复方斑蝥胶囊高效液相色谱数字化指纹图谱研究

目的建立复方斑蝥胶囊（Fufang Banmao Jiaonang,FFBMJN）HPLC数字化指纹图谱,作为其整体质量控制的一个判据标准。方法采用反相HPLC法以大连江申Century SIL C18BDS柱（25 cm×4.6 mm,5μm）;流动相为水（含1%HAc）和甲醇（含1%HAc）,采用梯度洗脱,检测波长280 nm,柱温（30±0.15）℃,进样量20μL。用＂中药色谱指纹图谱超信息特征数字化评价系统3.0＂软件进行数字化评价。结果以5-羟甲基糠醛（5-hydroxymethylfurfural,5-HMF）为参照物峰,确定33个指纹峰,获得了可以判别其质量的重要数字化信息,并以系统指纹定量法鉴别出S4和S10的质量很好,S1、S2、S3、S7和S8的质量好,S5和S9的质量为中,S6的质量一般。结论所建立的FFBMJN-HPLC数字化指纹图谱可清晰反映FFBMJN的质量变异,用数字化指纹图谱控制中药质量准确可行。

Digitized HPLC fingerprints of Fufang Banmao Jiaonang

Objective To establish digitized HPLC fingerprints for Fufang Banmao Jiaonang（FFBMJN） and serve as digital criteria for its overall quality control.Methods The chromatographic fingerprints（CFP） were obtained by injecting 20 μL of the sample solution each time on a Dalian Jiangshen SIL C18 BDS column（25 cm×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±0.15）℃ and the detection wavelength was 280 nm.The CFPs were characteristically digitized and evaluated by the software of the digitized evaluation system for super-information characteristics of traditional Chinese medicine（TCM） fingerprint.Results A total of 33 common peaks were selected as the CFP peaks when taking 5-hydroxymethylfurfural as the referential peak,and the identification results were obtained by the systematic quantified fingerprint method which indicated that S4 and S10 were very good,S1,S2,S3,S7 and S8 were good,S5 and S9 were moderate,while S6 was so so.Conclusion FFBMJN digitized HPLC fingerprints can clearly reflect the variation of FFBMJN quality,and the digitized HPLC fingerprints can control the TCM quality accurately and feasibly.