CAJ | 학술논문

热熔挤出技术是指将药物、增塑剂或聚合物等辅料在熔融状态下混合，以一定的压力、速度和形状挤出形成产品的技术。它结合固体分散体技术和机械制备的诸多优势，具有连续化操作、减少粉尘、挤出过程持续时间短、不使用有机溶剂和水、不需加热干燥，不易发生水解等优点。该技术在提高难溶性药物溶出度、掩盖药物异味、增强药物稳定性和维持药物释放等方面具有突出优势，并有良好的重现性、极高的生产效率和在线监测。因此，近年来被广泛应用于药剂研究开发中，制备各种不同类型的制剂，如速释制剂、缓释制剂、胃肠定位释放制剂和经皮给药制剂等。本文将综述热熔挤出技术用于药剂研究的优点及其近年来在药剂研究中的应用。
열용제출기술시지장약물、증소제혹취합물등보료재용융상태하혼합，이일정적압력、속도화형상제출형성산품적기술。타결합고체분산체기술화궤계제비적제다우세，구유련속화조작、감소분진、제출과정지속시간단、불사용유궤용제화수、불수가열간조，불역발생수해등우점。해기술재제고난용성약물용출도、엄개약물이미、증강약물은정성화유지약물석방등방면구유돌출우세，병유량호적중현성、겁고적생산효솔화재선감측。인차，근년래피엄범응용우약제연구개발중，제비각충불동류형적제제，여속석제제、완석제제、위장정위석방제제화경피급약제제등。본문장종술열용제출기술용우약제연구적우점급기근년래재약제연구중적응용。
Hot-melt extrusion (HME) is the process of pumping raw materials with a rotating screw under the elevated temperature and pressure through a die to from a product with the uniform shape. This technique combines many advantages of solid dispersion technology and mechanical preparation, including dust reduction, short duration of extrusion process, without use of organic solvents and water, without heat drying and hydrolysis, etc. In addition, it has the superiority in solubility, taste masking, drug stability and drug release. Besides, this technique has good reproducibility, high production efficiency, and it can be online monitored in the mass production. Therefore, this technique is widely used in the research and development of drug dosage forms involved in rapid and immediate drug release, sustained drug release, gastrointestinal drug site-specific release, transdermal drug delivery systems and so on. This paper reviews the advantages of HME and its recent application in the pharmaceutical research.