口服胰岛素制剂的研究进展
收稿日期: 2025-07-14
修回日期: 2026-01-15
录用日期: 2026-05-26
网络出版日期: 2026-05-26
基金资助
重庆市科学技术局科研机构绩效激励引导专项项目(cqifdc-yjkt-2021-09)
Research Advances in Oral Insulin Formulations
Received date: 2025-07-14
Revised date: 2026-01-15
Accepted date: 2026-05-26
Online published: 2026-05-26
目的:综述口服胰岛素制剂的研究进展,探讨其在糖尿病治疗中的应用潜力及挑战。方法:检索中国知网(CNKI)、万方(WanFang)、PubMed、Web of Science 等数据库2010—2025年的相关文献,结合国家药品监督管理局(NMPA)、美国FDA和欧洲EMA的监管数据,从制剂技术、药效学、临床研究及安全性等方面进行分析。结果:胰岛素是糖尿病治疗的关键药物,但传统注射给药方式存在依从性低、低血糖风险等问题。近年来,口服胰岛素制剂在吸收促进剂、酶抑制剂、微粒、凝胶剂、乳剂等技术的推动下取得进展,部分产品已进入临床试验阶段,但仍面临生物利用度低、胃肠道降解、胰岛素聚集、胰岛素稳定性等挑战。结论:口服胰岛素的研究对提高患者用药便利性、改善长期治疗依从性具有重要意义,未来需进一步优化递送系统,以提高其稳定性和临床适用性。
武静文
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口服胰岛素制剂的研究进展
Objective: To review the research progress of oral insulin formulations and explore their application potential and challenges in diabetes treatment.Methods: Relevant literatures from 2010 to 2025 was retrieved from databases including CNKI, WanFang, PubMed, and Web of Science, along with regulatory data from the NMPA, US FDA, and EMA. Analysis was conducted from perspectives of formulation technology, pharmacodynamics, clinical studies, and safety. Results: Insulin plays a key role in diabetes therapy, but traditional injection administration method faces issues such as poor patient compliance and hypoglycemia risks. In recent years, oral insulin formulations have advanced with technologies like absorption enhancers, enzyme inhibitors, microparticles, gels, and emulsions, with some products entering clinical trials. However, challenges remain, including low bioavailability, gastrointestinal degradation, insulin aggregation, and stability issues.Conclusion: Research on oral insulin holds significant promise for improving patient convenience and long-term treatment adherence. Future efforts should focus on optimizing delivery systems to enhance stability and clinical applicability.
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