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PEGylated recombinant human granulocyte colony stimulating factor freeze-dried preparation

A technology of colony stimulating factor and PEGylation, applied in the field of biomedicine, can solve the problems of challenging and difficult product quality, uncontrollable particle size, lack of liquid formation process, etc., and achieves short reconstitution time and short production cycle. , the effect of high drug safety

Active Publication Date: 2021-12-17
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, the traditional freeze-drying technology, due to the lack of liquid formation process, cannot control the size of the particles, and the energy consumption is high, the drying time is long, the challenge and difficulty brought about by the stability of product quality are relatively large, and the cost input is high.

Method used

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  • PEGylated recombinant human granulocyte colony stimulating factor freeze-dried preparation
  • PEGylated recombinant human granulocyte colony stimulating factor freeze-dried preparation
  • PEGylated recombinant human granulocyte colony stimulating factor freeze-dried preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] prescription:

[0031] Name Dosage / g

[0032] PEG-rhG-CSF 1

[0033] Sorbitol 3

[0034] Preparation:

[0035] 1) Spray freezing: Dissolve sorbitol and PEG-rhG-CSF in 100ml of water for injection, filter through a 0.22 μm filter membrane, add to a spray bottle, feed flow rate 25mL / min, and conduct spray freezing at -30°C to form Small ice crystals.

[0036] 2) Drying: The pressure in the drying chamber is adjusted to about 20 Pa, the temperature in the drying chamber is -40°C, and the small ice crystals obtained by spray freezing are dried for 8 hours to obtain the finished powder, which is then packaged.

Embodiment 2

[0038] prescription:

[0039] Name Dosage / g

[0040] PEG-rhG-CSF 1

[0041] Sorbitol 2

[0042] Preparation:

[0043] 1) Spray freezing: Dissolve sorbitol and PEG-rhG-CSF in 100ml of water for injection, filter through a 0.22 μm filter membrane, add to a spray bottle, feed at a flow rate of 25mL / min, and conduct spray freezing at -25°C. Small ice crystals are formed.

[0044] 2) Drying: The pressure in the drying chamber is adjusted to about 20 Pa, the temperature in the drying chamber is -30°C, and the small ice crystals obtained by spray freezing are dried for 8 hours to obtain the finished powder, which is then packaged.

Embodiment 3

[0046] prescription:

[0047] Name Dosage / g

[0048] PEG-rhG-CSF 1

[0049] Sorbitol 15

[0050] Preparation:

[0051] 1) Spray freezing: Dissolve sorbitol and PEG-rhG-CSF in 120ml of water for injection, filter through a 0.22 μm filter membrane, add to a spray bottle, feed at a flow rate of 15mL / min, and conduct spray freezing at -35°C. Small ice crystals are formed.

[0052] 2) Drying: The pressure in the drying chamber is adjusted to about 30 Pa, the temperature in the drying chamber is -30° C., and the small ice crystals obtained by spray freezing are dried for 8 hours to obtain the finished powder, which is then packaged.

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PUM

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Abstract

The invention provides a PEGylated recombinant human granulocyte colony stimulating factor (PEG-rhG-CSF) freeze-dried preparation. The PEG-rhG-CSF and an excipient are subjected to spray freeze-drying treatment, when the prepared PEG-rhG-CSF freeze-dried preparation is clinically used, a special solvent containing sodium chloride and acetate is prepared, and the freeze-dried preparation can be used after being mixed and dissolved with the special solvent. The PEG-rhG-CSF freeze-dried preparation prepared by the invention does not contain a surfactant namely Tween 20, is high in medication safety and good in stability, can be stored for a long time, and is simple in preparation process and short in production period.

Description

technical field [0001] The invention belongs to the technical field of biomedicine, and in particular relates to a freeze-dried preparation of pegylated recombinant human granulocyte colony-stimulating factor and a preparation method thereof. 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 oxygen, bactericidal ability and adhesion to foreign bodies. It also mobilizes mature neutrophils from the bone marrow ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/19A61K47/26A61K47/60A61P7/00
CPCA61K38/193A61K9/19A61K47/60A61K47/26A61P7/00
Inventor 郝贵周王苗苗
Owner SHANDONG NEWTIME PHARMA
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