双黄连粉针剂UPLC-MS指纹图谱的建立及聚类分析-中国中医药信息.PDF

2015 年6月第 22卷第6期 中国中医药信息杂志 ·91· 双黄连粉针剂 UPLC-MS 指纹图谱的建立及聚类分析 1 2 1 1 顾媛媛 ,李殿明 ,徐红英 ,陈大忠 1.黑龙江中医药大学中医药研究院,黑龙江 哈尔滨 150040；2.哈药集团中药二厂,黑龙江 哈尔滨 150040 摘要：目的 建立双黄连粉针剂的超高效液相色谱(UPLC)指纹图谱。方法 采用 Acquity UPLCTM BEH C18 色谱柱(2.1 mm×50 mm,1.7 μm)；流动相为乙腈-0.1%甲酸,梯度洗脱,流速为 0.3 mL/min,柱温 40 ℃。对 13 批双黄连粉针剂的特征色谱图进行聚类分析,同时采用《中药色谱指纹图谱相似度评价系统(2004 A)》对其质 量进行评价。结果 建立了 13批双黄连粉针剂的 UPLC 指纹图谱共有模式,特征图谱有 16个共有峰,以对照品 为对照,指认了 3 个主要色谱峰,各色谱峰有较好的分离效果。各批次间一致性良好,工艺稳定。结论 本方法 快速、高效,可用于全面控制双黄连粉针剂的质量。 关键词：双黄连粉针剂；指纹图谱；超高效液相色谱法；聚类分析 DOI：10.3969/j.issn.1005-5304.2015.06.026 中图分类号：R284.1 文献标识码：A 文章编号：1005-5304(2015)06-0091-04 Establishment and Cluster Analysis of UPLC-MS Fingerprint of Shuanghuanglian 1 2 1 1 Powder-injection GU Yuan-yuan , LI Dian-ming , XU Hong-ying , CHEN Da-zhong (1.Institute of Chinese Medicine, Heilongjiang University of Chinese Medicine, Harbin 150040, China ；2.Second Chinese Medicine Factory of Harbin Pharm Group Co. Ltd., Harbin 150040, China) Abstract ：Objective To establish the UPLC fingerprint of Shuanghuanglian powder-injection. Methods Acquity UPLCTM BEH C Column (2.1 mm × 50 mm, 1.7 μm) was established；mobile 18 phase was acetonitrile and 0.1% formic acid with gradient elution；the flow rate was 0.3 mL/min； the column temperature was 40 ℃ . Characteristic spectrum cluster of 13 batches of Shuanghuanglian powder-injection were analyzed, and Chinese Medicine Chromatographic Fingerprint Evaluation System (2004 A) was used to evaluate their quality. Results UPLC fingerprint common mode of 13 batches of Shuanghuanglian powder-injection was established. There were total 16 comm