附子理中丸数字化指纹图谱研究

目的建立附子理中丸HPLC数字化指纹图谱,为其质量控制提供依据。方法采用Century SIL C18 BDS色谱柱（250mm×4.6mm,5μm）,流动相为1%冰醋酸水-1%冰醋酸甲醇低压梯度洗脱,检测波长：280nm,柱温：30℃,进样量：5μL。用“中药色谱指纹图谱超信息特征数字化评价系统3.0”软件从分离度、信息量、相似度等6个方面对不同批次的附子理中丸指纹图谱进行潜信息特征数字化评价。同时以双参照物体系标定指纹峰的峰位、洗脱动量数ε、折合相对积分φ。结果建立了附子理中丸HPLC数字化指纹图谱,以5-羟甲基糠醛峰为参照物峰,确定31个共有峰,获得了判别附子理中丸质量的重要数字信息,以双定性双定量相似度法评价附子理中丸批间质量稳定。结论所建立HPLC数字化指纹图谱具有较好的精密度和重现性,适用于附子理中丸的质量控制。

Digitized fingerprints of Fuzilizhong pills by HPLC

Objective To establish an HPLC digitized fingerprint for Fuzilizhong pills to serve as digitized method criteria for its overall quality control.Methods The chromatographic fingerprints were obtained on a Century SIL C18 BDS column（250 mm×4.6 mm,5 μm）with the gradient elution solvent system composed of 1% acetic acid water and 1% acetic acid methanol.The column temperature was 30 ℃ and the detection wavelength was 280 nm.The fingerprints were characteristically digitized and evaluated by the software of the digitized evaluation system of Traditional Chinese Medicine fingerprint from 6 aspects such as resolution, information, similarity and so on.The peak position,elution fore index and pseudo peak areas were marked when 2 peaks were selected as the referential peaks.Results Altogether 31 co-possessing peaks were selected for the fingerprints of Fuzilizhong pills by taking 5-HMF peaks as the referential peaks to establish the digitized fingerprints,and important digitized information was obtained for the quality control of the preparation.The stabilities among different batches of samples were evaluated by the dual qualitative and dual quantitative similarity method.Conclusion The digitized fingerprints with good precision and reproducibility may be useful for the quality control of Fuzilizhong pills.