补中益气丸高效液相色谱数字化指纹图谱研究

目的建立补中益气丸（Buzhongyiqi Pills，BZYQPs）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RP—HPLC法以Century SIL C18 BDS柱（200mm×4．6mm，5μm）；流动相为0．2％磷酸水-0．2％磷酸乙腈，采用梯度洗脱，检测波长265nm，柱温（30±0．15）℃，进样量10μL。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。结果以甘草酸（glycyrrhizin，GHIA）为参照物峰，确定66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S6质量极好，S1、S5和S8质量很好，S3和S4质量好，S7、S9和S10质量一般，S2质量差。结论所建立的BZYQPs—HPLC数字化指纹图谱可清晰反映BZYQPs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 Buzhongyiqi pills

Objective To establish a digitized HPLC fingerprint for Buzhongyiqi pills （BZYQP） and serve as digital criteria for its overall quality control. Methods The chromatographic fingerprints （CFP） were obtained by injecting 10 μL of the sample solution each time on a Century SIL C18 BIDS column （200mm×4.6mm,5μm） with the gradient elution solvent system composing of 0. 2% phosphate-water and 0.2% phosphate-acetonitrile. The column temperature was （30±0. 15）℃ and the detection wavelength was 265 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） fingerprints. Results Sixty-six common peaks were selected as the CFP peaks when GHIA was used as the referential peak, and the identification results were obtained by systematic quantified fingerprint method which indicated that S6 was the best, S1, S5 and S8 were better, S3 and S4 were good, S7, S9 and S10 were common, while S2 was inferior. Conclusion BZYQP digitized HPLC fingerprints can clearly reflect the variation of BZYQPs quality, and the digitized HPLC fingerprints can control the TCM quality accurately and feasibly.