Cell-free preparations of immunopotentiators, and preparation methods and uses thereof

A technology of cell-free preparation and Pseudomonas preparation is applied in the field of cell-free preparations of various immune enhancers, which can solve the problems of cell fragmentation and difficulty in realization.

Inactive Publication Date: 2014-01-15
熊慧
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there are many methods for cell disruption, it is difficult to disrupt cells to the nanometer level with uniform particle size
It is technically difficult to process drugs to a particle size of mostly less than 100nm, and studies have shown that nano-scale drugs still have safety risks that are difficult to accurately assess with current technology.

Method used

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  • Cell-free preparations of immunopotentiators, and preparation methods and uses thereof
  • Cell-free preparations of immunopotentiators, and preparation methods and uses thereof
  • Cell-free preparations of immunopotentiators, and preparation methods and uses thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0067] Embodiment 1 treatment uses the preparation of Brucella preparation cell-free preparation

[0068] 1. Preparation of Brucella preparations for treatment

[0069] According to the method described in the 2000 edition of "China Biological Products Regulations", the establishment, verification and other verification of bacterial seed batches were carried out.

[0070] 1. Seeds for production: After opening the batch of working seed strains, inoculate them on the slant of liver infusion agar or other suitable medium, and cultivate them at 37°C for 44-48 hours to form the first-generation strains. The first-generation strains can be stored at 2-8°C for 15 days; transplant the first-generation strains onto liver agar or other suitable medium, and culture them at 37°C for 44-48 hours to become the second-generation strains. After passing the pure bacteria inspection, wash the bacterial lawn with sterile physiological sodium chloride solution to make a suspension. Use this as...

Embodiment 2

[0079] The preparation of the cell-free preparation of embodiment 2 BCG polysaccharide, nucleic acid preparation

[0080] BCG polysaccharides and nucleic acid preparations are made by extracting polysaccharides and nucleic acids from BCG by thermal phenol method, and mixing them with sterilized physiological sodium chloride solution. They are used for the prevention and treatment of chronic bronchitis, colds, asthma and other diseases.

[0081] According to the method described in the 2000 edition of "China Biological Products Regulations", the establishment, verification and other verification of bacterial seed batches were carried out.

[0082] 1. Preparation of BCG polysaccharide and nucleic acid preparations

[0083] Source: The strains approved by the National Drug Administration are used for production, and the use of strains passed through animals is strictly prohibited for production.

[0084]Freeze-dried strains are passed once on Sutong potato medium, bile potato me...

Embodiment 3

[0093] Example 3: Preparation of Cell Free Preparation of Group A Streptococcus Preparation

[0094] Group A Streptococcus preparation is a freeze-dried product made from the attenuated strain of Group A Streptococcus after cultivation, potentiation and penicillin treatment, and is used for immunotherapy of cancerous pleural effusion and malignant tumors.

[0095] According to the method described in the 2000 edition of "China Biological Products Regulations", the establishment, verification and other verification of bacterial seed batches were carried out.

[0096] One, the preparation of group A streptococcus preparation

[0097] The strain is CMCC32235 strain or SIPI722 strain, which is inoculated in Todd-Hewitt broth or yeast extract or other suitable solid or liquid medium.

[0098] After opening the batch of working seed bacteria, inoculate it on a suitable solid or liquid medium, cultivate it at 36±1°C, and amplify it for 2 to 4 generations, so as to prepare a suitable...

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Abstract

The invention relates to a cell-free preparation of a pseudomonas preparation, a cell-free preparation of a Bacillus Calmette-Guerin polysaccharide and nucleic acid preparation, a cell-free preparation of a Nocardia rubra cell wall skeleton preparation, a cell-free preparation of a Group A Streptococcus preparation, a cell-free preparation of a Pseudomonas aeruginosa preparation, and a cell-free preparation of a Brucella preparation. The above cell-free preparations have a granularity of 10-1000nm, preferably 10-800nm, and more preferably 10-500nm. The pyrogens of Gram-positive bacteria are below 320EU/ml, and preferably below 120EU/ml. The preparation methods of the cell-free preparations comprise the following steps: heating the preparations for boiling for 15-60min to obtain inactivated bacterial liquids; washing aseptic-test-qualified bacterial liquids, and breaking thalli under an aseptic condition by using a breaker; centrifuging a suspension obtained after breaking the thalli, collecting the above obtained precipitate, and washing the precipitate to prepare a suspension; and packaging the suspension, and carrying out heating disinfection to obtain the cell-free preparations of the preparations. The invention also relates to applications of the cell-free preparations.

Description

technical field [0001] The present invention relates to various immune enhancers, specifically, to cell-free preparations of various immune enhancers, their preparation methods and applications. Background technique [0002] Immunopotentiator is a class of immunotherapeutic drugs that enhance the body's immunity in different ways. Clinically, it is often used to treat diseases related to low immune function and immunodeficiency diseases. At present, there are many studies on immune enhancers. [0003] Modern pharmacological research shows that after the drug is processed to the nanometer level, the absorption and diffusion can be significantly improved, which is beneficial to reduce some side effects of the drug and improve the efficacy of the drug. Generally, there are two kinds of crushing techniques for microbial cells: mechanical method and non-mechanical method. Mechanical methods include: high-pressure homogenizer, high-speed bead mill, ultrasonic oscillator, and no...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K35/74A61K31/715A61K39/10A61P37/04A61P31/04
Inventor 熊慧
Owner 熊慧
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