Oral capsule for intestinal flora transplantation and preparation method thereof

A technology of intestinal flora and capsules, applied in the field of biomedicine, can solve the problems of changing the ecological balance of intestinal flora, reducing the activity of intestinal flora, and difficult to obtain therapeutic effects, so as to avoid killing and destroying effects and improve success. efficiency, guaranteed abundance and activity

Pending Publication Date: 2022-04-29
北京富玛特生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Freeze-drying not only has high cost and long cycle, but also has a great killing effect on the intestinal flora. A large part of the intestinal flora dies during the freeze-drying process, which greatly reduces the activity of the intestinal flora in the capsule and further limits the intestinal flora. The intestinal flora load of dissolved capsules also changed the ecological balance of the intestinal flora in colonized oral capsules, so that the flora ecology finally colonized in the intestines of patients was different from that of healthy donors. When the difference is large, it is difficult to obtain the desired therapeutic effect, and even severe side effects may occur

Method used

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  • Oral capsule for intestinal flora transplantation and preparation method thereof
  • Oral capsule for intestinal flora transplantation and preparation method thereof
  • Oral capsule for intestinal flora transplantation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of oral capsules for intestinal flora transplantation

[0029] The intestinal flora of this example comes from a strictly screened healthy donor, and all operations should be completed within 6 hours after the stool leaves the healthy donor. The screening of healthy donors strictly follows the relevant guidelines of the International Consensus on FMT, the European Consensus on FMT, the Asia-Pacific Consensus on FMT, and the Chinese Children’s Consensus on FMT, and adopts a strict "exclusion method". Screening includes review of medical history, serology to screen for infectious disease, stool examination, sequencing of gut microbiota, and confirmation of absence of gastrointestinal disorders and other neurodevelopmental problems. Serological tests ruled out hepatitis A, B, C, and E infection, human immunodeficiency virus type I / II infection, T-cell tuberculosis infection, TORCH virus infection, and syphilis infection, and liver and kidney function...

Embodiment 2

[0036] Example 2: Comparative test on the protective effect of different glycerol concentrations on the activity of flora in oral capsules

[0037] In order to protect the intestinal flora in the flora transplantation capsule from freezing damage, the present invention adds a non-toxic and edible cryopreservation agent when making the capsule, although most non-permeable macromolecular cryoprotectants are edible materials , but the medium and small capsule matrix of the present invention--sodium alginate solution is a viscous solution, and the non-permeable macromolecular cryoprotectant is difficult to dissolve therein. Therefore, the present invention selects food-grade glycerin as the small capsule cryoprotectant.

[0038] The present invention also examines the protective effect of different concentrations of glycerin on live bacteria in small capsules: the cryoprotectant can protect bacteria or cells from freezing damage during cryopreservation. Cryoprotectants are divided...

Embodiment 3

[0049] Embodiment 3: The oral capsule prepared by the present invention adopts the comparative test of the number of viable bacteria and the abundance of flora preserved by freezing and freeze-drying

[0050] (1) The preparation of frozen Enterobacteria small capsules is the same as in Example 1; some small capsules are directly frozen in a -80°C refrigerator, and the other small capsules are processed using a Biocool vacuum freeze dryer (Pilot 2-4H) Freeze drying;

[0051] (2) Take the same amount of frozen (-80°C for one week) and freeze-dried (freeze-dried) small capsules of Enterobacteriaceae, add 10 times the volume of 1% sodium citrate solution, shake and incubate for 30 minutes, and the small capsules are completely dissolved Afterwards, serial dilutions were performed with saline;

[0052] (3) Take 100 μl of frozen samples 10 -6 , freeze-dried samples to take 100μl 10 -6 The diluted bacterial solution was spread on the improved GAM plate, and the plate was placed in...

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Abstract

The invention relates to an oral capsule for intestinal flora transplantation and a preparation method thereof. The capsule comprises the following matrix components in percentage by mass: 2% of sodium alginate, 5-15% of glycerol, 2% of prebiotics, 0.9% of NaCl and the balance of deionized water. Intestinal flora is collected; uniformly mixing the capsule matrix and the bacterial sludge according to the mass ratio of 3: 1; inserting an inlet end of a peristaltic pump conduit into the mixture of the capsule matrix and the bacterial sludge, connecting a syringe needle with an outlet end of the peristaltic pump conduit in a sealing manner, fixing the syringe needle and the outlet end of the peristaltic pump conduit above a glass cup filled with a setting agent, starting a peristaltic pump, and dropwise adding the mixture of the capsule matrix and the bacterial sludge into the setting agent to form a capsule sphere; and solidifying, cleaning and drying, and then cryopreserving in a refrigerator at-80 DEG C, and taking when being used. The diameter of the oral capsule for transplanting the intestinal flora can be controlled to be 0.06-5mm, the success rate of transplanting the intestinal flora is improved, and although the diameter of the oral capsule is small, the oral capsule has the higher success rate of transplanting the intestinal flora.

Description

technical field [0001] The invention relates to the field of biomedical technology, in particular to an oral capsule for intestinal flora transplantation and a preparation method thereof. [0002] technical background [0003] At present, intestinal flora transplantation, as an emerging medical technology, has been gradually applied in practice. Bacterial flora transplantation is to transplant the functional flora in the feces of healthy people into the gastrointestinal tract of patients, rebuild new intestinal flora, and realize the treatment technology of intestinal and extraintestinal diseases. In the treatment of recurrent Clostridium difficile infection (CDI), the overall cure rate is even as high as 96%, and its effectiveness and safety have been further confirmed in follow-up studies. At present, microbiota transplantation has become the preferred treatment strategy for recurrent Clostridium difficile infection (rCDI), severe CDI unresponsive to standard treatment, an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K35/74A61P1/00A61J3/07
CPCA61K35/74A61K9/4866A61P1/00A61J3/07
Inventor 刘琼明赵春雪张家树
Owner 北京富玛特生物科技有限公司
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