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目的:研究清热解毒口服液的HPLC指纹图谱及测定其4种主要有效成分的含量,以建立其有效地质量评价方法。方法:通过建立HPLC指纹图谱和含量测定方法,对市售的产品质量进行分析;色谱条件为Shim-Pack VP-ODS C18色谱柱(4.6 mm×250 mm,5μm),流动相甲醇-0.1%磷酸梯度洗脱,检测波长227 nm。结果:得到色谱参数较好的HPLC指纹图谱,对10批次的市售清热解毒口服液指纹图谱进行了相似度评价,结果显示不同厂家的该制剂成分含量差异较大。结论:该方法简便准确,灵敏度高、重复性好,可以作为清热解毒口服液的质量控制方法;市售的该品种的制剂有明显差异性。
OBJECTIVE: To study the HPLC fingerprints of Qingrejiedu Oral Liquid and determine the contents of four main active ingredients in order to establish an effective quality evaluation method. Methods: Commercially available products were analyzed by HPLC fingerprinting and content determination. The chromatographic conditions were Shim-Pack VP-ODS C18 column (4.6 mm × 250 mm, 5 μm), mobile phase of methanol-0.1% phosphoric acid Gradient elution, detection wavelength of 227 nm. Results: The HPLC fingerprints with good chromatographic parameters were obtained. The similarity of fingerprints of 10 commercial detoxification oral solutions was evaluated. The results showed that the contents of the components in different manufacturers varied greatly. Conclusion: The method is simple, accurate, sensitive and reproducible. It can be used as a quality control method for Qingrejiedu oral liquid. There are obvious differences between the commercially available varieties of the preparations.