舒通散指纹图谱研究

Study on HPLC fingerprint of ShuTongSan

目的 本文作者以舒通散为研究对象,建立其指纹图谱,为科学评价其质量做参考。方法 采用高效液相色谱法,分别对流动相及其配比进行筛选并优化,确定了最佳的色谱条件,进行舒通散的指纹图谱研究,运用“中药色谱指纹图谱相似度评价”系统软件进行相似度评价,并进行特征峰指认。结果 以0.1%磷酸水-乙腈溶液为流动相进行梯度洗脱,检测波长为210 nm,采用的色谱柱为Inertsil ODS-3(250 mm×4.6 mm, 5μm),流速为1 mL·min^(-1),柱温为30℃,对舒通散的18个共有峰进行药材归属,并对其中3个色谱峰进行指认。结论 本文作者所建立的舒通散指纹图谱,准确度、稳定性、重复性均良好,能够有效地评价舒通散的质量。

Objective To establish the HPLC fingerprint of ShuTongSan of compound preparation of traditional Chinese medicine, for the quality control of its products.Methods The separation was developed on a Inertsil ODS-3(250 mm× 4.6 mm, 5 μm),with acetonitrile-0.1% phosphoric acid water as mobile phase with gradient elution, column temperature of 30 ℃,the flow rate was 1 mL·min^(-1)and detection wavelength was 210 nm.An HPLC fingerprint of ShuTongSan was set up by using "traditional Chinese medicine chromatographic fingerprint similarity evaluation system software of 10 batches of preparation for similarity evaluation to identify its characteristic peaks.Furthermore, the main characteristic peaks in HPLC fingerprint of New ZhiguZengsheng pill were identified.Results A total of 18 common peaks were identified in the HPLC fingerprints of ShuTongSan, The similarity of 10 batches of ShuTongSan was above 0.900.Conclusion The established HPLC fingerprint of ShuTongSan was specific, precise, reproducible and stable.The established HPLC fingerprint can be used for quality evaluation of ShuTongSan.The above work can provide the experimental basis to improve overall quality control of ShuTongSan.