Quality Evaluation of Fengshiding Capsules Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.09.009
- VernacularTitle:基于国家药品抽检的风湿定胶囊质量评价
- Author:
Lumei GUO
1
;
Tao CHENG
;
Donglan LIU
;
Xingpeng LIU
;
Ming YANG
;
Fangfang SI
;
Min ZOU
;
Jialiang ZHU
Author Information
1. 贵州省食品药品检验所中药室,贵阳 550018
- Publication Type:Journal Article
- Keywords:
Fengshiding capsules;
National drug sampling and testing;
Quality evaluation
- From:
Herald of Medicine
2025;44(9):1423-1430
- CountryChina
- Language:Chinese
-
Abstract:
Objective To systematically evaluate the quality of Fengshiding capsules,to analyze existing problems based on national drug sampling and testing,and to offer references and suggestions for improving quality control and regulatory supervision of this product.Methods A total of 136 batches of Fengshiding capsules were subjected to standard quality tests and exploratory analyses.HPLC was used to establish the content determination of Angelica dahurica,Cynanchum paniculatum,and Glycyrrhizae Radix,as well as the limit test for anabasine in the preparation.Additionally,an UPLC method was also employed to establish the characteristic chromatogram of Fengshiding capsules.A screening method for artificial pigments was developed,and UPLC-MS/MS was used to detect the illegal addition of chemical drugs in Fengshiding capsules.Results All 136 batches of samples passed inspection according to the current quality standards.However,based on exploratory study evaluations,the content determination results of Cynanchum paniculatum,Angelica dahurica,and Glycyrrhiza Radix were below the proposed limits.The limit test for anabasine did not exceed the proposed threshold.Furthermore,the characteristic chromatograms revealed missing peaks in several samples,and some batches contained artificial pigments and residues of acetaminophen.Conclusions The overall quality of Fengshiding capsules is rated as"average"based on national drug sampling and testing.To enhance product quality,it is recommended to improve quality standards,ensure the use of high-quality raw herbal materials,promote stronger internal oversight by manufacturers,and intensify regulatory supervision.
