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Recombinant human erythropoietin liquid preparation

An erythropoietin and liquid preparation technology, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, and drug combinations, etc. easy-to-get effect

Pending Publication Date: 2021-06-11
SHENZHEN SCIPROGEN BIO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, it is shown in CN1802171A that Eprex preparations are prone to denaturation and aggregation when stored at 40°C, and it has been reported that Eprex can stimulate the immune response or induce the formation of neutralizing antibodies, causing pure red blood cell aplasia (PRCA)

Method used

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  • Recombinant human erythropoietin liquid preparation
  • Recombinant human erythropoietin liquid preparation
  • Recombinant human erythropoietin liquid preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Prepare 1000 recombinant human erythropoietin injections of 10000IU / ml / bottle:

[0027]

[0028] Accurately weigh sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, and betaine respectively, add 700ml of water for injection, after fully mixing and dissolving, measure the mother liquor of polysorbate 80, mix and dissolve; The amount of recombinant erythropoietin stock solution was mixed evenly, and the volume was made up to 1000ml with ultrapure water and mixed evenly. The prepared solution was aseptically filtered into a sterilized container, and then distributed into glass tube injection bottles to make 1 ml / 10,000 units of recombinant human erythropoietin injection.

[0029] Control group 1: recombinant human erythropoietin injection without betaine, the difference from Example 1 is that it does not contain betaine.

[0030] Control group 2: recombinant human erythropoietin injection containing high concentration of betaine, the d...

Embodiment 2

[0037] Preparation of 1000 recombinant human erythropoietin injections of 8000IU / ml / support

[0038]

[0039] Accurately weigh sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate dihydrate, and betaine respectively, add 700ml of water for injection, after fully mixing and dissolving, measure the mother liquor of polysorbate 80, mix and dissolve; The amount of recombinant erythropoietin stock solution was mixed evenly, and the volume was made up to 1000ml with ultrapure water and mixed evenly. The prepared solution was aseptically filtered into a sterilized container, and then divided into glass tube injection bottles to make 1ml / 8000 units of recombinant human erythropoietin injection.

[0040] Control group 4: recombinant human erythropoietin injection containing polysorbate 20, the difference from Example 2 is that it does not contain polysorbate 80 and contains 0.20 mg / ml polysorbate 20.

[0041] Control group 5: recombinant human erythropoietin in...

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Abstract

The invention discloses a recombinant human erythropoietin liquid preparation, which does not contain human albumin and has long-term storage stability, the preparation comprises recombinant human erythropoietin, betaine, a pH buffer solution, a nonionic surfactant, an osmotic pressure regulator and water, and the preparation has good stability and biological activity; and the process is simple, the operability is high, auxiliary materials are relatively easily obtained, safe and stable, and the production cost is saved.

Description

technical field [0001] The invention relates to the field of biological pharmaceutical preparations, in particular to a liquid preparation of recombinant human erythropoietin without human serum albumin and having long-term storage stability. Background technique [0002] Erythropoietin (EPO) is a glycoprotein hormone that promotes erythropoiesis, which consists of 165 amino acids and has a molecular weight of about 34kD. Recombinant human erythropoietin (rhEPO) is generally expressed and produced by Chinese hamster ovary cells (CHO). It has the same structure and physiological functions as natural erythropoietin. It is a recombinant protein drug and is often used in the treatment of kidney disease patients. [0003] The most common physical instability of proteins is protein aggregation, and many factors may induce or affect protein aggregation. Protein aggregates may be inactive or have reduced activity, reduced solubility and altered immunogenicity. The most common meth...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K47/18A61K38/18A61P13/12
CPCA61K9/08A61K9/0019A61K47/186A61K38/1816A61P13/12
Inventor 程楚鸿吴园园黄俊龙杨艳群王梦格王康曲啸
Owner SHENZHEN SCIPROGEN BIO PHARMA
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