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

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.

Andrographolide: A review of its pharmacology, pharmacokinetics, toxicity and clinical trials and pharmaceutical researches.

Andrographis paniculata (Burm. f.) Wall. ex Nees, a renowned herb medicine in China, is broadly utilized in traditional Chinese medicine (TCM) for the treatment of cold and fever, sore throat, sore tongue, snake bite with its excellent functions of clearing heat and toxin, cooling blood and detumescence from times immemorial. Modern pharmacological research corroborates that andrographolide, the major ingredient in this traditional herb, is the fundamental material basis for its efficacy. As the main component of Andrographis paniculata (Burm. f.) Wall. ex Nees, andrographolide reveals numerous therapeutic actions, such as antiinflammatory, antioxidant, anticancer, antimicrobial, antihyperglycemic and so on. However, there are scarcely systematic summaries on the specific mechanism of disease treatment and pharmacokinetics. Moreover, it is also found that it possesses easily ignored security issues in clinical application, such as nephrotoxicity and reproductive toxicity. Thereby it should be kept a lookout over in clinical. Besides, the relationship between the efficacy and security issues of andrographolide should be investigated and evaluated scientifically. In this review, special emphasis is given to andrographolide, a multifunctional natural terpenoids, including its pharmacology, pharmacokinetics, toxicity and pharmaceutical researches. A brief overview of its clinical trials is also presented. This review intends to systematically and comprehensively summarize the current researches of andrographolide, which is of great significance for the development of andrographolide clinical products. Noteworthy, those un-cracked issues such as specific pharmacological mechanisms, security issues, as well as the bottleneck in clinical transformation, which detailed exploration and excavation are still not to be ignored before achieving integration into clinical practice. In addition, given that current extensive clinical data do not have sufficient rigor and documented details, more high-quality investigations in this field are needed to validate the efficacy and/or safety of many herbal products.