国家药品抽检工作是我国对药品质量监管的重要手段,为药品监管和标准完善提供了有力支持。本文对 2015年和2022年中国食品药品检定研究院中药民族药检定所完成的紫草品种的国家药品抽检工作进行总结,结果显示紫草的合格率由2015年的43.9%提高到87.5%,紫草合格率大幅度提升。2次全国性的紫草抽检,都反映了新疆紫草资源匮乏,内蒙紫草濒临枯竭,导致目前市场上的紫草饮片不合格样品占有率较高。2015年抽检的不合格样品的薄层鉴别斑点部分与合格样品一致,2022年抽检的不合格样品薄层鉴别与合格样品一致,但斑点的深浅程度与合格样品不一致,提示现在的不合格样品为掺伪样品,给紫草的质量监管带来更大的挑战。通过2次抽检工作的探索性研究初步认为,完善紫草药典标准,科学建立检验项目及加强质控体系建设对紫草监管有重要意义。
戴胜云, 刘杰, 袁苏宁, 连超杰, 乔菲, 昝珂, 过立农, 马双成, 郑健
. 基于2015年和2022年国家药品抽检探讨紫草的质量现状*[J]. 药物分析杂志, 2024
, 44(5)
: 740
-749
.
DOI: 10.16155/j.0254-1793.2024.05.01
The national drug sampling and inspection project is an important way of drug quality supervision in China which providing strong support for drug supervision and standard improvement. This article summarizes the national drug sampling and inspection project of Arnebiae Radix completed by Institute for Control of Chinese Traditional Medicine and Ethnic Medicine, National Institutes for Food and Drug Control in 2015 and 2022. The results illustrated that the qualification rate of Arnebiae Radix has increased from 43.9% in 2015 to 87.5%, and the qualification rate of Arnebiae Radix has significantly increased. The two nationwide inspections of Arnebiae Radix reflected the scarcity of Arnebiae Radix resources in Xinjiang and Inner Mongolia, resulting in a high market share of unqualified samples. The thin layer identification spots of the unqualified Arnebiae Radix sampled in 2015 were not consistent with the qualified samples. The thin layer identification of the unqualified samples sampled in 2022 was consistent with those of the qualified samples, but the depth of the spots were not consistent with those of the qualified samples, indicating that the current unqualified samples were adulterated samples, which posing greater challenges to the quality supervision of Arnebiae Radix. Through the exploratory research of twice National Drug Sampling and Inspection Project, it is preliminarily believed that it is of great significance to improve the standard test items of Arnebiae Radix, scientifically establish the limit value and strengthen the construction of the quality control system for the supervision.
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