Freeze-dried powder injection with recombinant human tumor necrosis factor receptor (TNFR)-Fc fusion protein

A tumor necrosis factor, freeze-dried powder injection technology, applied in the field of medicine, can solve the problems of poor reconstitution effect and unstable quality, and achieve the effects of rapid reconstitution, good drying effect and full appearance

Active Publication Date: 2011-05-25
SHANDONG NEWTIME PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Its main advantage is strong specificity, but its disadvantages are also obvious, such as unstable quality, poor reconstitution effect, etc.

Method used

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  • Freeze-dried powder injection with recombinant human tumor necrosis factor receptor (TNFR)-Fc fusion protein
  • Freeze-dried powder injection with recombinant human tumor necrosis factor receptor (TNFR)-Fc fusion protein
  • Freeze-dried powder injection with recombinant human tumor necrosis factor receptor (TNFR)-Fc fusion protein

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] TNFR-Fc 12.50g

[0019] Sucrose 1.00g

[0020] Dextran 3.50g

[0021] Tromethamine 0.14g

[0022] Water for injection, dilute to 1000ml

[0023] Accurately weigh according to the prescription, add water for injection and mix thoroughly, then adjust the pH to 7.30 with hydrochloric acid. The liquid medicine was sterilized and filtered through a 0.22 μm filter disc made of polyvinylidene fluoride under pressure. The rhTNFR-Fc semi-finished product was obtained.

[0024] The semi-finished product is divided into vials (1ml / bottle), put into the freeze dryer, and the freeze dryer is turned on. The process is as follows:

[0025] 1) Pre-freezing stage: the pre-freezing temperature is -38°C, keep the pre-freezing temperature for 3 hours;

[0026] 2) Sublimation drying stage: vacuum degree 3bar, temperature -32°C, keep for 12 hours;

[0027] 3) Analytical drying stage: Vacuum degree 3 bar, respectively at -20 ℃, -10 ℃, -5 ℃, 10 ℃, 20 ℃, 30 ℃ constant temperature drying ...

Embodiment 2

[0029] TNFR-Fc 12.50g

[0030] Sucrose 1.20g

[0031] Polyvinyl pyrrolidone 2.80g

[0032] Sodium acetate 0.10g

[0033] Water for injection, dilute to 1000ml

[0034] Accurately weigh according to the prescription, add water for injection and mix thoroughly, then adjust the pH to 7.44 with hydrochloric acid. The liquid medicine was sterilized and filtered through a 0.22 μm filter disc made of polytetrafluoroethylene under pressure. The rhTNFR-Fc semi-finished product was obtained.

[0035] Divide the semi-finished product into glass vials (1ml / bottle), put it into the freeze dryer, and turn on the freeze dryer. The process is as follows:

[0036] 1) Pre-freezing stage: the pre-freezing temperature is -45°C, keep the pre-freezing temperature for 2 hours;

[0037] 2) Sublimation drying stage: vacuum degree 3bar, temperature -35°C, keep for 9 hours;

[0038] 3) Analytical drying stage: vacuum degree 2bar, constant temperature drying at -20°C, -10°C, -5°C, 10°C, 20°C, 30°C...

Embodiment 3

[0040] TNFR-Fc 12.50g

[0041] Polyvinyl pyrrolidone 1.50g

[0042] Dextran 3.00g

[0043] Tromethamine 0.12g

[0044] Water for injection, dilute to 1000ml

[0045] Accurately weigh according to the prescription, add water for injection and mix thoroughly, then adjust the pH to 7.62 with hydrochloric acid. The liquid medicine was sterilized and filtered through a 0.22 μm filter disc made of polyvinylidene fluoride under pressure. The rhTNFR-Fc semi-finished product was obtained.

[0046] The semi-finished product is divided into vials (1ml / bottle), put into the freeze dryer, and the freeze dryer is turned on. The process is as follows:

[0047] 1) Pre-freezing stage: the pre-freezing temperature is -42°C, and the pre-freezing temperature is maintained for 3 hours;

[0048]2) Sublimation drying stage: vacuum degree 3bar, temperature -29°C, keep for 12 hours;

[0049] 3) Analytical drying stage: Vacuum degree of 1 bar, drying at -20°C, -15°C, -5°C, 5°C, 20°C, and 30°C fo...

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Abstract

The invention belongs to the technical field of medicines and in particular relates to a freeze-dried powder injection with recombinant human tumor necrosis factor receptor (TNFR)-Fc fusion protein and a preparation process thereof. The powder injection is prepared by adding the human TNFR-Fc fusion protein to pharmacologically allowable protective agents and buffers and adopting the optimized freeze-drying method and has stable quality, wherein the protective agent is one or more of cane sugar, polyethylene glycol, polyvinylpyrrolidone, mannite, trehalose, lactose, dextran and glucose; and the buffer is one or more of tromethamine, sodium acetate, sodium citrate and sodium dihydrogen phosphate.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a recombinant human tumor necrosis factor receptor-Fc fusion protein freeze-dried powder injection and a preparation method thereof. Background technique [0002] Rheumatoid arthritis (Rheumatoid Arthritis, RA) is one of the most common autoimmune diseases in humans, with a prevalence of about 1%. It is obviously related to human leukocyte antigen DR4 / DR1, and has a certain genetic tendency. The clinical features of RA are mostly inflammation of the joint synovium of the hands, feet, wrists, knees, buttocks, etc., eventually leading to joint damage. Synovitis causes a large number of lymphocyte infiltration, mainly including macrophages, T lymphocytes and plasma cells, and angiogenesis. Joint damage occurs primarily where the synovium adjoins cartilage and bone. [0003] Tumor Necrosis Factor α (Tumor Necrosis Factor Alpha, TNFα) and Lymphotoxin (Lymphotoxin, LT) exert biologi...

Claims

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Application Information

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IPC IPC(8): A61K39/395A61K9/19A61P19/02A61P29/00
Inventor赵志全冯中石其德
OwnerSHANDONG NEWTIME PHARMA