新扶正除疫颗粒HPLC指纹图谱的研究

Study on HPLC fingerprint of New Fuzheng Chuyi Granules

目的:为控制新扶正除疫颗粒剂质量,采用高效液相色谱(HPLC)法对其建立指纹图谱。方法:采用Agilent 1100高效液相色谱仪,用GRACE AlltimaTM C18(4.6mm×250mm,5μm)色谱柱,甲醇-0.1%磷酸水为流动相,二元系统梯度洗脱。检测波长275nm,流速:1.0m L/min,柱温:25℃。结果:新扶正除疫颗粒剂中选定的共有峰分离良好,且重现性RSD%均<3%。结论:新扶正除疫颗粒剂指纹图谱的建立方法通过实验结果证明是具有科学性和有效性的,并且该制剂指纹图谱为新扶正除疫颗粒及其它中药复方制剂质量标准的建立提供一定的理论依据。

Objective: To develop the fingerprint of the New Fuzheng Chuyi Granules with HPLC to control its quality. Methods: The chromatographic conditions were consisted of the Agilent 1100 High Performance Liquid Chromatography, GRACE AlltimaTM C18 column( 4.6mm×250mm, 5μm) and a mixture of methanol-0.1% phosphonic(gradient elution) mobile phase, and detection wavelength at 275 nm. The flow rate was 1.0m L/min, and the column temperature was 25℃. Results: A HPLC fingerprint determination with a less than 3% of reproducibility was established, which could well separate main principles of New Fuzheng Chuyi Granules. Conclusion: The method of establishing the fingerprint of the New Fuzheng Chuyi Granules was proved to be scientific and effective by the experimental results, and the fingerprint of the preparation provided some theoretical basis for the establishment of the quality standard of the New Fuzheng Chuyi Granules and other traditional Chinese medicine compound preparation.