用高效液相色谱数字化指纹图谱鉴定杞菊地黄丸质量

目的用HPLC数字化指纹图谱鉴别杞菊地黄丸（Qijudihuang Pill，QJDHP）的质量。方法采用RP-HPLC法，以5-羟甲基糠醛（5-HMF）为参照物峰，确定40个共有指纹峰，建立QJDHP-HPLC数字化指纹图谱。以数字化参数评价指纹图谱和鉴别其质量，并用系统指纹定量法鉴定11批QJDHPs的质量。结果用16个数字化指数鉴别出4批样品不合格，用系统指纹定量法鉴别出5批样品的质量合格，2批样品的含量明显偏高，4批样品的含量偏低。结论QJDHP-HPI。C数字化指纹图谱能够真实有效地控制其质量。

Quality identification of Qijudihuang pills by digitized HPLC fingerprints

Objective To identify the quality of Qijudihuang pills （Q.JDHP） by digitized HPLC fingerprints. Methods The digitized HPLC fingerprints were determined by RP-HPLC, in which 40 co possessing peaks were marked by choosing 5-hydroxymeth-2-furaldehyde （5-HMF） peaks as the referential peak. We applied the digitized parameters in assessing different CFPs from 11 batches of QJDHPs and identified their quality. In addition, the systematically quantified fingerprint method （SQFM） was used to evaluate QJDHP quality. Results The digitized HPLC fingerprints were completely established, in which 4 batches of QJDHPs were identified as unqualified by the 16 digital indices. In addition to 5 batches completely qualified, the content of another 2 batches was obviously higher but that of 4 batches was much lower. Conclusion Digitized HPLC fingerprints can effectively control QJDHP quality control.