Erythrogenin mimetic peptide-containing pharmaceutical composition

An erythropoietin and composition technology, which can be applied in the directions of drug combinations, medical preparations containing active ingredients, and medical preparations without active ingredients, etc., can solve problems such as limitation and low EC50, and achieve the effect of good stability

Active Publication Date: 2014-01-29
JIANGSU HANSOH PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the EC50 of peptides that can stimulate erythrocyte proliferation and differentiation is very low, between 20nM and 250nM, so the clinical application of these peptides is greatly limited.

Method used

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  • Erythrogenin mimetic peptide-containing pharmaceutical composition
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  • Erythrogenin mimetic peptide-containing pharmaceutical composition

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0040] 2. Preparation of SEQ ID NO:8 Cyclic Peptide

[0041] Dissolve 27g of erythropoietin mimetic peptide derivative monomer peptide SEQ ID NO:8 in 3000ml of 20% glacial acetic acid, then slowly add 5% iodomethanol solution dropwise until the yellow color does not disappear. The reaction solution was directly prepared and purified, using reverse phase chromatography, using octadecylsilane bonded silica gel as a chromatographic column filler (Waters Symmetry Shield TM RP18 3.5μm, 4.6*100mm), the column temperature is 60°C, the detection wavelength is 214nm; water (containing 0.05% trifluoroacetic acid) and acetonitrile (containing 0.05% trifluoroacetic acid) are used as mobile phases in different proportions, and collected together The target component, after most of the acetonitrile was evaporated under reduced pressure, was lyophilized to obtain 9.3g of SEQ ID NO: 8 cyclic peptide (yield: 15.7%)

[0042] 3. Preparation of functional small molecules (LG-2)

[0043]

[...

Embodiment 1

[0052] prescription:

[0053] HH-EPO-018B, 8g

[0054] Poloxamer 188, 15g

[0055] L-Arginine, 15g

[0056] Mannitol, 42g

[0057] Potassium dihydrogen phosphate, 20g

Embodiment 2

[0059] prescription:

[0060] HH-EPO-018B, 11g

[0061] Polysorbate 80, 13g

[0062] L-Glutathione, 14g

[0063] Sodium chloride, 44g

[0064] Potassium dihydrogen phosphate, 18g

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Abstract

The invention relates to an erythrogenin mimetic peptide-containing pharmaceutical composition. The composition also contains 10%-15% of a surfactant by weight, 10%-15% of a stabilizer by weight, 42%-46% of an isoosmotic adjusting agent by weight and 16-20% of a buffer solution by weight. The composition has the beneficial effects that specific pharmaceutical auxiliary materials are screened out by targeting specific erythrogenin mimetic peptides, so that the stable pharmaceutical composition is obtained.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing erythropoietin mimetic peptide, which further comprises 10% to 15% by weight of surfactant, 10% to 15% by weight of stabilizer, and 42% to 46% by weight of isotonic regulator And 16-20% buffer by weight. Background technique [0002] Peptide drugs have been widely used in clinical research or treatment. Stable, high-quality therapeutic peptide drug preparations that can be produced industrially are still a major challenge for researchers. The stability of polypeptide pharmaceutical preparations includes two aspects: chemical stability and physical stability; the factors affecting its chemical stability are mainly changes in covalent bonds, such as hydrolysis, deamination, oxidation, racemization or cross-linking; Factors affecting physical stability include denaturation, aggregation, adsorption or precipitation, etc. [0003] Erythropoietin (EPO) is a glycoprotein hormone with ...

Claims

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Application Information

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Patent Type & AuthorityApplications(China)
IPC IPC(8): A61K38/16A61K47/34A61K47/26A61P7/06
Inventor孙长安王小雷
OwnerJIANGSU HANSOH PHARMA CO LTD