Quality Analysis and Suggestion of Zukamu Preparation Based on National Drug Sampling and Testing
10.3870/j.issn.1004-0781.2025.10.013
- VernacularTitle:基于国家药品抽检的祖卡木制剂质量分析与建议
- Author:
Shengyun DAI
1
;
Dongxue WU
1
;
Rui WU
1
;
Meng XIAO
1
;
Jie LIU
1
;
Chaojie LIAN
1
;
Xiaoru HU
1
;
Feng WEI
1
;
Jian ZHENG
1
;
Jialiang ZHU
1
Author Information
1. 中国食品药品检定研究院中药民族药检定所民族药室,北京 102629
- Publication Type:Journal Article
- Keywords:
Zukamu preparations;
National drug sampling and testing;
Quality assessment
- From:
Herald of Medicine
2025;44(10):1600-1605
- CountryChina
- Language:Chinese
-
Abstract:
Objective To examine the quality of Zukamu preparations through the national drug sampling and testing,and further understand their current quality status and existing problems.This work is benefit for improving the quality standard of Zukamu preparations and providing technical support for the drug regulatory authorities.Methods Samples of Zukamu preparations were collected from a total of 29 provinces in China,and were tested for description,identification,other requirements(weight variation,particle size,determination of water,disprsion,and microbial limit items),and assay in accordance with the national pharmaceutical standards.The test data were analyzed to evaluate the quality status of the Zukamu preparations,and exploratory research was carried out to address the problems found in the test.Results A total of 97 batches of Zukamu preparations were sampled,and the passing rate was 100.0%according to the current quality standard.Exploratory study,revealed that Zukamu preparation were subject to 4 testing standards,with uneven test items,missing items,poor operability,and lack of exclusivity in some items.The test based on the existing standards can't comprehensively evaluate the quality of the preparation.Conclusions Based on the national drug sampling and testing,combined with exploratory research on drug safety,authenticity and effectiveness,it is recommended to unify the quality standards of Zukamu preparations by combining with the work of standard improving,revising the identification method of thin-layer chromatography,increasing the content determination,and establishing the quick test method,thereby effectively evaluating and controling the quality of the samples of Zukamu preparations.
