朝医经方鹿茸大补汤HPLC指纹图谱研究

Study on high performance liquid phase fingerprint of LurongDabu Decoction

[目的]建立朝医鹿茸大补汤HPLC指纹图谱,为不同批次的制剂进行质量控制提供参考.[方法]采用色谱柱为ACE C18(250 mm×4.6 mm,5μm),以0.1%(体积分数)磷酸水(A)-乙腈(B)为流动相进行梯度洗脱,流动速度为0.8 mL·min-1,进样量10μL,柱温30℃,检测波长220 nm;建立鹿茸大补汤HPLC指纹图谱,并使用中药色谱指纹图谱相似度评价系统对11批次制剂进行相似度评价.[结果]建立的鹿茸大补汤HPLC指纹图谱的精密度、稳定性、重复性均良好;11批次制剂的指纹图谱与对照指纹图谱的相似度均在0.9以上;并确定了19个共有峰.[结论]建立的鹿茸大补汤HPLC指纹图谱方法简便稳定,特征性强,重复性好,可为朝医鹿茸大补汤整体质量控制提供实验依据.

OBJECTIVE To establish the HPLC fingerprint of Korean medicine LurongDabu Decoction,so as to control the quality of preparations between different batches and to provide references.METHODS The chromatographic column was ACE C18(250 mm×4.6 mm,5μm),and 0.1%(volume traction)phosphoric acid water(A)-acetonitrile(B)was used as mobile phase for gradient elution,and the flow rate was 0.8 mL·min-1.The injection volume was 10μL,the column temperature was 30℃,and the detection wavelength was 220 nm;the HPLC fingerprint of LurongDabu Decoction was established,and the similarity evaluation system of the chromatographic fingerprint of traditional Chinese medicine was used to evaluate the similarity of 11 batches of preparations.RESULTS The precision,stability and repeatability of the established HPLC fingerprint of LurongDabu Decoction were sound;the similarity of fingerprints of 11 batches of preparations and control fingerprints were all above 0.9;and 19 common peaks were determined.CONCLUSION The established HPLC fingerprint method of LurongDabu Decoction is simple and stable,with strong characteristics and good reproducibility.It can provide experimental basis for the overall quality control of Korean medicine LurongDabu Decoction.