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Compatibility and Packaging Integrity between Human Albumin Injection and Container of Cyclic Olefin Polymer
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Sha LI1, Qiming ZHANG2, Chenyao LEI2, Mi WEI1, Xiangdong HAN2, *
Chinese Pharmaceutical Journal | 2024, 59(12) : 1129 - 1134
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Chinese Pharmaceutical Journal | 2024, 59(12): 1129-1134
Compatibility and Packaging Integrity between Human Albumin Injection and Container of Cyclic Olefin Polymer
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Sha LI1, Qiming ZHANG2, Chenyao LEI2, Mi WEI1, Xiangdong HAN2, *
Affiliations
  • 1 School of Biological and Pharmaceutical Engineering, Lanzhou Jiaotong University, Lanzhou 730070, China
  • 2 Sinopharm Lanzhou Biopharmaceuticals Co., Ltd, Lanzhou 730046, China
Published: 2024-06-22 doi: 10.11669/cpj.2024.12.008
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OBJECTIVE To explore the feasibility of using cyclic olefin polymer (COP) as packaging material for human albumin products. METHODS Human albumin products were stored in COP bottles. Under the conditions of long-term stability (2-8 ℃ for 24 months) and accelerated stability [(25±2) ℃ for 12 months], the key quality indexes of albumin and the probable extracts of COP material were analyzed, and the seal integrity of COP packages was tested. RESULTS Under both test conditions, the appearance, visible foreign matter, numbers of insoluble particles, pH, purity, polymer content, residual aluminum content, protein content, activity of prekallikrein activator and abnormal toxicity of the albumin products all conformed to the quality standards and met the requirements of Chinese Pharmacopoeia. In the products, the contents of molybdenum, nickel, methylbenzene, and cyclohexane that may be produced by COP bottles were all lower than the quality standard limits. Moreover, the human albumin packaging container assembled by COP bottle, halogenated butyl rubber plug and aluminum-plastic combination cap showed excellent package integrity. CONCLUSION COP can be used in the storage and transport of human albumin.

pharmaceutical packaging material  /  cyclic olefin polymer  /  human albumin  /  drug quality
Sha LI, Qiming ZHANG, Chenyao LEI, Mi WEI, Xiangdong HAN. Compatibility and Packaging Integrity between Human Albumin Injection and Container of Cyclic Olefin Polymer[J]. Chinese Pharmaceutical Journal, 2024 , 59 (12) : 1129 -1134 . DOI: 10.11669/cpj.2024.12.008
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Article Info
doi: 10.11669/cpj.2024.12.008
  • Receive Date：2023-12-13
  • Online Date：2025-11-25
  • Published：2024-06-22
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  • Received：2023-12-13
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    1 School of Biological and Pharmaceutical Engineering, Lanzhou Jiaotong University, Lanzhou 730070, China
    2 Sinopharm Lanzhou Biopharmaceuticals Co., Ltd, Lanzhou 730046, China
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https://castjournals.cast.org.cn/joweb/zgyxzz/EN/10.11669/cpj.2024.12.008
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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