目的:建立重组抗肿瘤抗病毒蛋白乐复能(novaferon）的质控方法和质量标准。方法：以WST1染色法检测Daudi细胞增殖，测定乐复能的抗肿瘤细胞增殖活性；以WISH细胞病变抑制法测定乐复能抗病毒活性；乐复能以胰蛋白酶酶切后，用HPLC分析肽图；其余检测项目按《中华人民共和国药典》(三部)2005年版的规定进行。结果：3批乐复能原液和成品的抗肿瘤比活性均≥2.0×106 U/mg、抗病毒比活性均≥1.0×109 IU/mg。3批乐复原液的HPLC肽图与参考品一致，乐复原液的蛋白含量、纯度、分子质量、等电点、末端氨基酸序列等指标及成品的细菌内毒素、苯甲酸含量、乙腈残留量等指标均符合规定。根据检定结果建立了乐复能的质量标准。结论：建立的质控方法和质量标准可以保证乐复能的安全、有效和质量可控，可用于乐复能的常规检定。

Objective:To establish the quality control methods and standards for recombinant antitumorantivirusprotein novaferon. Methods: Antitumor activity of novaferon was evaluated by determining its inhibitory effect on the proliferation of Daudi cells using WST1 staining. The antivirus activity of novaferon was examined by cytopathic inhibition assay on WISH cells. The peptide map of novaferon was obtained by trypsin digestion and HPLC assay. Other routine tests were all performed according to the pharmacopoeia of the People′s Republic of China.Results: The antitumor and antivirus activities of three batches of novaferon bulk and final products were ≥2.0×106 U/mg and ≥1.0×109 IU/mg, respectively. HPLC peptide maps of three batches of novaferon paralleled with that of standard product. Quantity, purity, molecular mass, isoelectic point and Nterminal amino acid sequence of three batches of novaferon bulk products and bacterial endotoxin content, benzyl alcohol content, acetonitrile of three final products were consistent with the quality standards. Results of other routine tests all complied with the standard requirements. The quality control methods and standards for recombinant antitumorantivirusprotein novaferon were established accordingly.Conclusion: The established quality control methods and standards for novaferon are safe and effective, which can be used for routine quality control of novaferon.