摘要
目的:建立小儿金青颗粒的HPLC指纹图谱分析方法,为控制和评价其质量提供依据。方法:采用Agilent TC-C18(2)色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-0.1%磷酸溶液,梯度洗脱,流速为1.0 ml·min^-1,检测波长为220 nm,柱温为25℃,以靛玉红为参照峰,采用"中药色谱指纹图谱相似度评价系统(2004A版)"软件,绘制了15批小儿金青颗粒样品的HPLC指纹图谱,并进行共有峰的确立和相似度评价,以及药材归属和共有峰的指认。结果:建立了小儿金青颗粒HPLC指纹图谱,共标定了14个共有峰,且全部进行了药材归属,并指认了其中4个共有峰的对应成分;15批样品的指纹图谱相似度均大于0.900。结论:本研究建立的方法具有良好的精密度、重复性和稳定性,为控制小儿金青颗粒的质量提供了新方法。
Objective: To establish an HPLC fingerprint analysis method for Xiaoer Jinqing granules to provide reference for controlling and evaluating the quality. Methods: The separation was developed on an Agilent TC-C18(2) column( 250 mm× 4.6 mm,5 μm) with the mobile phase consisting of methanol-0.1% phosphoric acid solution with gradient elution at the flow rate of 1.0 ml·min^-1. The detection wavelength was set at 220 nm and the column temperature was 25℃ . HPLC fingerprints of 15 batches of Xiaoer Jinqing granules were drawn with indirubin as the reference peak according to Chinese Medicine Fingerprint Similarity Evaluation System( 2004 A). The common peaks were established and the similarities were assessed. The common peaks were all assigned and chemically identified. Results: The HPLC fingerprint of Xiaoer Jinqing granules was established. Totally 14 common peaks were assigned in the fingerprint,and among them,4 common peaks were identified. The fingerprint similarities of the 15 batches of samples were above 0.900. Conclusion: The precision,reproducibility and stability of the method are satisfactory,and the method provides a new way for the quality control of Xiaoer Jinqing granules.
作者
万佳丽
明凯利
向阳
林凤杰
黄志军
Wan Jiali;Ming Kaili;Xiang Yang;Lin Fengjie;Huang Zhijun(School of Chemistry,Chemical Engineering and Life Sciences,Wuhan University of Technology,Wuhan 430070,China;Jianmin Pharmaceutical Group Co.Ltd.)
出处
《中国药师》
CAS
2020年第8期1525-1530,共6页
China Pharmacist
