重组人干扰素α2a软膏剂的质量控制及其临床疗效观察

The quality control and curative effect on recombinant human interferon α2a cream

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。方法连续试制三批样品并进行稳定性试验,生殖器疱疹的临床疗效观察。结果本品性质稳定,2～10℃保存18m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,为试验组的有效率为85.72%,对照组的有效率为65.27%,试验组优于对照组,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 control the quality and observe the curative effect on recombinant human interferon α2a cream. Methods Stability test and clinical trial to cure genital herpes were done. Results the bioactivity and other characters of the product were stable after 18 monthes storage at 2～10℃. The effective rate of therapeutic group is 85.72% and control group is 65.27%, the difference is significant. Conclusion the product is stable,curative and non-side effect.