Quality Evaluation on Xuanmai Ganjie Preparation Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.10.014
- VernacularTitle:基于国家药品抽检的玄麦甘桔制剂质量评价
- Author:
Jingyun LI
1
;
Liang HU
;
Jiangnan LUO
;
Yinghong WANG
;
Xunyou TANG
;
Sheng LIANG
;
Liqin ZHAN
;
Jingkai ZENG
;
Yan LUO
;
Hui SUN
;
Ye DING
;
Wenli LI
;
Jialiang ZHU
Author Information
1. 湖南省药品检验检测研究院,长沙 410001;湖南省药品质量评价工程技术中心,长沙 410001
- Publication Type:Journal Article
- Keywords:
Xuanmai Ganjie preparation;
National drug sampling and testing;
Quality evaluation
- From:
Herald of Medicine
2025;44(10):1606-1611
- CountryChina
- Language:Chinese
-
Abstract:
Objective Based on the national drug sampling inspection program,this study aims to comprehensively and systematically evaluate the quality of Xuanmai Ganjie preparations,analyze existing quality issues,and provide references and suggestions for quality control of this variety.Methods A total of 237 batches of Xuanmai Ganjie preparations were tested using legal standards,and methods were established for detecting adulteration of Ophiopogon japonicus with counterfeit varieties,paclobutrazol residue levels,and determining the content of platycodin D in Xuanmai Ganjie preparations.These methods were applied to the quality control and evaluation of Xuanmai Ganjie preparations.Results Through statutory inspection,one batch of Xuanmai Ganjie granules was found non-compliant.Specific batches were identified to contain the following irregularities:adulteration of Ophiopogon japonicus with counterfeit varieties,paclobutrazol residue levels exceeding proposed limits,and platycodin D content below the established threshold.Conclusion The overall quality of Xuanmai Ganjie granules was average,while the overall quality of Xuanmai Ganjie capsules and lozenges was relatively good.Manufacturing enterprises should strengthen their sense of primary responsibility and enhance control over the entire drug production process.
