蒙药红刺榆叶的质量标准研究OA

This study aimed to establish the quality standard for Mongolian medicine of Hemiptelea davidii leaf,the macroscopic identification and microscopic identification on 7 batches of collected H.davidii leaf medicinal materials were conducted.In accordance with the relevant requirements specified in the General Principles of the Pharmacopoeia of the People's Republic of China(2020 Edition,Volume IV),thin-layer chromatography(TLC)was adopted for qualitative analysis,and the contents of moisture,total ash and water-soluble extractives in the medicinal materials were determined;high-performance liquid chromatography(HPLC)was used for quantitative analysis.The results showed that the medicinal materials had distinct macroscopic and microscopic structural characteristics,and the TLC chromatograms presented clear spots with good resolution.The moisture content of the medicinal materials was in the range of 10.2%-10.8%,the total ash content 12.0%-16.8%,the acid-insoluble ash content 1.5%-3.6%,and the water-soluble extractive content 26.9%-30.9%.The linear range of the detection mass concentration of quercetin was 5.20-208.11 μg/mL(r=0.999 4).In the methodological validation,the relative standard deviations(RSD)of the repeatability,precision and stability tests were all less than 2.0%;the average sample recovery rate was 99.09%with an RSD of 2.80%.The quercetin content in the 7 batches of medicinal materials ranged from 2.50 to 6.96 mg/g.The determination method established in this study is simple and reproducible,which can provide a scientific reference for the subsequent formulation of its quality standards.