双黄连胶囊高效液相色谱数字化指纹图谱研究

Digitized HPLC fingerprints of Shuanghuanglian Jiaonang

目的建立双黄连胶囊(Shuanghuanglian Jiaonang,SHLJN)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,以黄芩苷(baicalin,BCL)为参照物峰,确定58个共有指纹峰,建立SHLJN-HPLC数字化指纹图谱。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SHLJN质量。结果用16个数字化指数鉴别出2批样品不合格,用系统指纹定量法鉴别出1批样品质量极好,3批样品质量很好,6批样品质量好,1批样品质量良好,1批样品质量为中。结论所建立的SHLJN-HPLC数字化指纹图谱可清晰反映SHLJN的质量变异,用数字化指纹图谱的方法控制中药质量准确可行。

Objective To establish digitized HPLC fingerprint of Tianwang Buxin Wan（TWBXW） and provide a basis for its quality control.Methods The chromatographic fingerprints（CFPs） were obtained by injecting 5 μL of the sample solution each time on a Century SIL C18 BDS column（200 mm×4.6 mm,5 μm） with the gradient elution solvent system composed of 0.2% phosphoric acid-water and 0.1% phosphoric acid-acetomitrile.The column temperature was（30.0±0.15）℃ and the detection wavelength was 203 nm.The CFPs were characteristically digitized and evaluated by Digitized Evaluation System for Super-information Characteristics of the traditional Chinese medicine Chromatographic Fingerprints 3.0.Results Altogether 62 co-possessing peaks were selected as the CFP peaks when taking glycyrrhizic acid as the referential peak.The digitized HPLC fingerprint of TWBXW was established.The identification results were obtained by the systematic quantified fingerprint method which indicated that S2,S7,S8 and S9 were better,S1,S3,S4,S5,S10 and S12 were good,S11 was fine and,S6 was acceptable.Conclusion TWBXW digitized HPLC fingerprints can clearly reflect the variation of TWBXW quality,and the digitized HPLC fingerprints can control the quality of traditional Chinese medicine accurately and feasibly.