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.
DAI Sheng-yun, LIU Jie, YUN Su-ning, LIAN Chao-jie, QIAO Fei, ZAN Ke, GUO Li-nong, MA Shuang-cheng, ZHENG Jian
. Discussion on the quality status of Arnebiae Radix based on the national drug sampling and testing in 2015 and 2022*[J]. Chinese Journal of Pharmaceutical Analysis, 2024
, 44(5)
: 740
-749
.
DOI: 10.16155/j.0254-1793.2024.05.01
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