一种中药组合物HPLC指纹图谱的建立方法及其指纹图谱的应用

By establishing fingerprint spectra of traditional Chinese medicine compositions using HPLC, the problem of limited quality testing indicators for traditional Chinese medicine compositions has been solved, enabling comprehensive and accurate evaluation of the quality of traditional Chinese medicine compositions and ensuring the stability and safety of the products.

CN122409913APending Publication Date: 2026-07-17HEBEI PING AN HEALTH GRP CO LTD
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Patent Information

Application Number
CN202610738423.6
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2026-05-27
Publication Date
2026-07-17

AI Technical Summary

Technical Problem

Existing methods for testing the quality of traditional Chinese medicine compositions use only one indicator, which cannot fully reflect their intrinsic quality, resulting in insufficient quality control.

Method used

Fingerprint chromatograms of traditional Chinese medicine compositions were established using HPLC. Common characteristic peaks were identified and recorded through gradient elution and multi-wavelength detection. Combined with a similarity evaluation system, standard fingerprint chromatograms of traditional Chinese medicine compositions were constructed to ensure good separation and stability of each characteristic peak.

Benefits of technology

It enables comprehensive and accurate evaluation of the quality of traditional Chinese medicine compositions, ensures the stability and consistency of product quality, provides reliable basis for identifying authenticity, and improves the safety and efficacy of traditional Chinese medicine preparations.

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Abstract

本发明公开了一种中药组合物HPLC指纹图谱的建立方法,该方法包括对照品及供试品溶液的制备、HPLC色谱条件的确定及HPLC标准指纹图谱的制作。同时公开了由该方法得到的中药组合物HPLC标准指纹图谱,该指纹图谱有10个共有峰,通过对照品指认3个共有峰。方法简便、稳定性及重现性好,所得图谱特征峰全面,通过标准指纹图谱共有峰的比对,可对中药组合物的质量进行全面评价和控制,有利于精准评估制剂的内在质量,确保其安全性、有效性。
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