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Application of recombined human vascellum esoderma inhibin in medicine preparation

A technology of vascular endothelium and inhibin, applied in drug combination, antineoplastic drugs, pharmaceutical formulations, etc., can solve the problems of easy injury and adjacent tissues, unstable curative effect, high risk, etc.

Inactive Publication Date: 2008-07-16
SHANDONG SIMCERE BIO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0010] At present, the methods used to prevent and treat angiogenic fundus diseases mainly include drugs, laser therapy, isotope therapy, surgery, etc., but these methods have their own shortcomings, such as easy damage to adjacent tissues, unstable curative effect, and high risk. Therefore, it is the focus of domestic and foreign researchers to find a treatment method with good specificity, significant curative effect and small side effects.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] An injection containing recombinant human endostatin was prepared so that each milliliter contained 2 mg of endostatin and 8 mg of mannitol, and a concentration of 10 mM sodium acetate was added to adjust the pH value to 6.5. Sterilized by filtration, filled aseptically, 3ml each.

[0055] Usage and dosage: Inject this drug into normal saline or glucose injection, and inject into the vitreous body. The dosage can be increased or decreased according to the condition, once every 4 weeks.

Embodiment 2

[0057] Use 30mM acetic acid-sodium acetate buffer system with pH5.5±0.5 to ultrafiltration dialysis the purified recombinant human endostatin protein solution to prepare 151.5ml recombinant human endostatin solution with a concentration of 9.9mg / ml, add 20 60ml of % mannitol and 7.5ml of 20% sucrose solution, 2.98ml of 1.5M acetic acid-sodium acetate buffer solution with a pH of about 5.5 was added, and water for injection was added to 300ml. Sterilize and filter through a 0.22 μm microporous membrane, dispense into prefilled syringes, and store at 4°C.

Embodiment 3

[0059] Use 30mM acetic acid-sodium acetate buffer system with pH5.5±0.5 to perform ultrafiltration and dialysis on the purified recombinant human endostatin protein solution to prepare 90.9ml recombinant human endostatin solution with a concentration of 9.9mg / ml, add 20 % Mannitol 60ml, add 4.20ml of 1.5M acetic acid-sodium acetate buffer solution with a pH of about 5.5, add water for injection to 300ml. Sterilize and filter through a 0.22μm microporous membrane, pack in vials, add butyl rubber stoppers, place the liquid in a freeze-drying box, drop the temperature of the product to -40°C, keep it for 3-4 hours, and then vacuumize it. Heating the partition to raise the temperature of the product to -20°C, keep it for 8 hours, continue heating to raise the temperature to 25°C, keep it for 6 hours, until the vacuum degree changes little, take it out after vacuum plugging, and cap it.

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PUM

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Abstract

The invention relates to the application of a recombinant human blood vessel endothelium inhibin in pharmacy, in particular to the application in preparing medicines for treating angiogenesis ocular fundus diseases. The invention adopts intravitreal injection of the recombinant human blood vessel endothelium inhibin to treat angiogenesis ocular fundus diseases, which effectively inhibits neovascular proliferation in ocular fundus diseased region, thus improving symptoms. The invention has the advantages of strong specificity, high efficiency and no significant side effect.

Description

technical field [0001] The invention relates to the technical field of biological products, in particular to the pharmaceutical application of recombinant human vascular endostatin, which can be used for the treatment of angiogenesis eye fundus disease. Background technique [0002] Fundus disease is a complex eye disease with a high rate of blindness. Most of the current epidemiological survey results show that the proportion of low vision and blindness caused by fundus disease in China is on the rise. The eyeball is a spherical object, and the vitreous body, retina, choroid and other parts at the back are the fundus. There are blood vessels, optic nerves, and macula in the fundus. Including age-related macular degeneration, diabetic retinopathy, retinochoroiditis, proliferative vitreoretinopathy, retinal detachment, retinoblastoma, ischemic optic disc disease, etc. Some of them are related to angiogenesis, such as age-related macular degeneration, central exudative retinc...

Claims

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Application Information

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IPC IPC(8): A61K38/17A61K47/42A61K47/48A61K47/10A61K47/18A61K47/26A61K9/10A61K9/19C07K14/475A61P35/00A61P27/02A61K47/60
Inventor 刘武罗兴洪姜静宋迪
Owner SHANDONG SIMCERE BIO PHARMA CO LTD
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