Abstract:
A certified reference material of chebulagic acid has been developed using a Tibetan medicine
Terminalia Chebula as the raw material.
Terminalia Chebula was extracted with 60% ethanol, enriched by the macroporous resin and through the preparative liquid chromatographic purification to obtain chebulagic acid. The purity analysis was carried out by high performance liquid chromatography (HPLC), liquid chromatography-mass spectrometry (LC-MS) and thin-layer chromatography (TLC). The structure was identified using ultraviolet (UV) spectroscopy, infrared (IR) spectroscopy, mass spectroscopy (MS) and nuclear magnetic resonance (NMR) spectroscopy. Finally, the homogeneity, stability and cooperative certification were carried out. The results indicated that the chebulagic acid has a good uniformity and a fine stability within 24 months at 4 ℃. The standard value of the purity of chebulagic acid was 99.33%, which was in accordance with the requirements of the certified reference material. The developed chebulagic acid (GSB 11-3724-2020) can be used for the content determination, method evaluation, testing and quality control of related products.