十子强肾酒的HPLC指纹图谱研究

Study on the HPLC Fingerprint of Shiziqiangshen Jiu

摘要: 目的：为考察生产工艺优化对十子强肾酒质量的影响，本文旨在构建十子强肾酒的HPLC指纹图谱，为其生产工艺变更后的质量一致性评价提供数据参考。方法：利用高效液相色谱法(HPLC)建立9批十子强肾酒的特征指纹图谱。色谱条件设定为：Promosil C18色谱柱(250 mm × 4.6 mm, 5 μm)，柱温控制在40℃，以乙腈-0.1%甲酸水溶液作为流动相进行梯度洗脱，流速1.0 mL/min，检测波长250 nm。借助《中药色谱指纹图谱相似度评价系统》(2012版)对9批样品的实验图谱进行一致性评价，并锁定共有特征峰。结果：建立的HPLC指纹图谱中有11个共有峰，9批样品相似度指标均大于0.90。通过与对照品比对，成功指认出莫诺苷、马钱苷、鞣花酸、淫羊藿苷、五味子醇甲、五味子甲素和五味子乙素等7个特征峰。结论：该方法操作简单、重现性好，可作为十子强肾酒工艺变更后质量评价的有效手段。

Abstract: Objective: In order to investigate the effect of production process optimization on the quality of Shiziqiangshen jiu, this paper aims to construct the HPLC fingerprint of Shiziqiangshen jiu, and provide reference for the quality consistency evaluation after the production process change. Methods: The characteristic fingerprints of 9 batches of Shiziqiangshen jiu were established by high performance liquid chromatography (HPLC). The chromatographic conditions were set as follows: Promosil C18 chromatographic column (250 mm × 4.6 mm, 5 μm), column temperature controlled at 40˚C, gradient elution with acetonitrile-0.1% formic acid aqueous solution as mobile phase, flow rate 1.0 mL/min, detection wavelength 250 nm. The consistency of the experimental chromatograms was evaluated by the “Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (Version 2012)”, and the common characteristic peaks were locked. Results: There were 11 common peaks in the established HPLC fingerprint, and the similarity indexes of 9 batches of samples were all greater than 0.90. By comparing with the reference substance, 7 characteristic peaks of morroniside, loganin, ellagic acid, icariin, schisandrin, deoxyschizandrin and schisandrin were successfully identified. Conclusion: The method is simple and reproducible, and can be used as an effective method for quality evaluation of Shiziqiangshen jiu after process change.