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High purity ulinastatin and its prepn process and medicine composition

A high-purity technology for ulinastatin, which is applied in the field of high-purity ulinastatin and pharmaceutical compositions containing ulinastatin, can solve the problem of low purity of ulinastatin, and achieve good stability and safety High, no side effects

Active Publication Date: 2009-08-19
GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The purpose of the present invention is to overcome the defect of low purity of existing ulinastatin, and provide a kind of ulinastatin with high potency, good stability, high purity and no side effects

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1 A kind of high-purity ulinastatin, it is prepared by the following steps:

[0042] (a) Pump 1.1 tons of urine into the stirring tank, adjust the pH to 5.5, add 500 g of chitin for adsorption, and elute with 10% ammonium sulfate solution (pH 7.0), and filter the eluent with diatomaceous earth Medium, carry out suction filtration, drain out ulinastatin crude product 100g;

[0043] (b) Take 100g of ulinastatin crude product, add 300ml of water and stir to dissolve, plate and frame filter, the filtrate circulates for 5-10 minutes, after clarification, filter to get the supernatant, adjust the pH to 6.5±0.2 with sodium hydroxide solution, add 1.1 times of 95% ethanol for the first precipitation, take the supernatant, add 2.5 times of 95% ethanol for the second precipitation, take the precipitate, add 5 times of water to fully dissolve, filter; take the filtrate, press the flow rate of 400cm / h on the Anion exchange column QAE Sephadex A-25, wash the column with ...

Embodiment 2

[0053] Embodiment 2 A kind of high-purity ulinastatin, it is prepared by the following steps:

[0054] (a) Pump 1.1 tons of urine into the stirring tank, adjust the pH to 6.0, add 500 g of chitin for adsorption, and elute with 10% ammonium sulfate solution (pH9.0), and filter the eluent with diatomaceous earth Medium, carry out suction filtration, drain out ulinastatin crude product 100g;

[0055] (b) Take 100g of crude product of ulinastatin, add 200ml of water and stir to dissolve, plate and frame filter, the filtrate circulates for 5-10 minutes, after clarification, filter to get the supernatant, adjust the pH to 6.5±0.2 with sodium hydroxide solution, add 1.1 times of 95% ethanol for the first precipitation, take the supernatant, add 2.5 times of 95% ethanol for the second precipitation, take the precipitate, add 6 times of water to fully dissolve, filter; take the filtrate, and put it on at a flow rate of 100cm / h Anion exchange column Q Sepharose H.P, wash the column wit...

Embodiment 3

[0067] Embodiment 3 a kind of pharmaceutical composition containing ulinastatin

[0068] The ulinastatin pharmaceutical composition of each dosage unit contains:

[0069]100,000 units of high-purity ulinastatin prepared in Example 2

[0070] Mannitol 30mg

[0071] Preparation:

[0072] Take 100 million units of high-purity ulinastatin prepared in Example 2, weigh 30 g of mannitol, add 500 ml of water for injection to dissolve, adjust the pH value to 6 to 7 after mixing, then add water for injection to 2000 ml, filter membrane without Bacterial filtration, packed in 1000 vials, freeze-dried and covered.

[0073] Illustrate the safety of ulinastatin of the present invention below by clinical experiment:

[0074] Healthy people were selected as subjects, and the test drug was ulinastatin according to Example 3 of the present invention, and single-dose tolerance and multiple-dose tolerance tests were carried out respectively. In the single-dose test, the subjects were randoml...

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PUM

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07K14/81C07K1/14A61K38/57A61P1/18A61P7/00A61P29/00A61P43/00
Inventor 傅和亮王晓岩苗丕渠郑少亮许文勤侯永敏
Owner GUANGDONG TECHPOOL BIO-PHARMA CO LTD
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