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Pegylated recombinant human granulocyte colony stimulating factor freeze-dried powder/injection and preparation method thereof

A technology of colony-stimulating factor and PEGylation, which is applied in the field of biomedicine, can solve the problems of molecular structure changes, increase the risk of drug use, and recombined human granulocytes without PEGylation, and achieve the effect of preventing degeneration

Active Publication Date: 2011-04-27
LUNAN PHARMA GROUP CORPORATION
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, the Amgen company in the United States has an injection on the market under the trade name Neulasta, which contains pegylated recombinant human granulocyte colony-stimulating factor, sorbitol, Tween 20, acetic acid, and sodium acetate, of which sorbitol is used to regulate osmotic pressure, and acetic acid Buffer salt can maintain the pH at about 4.0, and Tween 20 can prevent the aggregation of the main drug and make the injection stable. However, Tween 20 has a strong hemolytic effect, which will increase the risk of medication
In addition, the currently marketed recombinant human granulocyte colony-stimulating factor lyophilized powder injection (trade name Granosate) contains 0.1 mg of polyoxyethylene sorbitan monododecanoate, 10 mg of L-arginine, and 1 mg of L-arginine. -Phenylalanine 10mg, L-methionine 10mg, D-mannitol 25mg, pH value is 6.0-7.5, but the molecular structure of recombinant human granulocyte colony-stimulating factor changes after PEGylation, in order to protect it during the freeze-drying process Invariant inactivation, need to explore new freeze-drying protective agent and freeze-drying method
At present, there is no report on the lyophilized powder preparation of recombinant human granulocyte colony-stimulating factor pegylated

Method used

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  • Pegylated recombinant human granulocyte colony stimulating factor freeze-dried powder/injection and preparation method thereof
  • Pegylated recombinant human granulocyte colony stimulating factor freeze-dried powder/injection and preparation method thereof
  • Pegylated recombinant human granulocyte colony stimulating factor freeze-dried powder/injection and preparation method thereof

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Experimental program
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Effect test

Embodiment 1

[0024] 1) Preparation of diluent: all the utensils used have been treated without pyrogens, and the whole process is aseptically operated. Weigh 15g of mannitol, 20g of glycine, 0.492g of glacial acetic acid, and 0.148g of sodium acetate. When the pH of the liquid reaches 4.0, it is sterilized and filtered with a 0.22 μm filter membrane, and the endotoxin content of the diluted liquid measured by the Limulus reagent method should be less than 0.25 EU / mL;

[0025] 2) Preparation of semi-finished products: Take the stock solution of PEGylated recombinant human granulocyte colony-stimulating factor that meets the quality standards, filter it with a 0.22 μm filter membrane to sterilize and filter, measure the protein concentration, and dilute it to PEGylated recombinant human with freshly prepared diluent. The concentration of granulocyte colony-stimulating factor is 1.0mg / mL, and the semi-finished product is obtained;

[0026] 3) Filling and freeze-drying: Fill the semi-finished ...

Embodiment 2

[0032] 1) Preparation of diluent: all the utensils used have been treated without pyrogens, and the whole process is aseptically operated. Weigh 13g of mannitol, 17g of glycine, 0.356g of glacial acetic acid, and 0.162g of sodium acetate. When the pH of the solution reaches 6.3, the 0.22μm filter membrane is sterilized and filtered, and the endotoxin content of the diluted solution measured by the Limulus reagent method should be less than 0.25EU / mL;

[0033] 2) Preparation of semi-finished products: Take the stock solution of PEGylated recombinant human granulocyte colony-stimulating factor that meets the quality standards, filter it with a 0.22 μm filter membrane to sterilize and filter, measure the protein concentration, and dilute it to PEGylated recombinant human with freshly prepared diluent. The concentration of granulocyte colony-stimulating factor is 2.0mg / mL, and the semi-finished product is obtained;

[0034]3) Filling and freeze-drying: Fill the semi-finished produ...

Embodiment 3

[0039] 1) Preparation of diluent: all the utensils used have been treated without pyrogens, and the whole process is aseptically operated. Weigh 15g of glycine, 0.412 glacial acetic acid, and 0.153 sodium acetate, and use the level for injection to determine the volume to 1000mL. Adjust the pH of the diluent to 3.2. 0.22μm filter membrane to sterilize and filter, and the endotoxin content of the diluent measured by the Limulus reagent method should be less than 0.25EU / mL;

[0040] 2) Preparation of semi-finished products: Take the stock solution of PEGylated recombinant human granulocyte colony-stimulating factor that meets the quality standards, filter it with a 0.22 μm filter membrane to sterilize and filter, measure the protein concentration, and dilute it to PEGylated recombinant human with freshly prepared diluent. The concentration of granulocyte colony-stimulating factor is 3.0mg / mL, and the semi-finished product is obtained;

[0041] 3) Filling and freeze-drying: Fill ...

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Abstract

The invention belongs to the field of biomedicine, and particularly relates to pegylated recombinant human granulocyte colony stimulating factor freeze-dried powder / injection and a preparation method thereof. The freeze-dried powder / injection comprises pegylated recombinant human granulocyte colony stimulating factor serving as an active ingredient, freeze-drying protective agent, glacial acetic acid and sodium acetate. The preparation method comprises the following steps of: preparing diluent from auxiliary materials, then diluting the stock solution containing the active ingredient to the required concentration by using the diluent, filling the diluted solution into a clean amoxicillin bottle, sealing the bottle by using a rubber stopper, putting the bottle into a vacuum freeze dryer, and freeze-drying the solution in vacuum to obtain the freeze-dried powder / injection. The prepared pegylated recombinant human granulocyte colony stimulating factor freeze-dried powder / injection has long-term stability on appearance, purity and average potency.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and specifically relates to a freeze-dried powder injection of recombinant human granulocyte colony-stimulating factor pegylated, and also relates to a method for preparing the freeze-dried powder injection of recombinant human granulocyte colony-stimulating factor pegylated . Background technique [0002] Nonmyelogenous neutropenia after cancer chemotherapy is a common clinical complication of chemotherapy and one of the important causes of death in cancer patients. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) is an effective drug for the prevention and treatment of neutropenia caused by tumor chemotherapy and radiotherapy. It can promote the formation of granulocyte colonies and promote the proliferation and differentiation of hematopoietic stem cells into neutrophils. For mature neutrophils, it can promote migration, phagocytosis, enzyme production, release of active ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K38/19A61K47/12A61P7/00
Inventor 赵志全刘忠
Owner LUNAN PHARMA GROUP CORPORATION
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