促卵泡激素和干细胞因子缓释微球的制备

Preparation of Sustained Release FSH and SCF Microspheres

目的以乳酸-羟乙酸聚合物为载体材料,制备包含促卵泡激素和干细胞因子的长效缓释微球,并考察微球质量相关参数,探讨影响微球粒径和包封率的因素.方法使用复乳-溶剂挥发法制备微球,观察微球形态,计算微球粒径、回收率、包封率和载药量等相关参数.用不同分子量和浓度的乳酸-羟乙酸聚合物制备微球,观察微球粒径及包封率的变化.结果所得微球形态呈圆整规则的球形,粒径呈正态分布,主要分布在6~12μm范围内,再分散性好,促卵泡激素的包封率为85.5%,载药量为33.7 m IU/mg.干细胞因子的包封率为87.1%,载药量为4.6 ng/mg.PLGA分子量增加,微球粒径增加,PLGA浓度升高,微球粒径及包封率也升高.结论复乳-溶剂挥发法工艺简单,重现性好.所制促卵泡激素和干细胞因子微球粒径均匀,包封率高.

Objective This study was aimed to prepare poly （lactic-co-glycolic acid） （PLGA） microspheres containing follicle stimulating hormone （FSH） or stem cell factor （SCF） , investigate its quality parameters, and study the influence factors of microsphere size and encapsulation efficiency. Methods FSH and SCF microspheres were prepared by a double emulsion-solvent evaporation method. Scanning electron microscopy was used for the observation of microspheres. The quality parameters such as particle size, recovery, encapsulation efficiency and drug loading were calculated. The microspheres were prepared with different molecular weight and concentration of PLGA, and the changes about particle size and encapsulation efficiency were observed. Results The microspheres of FSH and SCF showed regular spherical. Diameter of the particles with 6 μm to 12 μm mainly showed a normal distribution. The rate of encapsulation and quantity of drug loading of FSH were 85.5% and 33.7 mIU/mg, and of SCF were 87.1% and 4.6 ng/mg. The particle diameter and encapsulation efficiency of microspheres were increased when increasing molecular weight and concentration of PLGA. Conclusion This technique of double emulsion-solvent evaporation process was simple and had a good reproducibility, and it might get uniform particle size and high encapsulation efficiency of FSH and SCF microspheres.