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Application of trehalose in preparation of recombinant human erythropoietin liquid preparation, the recombinant human erythropoietin liquid preparation, preparation method and application

A technology of liquid preparations and erythropoietin, which is applied in the direction of blood diseases, drug combinations, and pharmaceutical formulas, can solve the problems of many excipients, complex production processes, poor safety and reliability, etc., and achieve easy acquisition, simple process, easy storage and transport effect

Inactive Publication Date: 2020-08-21
SHANDONG EHUA BIOLOGICAL PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to overcome the defects or deficiencies of the recombinant human erythropoietin preparations that do not contain human serum albumin in the prior art, such as poor safety and reliability, many auxiliary materials, and complicated production processes, and provide trehalose as the preparation of recombinant human erythropoietin. Application of protective agent in preparation of liquid preparation of recombinant human erythropoietin

Method used

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  • Application of trehalose in preparation of recombinant human erythropoietin liquid preparation, the recombinant human erythropoietin liquid preparation, preparation method and application
  • Application of trehalose in preparation of recombinant human erythropoietin liquid preparation, the recombinant human erythropoietin liquid preparation, preparation method and application
  • Application of trehalose in preparation of recombinant human erythropoietin liquid preparation, the recombinant human erythropoietin liquid preparation, preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The present embodiment provides a kind of recombinant human erythropoietin injection, and its preparation process is as follows, and specifically prepares 5000 recombinant human erythropoietin injections of 2000IU / 1ml / bottle.

[0044] 1. Formula composition:

[0045]

[0046] 2. Preparation:

[0047] Weigh 150g trehalose, 23.4g sodium chloride, 11.3g sodium dihydrogen phosphate dihydrate and 2.4g disodium hydrogen phosphate according to the formula, dissolve with a certain amount of water for injection, measure and slowly add recombinant human erythropoietin stock solution, Then add water for injection to make the volume to 5000mL, and mix well to form a semi-finished solution; the prepared semi-finished solution is sterilized and filtered into a sterile container with a sterilized 0.22μm microporous filter membrane, and samples are taken to detect endotoxin and bacteria.

[0048] 3. Packing:

[0049] After the endotoxin test is qualified, subpackage is carried ou...

Embodiment 2

[0051] The present embodiment provides a recombinant human erythropoietin injection, the preparation process of which is as follows, specifically preparing 5000 recombinant human erythropoietin injections of 5000IU / 1mL / bottle.

[0052] 1. Formula composition:

[0053]

[0054] 2. Preparation:

[0055]Weigh 150g trehalose, 23.4g sodium chloride, 11.3g sodium dihydrogen phosphate dihydrate and 2.4g disodium hydrogen phosphate according to the formula, dissolve with a certain amount of water for injection, measure and slowly add recombinant human erythropoietin stock solution, Then add water for injection to make the volume to 5000mL, and mix well to form a semi-finished solution; the prepared semi-finished solution is sterilized and filtered into a sterile container with a sterilized 0.22μm microporous filter membrane, and samples are taken to detect endotoxin and bacteria.

[0056] 3. Packing:

[0057] After the endotoxin test is qualified, subpackage is carried out, and ...

Embodiment 3

[0059] This embodiment provides a recombinant human erythropoietin injection. During the preparation process, except for the amount of trehalose selected in the formulation, the rest are the same as in Example 1. Specifically, the concentration of trehalose in the recombinant human erythropoietin injection in this example is 1% g / mL, and the dosage thereof is 50 g.

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Abstract

The invention relates to application of trehalose in preparation of a recombinant human erythropoietin liquid preparation, the recombinant human erythropoietin liquid preparation, a preparation methodand application. The recombinant human erythropoietin liquid preparation comprises recombinant human erythropoietin, trehalose, an osmotic pressure regulator, a pH buffer system and water. The trehalose has no potential viral pollution, can protect the activity and stability of the recombinant human erythropoietin drug, and also can prevent the glass container from adsorbing the drug protein to the bottle wall to influence the stability of the content of the drug protein, so that the pharmaceutical preparation is easier to store and transport. A stability experiment proves that the pharmaceutical preparation can well maintain the activity and stability of protein at normal temperature; as no human serum albumin is used, the possibility of virus blood-borne pollution is eliminated; trehalose is easy to obtain, so that the production cost of the recombinant human erythropoietin finished product is reduced.

Description

technical field [0001] The invention belongs to the field of biopharmaceutical engineering, and specifically relates to the application of trehalose in the preparation of recombinant human erythropoietin liquid preparation, the recombinant human erythropoietin liquid preparation, the preparation method and the application. Background technique [0002] Human erythropoietin (EPO) is a glycoprotein and a human hormone secreted by the kidneys. Its physiological function is mainly to stimulate the production of hemoglobin and red blood cells in the human bone marrow. Recombinant human erythropoietin (rhEPO) is a medicinal protein produced by genetic engineering. It has the same physiological functions in vivo and in vitro as natural human erythropoietin. It is mainly used clinically for anemia caused by renal insufficiency patients, including dialysis and Treatment of non-dialysis patients; treatment of red blood cell mobilization in the perioperative period of surgery; treatmen...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/26A61K38/18A61K9/08A61P7/06
CPCA61K47/26A61K38/1816A61K9/08A61P7/06
Inventor 庞甲佩解福生郝向慧马晓英姜栋徐兴贵秦绪才吴化斌
Owner SHANDONG EHUA BIOLOGICAL PHARMA