摘要
目的:运用HPLC指纹图谱技术建立山黄口腔贴片中生物碱类成分的定性和定量方法。方法:采用C18柱;以乙腈-0.01mol·L-1KH2PO4水溶液(用氨水调至pH值为8.0)为流动相,梯度洗脱;检测波长为215nm;柱温为35℃。结果:得到分离度和重现性良好的HPLC/UV指纹图谱,可检出8个相对位置稳定的共有峰,通过与对照品的保留时间及紫外光谱比较,成功鉴别了氧化苦参碱、苦参碱和盐酸小檗碱3种成分。其中苦参碱的平均回收率为99.1%,可用于该制剂的含量测定。结论:山黄口腔贴片中生物碱类成分的HPLC指纹图谱定性和苦参碱的定量分析方法具有较强的针对性和准确性,可用于该制剂的质量控制。
Objective:To establish a qualitative and quantitative HPLC method with fingerprinting technology for the quality control of Shanhuang buccal adherent tablets. Methods:The analysis was performed on a C18 column using acetonitrile-0.01 mol· L^- 1 potassium dihydrogen phosphate(adjusting pH to 8.0 with ammonia water) as mobile phase in gradient elution. The detection wavelength was 215 nm and the column temperature was 35 ℃. Resuits:Perfect fingerprints with excellent separation and reproducibility were obtained and 8 common peaks were used as index peaks for qualitative identification. By comparison of the retention time and the online UV spectra of chemical standards,peakl ,3 and 8 were identified as oxymatrine,matrine and berberine hydroehloride respectively. Especially the average recovery of matrine was 99.1%. Conclusion :The analytical method with qualitative fingerprint and quantitative assay of matrine can be used to control the quality of the preparation.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2009年第16期1577-1580,共4页
Chinese Journal of New Drugs
基金
广东省中医药局科技项目(2007364)
关键词
山黄口腔贴片
生物碱
苦参碱
高效液相色谱法
指纹图谱
Shanhuang buceal adherent tablets
alkaloid
matrine
high performance liquid chromatography ( HPLC )
fingerprint