Quality Evaluation of Commercially Available Huoxiang Zhengqi Preparations
10.13422/j.cnki.syfjx.20260965
- VernacularTitle:市售藿香正气制剂的优质性评价
- Author:
Yue GUO
1
;
Siyuan LI
2
;
Qingxia XU
2
;
Sha CHEN
2
;
Shuangyan LI
1
;
Jipeng DI
2
;
An LIU
2
;
Yan LIU
2
Author Information
1. Tianjin University of Traditional Chinese Medicine， Tianjin 301617， China
2. Institute of Chinese Materia Medica， China Academy of Chinese Medical Sciences， Beijing 100700， China
- Publication Type:Journal Article
- Keywords:
Huoxiang Zhengqi preparations;
ultra-performance liquid chromatography-triple quadrupole-tandem mass spectrometry （UPLC-QqQ-MS/MS）;
gas chromatography-triple quadrupole-tandem mass spectrometry （GC-QqQ-MS/MS）;
multi-component quantification;
quality evaluation
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2026;32(19):238-247
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo establish a comprehensive evaluation framework combining multi-component quantification with daily intake in response to the challenges posed by multiple coexisting dosage forms， single-faceted quality evaluation， and ambiguous clinical equivalence of Huoxiang Zhengqi preparations， and to compare the quality differences and superiority among eight commercially available dosage forms. MethodsA total of 75 batches of Huoxiang Zhengqi preparations from 25 manufacturers were investigated. Ultra-performance liquid chromatography-triple quadrupole-tandem mass spectrometry （UPLC-QqQ-MS/MS） coupled with gas chromatography-triple quadrupole-tandem mass spectrometry （GC-QqQ-MS/MS） was adopted to simultaneously quantify 20 core marker components. Normalization was performed based on equivalent raw herb concentrations to eliminate interferences from dosage forms， excipients， and specifications. Considering the specified clinical dosage， the actual daily intake level was calculated to comprehensively evaluate component retention， content uniformity， and potential differences in in vivo exposure among different dosage forms. ResultsThe quality of Huoxiang Zhengqi preparations differed greatly among dosage forms and manufacturers. On the basis of the recommended daily doses in the package inserts， the total daily intake of the 20 tested components ranged from 3.14 to 614.30 mg·d-1， while that of hesperidin， a quality-control marker， ranged from 0.03 to 40.65 mg·d-1. Atractylodin was detected only in tinctures and soft capsules， with concentrations ranging from （2.68±0.01） to （5.73±0.37） mg·L-1. The soft capsules from manufacturer M22 had the highest atractylodin level， while atractylodin was not detected in the other dosage forms. Nucleosides were most abundant in the oral liquids and tinctures （M4 to M13）. The tincture from manufacturer M5 showed the highest nucleoside level of 29.12 mg·L-1， whereas the granules had the lowest nucleoside levels， with that of M23 being only 3.48 mg·L-1. Perillae Folium-related components varied greatly among batches， with an relative standard deviation （RSD） of 87.55%. The daily intake of hesperidin from all three granule products was below 3.6 mg·d-1， the reference value calculated for Huoxiang Zhengqi Shui according to the 2025 edition of the Chinese Pharmacopoeia. ConclusionThe levels of active components differed significantly among different dosage forms of Huoxiang Zhengqi preparations. Tinctures contained more types and higher overall levels of active components， while soft capsules were better at preserving volatile components. Granules and dripping pills had lower overall levels of active components. The comprehensive evaluation method established in this study can provide a basis for the quality control， process optimization， and the selection of high-quality products.
