Urofollitropin products: preparation process explained
The invention discloses a method for preparing urofollitropin. The
preparation method has the advantages of simple operation and low production
cost, and the obtained urofollitropin has higher purity and no foreign protein
pollution. The specific activity of FSH is greater than 10000IU/mg protein, and
the titer of LH:FSH is lower than 1:100. The preparation method comprises the
following steps:
(1) The crude product of human menopausal gonadotropin is purified by anion
exchange chromatography to obtain Urofollitropin intermediate I;
(2) Urofollitropin intermediate I is purified by cation exchange
chromatography to obtain Urofollitropin intermediate II;
(3) Urofollitropin intermediate II is purified by dye affinity
chromatography to obtain Urofollitropin intermediate III;
(4) Urofollitropin intermediate III is purified by hydrophobic
chromatography to obtain a solution of high-purity Urofollitropin;