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机构地区:[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
出 处:《中国中医药信息杂志》2015年第6期91-94,共4页Chinese Journal of Information on Traditional Chinese Medicine
基 金:国家科技重大专项-重大新药创制(2011ZX09201-201-15);黑龙江省应用技术研究与开发计划(GC13C109)
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,1.7μm);流动相为乙腈-0.1%甲酸,梯度洗脱,流速为0.3 m L/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。Objective To establish the UPLC fingerprint of Shuanghuanglian powder-injection. Methods Acquity UPLCTM BEH C18 Column (2.1 mm × 50 mm, 1.7 μm) was established;mobile 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 common spectrum peaks in the reference for comparison, and three main peaks were identified with better separation. The 13 batchs had good consistency, and the process was stable. Conclusion The method is rapid, efficient and can be used for full control of the quality of Shuanghuanglian powder-injection.
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