【摘要】 目的该课题对肝康颗粒进行质量标准研究,为申报新药打下良好的基础。方法肝康颗粒由八味中药组成,已经应用于临床多年。起初质量标准研究的方法是用紫外分光光度仪检测总黄酮的含量。该研究对处方中黄芪、五指毛桃根、十大功劳采用TLC鉴别。HPLC测定大黄素和淫羊藿苷的含量,并考察含量测定方法的精密度、稳定性和重复性。结果黄芪、五指毛桃根、十大功劳采用TLC鉴别专属性较强。大黄素和淫羊藿苷的HPLC含量测定方法简单、快速、精密度、准确度高(r2=0.994),初步制订颗粒的大黄素和淫羊藿苷含量指标为不少于0.60mg/g和0.80mg/g。结论质量标准研究结果表明,肝康颗粒质量稳定可控,符合现代中药制剂的要求。更多还原

【Abstract】 【Objective】GanKang Granule(GKG),a traditional Chinese medicine(TCM) complex,has been used in clinic for many years,which consists of eight crude drugs.The determination of total flavonoids by UV spectrometry was the original quality standard.Our aim is to improve the original quality control of GKG.【Methods】In this study,Ficus simplicissima Lour.root,Astragalus monghbolicus(Bge.) Hsiao and Mahonia bealei(Fort) Carr were identified by thin-layer chromatography(TLC).A HPLC-UV method was optimized and validated for the determination of bioactive constituents of Emodin and Icariin from Rumex japonicus Houtt.and Epimedium brevicornum Maxim,respectively.The analyte was resolved chromatographically on a 150 mm × 4.6 mm VP-ODS analytical column.The proposed method was validated for various ICH regulatory parameters like linearity,precision,robustness,reproducibility and limit of detection(LOD),etc.【Results】The specific spots of Psoralen in Ficus simplicissima Lour.root,astragaloside in Astragalus monghbolicus(Bge.) Hsiao and Berberine in Mahonia bealei(Fort) Carr were clear without interference.A precise and accurate quantification can be performed in the linear working concentration with good correlation(r2=0.994).【Conclusions】All results were acceptable and confirmed that the TLC and HPLC method is suitable and reliable for quality control of GKG.更多还原