What is transforming bear bile powder?

The standard of "transforming Chinese herbal medicines into bear bile powder" was issued and officially implemented by Hainan Drug Administration on June 5438+February 65438+February 7, 2022. This product simulates the bile acid production environment in bear body and is made by modern Chinese medicine fermentation technology. The content of TUDCA (TUDCA) in transformed bear bile powder is greater than or equal to 28%, chenodeoxycholic acid taurocholic acid (TCDCA) is greater than or equal to 65,438+05%, and the ratio of TUDCA to taurocholic acid is between 65,438+0.3 ~ 2.0, reaching the traditional "golden gallbladder" level.

Bear bile is the dry bile of black bear and brown bear in Xiong Ke, and it is the first of the four precious animal traditional Chinese medicines. It has pharmacological effects of calming the liver, benefiting gallbladder, clearing away heat and toxic materials, relieving spasm and soothing the liver. Modern medicine shows that bear bile has anti-inflammatory, analgesic, bacteriostatic and litholytic effects.

Bear bile can be divided into three types: natural bear bile (killing bears to get bile), draining bear bile powder (taking live bear bile) and transforming bear bile powder (transforming in vitro). At present, the commercial drainage bear bile powder was introduced from North Korea in 1980s. As a technique to replace natural bear bile, bear bile powder was made by drying the bear bile discharged by draining gallbladder through cholecystostomy. Although this technology has alleviated the contradiction between supply and demand of medicinal resources to a certain extent, it has also caused a series of problems. Among them, the IPO event of the live bear bile enterprise caused widespread concern and heated discussion in society due to animal protection and other issues, and the IPO declaration of the enterprise was finally terminated due to animal protection and other issues. At the same time, due to the individual differences of bile-taking bears and the displacement of gallbladder organs, bear bile powder drainage has certain quality instability and health and safety risks, such as visceral lesions caused by inflammation, bacterial viruses from animals, antibiotic residues and other problems.

As an endangered protected animal species in CITES Appendix I, black bear bile-derived animals are explicitly prohibited from international trading, and it has gradually become a social consciousness to terminate the live bear bile-taking industry. In recent years, using modern science and technology to develop new bear bile substitutes has become a research hotspot in the medical field. At present, relevant research shows that, based on the research of major new drug creation projects in the Twelfth Five-Year Plan and the Thirteenth Five-Year Plan, the transformed bear bile powder made by modern Chinese medicine fermentation technology is basically close to "chemical equivalence and bioequivalence", and the tons of mass-produced products transformed into bear bile powder have stable quality, uniform batches and obvious advantages in mass production, which is expected to alleviate the contradiction between animal protection and the sustainable development and utilization of Chinese medicine resources to some extent, promote the inheritance and innovation of endangered medicinal materials, and ensure the clinical use and large-scale utilization of bear bile.