颈复康片高效液相色谱指纹图谱的研究

HPLC fingerprints of Jingfukang tablets

目的建立颈复康片HPLC指纹图谱,从而实现对颈复康片产品质量的整体控制。方法采用HPLC技术对颈复康片制剂中的药物成分进行研究,并确立该制剂的指纹图谱。结果建立了颈复康片HPLC指纹图谱,在共有模式下选择并标定共有峰22个,鉴定出了3-羟基葛根素、染料木苷、芍药苷、葛根素、3-甲氧基葛根素、大豆苷、王不留行黄酮苷、龙胆苦苷8个色谱峰,分析了12批次颈复康片样品,生成了对照指纹图谱,以相似度为评价指标,12批次样品的相似度值均在0.99以上。结论建立HPLC指纹图谱鉴别方法,可操作性强,质控性好,专属性高,为有效地评价、控制颈复康片质量以及进一步深入研究提供了有效的数据支持。

Objective To establish HPLC fingerprints for Jingfukang tablets, and to control the quality of the product. Methods Fingerprints of Jingfukang tablet were established by HPLC. Results A total of 22 common chromatographic peaks were identified in the cocalibration mode. Puerarin, 3-hydroxy puerarin, 3-methoxypuerarin, genistin, daidzin, paeoniflorin, flavonoid glycoside and gentiopicroside were identified. The similarity of the fingerprints of 12 batches of Jingfukang tablet fingerprints was similar to that of the control fingerprints. The similarities of 12 batches of Jingfukang tablets were over 0.99. Conclusion The method is simple, stable, and strongly specific, which can provide scientific basis for effective and comprehensive evaluation and quality control of Jingfukang tablets.