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Pharmaceutical preparation containing recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein and preparation thereof

A pharmaceutical preparation and protein technology, applied in the field of pharmaceutical preparations containing recombinant human serum albumin-human granulocyte colony-stimulating factor fusion protein and its preparation, can solve the problems that have not yet been reported

Active Publication Date: 2012-09-19
JIANGSU T MAB BIOPHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, so far, there have been no research reports on this

Method used

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  • Pharmaceutical preparation containing recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein and preparation thereof
  • Pharmaceutical preparation containing recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein and preparation thereof
  • Pharmaceutical preparation containing recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein and preparation thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Example 1 The effect of pH value on the stability of rHSA / G-CSF formulation

[0046] rHSA / G-CSF refers to the description of Halpern W et al. (Pharm Res. 19: 1720-1729.2002), after the fusion of HSA and G-CSF gene, it was constructed in the expression plasmid pPIC9, and in Pichia pastoris GS115 (INVITROGEN company) expression obtained.

[0047] The present invention firstly studies the effect of pH on the stability of rHSA / G-CSF. In order to investigate the stability of the preparation under different pH conditions, the effects of different pH on the stability of the preparation were carried out according to the following conditions:

[0048] In test 1, the protein content of rHSA / G-CSF was 5.0 mg, and each group contained a certain concentration of acetate or phosphate buffer with different pH, pH 4.5 to pH 8.0, with an interval of 0.5, and a total of 8 points were set. Accelerated investigation at 37°C for four weeks, sampling analysis every two weeks, detection met...

Embodiment 2

[0052] Example 2 Influence test of excipients on stability

[0053] The present invention screened some excipients and protective agents suitable for human application, such as mannitol, trehalose, PEG4000, glycerin, glycine, arginine, phenylalanine, methionine and histidine, and studied their effect on rHSA / G-CSF stability.

[0054] The excipients were prepared into a high-concentration stock solution, mixed with a high-concentration stock solution of pH 6.5 phosphate buffer, and then added to a high-concentration rHSA / G-CSF protein solution containing a pH 6.5 phosphate buffer, followed by 1 mol / L HCl Or adjust the pH value with 1 mol / L NaOH to obtain a certain volume of sample solution containing 10 mmol / L pH6.5 phosphate buffer and a protein concentration of 5.0 mg / ml. The sample solution was filtered and sterilized and then packed in sterile vials with a volume of 1.0 ml, half stoppered, and freeze-dried. The lyophilized preparations were visually inspected and analyze...

Embodiment 3

[0062] Weigh an appropriate amount of arginine, mannitol, disodium hydrogen phosphate and sodium dihydrogen phosphate, add water for injection and stir to dissolve, and then add an appropriate amount of high-concentration rHSA / G-CSF protein solution to obtain 5.0 rHSA / G-CSF protein per ml. mg, mannitol 30mg, arginine 10mg, phosphate 10umol solution, adjust the pH value to 6.5±0.1 with 1mol / L hydrochloric acid and 1mol / L sodium hydroxide.

[0063] The prepared solution was filtered with 0.22um PVDF or PES hydrophilic membrane.

[0064] The solution after sterilization and filtration is subpackaged and put into the freeze-drying box under aseptic conditions. The temperature of the freeze-drying machine is pre-frozen to below -10°C, and the half-stoppered sample is quickly put into the freeze-drying box. The average temperature of the product was kept below -35°C for 2 hours, and the cooling of the condenser was started. After the temperature of the condenser drops to -45°C, the...

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Abstract

The invention discloses a pharmaceutical preparation containing recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein and preparation of the pharmaceutical preparation. According to the invention, the medical preparation containing the rHSA / G-CSF (recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein) is a freeze-drying preparation, and each freeze-drying preparation comprises the following components: 1-30mg of rHSA / G-CSF protein, 10-80mg of pharmaceutically acceptable water-soluble excipient, 5-30mg of pharmaceutically acceptable protective agent and 5-50 mu mol of pH regulator. The pharmaceutical preparation containing the rHSA / G-CSF protein is suitable for administration in the ways of subcutaneous injection or intravenous injection and the like after being dissolved in water for injection, and the pharmaceutical preparation can be injected for the right dosage for treatment of neutrophilic granulocytopenia.

Description

technical field [0001] The present invention relates to a pharmaceutical preparation containing recombinant human serum albumin-human granulocyte colony stimulating factor fusion protein (hereinafter referred to as rHSA / G-CSF) and its preparation. Background technique [0002] Human granulocyte colony stimulating factor (G-CSF), a long-chain polypeptide glycoprotein derived from monocytes and fibroblasts, can induce the proliferation and differentiation of hematopoietic stem cells, and promote the number of neutrophils in the blood Increase; also has the function of stimulating the release of mature neutrophils from the bone marrow and activating neutrophils. [0003] However, due to its small molecular weight, natural or recombinant G-CSF is easily filtered by the glomerulus, and its circulating half-life in the human body is very short, only 2-4 hours. Each chemotherapy cycle needs to be injected 1-2 times a day for continuous 5-7 days of injection (Welte K et al, Proc Na...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K38/38A61K38/19A61K47/16A61P7/00A61P7/06
Inventor 王叶飞范敏吴亦亮陆游李虎
Owner JIANGSU T MAB BIOPHARMA
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