注射用重组人干扰素α-1b溶解后活性稳定性及雾化粒径研究

目的探讨注射用重组人干扰素α-1b(rhIFNα-1b)溶解后的活性稳定性,并考察不同雾化器雾化对微粒粒径的影响。方法rhIFNα-1b分别以氯化钠注射液和灭菌注射用水为溶剂,考察4℃和25℃温度条件下的生物活性变化;用Winner311XP激光粒度仪检测药液用不同雾化器雾化后微粒的粒径分布。结果rhIFNα-1b以灭菌注射用水为溶剂,4℃存放1,6,12,24 h后的生物学活性相当于0 h活性的96.76%~100.46%,在25℃存放1,6,12,24 h后的生物学活性相当于0 h活性的91.24%~103.69%。rhIFNα-1b以氯化钠注射液为溶剂,4℃存放1,6,12,24 h后的生物学活性相当于0 h活性的96.73%~103.74%,在25℃存放1,6,12,24 h后的生物学活性相当于0 h活性的95.35%~105.58%。雾化rhIFNα-1b后,药液微粒可到达肺泡组织。结论rhIFNα-1b溶解后,在4℃及25℃温度条件下24 h内稳定,雾化后的粒径范围符合要求。

Stability and Atomized Particle Size of Recombinant Human Interferon Alpha 1b for Injection After Dissolution

Objective To study the activity stability of recombinant human interferon alpha 1b(rhIFNα-1b)for injection after dissolution,a nd to investigate the influence of different atomizers on the particle size.Methods Sodium chloride injection and water for sterilization injection were used as solvent respectively.The biological activity of rhIFNα-1b in different periods after being dissolved at 4℃and 25℃was investigated.Winner 311XP laser particle size analyzer was used to detect the particle size distribution of aerosolized particles.Results Using water for sterile injection as solvent,rhIFNα-1b at 4℃for 1,6,12,24 h had biological activities equivalent to 96.76-100.46%at 0 h;rhIFNα-1b at 25℃for 1,6,12,24 h had biological activities equivalent to 91.24%-103.69%at 0 h.Using Sodium chloride injection as solvent,rhIFNα-1b at 4℃for 1,6,12,24 h had biological activities equivalent to 96.73-103.74%at 0 h;rhIFNα-1b at 25℃for 1,6,12,24 h had biological activities equivalent to 95.35%-105.58%at 0 h.After aerosolization,the rhIFN-α1b could reach the alveoli.Conclusion After dissolution,rhIFNα-1b at 4℃and 25℃has stable properties within 24 h;the range of particle size after atomization meets the requirements.