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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 control the quality of Xifuzheng Granule, HPLC method was used to establish the fingerprint. Methods: An Agilent 1100 high performance liquid chromatograph was used with a mobile phase of GRACE AlltimaTM C18 (4.6 mm × 250 mm, 5 μm) and methanol-0.1% phosphoric acid as the mobile phase. The binary system was used for gradient elution. Detection wavelength of 275nm, flow rate: 1.0m L / min, column temperature: 25 ℃. Results: The selected common peaks of Xifuzheng Granules were well separated and the reproducibility RSD% were less than 3%. Conclusion: The method of establishing the fingerprint of Xifuzheng Granules is proved to be scientific and effective by the experimental results, and the fingerprints of the preparation can provide certain theory for establishing the quality standard of Xifuzheng Granules and other traditional Chinese medicines in accordance with.