Quality Research and Evaluation of Ketoconazole Lotion Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.10.012
- VernacularTitle:基于国家药品抽检的酮康唑洗剂质量研究评价
- Author:
Yanbin XUN
1
;
Kai DUO
;
Changying XIN
;
Xiaoxu HAN
;
Xia ZHAO
;
Siwen WANG
;
Chunyu WANG
;
Yu XIAO
;
Longshan ZHAO
;
Changyu WANG
;
Xinying YU
Author Information
1. 黑龙江省药品检验研究院,哈尔滨 150088
- Publication Type:Journal Article
- Keywords:
Ketoconazole lotion;
National drug sampling and testing;
Legal standards;
Exploratory research;
Prescription process
- From:
Herald of Medicine
2025;44(10):1595-1600
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.
