不同厂家三黄片HPLC指纹图谱的比较

Comparison among HPLC Fingerprints of San-Huang Tablets from Different Manufacturers

目的:采用高效液相色谱法(HPLC)建立市售三黄片的指纹图谱,为其质量控制提供新依据。方法:色谱柱:Grace-C1(84.6 mm×250 mm,5μm),流动相:乙腈-0.1%磷酸(梯度洗脱),柱温:30℃,检测波长:254 nm,分析时间:110 min,流速:0.8 mL.min-1。结果:精密度、重现性、稳定性试验中共有峰面积和保留时间的RSD均小于5%。以大黄酚为参照物,共标出16个共有峰。通过聚类分析,10个不同厂家三黄片样品被聚为4类;通过相似度计算,同一厂家5个批次三黄片样品的相似度良好,10个不同厂家三黄片样品的相似度差别明显。结论:本方法稳定、可靠、重复性好,可通过分析结果判断同厂家不同批次和不同厂家之间三黄片质量的差异,为全面控制三黄片质量提供依据。

This study was aimed to establish the fingerprints of San-Huang tablets by high performance liquid chromatography（HPLC） to provide the new basis of quality control.The Grace-C18（4.6 mm × 250 mm,5 μm） column was used with a mobile phase of acetonitrile and 0.1% phosphoric acid aqueous solution in a gradient mode.The detection wavelength,the temperature and the flow rate were set at 254 nm,30℃ and 0.8 ml·min-1,respectively,with the analysis time of 110 min.The results showed that all RSD of peak areas and retention times of common peaks in the test of precision,repeatability and stability were less than 5%.For the reference to chrysophanol,there are 16 common peaks marked.By using cluster analysis,samples from ten different pharmaceutical factories were classified as four clusters with different similarities.Five batches samples from the same manufacturer had a good similarity by similarity calculation,while batches of San-Huang tablets from ten different manufacturers showed the relatively low similarity.It was concluded that analysis result from this method can be used in the quality determination of San-Huang tablet from same manufacturer and different batches,or different manufacturers.This method is simple and accurate with a good reproducibility.This method can provide evidences in the effective quality control of San-Huang tablets.