熱熔擠出技術(shù)（HME）是一種制備固體分散體的新技術(shù)。固體分散體的制備和性質(zhì)主要依賴于輔料的選擇。HME的輔料應(yīng)具有較強(qiáng)的熱塑性、較高的熱穩(wěn)定性、適宜的熔融黏度和原輔料的相容性。依據(jù)輔料的用途，HME的輔料主要分為載體、塑化劑和功能性輔料。依據(jù)載體溶解能力的不同，載體又分為水溶性、難溶性和腸溶性3類，對(duì)應(yīng)制備出速釋、緩控釋功能的固體分散體。通過塑化劑和功能性輔料的修飾和輔助，進(jìn)一步優(yōu)化固體分散體的穩(wěn)定性和釋放特性。主要從載體、塑化劑和功能性輔料等方面對(duì)HME的輔料進(jìn)行綜述，旨在為固體分散體載體的選擇、固體分散體的制備提供參考和依據(jù)。

Hot melt extrusion (HME) technique has emerged as a novel process technology for preparing solid dispersion. The preparation and properties of solid dispersion mainly depend on the choice of excipients. HME excipients should have strong thermoplasticity, high thermal stability, suitable melt viscosity, and compatibility of raw materials. In terms of the use of excipients, HME excipients were mainly divided into carrier, plasticizer, and functional materials. Based on the solubility of carrier, it could be divided into three categories such as water soluble, insoluble, and enteric carriers, corresponding to a fast, time controlled, or modified release of solid dispersion. Through the assistance of plasticizer and functional materials, the stability and release characteristics of solid dispersion are much better. In this paper, excipients were reviewed from above several aspects, which would be very helpful in choosing excipients, in order to offer the reference and basis for the selection of carrier and preparation for solid dispersion.

國(guó)家重點(diǎn)基礎(chǔ)研究發(fā)展計(jì)劃（973計(jì)劃）項(xiàng)目基金（2012CB724002）