基于指纹图谱、化学模式识别和多指标含量测定的金贝口服液质量控制研究 点击下载
| 论文标题： | 基于指纹图谱、化学模式识别和多指标含量测定的金贝口服液质量控制研究 |
| 英文标题： | |
| 中文摘要： | 目的 基于多波长切换高效液相色谱（HPLC）指纹图谱、化学模式识别和多指标含量测定，建立金贝口服液的质量控制方法。方法以15批金贝口服液为样品，采用《中药色谱指纹图谱相似度评价系统（2012版）》建立多波长切换HPLC指纹图谱，并进行色谱峰指认和相似度评价。采用聚类分析、主成分分析、正交-偏最小二乘判别分析对15批金贝口服液样品进行化学模式识别分析。采用多波长切换HPLC法同时测定样品中新绿原酸、绿原酸、隐绿原酸、连翘酯苷A、黄芩苷、丹酚酸B、汉黄芩苷含量。结果15批金贝口服液的指纹图谱中共标定了25个共有峰，并指认出其中7个共有峰，各样品相似度均大于0.960。化学模式识别分析结果发现，样品S1～S8聚为第1类，S9～S15聚为第2类，且黄芩苷、汉黄芩苷、新绿原酸、绿原酸、丹酚酸B为质量差异成分。15批金贝口服液中新绿原酸、绿原酸、隐绿原酸、连翘酯苷A、黄芩苷、丹酚酸B、汉黄芩苷的平均含量分别为0.2137、0.0853、0.1049、0.2873、0.4201、0.0621、0.1760mg/mL。结论本研究基于多波长切换HPLC指纹图谱、化学模式识别和多指标含量测定建立的金贝口服液质量控制方法稳定、可靠，可为该制剂的质量标准制定提供参考。 |
| 英文摘要： | OBJECTIVE To establish a quality control method for Jinbei oral liquid based on multi-wavelength switching high performance liquid chromatography （HPLC） fingerprint， chemical pattern recognition and multi-index content determination. METHODS A total of 15 batches of Jinbei oral liquid were used as test samples. The Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine （ Version 2012 ） was adopted to establish multi-wavelength switching HPLC fingerprints， followed by chromatographic peak identification and similarity evaluation. Cluster analysis， principal component analysis and orthogonal partial least squares-discriminant analysis were applied to conduct chemical pattern recognition on the 15 batches of samples. The multi-wavelength switching HPLC method was used to simultaneously determine the contents of neochlorogenic acid， chlorogenic acid， cryptochlorogenic acid， forsythoside A， baicalin， salvianoli c acid B and wogonoside in samples. RESULTS A total of 25 common peaks were calibrated in the fingerprints of 15 batches of Jinbei oral liquid， among which 7 common peaks were unambiguously identified. The similarity of all samples was higher than 0.960. Chemical pattern recognition results showed that samples S1-S8 were clustered into group 1， and samples S9-S15 were clustered into group 2. Baicalin， wogonoside， neochlorogenic acid， chlorogenic acid and salvianolic acid B were identified as the differential quality markers. The average contents of neochlorogenic acid， chlorogenic acid， cryptochlorogenic acid， forsythoside A， baicalin， salvianolic acid B and wogonoside in 15 batches of Jinbei oral liquid were 0.213 7， 0.085 3， 0.104 9， 0.287 3， 0.420 1， 0.062 1， 0.176 0 mg/mL， respectively. CONCLUSIONS The established quality control method for Jinbei oral liquid combining multi-wavelength switching HPLC fingerprint， chemical pattern recognition and multi-index content determination is stable and reliable， which can provide a reference for the formulation of quality standards of this preparation. |
| 期刊： | 2026年第37卷第13期 |
| 作者： | 田婧；崔伟亮；臧远芳；汪冰；李慧芬；张爱均；薛菲；解盈盈；林永强 |
| 英文作者： | TIAN Jing， CUI Weiliang，ZANG Yuanfang，WANG Bing，LI Huifen，ZHANG Aijun，XUE Fei，XIE Yingying，LIN Yongqiang |
| 关键字： | 金贝口服液; 多波长切换; 指纹图谱; 含量测定; 化学模式识别; 质量标准 |
| KEYWORDS： | Jinbei oral liquid; multi-wavelength switching; fingerprint; content determination; chemical pattern recognition; quality standard |
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