白果内酯标准样品的研制

doi:10.3976/j.issn.1002-4026.2022.01.002

Abstract

Abstract:

A preparation method for bilobalide certified reference material (CRM) was developed in this study to enrich and prepare bilobalide from ginkgo biloba using silica gel column chromatography combined with gel column chromatography and preparative liquid chromatography. The structure of bilobalide was characterized using UV, IR, MS, and NMR. Bilobalide samples were tested for homogeneity and stability according to the technical requirements of GB /T 15000. 3—2008/ISO Guide 35:2006. Cooperative certification was conducted by eight laboratories. The results indicated that the standard value was 99.88% and the uncertainty was 0.22% with a confidence interval of 95%. The prepared samples had good uniformity and were stable for 24 months at storage temperatures of 2~8 °C, which were acceptable to the expert group. The preparation method of high-purity bilobalide has low preparation cost, simple operation, and high efficiency, which solves the problem of the lack of national standard samples for bilobalide and can be applied for quality control, analysis, and testing of Chinese medicinal materials and related products.

Key words: bilobalide, certified reference material, homogeneity, stability, certification

CLC Number:

R284.2

FU Rui-ming,HU Jin-chun,MENG Zhao-qing,LI Qiang,CAO Gui-yun,WANG Dai-jie,YAN Hui-jiao. Preparation of certified reference material of bilobalide[J].Shandong Science, 2022, 35(1): 6-13.

References 19

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Preparation of certified reference material of bilobalide

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