Identification of the Authenticity and Geographical Origin of Bear Bile Powder by Using High Performance Liquid Chromatography - Charged Aerosol Detector Fingerprints Combined with Chemometrics.

Abstract

Bear bile powder (BBP) is a rare animal-derived traditional Chinese medicine, and it has been widely used to treat visual disorders and hepatobiliary diseases in East Asia. However, there is still a lack of reliable quality control methods for BBP. This study was designed to establish a comprehensive quality map of BBP based on bile acids. High-performance liquid chromatography coupled with charged aerosol detector (HPLC-CAD) was used for fingerprint establishment and quantitative analysis of BBP. The similarities of HPLC-CAD chromatograms for 50 batches of BBP were more than 0.95, while the similarities of reference chromatograms between 6 other animal bile and BBP were low than 0.7. Additionally, five bile acids in BBP, including tauroursodeoxycholic acid, taurocholic acid, taurochenodeoxycholic acid, ursodesoxycholic acid, and chenodeoxycholic acid, were simultaneously quantified. This method has been validated with good regression as well as satisfactory precision, sensitivity, stability, repeatability, and accuracy. Using this method, the contents of five bile acids in BBP samples from five producing areas were determined and compared. Furthermore, Fisher linear discriminant analysis was performed to discriminate the geographic origins of BBP. The result demonstrated that HPLC-CAD fingerprint combined with multi-components quantification is an effective and reliable method for quality control of BBP, it could be a meaningful reference for the quality evaluation of medicinal bile.