水溶液-乙腈为流动相进行梯度洗脱,柱温为30℃,体积流量为1.0 mL/min。测定10批冠心舒通胶囊样品,应用中药色谱指纹图谱相似度评价系统(2009版)建立冠心舒通胶囊HPLC指纹图谱,并通过对照品对共有峰进行指认。结果 通过10批样品的测定,建立冠心舒通胶囊HPLC指纹图谱,相似度均在0.95以上,共标定45个共有色谱峰,34个共有峰归属到各药材,其中5个共有峰来源于广枣,23个共有峰来源于丹参,7个共有峰来源于丁香(其中1号峰为广枣和丁香共有),并通过对照品比较指认了其中13个色谱峰,分别为没食子酸(1号峰)、丹参素(3号峰)、原儿茶酸(5号峰)、原儿茶醛(6号峰)、鞣花酸(10号峰)、迷迭香酸(16号峰)、丹酚酸B(19号峰)、丹酚酸A(23号峰)、丁香酚(24号峰)、二氢丹参酮Ⅰ(30号峰)、隐丹参酮(34号峰)、丹参酮Ⅰ(35号峰)、丹参酮Ⅱ_A(39号峰)。结论 此方法专属性强、准确可靠、重复性好,可为冠心舒通胶囊的质量控制提供依据。

Objective To establish an HPLC method for fingerprint analysis of Guanxin Shutong Capsule(GSC) for its quality control. Methods The chromatographic behaviors were obtained by an Agilent TC-C₁₈ column(250 mm×4.6 mm, 5μm) with gradient elution using 0.05% phosphoric acid and acetonitrile as the mobile phase. The column temperature was set at 30℃ and the flow rate was 1.0 mL/min. The detection wavelength was set at 280 nm. The common mode of HPLC fingerprint for 10 batches of GSC was established with Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine(2009 edition) and the common peaks were identified by reference compounds. Results Fingerprints of 10 batches of GSC were established and the similarities to the common mode were above 0.95. Totally 45 common peaks were found, and 34 belonged to herbs. Five mutual peaks were from Choerospondias axillaris, 23 mutual peaks were from Salvia miltiorrhiza, and seven mutual peaks were from Syzigium aromaticum. Based on the retention time of reference substances, 13 constituents including gallic acid(peak 1), danshensu(peak 3), protocatechuic acid(peak 5), procatechuic aldehyde(peak 6), ellagic acid(peak 10), rosmarinic acid(peak 16), salvianolic acid A(peak 19), salvianolic acid B(peak 23), eugenol(peak 24), dihydrotanshinone Ⅰ(peak 30), cryptotanshinone(peak 34), tanshinone Ⅰ(peak 35), and tanshinone Ⅱ_A(peak 39) were identified. Conclusion This method is specific and reliable, which will be conducive to the quality control of GSC.

国家自然科学基金青年基金项目(81303197)