| Objection:Hyperbilirubinemia is caused by bilirubin metabolism disorder with elevated plasma bilirubin concentration, and then to damage the tissue and organ in the body. Plasma perfusion was widely used to treat hyperbilirubinemia and gain more attention. High adsorption capacity and fast adsorption equilibrium are the important indices for evaluating clearing rate of adsorbent, and particle size and uniformity of adsorbent microspheres also affects absorption rate. The paper explores preparation, physical properties and biological compatibility of the novel bilirubin adsorption microspheres,named ERM – 0100, and evaluates bilirubin adsorption performance of the high,medium and low initial concentration by dynamic adsorption experiments in vitro with ERM-0100.Methods:1. Conventional suspension polymerization was improved using a pre-dispersion homogenizer to obtain a novel adsorbent microspheres. Microsphere-related characteristics and attributes were investigated through Fourier transform infrared spectroscopy(FTIR), scanning electron microscopy(SEM), and determination of density and pore size. The in vitro cytotoxicity experiment was carried out by MTT colorimetric method, and the biocompatibility of ERM- 0100 porous microspheres was investigated.2. Dynamic adsorption experiments under similar to normal physiological conditions were also conducted in vitro to evaluate the adsorption efficiency of ERM-0100 for three groups of high, medium, low initial concentrations of bilirubin, then compared with BRS350 and HB-H-6, adsorbent resin for clinical use. For high concentration group, the adsorption performance of other related components in the plasma, such as DBIL, IBIL, TP, ALB, K+, Na+, and Cl-, were deeply discussed.Result:1. ERM-0100 have a high specific surface area(average 674.5 m2/g) and large pores(average 200 ?m), with good particle size and homogeneity. The pick-up rate is higher than that produced by the traditional preparation methods. In vitro cytotoxicity test results show that cell proliferation rate of ERM- 0100 was 63.9%, belong to the toxicity reaction class 2, means good biocompatibility.2. With continuous dynamic adsorption experiments of 8h, the results showed that ERM-0100 have higher bilirubin adsorption rate, the maximum adsorption rate of60.28%±5.25%, adsorption equilibrium time was about 4h.The result of dynamic adsorption experiments in vitro showed that ERM-0100, BRS350 and HB-H-6 all could adsorb plasma bilirubin of three groups different initial concentration plasma bilirubin. The three groups were high concentration group with 401.4±64.6?mol/L,medium concentration group with 189.0±9.7?mol/L, and low concentration group with 137.5±17.3?mol/L. For bilirubin adsorption experimental of high concentration group, ERM-0100 had high absorption rate of TBIL, absorption rate of 4h was59.72%±1.08%, similar to that of BRS350(62.83%±3.83%, P=0.199), higher than that of HB-H-6(26.38%±1.43%, P=0.000). At medium concentration group, TBIL absorption rate of ERM-0100 was 53.61%±8.44%, compared with BRS350(63.25%±5.54%), there was no statistically significant difference(P =0.076), and HB-H-6(25.40%±2.26%), difference was statistically significant(P = 0.000). At low concentration group, TBIL absorption rate of ERM-0100(38.65%±2.55%) compared that with BRS350(54.63%±6.80%) and HB-H-6(24.79%±1.68%), difference both were statistically significant(P=0.000,P=0.001).The result of adsorption experiments of other related components in the plasma showed that DBIL absorption rate of ERM-0100 was similar to that of BRS350,absorption rates were 57.69%±1.04% and 59.34%±3.90% for respectively(P=0.477).For IBIL adsorption efficiency, absorption rate of ERM-0100(70.69%±4.13%) was behind that of BRS350(98.42%±9.59%, P=0.004). In addition, for TP and ALB, the loss rates of ERM-0100 were 15.65% ± 0.36% and 23.23% ± 1.11%, respectively.The ERM-0100 had no significant adsorption for electrolyte(K+, Na+, and Cl-). The K+ concentration of before and after adsorption were 4.61±0.13?mol/L and4.41±0.12?mol/L for respectively(P=0.001), The Na+concentration of before and after adsorption were 137.49±8.39?mol/L and 135.01±7.49?mol/L for respectively( P=0.008). The Cl-concentration of before and after adsorption were104.5±5.68?mol/L and 104.9±4.82?mol/L for respectively(P=0.935).Conclusion:1. ERM-0100 is a kind of opaque and spherical particle without any functional groups.Using a pre-dispersion homogenizer in the process of preparing resin, which can greatly improve the production efficiency, reduce cost, simplify the preparation process, and let the novel adsorbent possible service more need plasma perfusion treatment.2. Cytotoxicity effect in vitro of ERM-0100 was analysed by MTT colorimetric method, the result verified that the novel porous microspheres conform to cytotoxic evaluation standard of medical equipment, and has good biocompatibility3. ERM-0100 have good adsorption efficiency on three groups with high, medium and low initial concentration of plasma bilirubin. The higher initial bilirubin concentration, the higher bilirubin absorption rate. At high concentration group, TBIL adsorption rate of ERM-0100 was similar to that of BRS350, both much higher than that of HB-H-6.4. In the process of bilirubin adsorption, ERM-0100 could adsorb a small amount of protein, which could further improve the microspheres to reduce the adsorption of protein.5. ERM-0100 had no significant adsorption for electrolyte(K+, Na+, and Cl-). The ERM-0100 is potential biomedical material for plasma perfusion for good effect, less costs and safety. |
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