Establishment of HPLC fingerprint of Changyile capsule (I)

By using HPLC fingerprinting, a fingerprint spectrum of Changmaile capsules was established, which solved the problem that the existing technology could not fully characterize the main components, and realized comprehensive quality control and batch-to-batch quality monitoring of Changmaile capsules.

CN117783360BActive Publication Date: 2026-07-24THE SECOND PEOPLES HOSPITAL OF FUJIAN PROVINCE
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
THE SECOND PEOPLES HOSPITAL OF FUJIAN PROVINCE
Filing Date
2023-12-28
Publication Date
2026-07-24

AI Technical Summary

Technical Problem

Existing technologies have failed to fully characterize the main components of Changmaile capsules, making it impossible to fully determine their quality and lacking comprehensive fingerprint spectral studies.

Method used

The fingerprinting method of HPLC was used to establish the fingerprint of Changmaile capsules by preparing reference solution and test solution and combining HPLC/DAD detection. The simultaneous determination of 16 active ingredients was achieved by using a Thermo Scientific Accucore™ XL C18 column, dual wavelength mode (230 nm and 280 nm) and gradient elution program.

Benefits of technology

It enables comprehensive characterization of the main components of Changmaile capsules, improves the precision and reproducibility of quality control, and can effectively monitor quality changes between different batches.

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Abstract

The application provides a method for establishing HPLC fingerprint of Changnyle capsule (I), which is characterized in that 16 active components including gastrodin, danshensu, quercetin-3-O-beta-D-glucose-7-O-beta-D-gentiopicroside, 3'-hydroxy puerarin, puerarin, 3'-methoxy puerarin, puerarin apioside, paeoniflorin, daidzin, rosmarinic acid, shikonin, isoquercitrin, ononin, daidzein, salvianolic acid B and calycosin are used as reference substances, HPLC is adopted, methanol-acetonitrile-0.5vol% phosphoric acid aqueous solution is used as a mobile phase, different batches of samples are detected, and finally the fingerprint of Changnyle capsule (I) is obtained. The fingerprint can comprehensively represent the main components in Changnyle capsule (I), thereby being beneficial to the quality control of Changnyle capsule (I).
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