Research on the current quality status of domestic human serum albumin

Published on Feb. 28, 2026Total Views: 53 times Total Downloads: 11 times Download Mobile

Author: XIE Yuyuan ^1, ² ZHAN Li ^1, ² KE Bingbing ^1, ² YANG Juan ^1, ² WANG Wenxi ^1, ²  GUO Jianghong ^1, ²

Affiliation: 1. Hubei Institute for Drug Control, Wuhan 430075, China 2. Key Laboratory of Quality Control of Blood Products, National Medical Products Administration, Wuhan 430075, China

Keywords: Human serum albumin Quality evaluation Aluminum residue Impurity proteins Flow particle imaging Protein particle Silicone oil Packaging materials

DOI: 10.12173/j.issn.2097-4922.202510062

Reference: XIE Yuyuan, ZHAN Li, KE Bingbing, YANG Juan, WANG Wenxi, GUO Jianghong. Research on the current quality status of domestic human serum albumin[J]. Yaoxue QianYan Zazhi, 2026, 30(2): 246-255. DOI: 10.12173/j.issn.2097-4922.202510062.[Article in Chinese]  Copied

Abstract
Full-text
References

Abstract

Objective To evaluate the quality of domestic and imported human serum albumin (HSA) and to analyze trends in critical quality attributes.

Methods According to the Chinese Pharmacopoeia (2020 edition) and manufacturer registration standards, 57 batches of HSA from 21 manufacturers were subjected to statutory testing. Exploratory studies (aluminum residue, impurity proteins, flow imaging particle analysis) and historical data comparisons were integrated to assess product quality comprehensively.

Results All batches complied with statutory standards (100% compliance). Aluminum residue levels (2023 domestic mean: 28 μg/L, imported products: 14 μg/ L) decreased significantly compared to 2018, with a 65% reduction. Impurity protein types declined from 24 in 2018 to 11. The main components of sub-visible particles (1-100 μm) in both domestic and imported products were protein particles and silicone oil, with no significant difference between them.

Conclusion The quality of domestic HSA products has been significantly improved, with packaging material improvement and production process optimization being key factors driving quality improvement. It is recommended to further strengthen packaging material compatibility studies and actively promote the application of new technologies.

Full-text

Please download the PDF version to read the full text: download

References

1.Burnouf T, Radosevich M. Affinity chromatography in the industrial purification of plasma proteins for therapeutic use[J]. J Biochem Biophys Methods, 2001, 49: 575-586. DOI: 10.1016/S0165-022X(01)00221-4.

2.李璐, 兰学渊, 林宏辉. 95%乙醇循环系统对人血白蛋白质量的影响分析[J]. 中国生物制品学杂志, 2017, 30(7): 747-750. [Li L, Lan XY, Lin HH. Analysis of the effect of 95% ethanol circulation system on the quality of human serum albumin[J]. Chinese Journal of Biologicals, 2017, 30(7): 747-750.] DOI: 10.13200/j.cnki.cjb.001805.

3.王超花, 刘婷婷. 医院人血白蛋白临床合理应用的效果评价及药学干预措施分析[J]. 中国处方药, 2024, 22(7): 51-56. [Wang CH, Liu TT. Effect evaluation of rational clinical application of hospital human blood albumin and analysis of pharmaceutical intervention measures[J]. Journal of China Prescription Drug, 2024, 22(7): 51-56.] DOI: 10.19962/j.cnki.issn1008-049X.2024.03.018.

4.谢丹, 杨薇薇, 庹康秀. 人血白蛋白的临床合理使用探讨 [J]. 中国合理用药探索, 2024, 21(8): 65-70. [Xie D, Yang WW, Tuo KX. Discussion on rational clinical use of human albumin[J]. Chinese Journal of Rational Drug Use, 2024, 21(8): 65-70.] DOI: 10.3969/j.issn.2096-3327.2024.08.006.

5.张玉. 人血白蛋白临床应用管理中国专家共识[J]. 中国医院药学杂志, 2024, 44(7): 739-751. [Zhang Y. Expert consensus on clinical application management of human albumin[J]. Chinese Journal of Hospital Pharmacy, 2024, 44(7): 739-751.] DOI: 10.13303/j.cjbt.issn.1004-549x.2024.07.011.

6.中国药典2020年版. 三部[S]. 2020: 245-246.

7.中国药典2025年版. 三部[S]. 2025: 215-216.

8.USP 46-NF41[S]. 2023: Albumin Human. DOI: https://doi.org/10.31003/USPNF_M1180_01_01.

9.EP 11.0[S]. 2023: 2971-2973.

10.柯兵兵, 谢育媛, 王德蓉, 等. 人血白蛋白中杂蛋白的生物质谱分析[J]. 中国药学杂志, 2020, 55(2): 148-152. [Ke BB, Xie YY, Wang DR, et al. Analysis of impurity proteins by biomass spectrometry in human serum albumin[J]. Chinese Pharmaceutical Journal, 2020, 55(2): 148-152.] DOI: 10.11669/cpj.2020.02.012.

11.谢力琦, 毕宝帅, 黄懿. 微流数字成像技术在蛋白药物制剂不溶性微粒分析中的应用[J]. 中国医药工业杂志, 2024, 55(1): 36-41. [Xie LQ, Bi BS, Huang Y. Application of microflow digital imaging in analysis of insoluble particles in protein drug formulations[J]. Chinese Journal of Pharmaceuticals, 2024, 55(1): 36-41.] DOI: 10.16522/j.cnki.cjph.2024.01.003.

12.USP. General Chapter <1787>[S]. 2023.

