POLYETHYLENE GLYCOL MODIFIED INTERFERON ALPHA 2B, PRODUCING AND USING PREPARATION

FIELD: medicine, pharmaceutics.SUBSTANCE: group of inventions refers to biochemistry. What is presented is pegylated interferon-?2b (IFN-?2b) having a structure as shown in the patent claim. Pegylated interferon-?2b is prepared by combining IFN-?2b with branched Y-polyethylene glycol (YPEG), wherein YPEG is bound to IFN-?2b by an amide bond formed by ?-amino group of a side of Lys residue in IFN-?2b in the position of 134 in SEQ ID No. 1. A method for preparing and purifying pegylated IFN-?2b involves the stages as follows. In an alkaline medium at pH 9.0, branched Y-polyethylene glycol is reacted with IFN-?2b to prepare pegylated IFN-?2b. The prepared reaction products are recovered by an anion exchange resin, and the given products are eluted by an anion gradient to prepare modified products. The anion exchange resin is Q Sepharose FF, and the anion gradient is a chloride ion gradient. Further, the modified products are eluted by a cation exchange resin with a cation gradient. The cation exchange resin is SP Sepharose FF, and the cation gradient is a sodium ion gradient. Thereafter, each peak is collected separately. The product activity of each peak is determined to choose a peak corresponding to the reaction product having the highest activity. What is also presented is a formulation for treating a disease requiring IFN-?2b to be used, which consists of a pharmaceutically effective amount of said pegylated IFN-?2b and a pharmaceutically acceptable carrier, or an inactive substance. Pegylated IFN-?2b or the above formulation is also used for preparing a medicine for treating various diseases requiring IFN-?2b to be used.EFFECT: presented pegylated IFN-?2b has a higher specific activity of 2,65±0,185×10IU/mg and a prolonged serum half-life.26 cl, 11 dwg, 5 tbl, 3 ex Группа изобретений относится к области биохимии. Предложен пегилированный интерферон-α2b (IFN-α2b), имеющий структуру, как указано в формуле изобретения. Пегилированный интерферон-α2b получают соединением IFN-α2b с Y-образным разветвленным полиэтиленгликолем (YPEG), где YPEG связан с IFN-α2b с помощью амидной связи, сформированной ε-аминогруппой боковой цепи остатка Lys в IFN-α2b в положении 134 в SEQ ID No.1. Способ получения и очистки пегилированного IFN-α2b включает следующие этапы. В щелочной среде при рН 9,0 проводят реакцию Y-образного разветвленного PEG с IFN-a2b и получают пегилированный IFN-α2b. Извлекают полученные продукты реакции с помощью анионообменной смолы и элюируют данные пр