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Recombinant human brain natriuretic peptide injection and preparation method thereof

A technology for human brain natriuretic peptides and injections, which is applied in pharmaceutical formulations, drug combinations, peptide/protein components, etc. It can solve the problems of high requirements for product dosage accuracy, cumbersomeness, secondary pollution, etc., and achieve good stability Sex and activity, easy to use, accurate effect of medication

Inactive Publication Date: 2015-04-29
SHIJIAZHUANG WOTAI BIOTECH
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Problems solved by technology

Compared with the water injection dosage form, the clinical use of the freeze-dried powder dosage form is cumbersome, and solvents are required for dissolution, which may cause secondary pollution during the operation process; at the same time, the recombinant human brain natriuretic peptide needs to be adjusted according to the body weight in the intravenous injection process. Impulse dose and intravenous infusion rate, so there is a high requirement for product dosage accuracy during the administration process. In addition, this product is an emergency drug for heart failure, and the convenience of product use should also be considered
[0005] The present invention aims to develop the recombinant human brain natriuretic peptide pre-filled injection water injection dosage form on the basis of ensuring the stability and activity of the recombinant human brain natriuretic peptide by screening prescriptions for different excipient combinations, so as to solve the current problems Problems such as poor stability of drugs in liquid state

Method used

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  • Recombinant human brain natriuretic peptide injection and preparation method thereof
  • Recombinant human brain natriuretic peptide injection and preparation method thereof
  • Recombinant human brain natriuretic peptide injection and preparation method thereof

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Embodiment Construction

[0026] 1. Dose selection:

[0027] This product adopts the combination of intravenous push injection and continuous intravenous infusion. Firstly, after the intravenous pulse of 1.5 μg / kg, it is continuously intravenously infused at a rate of 0.0075 μg / kg / min for 24 hours; loading dose: 1.5-2 μg / kg, maintenance dose rate: 0.0075-0.01 μg / kg / min. This patent is calculated based on the average body weight of domestic patients and the method of administration, and finally selects 500 μg / ml (dose) with reference to the specifications of the marketed products.

[0028] 2. Buffer system screening:

[0029] To investigate the effects of different buffers, different pH values ​​and different buffer concentrations on the stability of recombinant human brain natriuretic peptide, 500 μg recombinant human brain natriuretic peptide was placed in 1 ml of different types of buffers, and the buffer systems were respectively Phosphate buffer system, acetate buffer system and citrate buffer sy...

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Abstract

The invention provides a formula of a human brain natriuretic peptide liquid preparation which comprises human brain natriuretic peptide 0.5 mg / ml, a buffer solution system, polysaccharide alcohol, amino acid and a salt compound. The invention further discloses a preparation method of the human brain natriuretic peptide liquid preparation. Through selecting auxiliary materials, the recombinant human brain natriuretic peptide liquid preparation has favorable stability and activity so that the safety and effectiveness of medication are ensured.

Description

technical field [0001] The invention belongs to the technical field of biomedical engineering, and in particular relates to a prescription of a recombinant human brain natriuretic peptide injection preparation and a preparation method thereof. Background technique [0002] Protein instability mainly includes chemical instability and physical instability. Chemical instability leads to protein modification through bond formation or breakage, mainly including deamidation, racemization, hydrolysis, oxidation, β-elimination and binary Sulfur bond breaking or exchange, etc. Physical instability will not lead to covalent changes in proteins, but changes in higher-order structures (secondary structures and above) of proteins, mainly including denaturation, adsorption, aggregation, and precipitation. The purpose of research on the prescription of protein drug preparations is to stably prolong the storage time of protein drugs on the basis of maintaining the natural and pharmaceutical...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K38/17A61K47/18A61K47/26A61K47/12A61K47/04A61P9/04
Inventor 张世光周晓雷邹卫张娜刘盼盼王雅周志艳张文君延志芬宋浩雷
Owner SHIJIAZHUANG WOTAI BIOTECH
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