雷公藤药材及制剂的HPLC指纹图谱研究.doc

文档介绍：专业:药物分析
雷公藤药材及制剂的HPLC指纹图谱研究
高旋*,庄莹,宋敏,翟清波,杭太俊
(中国药科大学药物分析教研室,南京 210009)
摘要目的:建立雷公藤药材及制剂的HPLC指纹对照测定法,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指纹图谱,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指纹对照,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含量两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指纹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指纹图谱测定条件分离良好、专属性强,可用于全面控制雷公藤的质量。结论:以指纹对照品为参照进行雷公藤药材及制剂指纹图谱相似性评价,重复性和耐用性良好。测得雷公藤药材及制剂的指纹特征差异显著。
关键词:雷公藤药材;雷公藤片剂;雷公藤内酯醇;指纹图谱;高效液相色谱法
Study of Tripterygium wilfordii Hook. f and tripterygium tablets by HPLC Fingerprint Chromatogram
GAO Xuan*作者简介: 高旋,女,药物分析硕士研究生 Tel: [phone] E-mail: xiaohongxie@
, ZHUANG Ying, SONG Min, ZHAI Qing-bo, HANG Tai-jun
(China Pharmaceutical University, Nanjing 210009,China)
Abstract Objective: To establish a stable and repeatable HPLC reference fingerprint chromatogram standard for the quality analysis and control of Tripterygium wilfordii Hook. f. and its preparations. Methods: HPLC separation was performed on a C18 column with methanol-water as mobile phase in a gradient elution mode. The reference fingerprint chromatogram was determined as the most typical chromatogram that represented most properties of Tripterygium wilfordii Hook. f. and tripterygium tablets, respectively, from both constitutes and quantity view of points, established by statistical and similarity analyses. Results: The results indicate that the quality assessments of Tripterygium wilfordii Hook. f. and tripterygium tablets with reference to the itantly measured HPLC reference fingerprint chromatograms have good ruggedness, specificity, and reproducibility. Conclusion: The fingerprint chromatograms of Tripterygium wilfordii Hook. f. and its preparations can be quantitatively and qualitatively evaluated parison with the established fingerprint reference standards by using Cosine q and relative Euclid distance methods, respectively. The fingerprint chromatograms of both Tripterygium wilfordii Hook. f. and its preparations varies significantly.
Key words: Tripterygium wilfordii