柏子养心丸的高效液相色谱数字化指纹图谱研究

目的建立柏子养心丸(Baizi Yangxin Wan,BZYXW)HPLC数字化指纹图谱,从整体化学指纹角度定量控制其质量。方法 采用RP-HPLC法,以Century SIL C18BDS柱(200mm×4.6mm,5μm)为色谱柱;流动相A为0.1%磷酸-水溶液,B为0.1%磷酸-乙腈溶液;梯度洗脱;紫外检测波长228nm;柱温(35.0±0.15)℃。用"中药色谱指纹图谱超信息特征数字化评价系统3.0"软件对BZYXW-HPLC数字化指纹图谱进行评价。结果以绿原酸为参照物峰,确定56个共有指纹峰,建立了BZYXW-HPLC数字化指纹图谱。以46个数字化参数评价指纹图谱和其代表的质量情况,用16个数字化指数鉴别出1批样品不合格,用系统指纹定量法鉴定12批BZYXW中2批质量极好,6批质量很好,2批质量好,1批质量中,1批质量为劣。结论所建立的BZYXW-HPLC数字化指纹图谱能准确反映BZYXW质量变化,是全面控制其质量的可靠方法。

Digitized HPLC fingerprint of Baizi Yangxin Wan

Objective To develop a digitized HPLC fingerprint for Baizi Yangxin Wan （BZYXW） to control its overall quality by the chemical fingerprints. Methods The chromatographic fingerprints （CFP） were determined by RP- HPLC, in which the chromatographic separations were carried out on a Century SIL C18 BDS column （200 mm× 4. 6 mm, 5 μm）. The mobile phase, with a gradient program, consisted of 0. 1% phosphoric acid water （A） and 0. 1% phosphoric acid acetonitrile （B）. The DAD detector was 228 nm, the column temperature was （35.0± 0. 15） ℃, and the chromatograms were assessed by the software of the Digitized Evaluation System for Super-informa- tion Characteristics of the Traditional Chinese Medicine Fingerprints 3.0. Results A total of 56 co-possessing peaks were marked by choosing chlorogenic acid （CGA） peaks as the referential peak. We applied 46 digitized parameters to assess different fingerprints and the qualities. One batch of BZYXW was unqualified by the 16 digital indice. The sys- tematically quantified fingerprint method （SQFM） was applied to evaluate the quality of BZYXW： the quality of 2 batches was the best, that of 6 batches was better, that of 2 batches was good, 1 batch moderate, and 1 batch inferior. Conclusion The digitized HPLC fingerprints can clearly reflect the quality variation of BZYXW, and control the quality of traditional Chinese medicine accurately and feasibly.