Purified ustading and its preparation method and medicinal composition containing said ustading

A technology of ulinastatin and content, which is applied in the direction of drug combination, medical preparations containing active ingredients, antipyretics, etc., can solve the problem of low purity of ulinastatin, achieve good stability, high safety, no side effects

Active Publication Date: 2008-10-15
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 ulinasta

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0042] Embodiment 1 A kind of high-purity ulinastatin, it is prepared by the following steps:

[0043] (a) Pump 1.1 tons of urine into the mixing tank, adjust the pH to 4.5, 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;

[0044] (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 a ...

Embodiment 2

[0055] Embodiment 2 A kind of high-purity ulinastatin, it is prepared by the following steps:

[0056] (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;

[0057] (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

[0068] Embodiment 3 a kind of pharmaceutical composition containing ulinastatin

[0069] The ulinastatin pharmaceutical composition of each dosage unit contains:

[0070] 100,000 units of high-purity ulinastatin prepared in Example 2

[0071] Mannitol 30mg

[0072] Preparation method: take 100 million units of high-purity ulinastatin prepared in Example 2,

[0073] Weigh 30g of mannitol, add 500ml of water for injection to dissolve, adjust the pH value to 6-7 after mixing, then add water for injection to 2000ml, filter aseptically, divide into 1000 vials, lyophilize and cover. become.

[0074] Illustrate the safety of ulinastatin of the present invention below by clinical experiment:

[0075] In the clinical trial that ulinastatin is used for acute lung injury, healthy people are selected as subjects, and the test drug is the ulinastatin drug of the embodiment 3 of the present invention, and single administration tolerance and multi-dose tolerance are tested respectively. D...

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PUM

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Abstract

A purified ulinastatin is prepared through adsorbing by hydrophobic column, separating by gel column, combining metalloprotein by metallic chelating column, and eluting with phosphate buffering liquid. A composite medicine containing the purified ulinastatin also disclosed.

Description

technical field [0001] The invention relates to purified ulinastatin, pharmaceutical compositions containing the same, and their preparation methods. More specifically, the present invention relates to ulinastatin, which is colorless, high in clarity, high in potency, and has a human urinary kininogenase content of no more than 0.0005 PNAU, a preparation method thereof, 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 ChOS)....

Claims

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Application Information

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IPC IPC(8): A61K38/57A61P1/18A61P29/00A61P43/00
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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