纳米制剂的研究进展

Research Progress of Nano-Formulations

与常规药物制剂相比,纳米制剂具有许多难以比拟的优势,因而被用于递送难溶性药物、抗肿瘤药物、基因药物以及需要突破血脑屏障的药物等。纳米制剂的基础研究十分活跃,其转化研究也逐渐深入,新产品在国内外陆续上市或进入不同阶段的临床试验。尤其是在新型冠状病毒mRNA疫苗的研发中,纳米制剂技术发挥了不可替代的作用。我国在纳米制剂研究的各个领域还存在明显不足,需要加强关键性的基础研究,促进基础与应用研究的融通发展,完善相应的监管体制等。纳米制剂的发展将带来更多创新或个性化的疗法,为攻克更多重大疾病带来希望,但纳米制剂的安全性、工艺及质量的可控性、关键设备及辅料对国外的过度依赖性等问题是需要应对的挑战。

Nano-formulation refers to the drug particles with nanometer scale that are directly made from the raw material by the nano-preparation technology,or the nano-scale particles formed by combining the appropriate carrier materials and drugs,and the final drug preparation.Compared with conventional pharmaceutical preparations,nano-formulations possess various incomparable advantages,so they are used to deliver poorly soluble drugs,anti-tumor drugs,genetic drugs,and drugs that need to be delivered through the blood-brain barrier.In recent years,basic research on nano-formulations has been very heated.Simultaneously,the translational research of nano-formulations has gradually improved,and new products have come into the market at home and abroad or entered different stages of clinical trials.Especially in the development and product marketing of COVID-19 mRNA vaccines,nano-formulation technology has played an irreplaceable role.However,compared with developed countries,China still has obvious shortcomings in various fields of nano-formulation research.It is necessary to strengthen key basic research,promote the development of basic and applied research,and improve the corresponding regulatory system.The development of nano-formulations will bring more innovative or personalized therapies,and bring hope to overcome more complicated and miscellaneous diseases.However,for nano-formulations,the safety,the controllability of processing technology and quality,the excessive dependence of key equipment and excipients on foreign countries,are challenges that still need to be addressed.