石见穿配方颗粒的特征图谱和含量测定

Characteristic atlas and assay of Shijianchuan formula granules

目的建立石见穿配方颗粒HPLC特征图谱及含量测定的方法,为其质量控制提供依据。方法采用OSAKA SODA CAPCELL PAK C18 MGⅡ色谱柱(150 mm×4.6 mm,3.0µm),以乙腈-0.1%甲酸溶液为流动相,梯度洗脱,柱温25℃,流速1.0 ml/min,检测波长240 nm(特征图谱)、330 nm(含量测定)。结果建立了石见穿配方颗粒的特征图谱,标定了5个共有特征峰,采用对照品指认了其中的4个色谱峰。13批石见穿配方颗粒样品中有10批特征图谱的相似度大于0.9。10批石见穿配方颗粒中迷迭香酸的含量测定范围为0.67~0.81 mg/g。结论建立的HPLC特征图谱及含量测定方法操作简便、可靠,为石见穿配方颗粒的质量控制和临床合理应用提供了科学依据。

Objective To establish the method to understand HPLC characteristic atlas and assay of Shijianchuan formula granules,and provide the basis for its quality control.Methods The OSAKA SODA CAPCELL PAK C18 MGⅡ chromatographic column(150 mm×4.6 mm,3.0µm)was used for gradient elution,with acetonitrile-0.1%formic acid solution as the mobile phase,column temperature of 25℃,flow rate of 1.0 ml/min and detection wavelength of 240 nm(characteristic spectrum)or 330 nm(assay).Results The characteristic atlas of Shijianchuan formula granules was established,five common characteristic peaks were calibrated,and four of them were identified with reference substance.The similarity of characteristic atlas of 10 out of 13 batches of Shijianchuan formula granule samples was greater than 0.9.The assay range of rosmarinic acid in 10 batches of Shijianchuan formula granules was 0.67-0.81 mg/g.Conclusion The established HPLC characteristic atlas and assay method is easy to use and reliable,and provides a scientific basis for the quality control and clinically reasonable use of Shijianchuan formula g ranules.