复方增氧分散片变波长指纹图谱

Variable-wavelength fingerprints of compound oxygen dispersible tablets

目的:建立复方增氧分散片变波长高效液相色谱(HPLC)指纹图谱,为评价其质量提供依据。方法:采用Alltima-C_(18)色谱柱(250 mm×4.6 mm,5μm);以乙腈-水为流动相梯度洗脱;流速1.0 mL·min^(-1);柱温35℃;进样量10μL;检测波长283nm(0～34 min),223 nm(34～55 min),283 nm(55～150 nm)。结果:建立了10批复方增氧分散片的对照指纹图谱,运用"中药色谱相似度评价系统软件"对10批样品进行相似度评价确定了18个共有峰,并全部归属到各药材,其中有6个共有峰确定成分,相似度均在0.91以上。通过系统聚类分析法(HCA),10批复方增氧分散片可以分为两类。结论:所建立的指纹图谱简便可靠,可用于复方增氧分散片的质量控制。

OBJECTIVE To establish the variable-wavelength HPLC fingerprint of compound oxygen dispersible tablets,and to provide experimental evidence for its quality control. METHODS The analysis was performed on an Alltima-C18 column（250 mm ×4. 6 mm,5 μm） column with acetonitrile-water as the flow phase for gradient elution. The flow rate was 1. 0 mL·min^-1,and the column temperature was 35 ℃. The detection wavelengths were 283 nm（0-34 min）,223 nm（34-55 min）,283 nm（55-150 nm）. RESULTS The control fingerprints of 10 batches of compound oxygen dispersible tablets were established, ＂ Chinese medicine chromatogram similarity evaluation software＂ was used to evaluate similarity of 10 batches of samples which identified 18 common peak,all belonging to the medicinal materials. There were six common peaks to determine the composition,with the similarity value all above 0.91. The ten samples were classified into two clusters by cluster analysis. CONCLUSION The fingerprint is simple and reliable,and can be used in the quality control of compound oxygenation dispersible tablets.