Novel integrated analysis platform for evaluating quality of complex natural products

By integrating qualitative and quantitative fingerprint data with biophysical activity data through multivariate analysis, the batch-to-batch reproducibility and safety issues of complex natural products were resolved, enabling multidimensional characterization and verification of the products and meeting regulatory requirements.

CN121039742APending Publication Date: 2025-11-28ABOCA S P A SOC AGRI
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Patent Information

Application Number
CN202480022413.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2023-03-28
Filing Date
2024-03-27
Publication Date
2025-11-28

AI Technical Summary

Technical Problem

Existing technologies cannot effectively characterize and verify complex natural products as a whole system, resulting in the inability to guarantee the reproducibility and risk-benefit ratio between different batches of products, especially in medical devices and food supplements where regulatory and safety issues exist.

Method used

By employing an integrated analysis platform, qualitative and quantitative fingerprint data are combined with physical and biophysical activity data, and a correlation model is established using multivariate analysis methods to achieve multidimensional characterization and verification of complex natural products.

Benefits of technology

This ensures the reproducibility of the quality and efficacy characteristics of complex natural products across different batches, meets regulatory requirements, and provides assurance of product safety and effectiveness.

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Abstract

The present invention provides a novel integrated platform capable of verifying the production process, standardizing and evaluating complex natural products, thereby enabling "as an integral system" characterization of complex mixtures contained in products (based on or consisting of natural substances) with therapeutic and / or health care effects, the characterization of the metabonomics is not limited to a reductive chemical method aiming at a single marker, and qualitative and quantitative data and fingerprint characterization metabonomics of the mixture are integrated with physical and biophysical activity data, so that the characterization of the product is realized, which is the basis of the verification process of the production process; and the reproducibility of different batches of products in the aspects of efficacy and safety can be ensured. The analysis platform described herein can ensure that a complex natural product is a whole, and all quality and efficacy characteristics of the product are considered, thereby ensuring reproducibility of effect and safety through a multi-dimensional analysis method.
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