基于HPLC指纹图谱及化学模式识别分析不同剂型双黄连口服制剂的质量差异

Study on quality differences of Shuanghuanglian oral preparation in different preparations based on HPLC finger print and chemical pattern recognization

目的:建立不同剂型的双黄连口服制剂的HPLC指纹图谱,通过化学模式识别的方法全面评价其内在质量。方法:采用HPLC法,确定了40批不同厂家和剂型的双黄连口服制剂指纹图谱的31个共有峰,指认了其中25个共有峰的化学成分,采用指纹图谱相似度评价,结合主成分分析和聚类分析对不同双黄连口服制剂的质量进行评价。结果:40批双黄连样品图谱与对照图谱比较,样品间相似度为0.22~0.99,主成分分析与聚类分析均可将不同双黄连口服制剂很好地分类,且分类结果基本吻合。结论:HPLC指纹图谱结合化学模式识别研究,可以对不同剂型的双黄连口服制剂进行客观有效地评价,有助于双黄连口服制剂的整体质量控制,同时为其质量评价提供一种有效手段。

Objective: To establish the finger print of different preparations of Shuanghuanglian oral preparation by HPLC, and completely assess the quality of them by chemical pattern recognization techniques. Methods: Thirty-one common peaks of fingerprints of 40 batches of Shuanghuanglian oral preparation from different manufacturers and preparations were identified by HPLC. The chemical constituents of 25 common peaks were identified. The quality of different Shuanghuanglian oral preparation was evaluated by similarity evaluation of fingerprints, combined with principal component analysis(PCA) and hierarchical cluster analysis(HCA). Results: Compare sample atlas and control atlas of 40 batches of Shuanghuanglian oral preparation. The similarity of 40 batches of Shuanghuanglian oral preparation was 0.22~0.99. Principal component analysis and hierarchical cluster analysis could classify different Shuanghuanglian oral preparation well, and the results of classification were consistent. Conclusion: The results indicate that HPLC fingerprint combined with the chemical pattern recognization can objectively and effectively evaluate different preparations of Shuanghuanglian oral preparation, which is helpful to the overall quality control of Shuanghuanglian oral preparation, and provide an effective means for its quality evaluation.