容舒口服液原药材HPLC指纹图谱的建立及成品的质量评价

Herbs of Rongshu Oral Liquid:HPLC Fingerprints Analysis and Quality Evaluation

为建立容舒口服液单味药材的HPLC指纹图谱,并建立成品口服液HPLC检测方法,对不同产地的口服液原药材酸枣仁、当归、五味子和玫瑰花进行HPLC指纹图谱评价,建立以槲皮素和山奈素为指标的容舒口服液的HPLC检测方法。结果表明,不同产地主药材的HPLC指纹图谱峰形区分度较高,共有峰相似度高于98.2%,可以显著区别不同产地药材的含量差异。成品HPLC检测方法建立成功,检测指标槲皮素(5.79~38.6μg/m L,r=0.9999)和山奈素(3.68~24.55μg/m L,r=0.9999)在规定范围内线性关系良好;平均加样回收率分别为100.89%和99.86%,RSD值分别为1.96%(n=6)和1.39%(n=6)。通过指纹图谱法和HPLC法控制容舒口服液的质量,结果准确,方法稳定可行。

To establish HPLC fingerprints of herbs of Rongshu oral liquid and HPLC detecting method of fourcomposition herbs of the liquid, fingerprints of herbs（Ziziphi Spinosae Semen, Angelica sinensis radix,Schisandra chinensis and Rosae Rugosae Flos） were investigated by HPLC. With quercetin and kaempferol asindexes, the HPLC method was established to determine the quality of Rongshu oral liquid finished product.The results showed that herbs from different regions were of high similarity（98.2%）, the compositions of herbsfrom different regions could be significantly distinguished. In addition, the HPLC method was successfullyestablished to detect the content of quercetin and kaempferol in Rongshu oral liquid, for quercetin（5.79-38.6μg/m L, r=0.9999） and kaempferol（3.68-24.55 μg/m L, r=0.9999）, and the average recovery value was100.89% and 99.86%, respectively, with RSD as 1.96%（n=6） and 1.39%（n=6）, respectively. The establishedmethod was accurate, stable and suitable for the quality control of Rongshu oral liquid.