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Preparing method of novel gel immune adjuvant

A technology of immune adjuvant and gel, which is applied in the field of preparation of freeze-dried preparations of polymuscular cells, can solve the problems of heating of PIC products, achieve the effects of reducing impurities, simplifying the production process, and prolonging the storage time

Inactive Publication Date: 2019-04-30
关茜茹
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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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Examples

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 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 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 discloses a preparing method of a novel gel immune adjuvant, relates to the technical field of freeze-drying preparation and a preparing method thereof, and aims to provide the preparingmethod of the novel gel immune adjuvant. The technical proposal comprises that provided is the preparing method of the novel gel immune adjuvant; the novel gel immune adjuvant comprises a polymyocytes raw fluid and a freeze-drying additive, and the freeze-drying additive is basically composed of dexamethasone, sodium vitamin C, amino acid and kanamycin sulfate. The preparing method of the novel gel immune adjuvant comprises the following steps: (1) preparing the polymyocytes raw fluid; (2) filtering and concentrating the polymyocytes raw fluid; (3) adding the freeze-drying additive, mixing evenly, carrying out aseptic filtration, and sub-packing into penicillin bottles; (4) putting the penicillin bottles into a freeze dryer, and balancing for 1 h at the temperature of 5 DEG C, 0 DEG C, and -6 DEG C respectively; and freezing rapidly, reducing the product temperature to -50 DEG C, and maintaining for 3 h; (5) carrying out vacuum drying; (6) heating and drying, and lasting for 3 h whenthe product temperature reaches 30 DEG C; and (7) plugging and sealing mouths.

Description

technical field [0001] The invention relates to a preparation method of a novel gel immune adjuvant, in particular to a preparation method of a freeze-dried preparation of polymuscular cells. 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 impuri...

Claims

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Application Information

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IPC IPC(8): A61K39/39A61K9/19A61K47/22A61K47/28A61K47/12A61K47/18A61P37/04
CPCA61K39/39A61K9/19A61K47/12A61K47/183A61K47/22A61K47/28A61K2039/55561
Inventor 关茜茹
Owner 关茜茹
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