A method for establishing a fingerprint spectrum of Qihuangtongmi soft capsule and its standard fingerprint spectrum

Gradient elution was performed under a specific mobile phase system through HPLC method, and the fingerprint map of Qihuangtongmi soft capsule was established, solving the problem that existing detection methods could not fully reflect product quality, and achieving efficient and precise quality control.

CN112986415BActive Publication Date: 2025-04-01SHINEWAY PHARMA GRP LTD
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Patent Information

Application Number
CN202110117689.6
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2021-01-28
Publication Date
2025-04-01
Estimated Expiration
2041-01-28

AI Technical Summary

Technical Problem

The existing testing methods cannot fully reflect the quality information of Qihuangtongmi soft capsules, resulting in insufficient comprehensive quality control.

Method used

The fingerprint map of Qihuangtongmi soft capsules was established by HPLC method, and the simultaneous determination of multiple index components was achieved under a specific mobile phase system through gradient elution.

Benefits of technology

Through one measurement, the fingerprint map of Qihuangtongmi Soft Capsule was constructed, which enriched chemical information and detected 8 common feature peaks, which could fully reflect the characteristics of the product, had good specificity, simplicity, stability, high precision and good reproducibility.

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Abstract

The present invention provides a method for establishing a fingerprint spectrum of Qihuangtongmi soft capsule and a standard fingerprint spectrum thereof, and adopts HPLC method and performs detection according to the following conditions: chromatographic column: octadecyl bonded silica gel chromatographic column; ultraviolet detector, detection wavelength 254nm; mobile phase A: acetonitrile, mobile phase B is water, gradient elution. The method provided by the present invention can obtain a fingerprint spectrum by one measurement, and the fingerprint spectrum established by the method provides rich chemical information, 8 common peaks are detected in total, 4 known peaks are attributed, and the characteristics of Qihuangtongmi soft capsule can be fully reflected, and the specificity is good, and the basis is provided for the quality control of Qihuangtongmi soft capsule, and the practicality is good.
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