Biological Evaluation of a Novel Bilirubin Adsorbent and Its Therapeutic Effect on Animal Models of Hyperbilirubinemia

Background: Hyperbilirubinemia caused severe hepatobiliary diseases with various causes, especially hepatic fibrosis and cirrhosis caused by end-stage hepatitis B and C. Plasma adsorption perfusion has an absolute advantage in treating patients with hyperbilirubinemia and liver failure. A safe and effective adsorbent in PP is the key to clear bilirubin. The adsorbent must have good blood compatibility and high adsorption rate for bilirubin. Methods and Results: In the early stage, the homopolymer predispersion system is used to improve the traditional suspension polymerization and obtain a new porous polymer adsorption resin ERM-0100. The experimental results showed that ERM-0100 exhibited high specific surface area and uniform particle size distribution. The results of biocompatibility tests, including cytotoxicity, acute toxicity test, intradermal reaction, sensitization reaction, and hemolysis test, suggested that ERM-0100 met the requirements of GB/T 16886.5-2017 “Biological Evaluation of Medical Devices” and had a good biological phase. Good biocompatibility laid the foundation for subsequent determination of bilirubin adsorption in vivo in ERM-0100. This work used the experimental pure Bama Xiang pig to establish a high-bilirubin animal model via the surgical and drug methods. As such, the stability of the animal model, the safety of ERM-0100 in vivo, and the in vivo effectiveness of the resin material were evaluated. Conclusion: In this study, Bama pigs were used to establish a hyperbilirubinemia animal model using surgical methods to evaluate the biocompatibility and the effectiveness of ERM-0100 , which may reduce domestic patient's financial burden.