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目的采用从成品图谱逆向回溯至中间体及原料药材的方式,研究克感利咽口服液高效液相色谱指纹图谱,缩短试验周期,提高工作效率,建立中成药整体特征的质量评价方法。方法采用HPLC-DAD检测,Zorbax SB-C18色谱柱,以乙腈-0.1%磷酸为流动相,在25℃柱温下进行梯度洗脱,从克感利咽口服液成品指纹图谱回溯确认相关处方药材对指纹图谱中的贡献。结果建立的高效液相色谱指纹图谱中可检出68个特征峰,其中58个色谱峰分别溯源到处方中黄芩、金银花、栀子、射干、防风、薄荷、玄参、甘草、连翘、荆芥等10味药材,15个色谱峰可明确化学成分的归属,色谱整体构建了克感利咽口服液的指纹图谱。结论建立的HPLC-DAD指纹图谱表达了克感利咽口服液可测组分的整体特征,提高了对中药复方制剂质量控制的专属性,在鉴别和评价商品内在质量方面的作用远大于任选一至二个指标成分测定含量所起的作用。逆向回溯的研究模式扩展了大复方中成药质量研究的思路。
OBJECTIVE: To reverse the tracing back to the intermediates and raw herbs from the finished product map, to study the HPLC fingerprint of Kegan Liyan Oral Liquid, to shorten the test period and improve the work efficiency, and to establish the quality evaluation method of the overall characteristics of proprietary Chinese medicines. Methods HPLC-DAD was performed on a Zorbax SB-C18 column with acetonitrile-0.1% phosphoric acid as the mobile phase and gradient elution was carried out at a column temperature of 25 ℃. The fingerprint of the prescription drug Contribution to fingerprinting. RESULTS: Sixty-eight characteristic peaks were identified in HPLC fingerprint. Among them, 58 peaks were traceable to the prescriptions of Scutellaria baicalensis, Honeysuckle, Gardenia jasminoides, Radix puerariae, Windproof, Peppermint, Scrophulariae, Licorice, Forsythia, Mustard and other 10 herbs, 15 peaks can be attributed to the ownership of the chemical composition, the chromatogram of the overall construction of a gram sense of the pharynx oral liquid fingerprint. Conclusion The established HPLC-DAD fingerprinting method can express the whole characteristic of the measurable components of Kaili Liyan Oral Liquid and improve the specificity of the quality control of TCM compound preparations. The function in identifying and evaluating the intrinsic quality of the products is far greater than that of optional One or two indicators of the determination of the role of ingredients. The retrograde research model extends the thinking of research on the quality of proprietary Chinese medicines.