13.陈真, 王夙博, 石峰, 等. 基于特征肽液质联用技术的人血白蛋白鉴定与定量分析[J]. 药学研究, 2024, 43(8): 759-763, 805. [Chen Z, Wang SB, Shi F, et al. Identification and quantitative analysis of human blood albumin based on characteristic peptide and liquid technology[J]. Journal of Pharmaceutical Research, 2024, 43(8): 759-763, 805.] DOI: 10.13506/j.cnki.jpr.2024.08.006.

14.范蓓, 冯云安, 王振海, 等. 模制瓶及盐水透析对人血白蛋白制品中铝离子残留量的影响[J]. 中国生物制品学杂志, 2022, 35(1): 37-40. [Fan B, Feng YA, Wang ZH, et al. Effects of molded glass vials and saline dialysis on aluminum ion residues in human serum albumin products[J]. Chinese Journal of Biologicals, 2022, 35(1): 37-40.] DOI: 10.13200/j.cnki.cjb.003498.

15.白亦昊, 赵璇, 周长明. 激肽释放酶原激活剂在人血白蛋白制品中的评价分析[J]. 中国药事，2025，39(2): 175-181. [Bai YH, Zhao X, Zhou CM. Evaluation of prekalikrein activator in human serum albumin products[J]. Chinese Pharmaceutical Affairs, 2025, 39(2): 175-181.] DOI: 10.16153/j.1002-7777.2024-10-0028.

16.李剑, 金川, 李锐, 等. FIV静置对FIV沉淀分离及人血白蛋白质量影响的研究[J]. 中国新技术新产品, 2021, (15): 69-71. [Li J, Jin C, Li R, et al. Effects of FIV static storage on FIV precipitation and human serum albumin quality[J]. New Technologies and New Products of China, 2021, (15): 69-71.] DOI: 10.3969/j.issn.1673-9957.2021.15.024.

17.郭江红, 谢育媛, 柯兵兵, 等. 人血白蛋白质量评价与研究[J]. 中国药学杂志, 2019, 54(9): 734-740. [Guo JH, Xie YY, Ke BB, et al. Quality evaluation and research of human serum albumin[J]. Chinese Pharmaceutical Journal, 2019, 54(9): 734-740.] DOI: 10.11669/cpj.2019.09.011.

18.詹栎, 曾浩, 王文晞, 等. 人血白蛋白铝离子残留现状分析[J]. 中国药师, 2024, 27(3): 376-381. [Zhan L, Zeng H, Wang WX, et al. Analysis of the current status of residual aluminum ion in human albumin[J]. Zhongguo Yaoshi Zazhi, 2024, 27(3): 376-381.] DOI: 10.12173/j.issn.1008-049X.202401231.

19.U.S. Food and Drug Administration. Guidance for industry: container closure systems for packaging human drugs and biologics[EB/OL]. (2021-05)[2024-12-01]. https://www.fda.gov/media/70788/download.

20.徐明明, 赵沁, 周勤, 等. 人血白蛋白中蛋白聚合物的研究 [J]. 中国药事, 2021, 35(11): 1246-1252. [Xu MM, Zhao Q, Zhou Q, et al. Study on protein aggregates in human serum albumin[J]. Chinese Pharmaceutical Affairs, 2021, 35(11): 1246-1252.] DOI: 10.16153/j.1002-7777.2021.11.007.

21.陈家啡, 陈秀良, 连庆云, 等. PKA含量动力学检测方法的研究与建立[J]. 中国输血杂志, 2021, 34(3): 227-231. [Chen JF, Chen XL, Lian QY, et al. Development of a kinetic assay for prekallikrein activator content[J]. Chinese Journal of Blood Transfusion, 2021, 34(3): 227-231.] DOI: 10.13303/j.cjbt.issn.1004-549x.2021.03.007.

22.鲁松, 杨萍, 杨黎, 等. 人血白蛋白注射液的药品评价研究进展[J]. 中国药物警戒, 2022, 19(2): 228-232. [Lu S, Yang P, Yang L, et al. Progress in drug evaluation of human serum albumin injections[J]. Chinese Journal of Pharmacovigilance, 2022, 19(2): 228-232.] DOI: 10.19803/j.1672-8629.2022.02.27.

23.焦旭雯, 梁蔚阳, 陈宇堃, 等. 人血白蛋白中常见可见异物成因及控制分析[J]. 中国生物制品学杂志，2022，35(3): 285-288, 292. [Jiao XW, Liang WY, Chen YK, et al. Analysis on cause and control of visible particles in human albumin[J]. Chinese Journal of Biologicals, 2022, 35(3): 285-288, 292.] DOI: 10.13200/j.cnki.cjb.003699.

24.周亚菊, 张彬, 徐俊, 等. 玻璃瓶中可提取元素的测定及其对人血白蛋白中铝残留量的影响分析[J]. 中国医药工业杂志, 2022, 53(6): 896-900. [Zhou YJ, Zhang B, Xu J, et al. Determination of extractable elements in glass vials and its effect on aluminum residue in human serum albumin[J]. Chinese Journal of Pharmaceuticals, 2022, 53(6): 896-900.] DOI: 10.16522/j.cnki.cjph.2022.06.019.

25.李剑, 金川, 李锐, 等. FIV静置对FIV沉淀分离及人血白蛋白质量影响的研究[J]. 中国新技术新产品, 2021, (15): 69-71. [Li J, Jin C, Li R, et al. Effects of FIV static storage on FIV precipitation and human serum albumin quality[J]. New Technology New Products of China, 2021, (15): 69-71.] DOI: 10.3969/j.issn.1673-9957.2021.15.024.