Quality control for quality assessment of fecal microbiota transplantation preparation, preparation method and application thereof

CN122256472APending Publication Date: 2026-06-23SHANGHAI BIOTECAN PHARMA +1
View PDF 1 Cites 0 Cited by

Patent Information

Application Number
CN202610428047.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-04-02
Publication Date
2026-06-23

AI Technical Summary

Technical Problem

Existing technologies lack standardized, composite quality control materials for the quality assessment of intestinal microbiota transplantation (FMT) formulations. They cannot simulate the complex microbial communities of FMT formulations, making it difficult to assess systematic errors and batch-to-batch differences throughout the entire process. They also cannot simulate real matrix and assess the core functional bacterial genera of intestinal health, resulting in inaccurate microbial composition simulation.

Method used

A multi-donor non-culture mixing strategy was adopted to construct quality control products, which included composite microbial components, internal standard components and simulated matrix. By mixing total microbial cells and fecal filtrate from multiple healthy donors, combined with endogenous internal standard and core microbial community quantitative profile, realistic simulation and quality control standards were designed.

Benefits of technology

It enables full-process quality control of FMT formulations, improves the accuracy and representativeness of assessments, ensures the authenticity and complexity of the microbial community, reduces operational difficulty, reduces the risk of exogenous contamination, and is applicable to various quality control stages.

✦ Generated by Eureka AI based on patent content.

Smart Images

  • Figure SMS_1
    Figure SMS_1
  • Figure SMS_2
    Figure SMS_2
  • Figure SMS_3
    Figure SMS_3
Patent Text Reader

Abstract

The present application relates to a quality control product for quality evaluation of a preparation for intestinal flora transplantation, a preparation method and application thereof. The quality control product comprises a complex microbial component, an internal standard component, a simulated matrix and a stabilizer. The present application adopts a "multi-donor mixing" method, and compared with a scheme based on cultured strains, the quality control product prepared by the present application is highly consistent with a real FMT preparation in terms of species composition, relative proportion and bacterial activity state, and the quality control result has a strong clinical relevance. By constructing a "core bacterial spectrum", the complex flora quality control becomes simple, focused and cost controllable. In addition, the use of bifidobacterium as an internal standard has better compatibility with the sample matrix, more accurate monitoring and completely eliminates the risk of exogenous contamination.
Need to check novelty before this filing date? Find Prior Art

Citation Information

Patent Citations

  • Quality control method of bacterial liquid for intestinal flora transplantation

    CN118389715A