防风通圣丸高效液相色谱数字化定量指纹图谱研究

Digitized and quantified high performance liquid chromatography fingerprints of Fangfeng Tongsheng pills

目的建立防风通圣丸(FFTSP)高效液相色谱数字化定量指纹图谱,用于FFTSP质量控制。方法采用RP-HPLC法,以1%冰醋酸溶液(A)-甲醇(B)为流动相,梯度洗脱。以46个数字化参数评价指纹图谱并鉴别其质量,用系统指纹定量法鉴定12批FFTSPs质量。结果以黄芩素(BCE)为参照物峰,确定52个共有指纹峰,建立了FFTSP-HPLC数字化定量指纹图谱。用16个数字化指数鉴别出1批不合格,用系统指纹定量法鉴定1批质量很好(2级),1批质量好(3级),4批质量良好(4级),3批质量中等(5级),2批质量一般(6级),1批质量劣(8级)。结论所建立的FFTSP-HPLC数字化定量指纹图谱可清晰反映FFTSP质量变异,用数字化定量指纹图谱控制中成药质量准确可行。

Objective To develop the digitized and quantified high performance liquid chromatography fingerprint （HPLC- FP） of Fangfeng Tongsheng Pill （FFTSP） and control its quality. Methods RP-HPLC method was used, and 1% glacial acetic acid （A）-methanol （B） served as the mobile phase with gradient elution. We evaluated the digital fingerprints and identified the quality by the 46 digital parameters and also assessed the quality of 12 batches of FFTSPs by systematically quantified fingerprint method （SQFM）. Results Baicalein served as the reference peak, with which 52 co-possessing peaks were marked and the digital fingerprints of FFTSP-HPLC were successfully developed. Only 1 batch of FFTSPs was identi- fied as unqualified by the 16 digital indices, and the SQFM identification was as follows： 1 batch was very good （Grade 2）, 1 batch Grade 3, 4 batches Grade 4, 3 batches Grade 5, 2 batches Grade 6, and 1 batch inferior （Grade 8）. Conclusion The developed digital fingerprints can reflect the variation of FFTSP quality clearly.