Polypeptide vaccine, preparation method and application

A polypeptide vaccine and bottle cap technology, applied in the field of vaccines, can solve the problems of difficulty in dissolving polypeptides with a single solvent and different solubility, and achieve the effects of avoiding repeated freezing and thawing, avoiding pollution, and stable properties

Inactive Publication Date: 2020-08-21
浙江格源致臻生物医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] (1) The raw material polypeptides for the preparation of polypeptide vaccines have different solubility in solvents approved by the Pharmacopoeia, and it is difficult to dissolve all polypeptides with a single solvent

Method used

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  • Polypeptide vaccine, preparation method and application

Examples

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Effect test

preparation example Construction

[0041] Such as figure 1 As shown, the preparation method of the polypeptide vaccine provided by the embodiments of the present invention comprises the following steps:

[0042] S101: Clean and sterilize the body, cap and stopper of the vial separately; the details are as follows: add 1 L and 500 ml of ultrapure water to 100 2ml borosilicate vials and 100 caps and stoppers, respectively, and rinse. Rinse repeatedly 10 times. The rinsed bottle body, cap and cork are placed upside down in a clean aluminum box and dried at 80°C. Put the bottle body in an aluminum box, seal the two layers with tin foil, and perform dry heat sterilization at 200°C for 3 hours. The bottle cap and bottle stopper are placed in an aluminum box, packed with kraft paper and cotton thread, and sterilized at 121°C for 20 minutes under high temperature and high pressure. After the bottle cap and the bottle stopper are sterilized, they are dried in an oven at 80°C and are ready for use.

[0043] S102: Pre...

Embodiment 1

[0048]Add 1L and 500ml ultrapure water to 100 2ml medium borosilicate vials and 100 bottle caps and stoppers, respectively, and rinse for 10 times. The rinsed bottle body, cap and cork are placed upside down in a clean aluminum box and dried at 80°C. Put the bottle body in an aluminum box, seal the two layers with tin foil, and perform dry heat sterilization at 200°C for 3 hours. The bottle cap and bottle stopper are placed in an aluminum box, packed with kraft paper and cotton thread, and sterilized at 121°C for 20 minutes under high temperature and high pressure. After the bottle cap and the bottle stopper are sterilized, they are dried in an oven at 80°C and are ready for use.

[0049] A mixture of physiological saline and DMSO containing 0.5% DMSO was prepared as a solvent, and the solvent was shaken and mixed until ready for use.

[0050] Centrifuge the synthesized lyophilized powder at 1000rpm for 5min, add 667ul solvent to 2mg polypeptide lyophilized powder, pipette a...

Embodiment 2

[0053] The personalized polypeptide vaccine prepared in Example 1 was subjected to bacterial and fungal smear tests, endotoxin and fungal D-glucan tests, and abnormal toxicity tests in Balb / c mice.

[0054] The present invention has been tested by bacteria and fungi smears, and the results show that fungi inspection: no fungi were found, and pathogenic microorganism microscopic examination: no bacteria were found;

[0055] The present invention is tested for endotoxin and fungal D-glucan, and the results show that the endotoxin is 0.101eu / ml, and the fungal D-glucan is 30.142pg / ml.

[0056] The present invention has been tested for abnormal toxicity in Balb / c mice. The detection method is: 0.5ml of polypeptide vaccine is injected into the tail vein of mice; the results show that during the abnormal toxicity test, all animal-general behaviors, appearance signs, eating and drinking activities, etc. are normal; All animals were healthy and alive.

[0057] The preparation method ...

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Abstract

The invention belongs to the technical field of vaccines, and discloses a preparation method and application of a polypeptide vaccine. The preparation method comprises the following steps: respectively cleaning a packaging material penicillin bottle body, a bottle cap and a bottle plug, and sterilizing; preparing a mixed solution of normal saline containing 0.5% DMSO and DMSO as a solvent, and oscillating and uniformly mixing the solvent for later use; adding the solvent into a polypeptide freeze-dried powder, blowing and beating for 10 times, and uniformly mixing; sterilizing and filtering anobtained polypeptide-containing solution, and sub-packaging a filtered solution into the cleaned penicillin bottles. According to the method, microorganisms and residual endotoxin in the penicillin bottles are removed through dry heat sterilization, and bottle caps and bottle plugs are sterilized through high-temperature and high-pressure moist heat sterilization. According to the invention, a solvent which has little damage to polypeptide, can prevent side chain oxidation and can dissolve polypeptide is used. The polypeptide with the concentration prepared by the invention is stored at -80 DEG C, is stable in property and can be stored for a long time. The process provided by the invention is suitable for preparing personalized customized vaccines and meets the sterile and safety requirements specified in pharmacopeia.

Description

technical field [0001] The invention belongs to the technical field of vaccines, and in particular relates to a polypeptide vaccine, a preparation method and an application. Background technique [0002] my country is a big country for liver cancer. With the deepening of the application of tumor immunology and clinical immunotherapy, tumor immunotherapy is becoming a routine treatment after surgery, radiotherapy and chemotherapy, and targeted therapy. Tumor immunotherapy is a research hotspot in the field of tumor treatment in recent years. In 2013, the immunotherapy of tumors was rated as the top ten scientific breakthroughs of the year by Science magazine. In 2016, the American Society of Clinical Oncology (ASCO) announced immunotherapy as the top advance in annual cancer research. Tumor neoantigens (neoantigens) are polypeptides or proteins that are specifically present in tumor cells produced by tumor cells due to genetic mutations. Some neoantigen epitopes carried on ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00A61P35/00A61L2/02A61L2/04
CPCA61K39/0011A61L2/0017A61L2/04A61L2202/21A61L2202/23A61P35/00
Inventor 蔡振寨潘陈为俞耀军朱岳升苏小平李伟迎
Owner 浙江格源致臻生物医药科技有限公司
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