温脾养胃颗粒中黄芪甲苷和芍药苷含量测定方法及其应用

Determination of AstragalosideⅣand Paeoniflorin in Wenpi Yangwei Granules and Its Application

为了对中药方剂温脾养胃颗粒进行科学的质量控制,本研究建立了君药黄芪和白芍的主要成分含量测定方法并应用于制剂的稳定性研究。分别建立适用于温脾养胃颗粒中黄芪甲苷和芍药苷含量测定的UHPLC-MS/MS和HPLC-UV方法,并以芍药苷含量为指标,通过影响因素试验和经典恒温试验进行制剂稳定性研究,拟定贮藏条件,预测有效期。结果表明,黄芪甲苷和芍药苷的线性范围分别为1~60μg/mL(r=0.999 8)、10~100μg/mL(r=0.999 6),颗粒剂中黄芪甲苷和芍药苷的平均含量分别为0.126 mg/g、1.02 mg/g。颗粒剂的指标成分含量受温度及光照影响较小,但对环境湿度相对敏感,应密封置阴凉干燥处保存,有效期至少为1年。

In order to scientifically control the quality of the traditional Chinese medicine formula Wenpi Yangwei granules,methods for the determination of the main components of Astragali Radix and Paeoniae Radix Alba in monarch medicine are established and applied to the stability study of the preparation.UHPLC-MS/MS and HPLC-UV methods are established for the determination of astragaloside IV and paeoniflorin in Wenpi Yangwei Granules,respectively.The stability of the preparation is investigated using influencing factor testing and classical constant temperature experiment,and the storage conditions are developed to estimate the validity period using the paeoniflorin content as the index.The results show that the linear ranges of astragaloside IV and paeoniflorin are 1-60μg/mL(r=0.9998)and 10-100μg/mL(r=0.9996),the average contents of astragaloside IV and paeoniflorin in granules are 0.126 mg/g and 1.02 mg/g,respectively.The contents of index components of granules are less affected by temperature and light,but they are relatively sensitive to environmental humidity,so the preparation should be sealed and stored in a cool and dry place,and its validity period can reach at least one years.