雷公藤药材及制剂的HPLC特征图谱研究

Study of Tripterygium wilfordii Hook.f.and Tripterygium wilfordii preparations by HPLC specific chromatograms

目的:建立雷公藤药材及制剂的HPLC特征图谱对照测定法,为雷公藤质量控制提供参考。方法:采用C18色谱柱,甲醇-水为流动相梯度洗脱,测定雷公藤药材及制剂的HPLC特征图谱,统计分析确定共有模式;以最接近共有模式的雷公藤药材和制剂为特征图谱对照,采用夹角余弦法和相对欧氏距离法,分别从化学成分定性和定量2个方面对不同产地雷公藤药材和主要市售雷公藤片剂的HPLC特征图谱进行定性与定量相似性评价。结果:建立的雷公藤药材及制剂的HPLC特征图谱测定条件分离良好、专属性强,可用于雷公藤质量的比较与控制。结论:以特征对照品为参照进行雷公藤药材或制剂特征图谱相似性评价,重复性和耐用性良好。测得雷公藤药材或制剂的特征图谱差异显著。因此,雷公藤药物的质量和安全性亟待提高。

Objective ：To establish stable and repeatable HPLC specific reference chromatogram standards for the quality analysis and control of Tripterygium wilfordii Hook. f. and its preparations. Method： HPLC separation was performed on a C18 column with methanol -water as mobile phase in gradient elution. The specific reference chromatograms were determined as the most typical chromatograms representing most of the properties of wilfordii Hook. f. and Tripterygium wilfordii tablets, respectively, from both constitutes and quantity view of points, established by statistical and similarity analyses. Result： The results indicate that the quality assessments of Tripterygium wilfordii Hook. f. and its tablets with reference to the concomitantly measured HPLC specific reference chromatograms have good ruggedness, specificity, and reproducibility. Conclusion： The specific chromatograms of Tripterygium wilfordii Hook. f. and its preparations can be quantitatively and qualitatively evaluated by comparison with the established specific reference standards by using both Cosine 0 and relative Euclid distance methods, respectively. The specific chromatograms of both Tripterygium wilfordii Hook. f. and its preparations were found to be in great diverse. Therefore, the clinical safety and quality of the drug need to be improved significantly.