液体稳定干扰素及其相关研究

Study on Stable Interferon Liquid Formulation

采用模拟人体体液环境的仿生学思路制成稳定的干扰素液体制剂,以羟乙基淀粉-40为稳定剂,制剂中未添加人血清白蛋白、防腐剂成分,无需惰性气体保护。该制剂在8℃以下温度可长期稳定,并在一定范围内对温度、振摇、光照和冻融表现出较强的耐受性。急性毒性试验和局部刺激性试验表明液体稳定干扰素符合有关药物制剂要求。液体稳定干扰素对SARS冠状病毒有抑制作用,其半数有效浓度EC50为12 IU/ml,治疗指数TI>850。

A stable interferon liquid formulation was made by using bionics principle. Hydroxyethyl starch 40, citrate buffer and so on were used to stabilize interferon. The formulation is free of human serum albumin or preservative, and no inert gases protection was needed. The bioactivity of interferonα-2b in the formulation could be kept stable at 8℃ for 36 months, and good tolerance in temperature, vibration, illumination and freeing-thawing was shown. It was indicated by the acute toxicity experiments and topical irritative reaction experiments that the stable interferon liquid formulation accorded with the pharmaceutics regulations. The stable interferon solution had activity of anti-SARS, EC50= 12IU/ml, TI〉850.