Data Analysis and Suggestions on Unqualified Compound Danshen Tablets from Drug Sampling based on NMPA Drug Quality Announcement
Jie Hengbo, Li Wenhan, Zhang Cuilian*, Zuo Wei*
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Department of Pharmacy, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China
Objective: To provide references for further quality improvement of traditional Chinese patent medicines by extracting and analyzing the Unqualified information of Compound Danshen Tablets released by the National Medical Products Administration (NMPA) from 2016 to 2022. Methods: The data were extracted from the interface of “National Drug Sampling Database” on the NMPA official website. The research keyword was “Compound Danshen Tablets”. Through classification analysis, the data of Unqualified quality of Compound Danshen Tablets and unqualified batches of products from the involved pharmaceutical production enterprises were statistically analyze. Results: A total of 54 unqualified records of this product were retrieved, involving 46 batches of products from 24 manufacturing enterprises. 63.0% of the batches were Unqualified due to assay of content and 34.8% of them were unqualified due to weight variation. Among the 29 batches which were unqualified due to assay of content, the top unqualified items were content of Panax notoginseng (34.5%), content of Tanshinone IIA (20.7%) and content of Salvianolic acid B (20.7%). The phenomenon of Unqualified products was concentrated in certain production enterprises. Among the 24 enterprises involved, 6 (25.0%) of the enterprises had 3 or more batches of Unqualified products, involving 24 batches of Unqualified products which accounted for 52.17% of the total unqualified batches. Conclusion: The number of unqualified batches and items of Compound Danshen Tablets has been decreasing from 2017 to 2022, indicating that the overall quality of Compound Danshen Tablets was gradually improving. However, quality risks still exist. It is still necessary to remind the enterprises to continue strengthening internal quality control and improve the management of transportation and storage processes to avoid quality issues caused by environmental factors such as humidity. It is recommended that the regulatory authorities should strengthen the sampling and exploratory work and further improve the quality standard of Compound Danshen Tablets to ensure the safety of public medication.
Jie Hengbo, Li Wenhan, Zhang Cuilian, Zuo Wei.
Data Analysis and Suggestions on Unqualified Compound Danshen Tablets from Drug Sampling based on NMPA Drug Quality Announcement[J]. Chinese Pharmaceutical Affairs, 2024, 38(9): 1001-1007 https://doi.org/10.16153/j.1002-7777.20240385