Recombinant human B-type natriuretic peptide injection and preparation method thereof

A natriuretic peptide and injection technology, applied in the field of pharmaceutical inventions, can solve problems such as poor solubility and excessive bubbles, and achieve good stability

Inactive Publication Date: 2020-03-27
GUIZHOU JINGFENG INJECTION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The purpose of the present invention is to provide a recombinant human B-type natriuretic peptide injection to further exert the clinical effect of recombinant human B-type natriuretic peptide and overcome the technical problems of poor solubility and too many bubbles in the prior art

Method used

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  • Recombinant human B-type natriuretic peptide injection and preparation method thereof
  • Recombinant human B-type natriuretic peptide injection and preparation method thereof
  • Recombinant human B-type natriuretic peptide injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] Formula: recombinant human B-type natriuretic peptide 0.6mg / ml, citric acid 8mg / ml, sodium chloride 2mg / ml, activated carbon 0.2mg / ml, and the balance is water for injection.

[0047] Embodiment 1 is prepared by any of the following preparation methods:

[0048] Preparation method 1

[0049] 1) Turn on the chilled water system, add cooled water for injection into the liquid distribution tank, cool down to 12°C, close the chilled water system, and start stirring;

[0050] 2) adding recombinant human B-type natriuretic peptide under stirring;

[0051] 3) Slowly add sodium chloride and citric acid to control the pH value to 5.1-5.5;

[0052] 4) Add activated carbon, add water for injection to the total volume of the solution, continue to stir for 15 minutes to pre-dissolve, stop stirring, and let stand for 15 to 25 minutes;

[0053] (5) Simultaneously carry out decarburization at a temperature of 15°C and pass through a sterilizing filter with a pore size of 0.22um for on...

Embodiment 2

[0079] Formula: recombinant human B-type natriuretic peptide 1.0mg / ml, citric acid 11mg / ml, sodium chloride 5mg / ml, activated carbon 0.5mg / ml, and the balance is water for injection.

[0080] Embodiment 2 is prepared by any of the following preparation methods:

[0081] Preparation method 1

[0082] 1) Turn on the chilled water system, add cooled water for injection into the liquid distribution tank, cool down to 12°C, close the chilled water system, and start stirring;

[0083] 2) adding recombinant human B-type natriuretic peptide under stirring;

[0084] 3) Slowly add sodium chloride and citric acid to control the pH value to 5.1-5.5;

[0085] 4) Add activated carbon, add water for injection to the total volume of the solution, continue to stir for 15 minutes to pre-dissolve, stop stirring, and let stand for 15 to 25 minutes;

[0086] (5) Simultaneously carry out decarburization at a temperature of 15°C and pass through a sterilizing filter with a pore size of 0.22um for...

Embodiment 3

[0112] Formula: recombinant human B-type natriuretic peptide 0.7mg / ml, citric acid 8.5mg / ml, sodium chloride 2.5mg / ml, activated carbon 0.2mg / ml, and the balance is water for injection.

[0113] Embodiment 3 is prepared by any of the following preparation methods:

[0114] Preparation method 1

[0115] 1) Turn on the chilled water system, add cooled water for injection into the liquid distribution tank, cool down to 12°C, close the chilled water system, and start stirring;

[0116] 2) adding recombinant human B-type natriuretic peptide under stirring;

[0117] 3) Slowly add sodium chloride and citric acid to control the pH value to 5.1-5.5;

[0118] 4) Add activated carbon, add water for injection to the total volume of the solution, continue to stir for 15 minutes to pre-dissolve, stop stirring, and let stand for 15 to 25 minutes;

[0119] (5) Simultaneously carry out decarburization at a temperature of 15°C and pass through a sterilizing filter with a pore size of 0.22um ...

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Abstract

The invention relates to a recombinant human B-type natriuretic peptide injection. The recombinant human B-type natriuretic peptide injection adopts a formula comprising the following components: 0.6-1.0 mg / ml of a recombinant human B-type natriuretic peptide, 8-11 mg / ml of citric acid, 2-5 mg / ml of sodium chloride, 0.2-0.5 mg / ml of activated carbon, and the balance of water for injection; and thecomponents subject to stirring, standing, decarbonizing and sterilizing treatments so as to have clinical effects of the recombinant human B-type natriuretic peptide further developed with the technique problems of poor solubility and excessively many bubbles in the prior art overcome.

Description

technical field [0001] The invention relates to the field of medical inventions, in particular to a recombinant human B-type natriuretic peptide injection and a preparation method thereof. Background technique [0002] B-type natriuretic peptide BNP is a 17-ring polypeptide composed of 32 amino acid residues. It was first isolated from pig brain tissue by Japanese scholars in 1988. It is mainly secreted by ventricular cells when volume or pressure overload is overloaded. BNP increases the second messenger cyclic guanosine (cGMP) by binding to its receptor, thereby mediating a series of physiological effects, including diuresis, natriuresis, dilation of blood vessels, inhibition of the sympathetic nervous system and renin-angiotensin-aldosterone system activity, reduce myocardial fibrosis, inhibit the expression of tissue factor (TF) and plasminogen activator inhibitor-1 (PAI-1) in vascular endothelial cells, prevent thrombosis under hyperemia, and dilate epicardial coronary ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/22A61K47/12A61P9/04
CPCA61K9/0019A61K38/2242A61K47/12A61P9/04
Inventor 毕昌琼张剑罗江梅聂万碧
Owner GUIZHOU JINGFENG INJECTION
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