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Recombinant human interferon beta-1b freeze-dried preparation and preparing method thereof

A technology for recombinant human interferon and freeze-dried preparations, which is applied in peptide preparation methods, freeze-dry delivery, chemical instruments and methods, etc., and can solve the risk of increasing solvent residues, increasing interferon binding capacity, and increasing the risk of adverse reactions, etc. problems, to achieve the effect of reducing the risk of adverse reactions, good stability and active characteristics, and product safety

Inactive Publication Date: 2015-03-18
TASLY BIOPHARMACEUTICALS CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] U.S. Patent No. 6,994,847 discloses a kind of IFN-β preparation, wherein besides containing human serum albumin, also contains mannitol as a stabilizer, can increase the binding force of interferon, but increased the additive composition of this preparation at the same time, increased Risk of Adverse Reactions
[0010] Chinese patent CN200580025725.5 discloses a liquid preparation of interferon, which can be stored for 12-24 months at 2-8°C, but the interferon activity will be partially lost
[0011] U.S. Patent US5702699 discloses a preparation and purification preparation method of IFN-β, but organic solvents such as 2-butanol and 2-methyl-2-butanol are used in the purification process, which increases the risk of solvent residue

Method used

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  • Recombinant human interferon beta-1b freeze-dried preparation and preparing method thereof
  • Recombinant human interferon beta-1b freeze-dried preparation and preparing method thereof
  • Recombinant human interferon beta-1b freeze-dried preparation and preparing method thereof

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Experimental program
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Effect test

Embodiment 1

[0055] Embodiment 1: preparation stock solution

[0056] SEC chromatographic desalting preparation stock solution

[0057] The Escherichia coli fermentation broth is collected and purified to obtain a recombinant human beta-1b interferon solution. The solution system at this time is 0.1% (w / v) SDS + 10-100mM phosphate buffer solution, pH 7.0-7.4, so it is necessary to replace the interferon buffer system with the original preparation solution system by buffer replacement, and at the same time Residues of related substances in the original system were reduced to below the level specified in the Pharmacopoeia. The medium was changed by SEC chromatographic desalting method. Sephadex G-25Superfine was selected for SEC chromatographic desalting, size: 5.0×40cm, flow rate: 10mL / min, and mobile phase was 2.5Mm NaOH with pH 11.5. The samples were collected from the peak 5mAu to the peak tail 5mAu protein from UV280. The collected samples were mixed evenly and sterilized by filtrat...

Embodiment 2

[0061] Embodiment 2: acridine orange-spectrophotometric detection of SDS residues

[0062] After mixing the SDS standard substance with acridine orange at different concentrations, extract it with toluene, then measure the absorbance value of the toluene extraction phase at 499nm of visible light to obtain a standard curve, and calculate its SDS concentration.

[0063] Precisely prepare 10ml of SDS solutions with concentrations of 0, 0.005, 0.01, 0.02, 0.03, and 0.04g / L respectively. 0.5mol / L NaHSO 4 50ml of 0.4% acridine orange solution for solution configuration.

[0064] Take 100ul of SDS solutions of different concentrations and the sample to be tested in a stoppered test tube, and add 100ul of 0.5mol / L NaHSO 4 Mix the 0.4mol / L acridine orange solution prepared by the solution. After adding 3ml of toluene, plug the test tube tightly, shake vigorously for 3min, centrifuge at 2000g / min for 5min, take the supernatant and measure the absorbance at 499nm.

[0065] Table 1 ...

Embodiment 3

[0073] Embodiment 3: Semi-finished product preparation sub-package

[0074] The stock solution system of the interferon preparation obtained after desalting is a sodium hydroxide system, and the interferon can only maintain a stable activity in a short period of time, and this system cannot be used as the stock solution for testing, so the buffer system needs to be replaced again. Add stabilizers and buffers according to the following prescription composition and final concentration, and make semi-finished products after settling to a certain volume:

[0075] Recombinant human interferon β-1b 0.1~0.5mg / ml

[0076] Phosphate buffer 10~30mM

[0077] Human serum albumin (HSA) 1-3%

[0078] HSA within this concentration range is suitable for maintaining the solubility and activity stability of the recombinant human interferon-β-1b dosage form after freeze-drying; while the phosphate buffer is more conducive to maintaining the dissolved state and activity of this protein. During...

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Abstract

The invention provides a stable recombinant human interferon beta-1b freeze-dried preparation and a preparing method thereof. The freeze-dried preparation is prepared from recombinant human interferon beta-1b, human blood albumin, a phosphate buffer solution and the like according to a certain proportion and through a vacuum freeze-drying technology; and at the same time, the preparing method of the preparation can ensure the preparation has good stability and activity after redissolving.

Description

technical field [0001] The invention relates to the field of biotechnology and pharmacy, in particular to a stable recombinant human interferon beta-1b freeze-dried preparation and a preparation method thereof. Background technique [0002] Interferon (interferons, IFN) is a class of cytokines with antiviral activity, inhibition of cell proliferation, antitumor and immune regulation functions. It is divided into two subtypes according to the principle of binding to receptors. Type I currently includes IFN-a, IFN-β, IFN-τ, IFN-ω, type II interferon is only IFN-γ, which can be divided into natural interferon and genetically engineered recombinant interferon according to different preparation methods. [0003] Research on the mechanism of interferon action shows that it does not directly regulate the genes of its effector molecules as a trans-acting factor, but uses a receptor-mediated signal transduction system to trigger a series of specific biochemical reactions to regulate ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K38/21A61K47/42A61K9/19A61P31/12A61P35/00A61P37/02C07K1/34C07K1/16C07K14/565
CPCY02A50/30
Inventor 曹小丹李静徐立华范宝庆张玲张学况薛雯李剑
Owner TASLY BIOPHARMACEUTICALS CO LTD
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