Recombinant erythropoietin liquor preparation

A technology of recombinant human erythropoietin and solution, which can be used in extracellular fluid diseases, medical preparations containing active ingredients, blood diseases, etc. Purity and stability, high activity effect

Active Publication Date: 2007-08-15
华北制药金坦生物技术股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Since blood-derived albumin raw materials are derived from human blood, although the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), the International Conference on Harmonization of Technical Requirements for Drug Registration for Human Use (ICH) and China’s State Food and Drug Administration ( SFDA) have strict regulations on blood products and their production raw materials and processes, but as blood products, there are inevitably potential virus contamination problems (such as hepatitis virus, AIDS virus, etc.)
In addition, there is also the problem of periodic shortage of blood albumin

Method used

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  • Recombinant erythropoietin liquor preparation
  • Recombinant erythropoietin liquor preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: the preparation of 3000IU / ml rhEPO containing rHSA

[0021] formula:

[0022] Component Concentration Dosage

[0023] rhEP0 3000IU / ml 165ml

[0024] rHSA 2.5mg / ml 137.5ml

[0025] Sodium citrate, chloride Sodium citrate 20mmol / L, sodium chloride

[0026] 10697.5ml

[0027] Sodium buffer 100mmol / L (adjust pH to 6.9)

[0028]

[0029] 10000 sticks

[0030] Take rhEPO stock solution (2.0×10 5 IU / ml) 165ml, add rHSA (200mg / ml) 137.5ml, add sodium citrate, sodium chloride buffer 10697.5ml. After fully mixing, aseptically filter into a sterilized container, which is the semi-finished product of rhEPO.

[0031] Then fill the semi-finished solution into 3ml vials, and add 1.1ml to each bottle. Finally, stoppering, capping, and labeling were performed to make 3000 IU / branch of rhEPO injection.

Embodiment 2

[0032] Embodiment 2: the preparation of 1500IU / ml rhEPO containing rHSA

[0033] formula:

[0034] Ingredients Content Dosage

[0035] rhEPO 1500IU / ml 82.5ml

[0036] rHSA 2.5mg / ml 137.5ml

[0037] Sodium citrate, chloride Sodium citrate 20mmol / L, sodium chloride

[0038] 10780ml

[0039] Sodium buffer 100mmol / L (adjust pH to 6.9)

[0040]

[0041] 10000 sticks

[0042] Preparation method is the same as embodiment 1

Embodiment 3

[0043] Embodiment 3: the preparation of 6000IU / ml rhEPO containing rHSA

[0044] formula:

[0045] Ingredients Content Dosage

[0046] rhEPO 6000IU / ml 330ml

[0047] rHSA 4.0mg / ml 220ml

[0048] Sodium citrate, chloride Sodium citrate 20mmol / L, sodium chloride

[0049] 10450ml

[0050] Sodium buffer 100mmol / L (adjust pH to 6.9)

[0051]

[0052] 10000 sticks

[0053] Preparation method is the same as embodiment 1

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Abstract

This invention relates to a solution preparation of recombinant human erythropoietin. The preparation is prepared from recombinant human erythropoietin, recombinant human serum albumin, sodium citrate, and sodium chloride buffer. It can be used for treating renal anemia, preoperative surgical red blood cell mobilization, and anemia due to chemotherapy of tumor.

Description

technical field [0001] The invention relates to erythropoietin (EPO), in particular to a solution preparation of recombinant human erythropoietin (rhEPO). Background technique [0002] Erythropoietin is a polypeptide hormone that regulates red blood cell production, 90% of which is produced by the kidneys. Recombinant human erythropoietin has the same structure and physiological function as natural erythropoietin, 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] Human albumin is a blood product, which is extracted from the plasma of healthy people by low-temperature protein separation and other methods, and the preparation is made after inactivating the virus. Human albumin is often used as a drug because of its own characteristics, such as rigid frame structure, good stability, good biocompatibility, strong binding ability, and ability to release other ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/18A61K9/08A61P7/06
Inventor 魏敬双李梅彦贾茜姜扬贺建功任乐民程立均周兴军
Owner 华北制药金坦生物技术股份有限公司
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