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Preliminary Study on the Safety of Human Plasma Fraction Ⅳ-Derived α2-Macroglobulin
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Teng FENG1a, 2, Fang YUAN2, Fangling QI1b, 2, Shaowei WANG1a, Junting JIA2, Chongwei CHEN1a, *, Yuyuan MA2, *
Chinese Pharmaceutical Journal | 2025, 60(9) : 941 - 648
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Chinese Pharmaceutical Journal | 2025, 60(9): 941-648
Preliminary Study on the Safety of Human Plasma Fraction Ⅳ-Derived α2-Macroglobulin
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Teng FENG1a, 2, Fang YUAN2, Fangling QI1b, 2, Shaowei WANG1a, Junting JIA2, Chongwei CHEN1a, *, Yuyuan MA2, *
Affiliations
  • 1 The Second Clinical Medical College, 1b.College of Pharmacy, Shanxi Medical University, Taiyuan 030001, China
  • 2 Academy of Military Medical Sciences, NMPA Key Laboratory for Quality Control of Blood Products, Beijing 100850, China
Published: 2025-05-01 doi: 10.11669/cpj.2025.09.006
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OBJECTIVE To evaluate the safety of intra-articular injection of α2-macroglobulin(α2-M) derived from human plasma Cohn fraction Ⅳ. METHODS α2-M was prepared from human plasma Cohn fraction Ⅳ and its purity and activity were tested. A rabbit red blood cell hemolysis test was conducted using an in vitro test tube method. The local irritancy was evaluated by injecting α2-M into the knee joint cavity of rats. The abnormal toxicity test was conducted by injecting α2-M into the abdominal cavity of mice and guinea pigs. RESULTS The purity of fraction Ⅳ derived α2-M was 95%, with an activity of (6.835±0.104) μg·mL-1. In the in vitro hemolysis test, no hemolysis or aggregation was observed macroscopically, but slight hemolysis was detected by spectrophotometry. The irritancy test showed no obvious abnormalities at the injection site of the rats after administration, with good general condition, appearance, behavior, and spirit, and no abnormal changes in routine blood and blood biochemistry indicators except for PCT and Bas. In the abnormal toxicity test, no abnormal reactions were observed within 30 min after intraperitoneal injection of the test article in mice and guinea pigs, and the average body weight of mice and guinea pigs increased by the end of the observation period. CONCLUSION α2-M derived from human plasma Cohn fraction Ⅳ is considered to be safe in vivo.

Cohn fraction Ⅳ  /  α2-macroglobulin  /  safety  /  blood product  /  intra-articular injection
Teng FENG, Fang YUAN, Fangling QI, Shaowei WANG, Junting JIA, Chongwei CHEN, Yuyuan MA. Preliminary Study on the Safety of Human Plasma Fraction Ⅳ-Derived α2-Macroglobulin[J]. Chinese Pharmaceutical Journal, 2025 , 60 (9) : 941 -648 . DOI: 10.11669/cpj.2025.09.006
Year 2025 volume 60 Issue 9
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doi: 10.11669/cpj.2025.09.006
  • Receive Date:2024-12-17
  • Online Date:2025-11-11
  • Published:2025-05-01
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  • Received:2024-12-17
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    1 The Second Clinical Medical College, 1b.College of Pharmacy, Shanxi Medical University, Taiyuan 030001, China
    2 Academy of Military Medical Sciences, NMPA Key Laboratory for Quality Control of Blood Products, Beijing 100850, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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