新型缓控释辅料聚(乳酸-乙醇酸)的合成工艺研究

Research on Synthesis Technique of New Controlled Release Excipient Poly-( lactic-co-glycolic acid)

目的研究开环聚合合成聚（乳酸-乙醇酸）（PLGA）的工艺。方法采用正交实验优选常压合成聚（乳酸-乙醇酸）的工艺条件，并进行3批重复性验证。结果最佳工艺条件确定为：催化剂辛酸亚锡和引发剂十二醇的用量分别为0．03％和0．02％，反应温度160℃，搅拌速率300r·min，反应10h。通过筛选两种单体的投料比，确定合成聚（乳酸-乙醇酸）5050的乙交酯和丙交酯的比例为45：55。结论筛选出的工艺能常压合成聚（乳酸-乙醇酸）5050，产品重均相对分子质量达到52000，分布系数为1．5～1．7，工艺稳定，质量可控。

OBJECTIVE To study the synthesis technique of poly（lactic-eo-glyeolic acid）（PLGA） via ring-opening polymeriza- tion. METHODS Orthogona] experiments were tan＇ted out to optimize the synthesis conditions of PLGA under atmospheric eondilion. Three batches of repeated experiments were conducted to verify the technological conditions. RESULTS The target product could be synthesized by using 0. 03% stannous octoate and 0. 02% lamT1 alcohol reacted at 160 ℃ for 10 h at a stir speed of 300 r · min 1. The ratio of glyeolide and laetide was determined to be 45：55 to ensure the tbrmation of PLGAS050. CONCLUSION The screened out synthesis technique can obtain PLGAS050 with Mw of 52000 and coefl＇icient of distribution between 1.5 - 1.7 at atmospheric pressure, and its quality is controllable.