Objective  To explore the ex-factory value of aluminum ion in human albumin and the the current status of the residual aluminum ions during the shelf period, and focus on the quality improvement of glass bottles used in the products, so as to provide references for the evaluation of the use of packaging materials of the products.

Methods  The samples of human albumin in 2023 were determined by atomic absorption spectrometry and compared with the national sampling data of human albumin in 2018. The quality of two domestic medicinal glass bottles was investigated by accelerating test to compare the variation of aluminum content in samples.

Results  The ex-factory values of aluminum ions in 8 enterprises in 2023 decreased significantly compared with those in 2018 (the decline rates of 31%-75%). In 2023, the residual aluminum ions of domestic products during the shelf life was 65% lower than that of 2018 on average. Compared with 2018, the aluminum ion release of the two glass bottles used in 2023 decreased by 78% and 25%, respectively.

Conclusion  Both the residual aluminum ions of human albumin products in factory inspection and national sampling inspection, and the residual aluminum ions in glass bottle accelerated test samples of two domestic key pharmaceutical packaging material manufacturers decreased, indicating that the quality of domestic glass bottles has improved. It is suggested that the production enterprises should continue to pay attention to the use and compatibility of packaging materials.

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