聚乳酸乙醇酸（PLGA）的降解主要是通過酯鍵水解，自催化作用和巨噬細(xì)胞吞噬；水解產(chǎn)物為乳酸和乙醇酸，均可代謝分解生成二氧化碳和水，分別通過肺和腎排出體外，僅有微量的原型聚合物經(jīng)尿液排出，體內(nèi)沒有蓄積現(xiàn)象。PLGA具有良好的生物相容性和可生物降解性，作為組織工程支架和藥物控釋系統(tǒng)材料是安全的。美國食品藥品管理局（FDA）已經(jīng)批準(zhǔn)將PLGA作為組織工程細(xì)胞支架和藥物載體，在美國、日本市場應(yīng)用多年，未見嚴(yán)重的不良反應(yīng)報(bào)道。目前國產(chǎn)PLGA的質(zhì)量和控釋微球藥品的開發(fā)研究仍需要提高，尤其是制劑的載藥量、控釋技術(shù)以及穩(wěn)定性技術(shù)。介紹PLGA的生物降解與安全性研究進(jìn)展，為開發(fā)PLGA控釋系統(tǒng)提供參考。

Poly lactic-co-glycolic acid (PLGA) is biodegraded mainly through hydrolysis of its ester linkages, self-catalysis, or phagocytosis by macrophage. Lactic acid and glycolic acid, the products of hydrolysis process, are then eventually catabolized into carbon dioxide and water which are eliminated via lungs and kidneys, respectively. Only trace PLGA is excreted in urine. No accumulation of PLGA is found in the body. PLGA showed excellent biocompatibility and biodegradability, so it is safe for using as materials for scaffolds of tissue engineering and drug controlled release system, and the US Food and Drug Administration (FDA) has approved its use for preparation of scaffolds for tissue engineering and carrier of drug. It has been used in the market in United States and Japan for many years, and no serious side effects have been reported. At present, the quality of domestic PLGA and the development of drug controlled release system with this material still need improving, especially amount of drug loading, release controling, and stability of the preparation. This paper describes recent advances in the studies on biodegradation and safety of PLGA, which will provide the reference for the development of PLGA controlled release system.