Statistics of non-conformance information and quality risk analysis of domestic enteric coated tablets in sampling inspection

Published on Apr. 29, 2025Total Views: 52 times Total Downloads: 31 times Download Mobile

Author: WU Yanlin WANG Shanshan QIAO Ge  NIE Xiaochun

Affiliation: Wuhan Institute for Drug and Medical Device Control, Wuhan 430075, China

Keywords: Drug sampling inspection Enteric-coated tablets Dissolution Regulation

DOI: 10.12173/j.issn.2097-4922.202412032

Reference: WU Yanlin, WANG Shanshan, QIAO Ge, NIE Xiaochun. Statistics of non-conformance information and quality risk analysis of domestic enteric coated tablets in sampling inspection [J]. Yaoxue QianYan Zazhi, 2025, 29(4): 582-587. DOI: 10.12173/j.issn.2097-4922.202412032.[Article in Chinese]  Copied

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Abstract

Objective To summarize the abnormal results of dissolution degree of commercially available diclofenac sodium enteric-coated tablets found in the daily supervision and sampling test of Wuhan Institute for Drug and Medical Device Control, and analysis the quality status of enteric coated tablets in China. systematically analyze the reasons for its occurrence, assess its quality risks, provide risk warnings, and provide reference for improving the quality of such preparations and ensuring clinical drug safety.

Methods The product name, unqualified items, manufacturer, sampling location, batch number and year in the unqualified records of enteric-coated tablets were systematically collected and sorted, and the literature search, classification and causal analysis were conducted.

Results Among the 54 enteric-coated tablets, there were 124 batches of unqualified records for 15 varieties, of which 10 varieties had a total of 78 batches of unqualified dissolution projects.

Conclusion The unqualified dissolution of enteric-coated tablets is closely related to the enteric-coating materials, coating process, product storage conditions, etc. The quality of enteric-coated tablets can be improved by improving the coating materials, optimizing the process parameters, and strengthening the daily supervision and sampling.

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References

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