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Pharmaceutical formulation containing candida urate oxidase

A technology of uric acid oxidase and Candida, which is applied to medical preparations containing active ingredients, medical preparations without active ingredients, drug combinations, etc., can solve the problem of protein having no general value, unusable, molecular stability and properties Big difference and other issues

Inactive Publication Date: 2009-07-22
BEIJING SL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, domestic protein preparations cannot use this drug as an excipient
[0005] In addition, uric acid oxidase with different molecules has different primary and secondary structures, and its molecular stability and properties are quite different. A certain formulation has no general value for proteins with different structures.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Example 1 Preparation of stable Candida urate oxidase solution

[0065] Stock solution preparation: the recombinant Candida urate oxidase prepared according to the method of Chinese patent 031091504 was replaced by ultrafiltration into the following buffer solution: glycine 100mM / L, Tris-HCl (pH9.0 / 100mM / L), L-Cys ( 20mM / L), prepared into a stock solution whose concentration of recombinant Candida urate oxidase is 3.6mg / ml;

[0066] Dosing: take 500ml of the stock solution, add 25% mannitol 200ml, add water for injection to make up to 1000ml;

[0067] Sterilization by filtration: use 0.22 micron filter membrane to filter;

[0068] Subpackaging: vials are used to subpackage into 1ml preparations each;

[0069] Freeze-drying: Freeze-drying to make the final preparation.

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Abstract

The invention relates to a medicinal preparation containing Candida urate oxidase, in particular to a liquid or freeze-dried composition medicinal preparation containing the Candida urate oxidase. The composition comprises the following active ingredients: the Candida urate oxidase, glycine, cysteine and a buffer system. The composition is aseptic, and can be injected into human body or animal body to take effect through hypodermic injection, intravenous injection or intramuscular injection.

Description

technical field [0001] The invention relates to a pharmaceutical preparation containing Candida urate oxidase, in particular to a liquid or freeze-dried composition medicinal preparation containing Candida urate oxidase. Background technique [0002] Candida uric acid oxidase UOX has a full length of 303 amino acids, a molecular weight of 34.19 kDa, and a theoretical isoelectric point of 8.4. Uric acid oxidase (UOX) is one of the key enzymes in the purine metabolic pathway. Different species of organisms have different abilities to decompose purine bases, so the metabolites are also different. Humans, apes and some uricosuric animals use uric acid as the end product of purine base metabolism. Various organisms, including Candida and rats, produce urate oxidase, which further breaks down uric acid to form allantoin. The solubility of the latter in water is much greater than that of uric acid, which is beneficial to the elimination of uric acid in the body of rats and other...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/44A61K9/00A61K9/19A61K47/10A61K47/16A61P19/06
Inventor 徐明波王俊玲刘迎杨仲璠连治国张鹏梁果义倪娜齐燕明李亚军王延山孙涛吕升阳王勇波吴彦卓
Owner BEIJING SL PHARMA
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