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目的 对重组人干扰素α2a软膏的质量进行检定及临床疗效观察。方法 连续试制 3批样品进行稳定性试验及生殖器疱疹的临床疗效观察。结果 本品性质稳定 ,2～ 10℃保存 18个月生物学活性无明显下降 ,其他各项检定指标均符合质量要求。生殖器疱疹的临床疗效观察 ,治疗组有效率为 85 .72 % ,对照组的有效率为 6 5 .2 7% ,差异有显著意义。结论 该制品生产工艺稳定 ,疗效确切 ,安全性好
Objective To test the quality of recombinant human interferon α2a ointment and observe the clinical curative effect. Methods Three batches of samples were continuously tested for stability and clinical efficacy of genital herpes. Results The product was stable in nature, no significant decrease in biological activity after 18 months of storage at 2 ~ 10 ℃, and all the other test indexes met the quality requirements. Clinical curative effect of genital herpes observation, the effective rate of the treatment group was 85.72%, the effective rate of the control group was 65.27%, the difference was significant. Conclusion The production process of the product is stable, effective and safe