The safety of pharmaceutical packaging is one of the key attributes to ensure the safety of drugs,which can be achieved by biological evaluation. The biological evaluation for pharmaceutical packaging should not only rely on biological tests, but also should establish the scientific evaluation concept. This paper introduced the update of biological evaluation for pharmaceutical packaging at home and abroad, and put forward the concept of over all biological evaluation and test selection in the process of risk management for the first time. It focused on the basic principles of biological evaluation based on risk management principles, evaluation process, sample preparation, and the selection principles of extraction solvent and extraction conditions, aiming to better serve the biological evaluation for pharmaceutical packaging.
LIU Cheng-hu, SHI Yan-ping, SUN Xiao-xia, QIAO Chun-xia, SUN Li-kui, SUN Ling-xiao, LIU Jia, HOU Li, WANG Xin
. Progress in biological evaluation for pharmaceutical packaging*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(11)
: 1877
-1883
.
DOI: 10.16155/j.0254-1793.2022.11.02
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