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No-cell calmette-Guerin bacillus mucosa immune regulator and application thereof

A technique for mucosal immunity and BCG, applied in the biological field, can solve problems such as unsatisfactory drug efficacy, and achieve the effects of preventing the recurrence of condyloma acuminatum, promoting recovery, and preventing precancerous lesions.

Inactive Publication Date: 2009-07-08
NAT INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0040] (3) For viral tumors, it may promote the production of antiviral antibodies and interferon
The former has a strong adjuvant effect, while the latter can induce the production of lymphokines, but the drug effect is not satisfactory in the whole animal model

Method used

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  • No-cell calmette-Guerin bacillus mucosa immune regulator and application thereof
  • No-cell calmette-Guerin bacillus mucosa immune regulator and application thereof
  • No-cell calmette-Guerin bacillus mucosa immune regulator and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Example 1: Preparation of acellular BCG mucosal immune modulator

[0088] Different physical lysis methods can be used to prepare the acellular BCG mucosal immune modulator, such as ultrasonic crushing or high-pressure crushing, and high-pressure crushing is most preferred.

[0089] The BCG strain used for production is D 2 PB 302 S 11 First 10 Strain (preserved by Shanghai Institute of Biological Products), culture characteristics, toxicity test, safety test, spleen activation test, tumor inhibition test, toxicity test, etc. were carried out on it before production. The strains that pass the above six inspections can be used for production. It is stipulated in the production that the generation of the strain cannot exceed 12 generations.

[0090] It is strictly forbidden to use the strains of animals to manufacture BCG.

[0091] Preparation of cell-free BCG mucosal immune modulator by high pressure crushing method

[0092] 1.1 Strain subculture and cultivation ...

Embodiment 2

[0112] Example 2: Effect of acellular BCG mucosal immune modulator on immune function of tumor-bearing mice

[0113] This example mainly observes the effect of acellular BCG mucosal immune conditioning agent on the content of serum lysozyme in tumor-bearing mice and delayed hypersensitivity (PTH) by intragastric administration to illustrate the effect of acellular BCG mucosal immune conditioning agent on Effects on the immune function of tumor-bearing mice.

[0114] 2.1 Effect of cell-free BCG mucosal immunomodulator on serum lysozyme content of melanoma B16 tumor-bearing mice

[0115] According to the concentration of melanoma B16 cells at 1:3, 0.2ml was inoculated subcutaneously or intraperitoneally to mice, and then administered by intragastric administration 24 hours later. There are three dosage groups for acellular BCG mucosal immune conditioning agent, 25.00U / kg is selected as the high dosage group, 12.50U / kg is selected as the middle dosage group, and 6.25U / kg is sele...

Embodiment 3

[0127] Example 3: Effect of acellular BCG mucosal immune modulator on immune function of immunocompromised body

[0128] This example illustrates the effect of acellular BCG mucosal immune modulators on the immune function of immunocompromised mice induced by cyclophosphamide.

[0129] Seventy Balb / c mice were randomly divided into 5 groups, namely low, medium and high doses of acellular BCG mucosal immune modulator, negative control group and normal control group, 14 in each group, half male and half male.

[0130] The control group with normal immune function was not given any drugs;

[0131] The remaining experimental groups:

[0132] a. The positive control group was fed with 0.2ml of A collagen solution every other day for a total of 10 times.

[0133] b. The negative control group was fed with 0.2ml of normal saline every other day for a total of 10 times.

[0134] c. The high-dose group was given 20U / 0.2ml of acellular BCG mucosal immune conditioning agent every othe...

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Abstract

The present invention provides a kind of no-cell Calmette-Guerin bacillus preparation, and medicine composition or mucosa immune regulator including the preparation. The no-cell Calmette-Guerin bacillus preparation is prepared through crushing and cracking Calmette-Guerin bacillus in a homogenating crushing process or ultrasonic crushing process. The preparation can strengthen immunological function of normal body, promote restoring of immunological function in hypoimmunity body and inhibit excessive immune response in hyperimmunity body, and has bidirectional immunological regulation. The preparation has obvious tumor inhibiting effect, can prevent cancers, and is one kind of safe and effective mucosa immune regulator.

Description

technical field [0001] The invention relates to the fields of biotechnology, immunology, microbial products and pharmaceutical applications thereof, in particular to the verification of the immune regulation function of a cell-free BCG mucosal immune conditioning agent, and its effect on postoperative recurrence of gastric cancer and bladder cancer, and high-risk HPV viruses. , prevention and treatment of cervical cancer precancerous lesions, recurrence of condyloma acuminata and other mucosal immune system diseases. Background technique [0002] The mucous membrane of the body is one of the important routes for immunization and immunotherapy administration. Mucosal epithelial M cells can present antigens in the body cavity to the organized lymphoid tissue in Peyer's nodes (collective lymph nodes), and induce local immune responses or inflammation on the mucosal surface to remove abnormal cells and infected microorganisms, and can Activate the body's overall immune system. ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K35/74A61P35/00A61P31/12A61P37/04
Inventor 王国治邹宇玲贾淑珍寇丽杰乔来艳赵爱华
Owner NAT INST FOR FOOD & DRUG CONTROL
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