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为了实现重组水蛭素Ⅲ口服给药途径并验证其药效,将其制成乳糜微粒,比较了3种制备方法,确定了逆相蒸发法为r HV3乳糜微粒的最佳制备方法。优化了制备条件,通过正交实验确定了r HV3乳糜微粒配方,制得的r HV3乳糜微粒的包封率为(65.08±1.96)%。在-20℃保存条件下r HV3乳糜微粒稳定性良好。药效学实验结果表明,口服r HV3乳糜微粒具有良好的抗凝和抗栓作用。
In order to realize the oral administration route of recombinant hirudin III and verify its efficacy, it was made into chylomicrons. Three methods of preparation were compared, and the reverse phase evaporation method was determined as the best preparation method of rHV3 chylomicrons. The preparation conditions were optimized, and the formulation of r HV3 chylomicron was determined by orthogonal experiment. The encapsulation efficiency of r HV3 chylomicron was (65.08±1.96)%. The HV3 chylomicrons have good stability under -20°C storage conditions. Pharmacodynamic experiments showed that oral administration of r HV3 chylomicrons has good anticoagulant and antithrombotic effects.