高分子微针用于疫苗无痛皮下给药的研究

Currently, most vaccines are administrated by injections which will always cause pain, bleeding, mass of medical waste and the inconvenience for patients to get treatment only in hospitals and clinics. Biodegradable polymer dissolving microneedles offer a pain-free way to deliver drugs to the skin, so it might be one of the best administration methods for vaccine delivery in the future. Yet there are still some problems existed in polymer microneedles for vaccine delivery to be solved urgently, such as low dosage accuracy and low delivery efficiency, the immunogenicity of vaccines needed to be further improved, and the loss of vaccine activity in the process of microneedle fabrication and storage. Thus, in this project, we intend to launch the research according to the key points mentioned above. We will focus on: (a) designing structures of the new two-step microneedles to improve the dosage accuracy and delivery efficiency (over 95%); (b) selecting and optimizing the formula of vaccine adjuvant combined to polymer microneedles to dramatically increase the vaccines immunogenicity in the microneedles; (c) systematically studying the key factors for the loss of vaccine activity in the process of microneedle fabrication and storage, then presenting the improved preparation technology and formulas for microneedle fabrication, the improved storage conditions for vaccine microneedles to keep antigenicity more than 80%. This project will provide technical support and theoretical basis for the development of polymer microneedles for vaccine delivery.

目前，大部分疫苗的主要给药方式为打针注射，该方式有诸多缺点，如疼痛、需去医院由医护人员操作、产生大量医疗垃圾等。生物可降解高分子可溶微针可无痛地将疫苗类药物输送进皮下，是将来疫苗给药的最佳方式之一，但目前高分子微针在疫苗给药方面仍有一些问题亟待解决，如微针给药精度和效率较低、疫苗免疫原性有待进一步提高、微针制备和存储过程疫苗活性损失较大等。本项目拟针对以上关键问题展开研究。重点研究：（1）设计新型两段式微针结构，以增加微针给药精度与效率（95%以上）；（2）将疫苗佐剂的筛选与配方优化与高分子微针相结合，以大幅度增强疫苗在微针使用中的免疫原性；（3）系统研究在高分子微针制备与存储过程中影响疫苗活性损失的关键因素，提出优化微针制备的工艺及配方、提出疫苗高分子微针优化的存储环境，使疫苗在微针中的活性保持在80%以上。本项目的研究将为高分子微针在疫苗领域的进一步推广提供技术支持和理论基础。

目前，大部分疫苗的主要给药方式为打针注射，该方式有诸多缺点，如疼痛、需去医院由医护人员操作、产生大量医疗垃圾等。生物可降解高分子可溶微针可无痛地将疫苗类药物输送进皮下，是将来疫苗给药的最佳方式之一。本项目设计并开发了新型两段式微针，用于疫苗皮下免疫的研究，给药精度与效率在95%以上，优化了微针制备工艺、探讨了疫苗在微针中稳定性的机理、研究了疫苗微针的结构与性能的关系。研究结果表明，本项目所开发的高分子微针可有效、安全地用于无痛皮下免疫系统。项目研究成果为高分子微针用于疫苗皮下免疫的临床应用提供了重要的数据支撑与技术基础。