除了副作用之外:对制药中的动物成分的免疫伦理风险分析
Yedi Herdiana1, Dolih Gozali1, Norisca Aliza Putriana1
1Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, Universitas Padjadjaran, Sumedang, West Java, Indonesia.
Risk management and healthcare policy
|March 4, 2026
概括
药物中的动物成分带来了诸如阿尔法综合征 (AGS) 和道德冲突等风险. 开发无动物替代品 (AFA) 是至关重要的,但在扩展性和成本方面仍然存在挑战,以便更广泛地采用.
科学领域:
- 生物医学科学 生物医学科学
- 制药科学 制药科学
- 生物伦理学生物伦理学
背景情况:
- 来自动物的成分 (ADI) 占处方药的很大一部分,存在诸如阿尔法综合征 (AGS),道德宗教问题和供应链不透明等风险.
- 由于依赖ADI,因此需要进行彻底的评估,并在制药开发中推广无动物替代品 (AFA).
研究的目的:
- 批判性地审查药品中ADI的持久性.
- 分析与ADI相关的风险,包括生物 (例如,AGS) 和宗教 (例如,Halal) 因素.
- 评估开发和实施AFAs的进展和挑战.
主要方法:
- 一个全面的文献综述,综合来自生物医学,监管和伦理领域的证据.
- 制定一个双重风险分层框架,整合免疫学概况 (银糖α-1,3-银糖表位) 和哈拉尔司法判例标准.
- 评估现有的AFA (植物性,重组,合成) 和支持监管举措.
主要成果:
- 由于其在医疗产品中的功能,监管和生物相容性益处,ADI仍然很普遍.
- 双重风险框架有效地根据免疫学和宗教标准对制药成分进行分类.
- 虽然AFA正在推进,但在可扩展性,成本效益和生物等价性方面仍然存在重大障碍.
结论:
- 过渡到AFA对于患者安全,伦理考虑和供应链透明度至关重要.
- 克服AFA开发和实施的挑战需要一个统一的科学,伦理和宗教框架.
- 加快采用安全,包容性的AFA对于患者的自主性和福祉至关重要.
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