High-purity poly IC lyophilized preparation and preparation method thereof

A technology for freeze-dried preparations and polymyocytes, which is applied in the field of high-purity polymyocytes freeze-dried preparations and their preparation, can solve the problem of heating of PIC products, and achieve the effects of reducing impurities, simplifying the production process and prolonging the storage time.

Inactive Publication Date: 2019-05-24
南杰
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the nucleotide raw materials synthesized by enzymatic methods are all yeast extracts, which contain a large amount of endotoxin, residual DNA and bacterial protein. These substances can cause PIC products to produce side effects such as fever in clinical practice.

Method used

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  • High-purity poly IC lyophilized preparation and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Take the purified solution of polyinosinic acid and polycytidylic acid (1:0.5), mix them in a water bath at 40°C, stir for 45 minutes, filter with a 0.45 μm filter element, and concentrate with a 300KD membrane bag of the Millipore ultrafiltration system to a concentration of 0.8mg / ml of liquid, add cannacin sulfate 500 units / ml, amino acid 0.5%, sodium ascorbate 0.15%, dexamethasone 2.0%, mix well, sterile filter, subpackage and freeze-dry.

Embodiment 2

[0027] Take the purified solution of polyinosinic acid and polycytidylic acid (1:1), mix them in a water bath at 50°C, stir for 60 min, filter with a 0.45 μm filter element, and concentrate to a concentration of 2.0 mg / ml of liquid, add cannacin sulfate 3000 units / ml, amino acid 1.0, sodium ascorbate 0.2%, dexamethasone 3.8%, mix well, sterile filter, subpackage and freeze-dry

Embodiment 3

[0029] Take the purified solution of polyinosinic acid and polycytidylic acid (1:1.5), mix them in a water bath at 50°C, stir for 90 min, filter with a 0.45 μm filter element, and concentrate to a concentration of 4.0 mg / ml of liquid, add cannacin sulfate 5000 units / ml, amino acid 1.0%, sodium ascorbate 0.3%, dexamethasone 6.0%, mix well, sterile filter, aliquot and freeze-dry

[0030] The finished freeze-dried preparation is tested according to the method listed in the "Standard" and is qualified.

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Abstract

The invention relates to the field of lyophilized preparations and preparation methods thereof and discloses a high-purity poly IC lyophilized preparation and a preparation method thereof. The technical scheme includes that the high-purity poly IC lyophilized preparation comprises poly IC stoste and a lyophilizing additive, and the lyophilizing additive is basically prepared from dexamethasone, sodium vitamin C, amino acid and kanamycin sulfate. A method for preparing a novel gel immunologic adjuvant includes steps: (1) poly IC stoste preparation; (2) poly IC stoste filtration and concentration; (3) adding the lyophilizing additive, well mixing, performing sterile filtration, and sub-packaging into penicillin bottles; (4) putting the penicillin bottles into a lyophilizer, and equilibratingfor 1h at temperatures of 5 DEG C, 0 DEG C and -6 DEG C respectively; quickly freezing to reduce the product temperature to -50 DEG C, and keeping the temperature for 3h; (5) performing vacuum drying; (6) heating to dry, and keeping the product temperature at 30 DEG C for 3h; (7) plugging and sealing.

Description

technical field [0001] The invention relates to a high-purity polymyocyte freeze-dried preparation and a preparation method thereof. Background technique [0002] Polyinosinic acid (PolyIC or PIC) is a double-stranded nucleotide (RNA) synthesized by pairing artificially synthesized polyinosinic acid (PolyI) and polycytidylic acid (PolyC), and is a highly efficient interferon-inducing agent. At present, the nucleotide raw materials synthesized by enzymatic methods are all yeast extracts, which contain a large amount of endotoxin, residual DNA and bacterial protein, all of which can cause PIC products to produce side effects such as fever in clinical practice. Our company has carried out the purification and synthesis process exploration of refined polymyocytes. Refined poly muscle cell is refined by three-step chromatography technology on the basis of the original poly muscle cell preparation process to remove impurities such as endotoxin, residual DNA and residual host bact...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K47/26A61K47/12A61K47/18A61K47/22A61K47/28A61K31/713
Inventor 南杰
Owner 南杰
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