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在新药研发过程中,约有40%的药物存在溶解性差的问题,限制了药物的开发与应用。纳米混悬剂是20世纪末发展起来的一种纳米药物传递系统,可增加难溶性药物的溶解度和溶出速率、改变药物的体内药物动力学特征、提高口服生物利用度、安全性和有效性。纳米混悬剂不但适用于水溶性差的药物,而且适用于水溶性、脂溶性均较差的药物,其制备方法主要包括“bottom up”和“top down”两种。本文从纳米混悬剂的特点、理论基础、专利技术及应用等方面对纳米混悬剂的研究进展进行了综述。纳米混悬剂对改善难溶性药物的溶出、吸收,提高难溶性药物的有效性、安全性等方面具有显著优势,且适合工业化生产,已有越来越多的产品问世。纳米混悬技术是未来药物传递系统的发展方向之一,将具有良好的应用前景。
In the process of drug discovery and development, about 40% of the drugs have poor solubility, which limits the development and application of drugs. Nanosuspensions are a kind of nano-drug delivery system developed in the late 20th century, which can increase the solubility and dissolution rate of poorly-soluble drugs, change the in vivo pharmacokinetic characteristics of drugs, and improve oral bioavailability, safety and effectiveness. Nano-suspensions are not only suitable for poorly water-soluble drugs, but also for poorly water-soluble and fat-soluble drugs. The preparation methods include “bottom up” and “top down”. This review summarizes the research progress of nanosuspensions from the aspects of the characteristics, theoretical basis, patented technology and application of nanosuspensions. Nano-suspensions have significant advantages in improving the dissolution and absorption of insoluble drugs, improving the effectiveness and safety of poorly-soluble drugs, and are suitable for industrialized production. More and more products have come out. Nano suspension technology is one of the future directions of drug delivery system, which will have a good prospect of application.