Quality control method for synthesizing 3 '-sialic acid lactose through enzymatic process

3’-SL was synthesized by enzymatic process and HPLC-UV-RI combined detection method was used to solve the problem of strict control of 3’-SL product quality during enzymatic process synthesis, and accurate detection of impurities and isomers in products, starting materials and intermediates was achieved, ensuring the stability of product quality.

CN119688884APending Publication Date: 2025-03-25SHENZHEN READLINE BIOTECH CO LTD
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Patent Information

Application Number
CN202411988701.0
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-12-30
Publication Date
2025-03-25

AI Technical Summary

Technical Problem

It is difficult to effectively control the quality of 3’-sialic acid lactose (3’-SL) products in the prior art, especially during the enzymatic process synthesis, it is difficult to accurately detect impurities and isomers in products, starting materials and intermediates.

Method used

The quality control method of 3’-SL was synthesized by enzymatic method. The test samples were dissolved and high performance liquid chromatography (HPLC) was used to determine them. The HPLC-UV-RI combined detection method was used to achieve effective separation and quantification of 3’-SL and its isomers.

Benefits of technology

This method can accurately and reliably detect the quality of 3’-SL, ensure the conversion rate and yield of each step of the reaction, effectively control the quality of the product, especially the detection of isomers.

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Abstract

The invention provides a quality control method for synthesizing 3 '-sialic acid lactose by an enzymatic process, which comprises the following steps: A) dissolving and extracting a test sample by using a solvent to obtain a to-be-detected solution; the test sample is a reaction solution or a finished product of 3 '-sialic acid lactose synthesized by enzyme catalysis; b) determining the liquid to be detected by adopting a high performance liquid chromatography to obtain an HPLC (High Performance Liquid Chromatography) spectrum of the 3 '-sialic acid lactose; according to the method, an HPLC-UV-RI combined detection method is adopted, the specificity is high, the sensitivity is high, the linear correlation is good, and the pretreatment process of the sample is simple and rapid; according to the method, the content of 3 '-lactulose sialylate, 6'-lactose sialylate sodium salt, D-lactose, CMP, CMP-SA and SA in the 3 '-SL process development process can be accurately detected, control over the conversion rate and impurities in the process is facilitated, effective detection of a product 3'-SL related substance-isomer can be achieved, and control over the product quality is facilitated.
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