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Whole-bacterium capsule as well as preparation method and application thereof

A technology for capsules and enteric-coated capsules is applied in the field of whole-bacteria capsules and their preparation, which can solve the problems of low drug efficacy, complicated process, and low concentration of bacteria, and achieve the characteristics of significant drug efficacy, reduction in the number of food types, and increase in abundance. Effect

Active Publication Date: 2020-12-18
SUZHOU PRECISION BIOTECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this process needs to mix a certain volume of suspension with glycerin solution during operation, and the prepared intestinal flora preparation has low bacterial concentration and low drug efficacy
[0006] At present, fecal bacteria transplantation is mainly through mechanical intervention, the process is complicated, and the patient has a certain amount of pain.

Method used

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  • Whole-bacterium capsule as well as preparation method and application thereof
  • Whole-bacterium capsule as well as preparation method and application thereof
  • Whole-bacterium capsule as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0072] Example 1 Judgment Criteria for Healthy Donors

[0073] Feces come from healthy donors, and the selection criteria for healthy donors are as follows:

[0074] (1) Aged 18-23 years old, in good health, unmarried male or female;

[0075] (2) Regular life, no bad habits;

[0076] (3) No history of antibiotic use within three months;

[0077] (4) No gastrointestinal diseases;

[0078] (5) Both serology and fecal infectious pathogen examination and culture are negative;

[0079] (6) The types and diversity of intestinal flora are good: after high-throughput intestinal flora 16s rDNA gene detection, it is judged that the types and diversity of probiotics are good.

[0080] The exclusion criteria for healthy donors were as follows:

[0081] (1) Drug taking history: Those who have used antibiotics, laxatives, weight loss drugs or are taking immunosuppressants and chemotherapy drugs within three months;

[0082] (2) Virus exposure history: those who have been or recently e...

Embodiment 2

[0088] Example 2 Screening of fecal bacteria donors based on high-throughput sequencing

[0089] According to Example 1, people who are judged as healthy donors are used as fecal bacteria donors, and are further screened based on high-throughput sequencing technology. The flow chart is as followsfigure 1 As shown, the steps are as follows:

[0090] Extract DNA from the feces of fecal bacteria donors, construct a library for next-generation sequencing, and obtain original sequencing data; after removing the host genes of the original sequencing data, compare them with NCBI microbial databases (bacterial genomes, fungal genomes, and viral genomes). Carry out bacterial species identification and abundance detection; compare with the KEGG pathogenic bacteria database to confirm that there are no pathogenic bacteria in the fecal bacteria donor; compare with the intestinal flora of the fecal bacteria recipient to screen for complementation with the fecal bacteria recipient fecal don...

Embodiment 3

[0094] The preparation of embodiment 3 fecal bacteria liquid

[0095] Collect the feces of the fecal fungus donors screened in Example 2 on site, send them to the laboratory within 1 hour for information registration, feces identification, weighing, evaluation and treatment, and prepare the fecal fungi in an anaerobic environment solution, the steps are as follows:

[0096] (1) Soak the collected feces in sterile physiological saline at 5°C, use 2.0mm, 1.0mm, 0.5mm and 0.25mm filter screens to remove large particles, and then use 0.25mm filter screens to filter 3 times to obtain The liquid phase is fecal filtrate;

[0097] (2) The feces filtrate was centrifuged at 3000r / min for 10 minutes, and the precipitate was mixed with sterile saline to obtain a feces liquid.

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Abstract

The invention provides a whole-bacterium capsule as well as a preparation method and application thereof. The preparation method comprises the following steps: (1) screening a fecal bacterium donor byutilizing high-throughput sequencing; (2) collecting feces of the fecal bacterium donor screened in the step (1) and preparing fecal bacterium liquid; and (3) mixing the fecal bacterium liquid prepared in the step (2) with a freeze-drying protective agent and then carrying out cooling freezing and vacuum drying; filling a capsule shell with obtained fecal bacterium freeze-dried powder to obtain the whole-bacterium capsule. According to the whole-bacterium capsule provided by the invention, the fecal bacterium donor is screened by utilizing the high-throughput sequencing and the fecal bacterium donors aiming at different fecal bacterium receptors are rapidly screened; the whole-bacterium capsule prepared by the preparation method is accurately matched with the fecal bacterium receptors andthe medicine effect is remarkable.

Description

technical field [0001] The invention belongs to the technical field of fecal bacteria transplantation, and relates to a whole bacteria capsule, a preparation method and application thereof. Background technique [0002] Flora transplantation (FMT) is a technique to transplant the functional flora in the feces of healthy people into the intestinal tract of patients, establish new intestinal flora in the intestinal tract of patients, and treat intestinal and extraintestinal diseases. In the past 10 years, FMT has made breakthroughs in the treatment of intestinal and extra-intestinal diseases, and high hopes are placed on FMT in the treatment of difficult intestinal and extra-intestinal diseases. However, due to the complex establishment of FMT methodology, there is no unified standard at home and abroad, resulting in large heterogeneity in the efficacy of various studies, which greatly limits the clinical application of FMT. At present, fecal microbiota transplantation has a ...

Claims

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Application Information

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IPC IPC(8): A61K35/741A61K35/74A61K45/06A61K9/48A61K47/46A61K47/26A61K47/22A61P1/00A61P29/00A61P35/00A61P1/16A61P25/00A61P37/06A61P31/04C12Q1/689C12N1/20C12N1/04C12N1/02C12R1/19C12R1/145C12R1/01
CPCA61K35/74A61K35/741A61K45/06A61K9/4875A61K9/4858A61P1/00A61P29/00A61P35/00A61P1/16A61P25/00A61P37/06A61P31/04C12Q1/689C12N1/20C12N1/04C12N1/02A61K2300/00A61K9/19C12R2001/01C12R2001/19C12R2001/145Y02A50/30A61K9/4833A61K35/24
Inventor 陆敏张宝钰刘丹张水龙王一伟朱永亮朱蒙蒙
Owner SUZHOU PRECISION BIOTECH CO LTD
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