基于HPLC指纹图谱及化学计量学评价清热解毒口服液质量OA
Quality Evaluation of Qingre Jiedu Oral Liquids by Based on High-performance Liquid Chromatography Fingerprint and Chemometrics
目的 建立41个厂家清热解毒口服液的高效液相色谱(HPLC)指纹图谱,结合化学计量学为其质量评价提供科学依据.方法 选用HPLC法,Eclipse XDB-C18 色谱柱(250 mm×4.6 mm,5 µm),用0.5%冰乙酸(A)、10%甲醇(B)为流动相进行梯度洗脱,检测波长240 nm,流速1.0 mL/min,柱温30℃,结合中药色谱指纹图谱相似度评价系统进行数据分析.结果 本研究通过对41个厂家产品的指纹图谱进行相似度分析和聚类分析,发现各厂家生产的清热解毒口服液在质量上存在一定差异,根据综合评分分析得出样品质量的前10位分别为S26、S25、S5、S6、S41、S13、S15、S19、S36、S8.结论 该方法进一步规范和完善清热解毒口服液的质量评价标准,为临床用药的安全性与有效性提供了参考.
Objective To establish high-performance liquid chromatography(HPLC)fingerprint profiles for Qingre Jiedu oral liquid from 41 manufacturers and provide a scientific basis for its quality evaluation by combining chemometric analysis.Methods HPLC method was employed using an Eclipse XDB-C18 column(250 mm×4.6 mm,5 µm)with a mobile phase consisting of 0.5%glacial acetic acid(A)and 10%methanol(B)for gradient elution.The detection wavelength was set at 240 nm,the flow rate at 1.0 mL/min,and the column temperature at 30℃.Data analysis was performed using the Traditional Chinese Medicine Chromatographic Fingerprint Similarity Evaluation System.Results The study revealed certain quality variations among the 41 manufacturers'products based on similarity evaluation and cluster analysis of the fingerprint profiles.According to the comprehensive scoring analysis,the top 10 samples in terms of quality were S26,S25,S5,S6,S41,S13,S15,S19,S36,and S8.Conclusion This method further standardized and improved the quality evaluation criteria for Qingre Jiedu oral liquid,providing a reference for the safety and efficacy of clinical medication.
范雯轩;吴亚威;李健;郝鹏飞;张超云
南阳理工学院河南省张仲景方药与免疫调节重点实验室,河南 南阳 473000南阳理工学院河南省张仲景方药与免疫调节重点实验室,河南 南阳 473000河南全宇制药股份有限公司,河南 南阳 473000南阳理工学院河南省张仲景方药与免疫调节重点实验室,河南 南阳 473000南阳理工学院河南省张仲景方药与免疫调节重点实验室,河南 南阳 473000
医药卫生
清热解毒口服液指纹图谱聚类分析相似度评价
Qingre Jiedu oral liquidfingerprint spectrumcluster analysissimilarity evaluation
《光明中医》 2026 (4)
43-48,6
河南省重点研发专项(No.241111313700)南阳市重大专项(No.2023ZDZX213)
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