Kaifeng Pharmaceutical (Group) Co., Ltd.

The type I human interferon (IFN) family consists of a group of cytokines with a multiplicity of biological activities, including antiviral, antitumor, and immunomodulatory effects. However, because the half-life of IFN is short, its clinical application is limited. Increasing the yield and biological activity of IFN while extending its half-life is currently the focus of IFN research.

Two novel long-acting recombinant human IFN-α2b (rhIFN-α2b) proteins were designed in which the carboxyl-terminal peptide (CTP) of the human chorionic gonadotropin β su bunit and N-linked glycosylation sequences were linked to rhIFN-α2b. They were designated IFN-1CTPON (fused at the C-terminus of rhIFN-α2b) and IFN-2CTPON (fused at both the C-terminus and N-terminus of rhIFN-α2b). Monoclonal CHO cell strains stably and efficiently expressing the IFNs were successfully selected with methotrexate (MTX), and the highest expression levels were 1468 mg/l and 1196 mg/l for IFN-1CTPON and IFN-2CTPON, respectively. The proteins were purified with affinity chromatography and molecular sieve chromatography. IFN-1CTPON and IFN-2CTPON showed antiviral and antiproliferative activities in vitro. Notably, the half-life of IFN-1CTPON and IFN-2CTPON in vivo were three-fold and two-fold longer than that of commercially available rhIFN-α2b.

CHO cell strains stably expressing long-acting rhIFN-α2b were screened. The purified IFN-CTPON protein has biological activity and an extended half-life, and therefore potential applications.

A determination method for antioxidant sodium sulfite in Bromfenac Sodium Eye Drops was established.The UV spectrophotometry method was adopted.Fuchsia complex compound generated by sodium sulfite and fuchsin basic under the acidic condition was determined the absorbance at the wave length of 560 nm.Then the content of sodium sulfite was calculatedThis product within the range of 0.3-2.2 μg/mL showed the good linear relation with the peak area (r=0.999 4).The average recovery rate was 9.7% with RSD=1.31%.This method is simple and accurate for determination of antioxidant sodium sulfite in Bromfenac Sodium Eye Drops.

Using the area of each peak and the relative correcting factor, the contents of gentamicin C were determined by HPLC.The recovery rates of gentamicin C₁, C_1a and C₂ + C_2a were 100.5, 98.80 and 100.1%, and RSD were 2.186, 0.503 and 1.588%, resp.The content of C₁, C_1a and C₂ + c_2a in samples were 33.6, 25.17 and 41.23%, RSD were 2.183, 2.189 and 2.178%, resp.