Relaxin injection

A technology of peptide injection and relaxin peptide, which is applied in the fields of peptide/protein components, cardiovascular system diseases, non-effective components of polymer compounds, etc., and can solve the problem of inability to achieve high-concentration relaxin injection stability and relaxin injection concentration Problems such as increase and stability decrease, etc., to achieve the effect of being suitable for large-scale industrial production, easy control of process conditions, and improvement of stability

Inactive Publication Date: 2014-05-07
济南环肽医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, research findings (see the research paper "Stability and Characterization of Recombinant Human Relaxin" by Tue H. Nguyen and Steven J. Shire, published in Formulation, Characterization, and Stability of Protein Drugs: Case Histories. Pharmaceutical Biotechnology, 2002 No. 9 volumes, pages 247-274), relaxin can be configured in the range of pH 3.0-9.0 with physical stability, the highest concentration of aqueous solution can only reach 1.0mg/mL, after the concentration is higher than 1.0mg/mL,

Method used

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  • Relaxin injection

Examples

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preparation example Construction

[0023] Reference Example 1 Preparation of Relaxin Injection (without PEG200 or PEG400)

[0024] 1) Adjust the pH of 100mL water for injection with citrate buffer solution to 5.0, add NaCl to make the solution ionic strength 0.15μ;

[0025] 2) Dissolve 150 mg of relaxin peptide in the solution of step 1), add 35 mg of mannitol, and then add bovine serum albumin to make the concentration 2% (W / V), stir evenly at 3°C ​​for 20 hours, and use lemon Salt buffer solution to adjust the pH to 5.0.

Embodiment 2

[0026] Reference Example 2 Preparation of Relaxin Injection (without bovine serum albumin or human serum albumin)

[0027] 1) Adjust the pH of 100mL water for injection with acetate buffer solution to 5.5, add NaCl to make the solution ionic strength 0.18μ;

[0028] 2) Dissolve 150 mg of relaxin peptide in the solution of step 1), add PEG400 to make the concentration 6% (W / V), stir and mix evenly, leave it at 5°C for 24 hours, and adjust the pH to 5.5 with acetate buffer solution .

Embodiment 3

[0029] Reference Example 3 Preparation of Relaxin Injection (without PEG200, PEG400, bovine serum albumin, human serum albumin)

[0030] 1) Adjust the pH of 100mL water for injection with citrate buffer solution to 5.5, add NaCl to make the solution ionic strength 0.15μ;

[0031] 2) Dissolve 200 mg of relaxin peptide in the solution of step 1), add 50 mg of sorbitol, stir and mix evenly, leave it under stirring at 2°C for 12 hours, and adjust the pH to 5.5 with citrate buffer solution.

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Abstract

The invention discloses a relaxin injection preparation, which contains relaxin, citrate or acetate buffer solution, NaCl, PEG200 (polyethylene glycol 200) or PEG400 and bovine serum albumin or human serum albumin, wherein the concentration of relaxin is at least 1.5 mg/mL; the pH range is 4.5-5.5; the ion strength is 0.1-0.2 mu m; the concentration of the PEG200 or PEG400 is 5-15% (W/V); the concentration of bovine serum albumin or human serum albumin is 0.01-5% (W/V). Researches show that the relaxin injection disclosed by the invention is capable of keeping the stability of high-concentration relaxin in a water solution, solving the precipitation accumulation problem of injection caused by increased concentration of relaxin, being beneficial to realizing high-concentration micro-injection of the relaxin injection, and being convenient for patients to use.

Description

technical field [0001] The invention relates to a pharmaceutical preparation of relaxin, in particular to an injection preparation of relaxin. Background technique [0002] Relaxin, the English name is Relaxin, and the common name of the drug is Serelaxin, which is a kind of human relaxin-2 prepared by gene recombination or chemical synthesis. Its structure is composed of two peptide chains, the A chain contains 24 amino acids and there are disulfide bonds in the chain, the B chain contains 29 amino acids, and the A chain and the B chain are connected by two disulfide bonds. Its structural formula is as follows: [0003] [0004] Where pGlu is pyroglutamic acid, Tyr is tyrosine, Ser is serine, Asn is asparagine, Cys is cysteine, His is histidine, Val is valine, Gly is glycine, Thr is threonine Amino acid, Lys is lysine, Arg is arginine, Leu is leucine, Phe is phenylalanine, Asp is aspartic acid, Trp is tryptophan, Met is methionine, Glu is glutamic acid , Ile is isoleuc...

Claims

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Application Information

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IPC IPC(8): A61K38/22A61K9/08A61K47/42A61K47/34A61P9/10A61P9/00
Inventor 厉保秋袁强房世红
Owner 济南环肽医药科技有限公司
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