目的 評價重組人干擾素α1b注射劑的質(zhì)量現(xiàn)狀及存在問題。方法 抽取2個企業(yè)生產(chǎn)的31批注射用重組人干擾素α1b和11批重組人干擾素α1b注射液，按照《中國藥典》2010年版三部標準進行檢驗，統(tǒng)計分析生物學(xué)活性、滲透壓摩爾濃度、水分、pH值等檢驗結(jié)果，對國產(chǎn)重組人干擾素α1b注射劑的質(zhì)量現(xiàn)狀進行評價。結(jié)果 42批樣品檢驗全部合格，各生產(chǎn)企業(yè)生產(chǎn)工藝比較穩(wěn)定。結(jié)論 該品種總體質(zhì)量狀況良好，現(xiàn)行質(zhì)量標準能夠保證產(chǎn)品的安全有效，滲透壓摩爾濃度項目的標準規(guī)定應(yīng)進一步完善。

Objective To evaluate the quality status of recombinant human interferon α1b injection and find out some quality problems. Methods Totally 31 batches of recombinant human interferon α1b for injection and 11 batches of recombinant human interferon α1b injection from two enterprises were examined according to Chinese Pharmacopoeia Volume Ⅲ (2010), and the quality status of recombinant human interferon α1b injection was evaluated by statistical analysis of the results. Results All 42 batches of samples were qualified. The production process of each enterprise was steady. Conclusion At present the quality of recombinant human interferon α1b injection is generally good. The current standards are feasible, but the specified standard of osmolality needs to be improved.