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目的探讨超声微泡的制备条件对粒径、包封率、表面形态等的影响,确定制备超声微泡的最佳工艺条件。方法以W/O/W型乳化溶剂挥发法制备微球,采用单因素实验和正交设计实验优化制备工艺。结果制备超声微泡的最佳条件是10-羟基喜树碱(10-hydroxy-camptothecin,HCPT)25 mg,乳酸-羟基乙酸共聚物[poly(lactic-co-glycolic acid),PLGA]1.875 g,初乳和外水相体积比为1∶15,聚乙烯醇(PVA)浓度3%;此条件所制备超声微泡呈规则球形,表面光滑,电荷以-40～0 mV为主,粒径为500～1 000 nm,包封率为79.33%,载药量为0.478 3%,体外超声成像清楚。结论优化制备条件,可制备出符合注射要求的超声微泡。
OBJECTIVE To investigate the influence of preparation conditions of ultrasound microbubbles on particle size, entrapment efficiency, surface morphology and so on, and to determine the optimum technological conditions for the preparation of ultrasound microbubbles. Methods The microspheres were prepared by W / O / W emulsion solvent evaporation method. The single factor experiments and orthogonal design experiments were used to optimize the preparation process. Results The optimal conditions for preparation of ultrasound microbubbles were 25 mg of 10-hydroxy-camptothecin (HCPT), 1.875 g of poly (lactic-co-glycolic acid) The volume ratio of colostrum to external water was 1:15, and the concentration of polyvinyl alcohol (PVA) was 3%. The ultrasonic microbubbles prepared in this condition showed a regular spherical shape and the surface was smooth with the charge of -40 ~ 0 mV and the particle size was 500 ~ 1 000 nm, the entrapment efficiency was 79.33% and the drug loading was 0.478 3%. The in vitro ultrasound imaging was clear. Conclusion Optimization of preparation conditions can be prepared in line with the injection requirements of ultrasound microbubbles.