High purity ulinastatin and its prepn process and medicine composition

Abstract

The present invention relates to high purity ulinastatin and its medicine composition and their preparation process. Specially, the high purity ulinastatin in 50,000 U / ml concentration has optical absorption value at 405 nm not exceeding 0.05 and human urea kininogenase content not exceeding 0.0003 PNAU. The present invention purifies ulinastatin product through adsorption with hydrophobic column, purification in hydrophilic column, combination with metalloprotein in metal chelating column and elution with buffering phosphate solution.

Description

technical field

[0001] The invention relates to high-purity ulinastatin and pharmaceutical compositions containing ulinastatin, as well as their preparation methods. More specifically, the present invention relates to ulinastatin, which is colorless, high in clarity, high in potency, and contains no more than 0.0003 PNAU of human urinary kininogenase, its preparation method and a pharmaceutical composition containing the ulinastatin . Background technique

[0002] Ulinastatin, also known as Human Urinary Trypsin Inhibitor (Human Urinary Trypsin Inhibitor), is a trypsin inhibitor isolated and purified from human urine. In 1909, Beurer and Reich first reported human urine This trypsin inhibitor exists in . Ulinastatin is a glycoprotein composed of 143 amino acids, with alanine at the N-terminus, leucine at the C-terminus, and sugar chains at the 10th serine and 45th aspartic acid. The O-glycosidic chain on serine contains multiple chondroitin sulfate units (5 Ch4S and 10 Ch...