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Stable preparation formula of erythopoietin

A technology of erythropoietin and stabilizer, which is applied in the fields of pharmaceutical formulations, extracellular fluid diseases, medical preparations containing active ingredients, etc.

Inactive Publication Date: 2018-01-19
刘冬连 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But erythropoietin so far, there is no dosage form on the market for subcutaneous or intramuscular injection. The purpose of this invention is to solve the new dosage form of EPO for subcutaneous injection or intramuscular injection, which is convenient for medical staff and patients to use

Method used

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  • Stable preparation formula of erythopoietin
  • Stable preparation formula of erythopoietin
  • Stable preparation formula of erythopoietin

Examples

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Effect test

example 1

[0039] A stable erythropoietin formulation consists of the following components: 500ug / mL EPO, 10mM citrate buffer, pH7.0, 2.5mg / mL human albumin, 150IU / mL hyaluronidase, 0.01% polysorbate Ester 20.

[0040]

Embodiment 2

[0042] A stable erythropoietin formulation consists of the following components: 1.5mg / mL LEPO, 10mM citrate buffer, pH 7.0, 100mM trehalose dihydrate, 500IU / mL hyaluronidase, 0.04% polysorbate 20.

[0043]

Embodiment 3

[0045] A stable erythropoietin formulation consists of the following components: 5 mg / mL EPO, 10 mM phosphate buffer, pH 6.8, 150 mM trehalose dihydrate, 1000 IU / mL hyaluronidase, 0.04% polysorbate 20 .

[0046]

[0047]

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Abstract

The invention provides a stable preparation formula of erythopoietin (EPO). The stable preparation formula comprises erythopoietin, hyaluronidase, a buffering agent, a stabilizing agent and a nonionicsurfactant. The stable preparation formula of the EPO is used for subcutaneous or intramuscular injection, and the dosage form is an injection or freeze-dried powder injection. The EPO can be used for treating the diseases such as anemia caused by kidney failure, anemia caused by radiotherapy and chemotherapy of patients with cancer, autologous transfusion before operation, neonatal anemia and the like, and also can be used for cosmetics and the like.

Description

technical field [0001] The invention relates to the field of biopharmaceuticals, in particular to a formulation of erythropoietin (EPO), which can replace the traditional intravenous administration route and administer to patients by subcutaneous or intramuscular injection. Background technique [0002] Erythropoietin (Erythopoietin, EPO) has been on the market since June 1989, and its therapeutic indications have been increasing. In most cases, EPO is injected intravenously (IV), but for uremia caused by renal failure For patients, they need to work while receiving treatment, and intravenous injection needs to be completed under the guidance of medical staff, which takes a long time. By changing the route of administration, such as subcutaneous injection or intramuscular injection, it can greatly facilitate the use of patients or medical staff, and shorten the administration time, especially for patients who need to maintain doses for dialysis, training them to use them wil...

Claims

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Application Information

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IPC IPC(8): A61K38/18A61K47/42A61P7/06A61P17/00
Inventor 刘冬连刘诗雨
Owner 刘冬连
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