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Stable erythropoietin of recombined human red blood cell

A technology of human erythrocytes and propoietin, applied in the direction of extracellular fluid diseases, medical preparations containing active ingredients, drug combinations, etc., can solve the problems of stability impact, inconvenience, increased cost, etc., and achieve simple preparation methods and production Low cost, good application effect

Inactive Publication Date: 2006-03-29
SHENYANG SUNSHINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the patent US 4,992,419 research shows that long-term stabilization cannot be achieved with such reagents, that is, the effectiveness of rHuEPO is greatly reduced in mouse experiments, and immunogenic reactions can be caused when these reagents are injected; in addition, from patent US 4,992,419 and patent US 5,376,632 Some stabilizers suitable for lyophilized rHuEPO formulations, including urea, various amino acids and cyclodextrins, are known in
However, the use of lyophilized dosage forms is inconvenient for injection preparations, which increases the steps of dissolving and the chance of operation and contamination of impurities
In addition, due to the increase of the freeze-drying process in the production process, it not only increases the cost, but also makes it difficult to control the quality, which affects the stability between different batches

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] To prepare 1000 vials of 200 units of rHuEPO:

[0024] Ingredients Content

[0025] Citrate buffer 20mM

[0026] 20% Mannitol 4%

[0027] Sodium chloride 0.585%

[0028] Recombinant Human Erythropoietin 200 IU

[0029] The balance is water.

[0030] Measure 700 ml of ultrapure water, then accurately weigh 5.80 g of trisodium citrate dihydrate, 0.062 g of citric acid monohydrate, and 5.85 g of sodium chloride, dissolve them in 700 ml of ultrapure water, and make A solution, keep the temperature of the solution at 20-25°C, and measure the pH value of the solution between 6.9-7.0.

[0031] Accurately measure 200 ml of 20% mannitol and dissolve it in liquid A, mix thoroughly, and keep the solution temperature at 20-25°C. Add 2×10 to the mixed solution 5 Unit of rHuEPO protein, dilute to 1000 ml with ultrapure water. A finished formulation of rHuEPO is formulated.

[0032] The finished formulation is sterile filtered into sterile containers. Then sub-package, add 1...

Embodiment 2

[0034] To prepare 1000 vials of 1000 units of rHuEPO:

[0035] Ingredients Content

[0036] Phosphate buffer 10mM

[0037] 20% Mannitol 2%

[0038] Sodium chloride 0.584%

[0039] Recombinant Human Erythropoietin 1000 IU

[0040] The balance is water.

[0041] Measure 700 ml of ultrapure water, accurately weigh 2.51 grams of disodium hydrogen phosphate, 0.47 grams of sodium dihydrogen phosphate, and 5.84 grams of sodium chloride, dissolve them in 700 ml of ultrapure water, and make A solution after fully dissolving. The temperature of the solution is 20-25°C, and the measured pH value of the solution is between 6.9-7.0.

[0042] Accurately measure 100 ml of 20% mannitol and dissolve it in liquid A, mix well, and keep the solution temperature at 20-25°C. Add 1×10 to the mixed solution 6 Unit of rHuEPO protein, dilute to 1000 ml with ultrapure water. A finished formulation of rHuEPO is formulated.

[0043] The finished formulation is sterile filtered into sterile contai...

Embodiment 3

[0045] To prepare 1000 vials of 4000 units of rHuEPO:

[0046] Ingredients Content

[0047] Glycine buffer 50mM

[0048] 20% Mannitol 8%

[0049] Sodium chloride 0.9%

[0050] Disodium edetate 0.01%

[0051] Recombinant Human Erythropoietin 4000 IU

[0052] The balance is water.

[0053] Measure 500ml of ultrapure water, accurately weigh 3.75g of glycine and 9.0g of sodium chloride, dissolve them in 500ml of ultrapure water, and make A solution after fully dissolving, keep the solution temperature at 20-25°C, measure the solution The pH value is between 6.9 and 7.0.

[0054]Weigh 0.10 g of disodium ethylenediamine tetraacetate, add it to liquid A, mix and dissolve thoroughly, keep the temperature of the solution at 20-25°C, and this is liquid B.

[0055] Accurately measure 400 ml of 20% mannitol and dissolve it in solution B, mix well, and keep the solution temperature at 20-25°C. Add 4×10 to the mixed solution 6 Unit of rHuEPO protein, dilute to 1000 ml with ultrapur...

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PUM

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Abstract

A stable recombinant human guanophore poietin (rHuEPO) in the form of injection for treating renal anemia and the anemia caused by surgical operation and chemicotherapy contains rHuEPO, mannitol as protein protector, sodium chloride as the isotonic agent of buffer liquid and water. Its advantages are high safety and no by-effect.

Description

technical field [0001] The invention relates to a genetic engineering recombinant protein (recombinant human erythropoietin rHuEPO) preparation without human serum albumin and a preparation method thereof. Background technique [0002] Erythropoietin (EPO) is a glycoprotein with a molecular weight of about 30-39KD. According to the difference of its glycoform structure, it can be divided into α and β. Its physiological role is to stimulate the formation of hemoglobin or red blood cells in the bone marrow, which is mainly produced by the kidneys and enters the bone marrow through circulating blood to function. Recombinant human erythropoietin rHuEPO has the same structure and physiological function as natural erythropoietin EPO, and has been widely used clinically in renal anemia, red blood cell mobilization in the perioperative period of surgery, and anemia caused by tumor chemotherapy. [0003] The working concentration of EPO in the body is very low, and the human body i...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K38/18A61P7/06
Inventor 侯绪凤苏冬梅
Owner SHENYANG SUNSHINE PHARMA
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