Comparability Study of Human Albumin Produced with Different Shapes of Internal Packaging Materials

ZHAO Shuyi, YANG Lingtong, CAI Hui, REN He, ZHANG Daman, GOU Yangmei, HAN Xiangdong, YANG Xiaodong

Packaging Engineering ›› 2024 ›› Issue (7) : 38-44.

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PDF(471 KB)
Packaging Engineering ›› 2024 ›› Issue (7) : 38-44. DOI: 10.19554/j.cnki.1001-3563.2024.07.006

Comparability Study of Human Albumin Produced with Different Shapes of Internal Packaging Materials

  • ZHAO Shuyi, YANG Lingtong, CAI Hui, REN He, ZHANG Daman, GOU Yangmei, HAN Xiangdong, YANG Xiaodong
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Abstract

The work aims to compare the quality of human albumin in two materials of different shapes, and provide a basis for preparation enterprises to choose pharmaceutical packaging materials that can meet the requirements of drug manufacturing and use, so as to ensure the quality of drugs, and meet clinical needs and use safety. The stability of human albumin in the two packages was investigated at (25±2) ℃ for 6 months to observe the change of product quality index at different time points, and analyze the sealing of human albumin in the two internal packaging materials. The quality indexes at each time point of the inspection all met the "Pharmacopoeia of the People's Republic of China" (2020 edition), and the trends of key quality indicators were consistent. At the same time, small pharmaceutical packaging material of human albumin had better stability in pH, purity and aluminum residue. No leakage of human albumin was detected in two packages. Two internal packaging materials of different shapes have no significant effect on the quality of human albumin. They have good sealing, which can guarantee the quality and safety of drugs. At the same time, small specification pharmaceutical packaging material of human albumin has better stability.

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ZHAO Shuyi, YANG Lingtong, CAI Hui, REN He, ZHANG Daman, GOU Yangmei, HAN Xiangdong, YANG Xiaodong. Comparability Study of Human Albumin Produced with Different Shapes of Internal Packaging Materials[J]. Packaging Engineering. 2024(7): 38-44 https://doi.org/10.19554/j.cnki.1001-3563.2024.07.006
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