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Soluble preparation of bone morphogenesis protein-7 and application thereof

A morphogenic protein and soluble technology, which is applied in the direction of peptide/protein components, medical preparations containing active ingredients, bone diseases, etc., can solve the problems of low solubility, difficult to dissolve, hinder the development of other dosage forms and clinical application, etc., to achieve The effect of high solubility

Inactive Publication Date: 2008-09-24
SHANDONG MEDICAL BIO TECH RES CENT
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in addition to the above-mentioned dosage forms, the problem encountered in the development of dosage forms at present is that although the BMP-7 expressed by eukaryotic mammals is soluble, its solubility is extremely low. Due to the small solubility of its molecules, it is not easy to dissolve, which hinders other dosage forms. development and clinical application

Method used

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  • Soluble preparation of bone morphogenesis protein-7 and application thereof
  • Soluble preparation of bone morphogenesis protein-7 and application thereof
  • Soluble preparation of bone morphogenesis protein-7 and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Take 300 mg of recombinant human rhBMP-7 (purity up to 95%) expressed by CHO of purified mammalian cells and add it to 0.3M / L L-arginine solution (adjust pH=6.5), and use the same concentration of L-arginine The amino acid solution was fixed to 1000 milliliters, so that the final concentration of BMP-7 was 0.3 mg / ml, and then after depyrogenation and filter sterilization, it was subpackaged into bottled injections (3 mg / bottle) of clinically commonly used doses.

[0060] Clinical application method: for various kidney diseases, the dose of 300-400 μg recombinant human rhBMP-7 / kg·body weight is administered 2-3 times a week for 2-12 consecutive weeks. At the same time, urine output, serum creatinine, uric acid and other indicators were detected.

Embodiment 2

[0062] Measure each component according to the following prescription:

[0063] Bone Morphogenetic Protein-7 200mg

[0064] Urea 60g

[0065] L-Arginine 50g

[0066] Serum Albumin 40g

[0067] Dissolve the above components with water for injection, then set the volume to 1000 ml (pH7.0), so that the final concentration of BMP-7 is 0.2 mg / ml (200 μg / ml); Freeze-dry to prepare the freeze-dried powder injection of bone morphogenetic protein-7.

[0068] The bone morphogenetic protein-7 mentioned above refers to recombinant human rhBMP-7 expressed by mammalian cell COS with a purity of more than 95%, and its amino acid sequence is shown in SEQ ID NO.1.

[0069] Kidney disease application method:

[0070] The powder injection is dissolved in distilled water or saline when used. With the dose of 300-400 μg recombinant human rhBMP-7 / kg body weight, 2-3 times a week. Continuous administration for 2-12 weeks. At the same time, urine output, serum creatinine, uric acid and other ...

Embodiment 3

[0072] Get 300 mg of recombinant human rhBMP-7 expressed by purified prokaryotic cells (purity reaches more than 97%) and add it to 0.3M / L arginine solution (pH6.8-7.4), and use the same concentration of arginine solution to dilute to 1000ml, so that the final concentration of BMP-7 is 0.3mg / ml (300μg / ml), and then after depyrogenation and filter sterilization, it can be divided into 50μg / bottle; 300μg / bottle; 1mg / bottle; 3mg / bottle ; 5mg / bottle; 10mg / bottle injection.

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Abstract

The invention discloses a dissoluble preparation of bone morphogenetic protein-7, which contains bone morphogenetic protein-7, L-arginine or / and urea, protein stabilizer and water for injection, and has the advantages that the solubility is high, and deposition does not occur in the serum, and the consistence can reach 0.2-1.0 mg / ml. The dissoluble preparation of bone morphogenetic protein-7 of the invention can be used for curing clinical kidney disease and vascular calcification, and for curing resumption of cerebral apoplexy, and liver and lung fibrosis as well.

Description

technical field [0001] The invention relates to a soluble preparation of bone morphogenetic protein-7 (OP-1 / BMP-7) and its application, in particular to a soluble preparation of recombinant human bone morphogenetic protein-7 (rhOP-1 / rhBMP-7) And its application as a drug for the treatment of kidney disease and vascular calcification, as well as cerebral apoplexy, liver and pulmonary fibrosis. It belongs to the field of biotechnology and pharmaceuticals. Background technique [0002] Bone morphogenetic protein BMP-7 (BMP-7), also known as osteogenic protein-1 (osteogenic protein, OP-1), is a member of the BMPs family and belongs to transforming growth factor-β (TGF - A member of the β) superfamily with potent osteoinductive activity. There are a lot of studies on its osteogenic effect, and BMP-7 has been used clinically in the treatment of bone defects and spinal fusion. [0003] At the same time, BMP-7 is also an important inducer of kidney development, and it is expresse...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K9/08A61K9/19A61K47/42A61K47/10A61P19/10A61P13/12A61P9/14A61P9/10A61P1/16A61P11/00A61K31/198A61K31/17A61K47/18
Inventor 韩金祥王世立迟名峰张翠王素红葛鲁娜
Owner SHANDONG MEDICAL BIO TECH RES CENT
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