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目的制备青藤碱聚乳酸-羟基乙酸共聚物[poly(1actide-co-glycolide acid),PLGA]纳米粒,并优化该处方及其制备工艺。方法采用纳米沉淀法制备纳米粒,以青藤碱和PLGA的质量比、有机相和水相的体积比、表面活性剂聚氧乙烯氢化蓖麻油(RH40)的浓度为考察因素,以包封率和载药量为指标,通过星点设计-效应面法优化处方及制备工艺,并对其进行验证。结果青藤碱PLGA纳米粒的最佳处方和工艺条件为:青藤碱与PLGA的质量比1.4∶10;有机相与水相的体积比为2.2∶10,表面活性剂RH40的浓度为0.7%。制备的纳米粒平均粒径为113 nm,平均包封率为81.53%,平均载药量为7.65%。结论星点设计-效应面法简便可行,适用于青藤碱聚乳酸-羟基乙酸纳米粒的制备工艺优化。
OBJECTIVE To prepare poly (lactide-co-glycolide acid) (PLGA) nanoparticle and to optimize the formulation and its preparation process. Methods Nanoparticles were prepared by nano-precipitation method. The mass ratio of sinomenine to PLGA, the volume ratio of organic phase and aqueous phase, the concentration of polyoxyethylene hydrogenated castor oil (RH40) as the investigation factors, the entrapment efficiency And drug loading as an indicator, through the star design - response surface optimization prescription and preparation process, and verify. Results The optimal formulation and technological conditions of sinomenine PLGA nanoparticles were as follows: the mass ratio of sinomenine to PLGA was 1.4: 10; the volume ratio of organic phase to aqueous phase was 2.2: 10; the concentration of surfactant RH40 was 0.7% . The prepared nanoparticles had an average diameter of 113 nm, an average encapsulation efficiency of 81.53% and an average drug loading of 7.65%. Conclusion The design of apical point-response surface method is simple and feasible, and is suitable for the preparation of sinomenine poly (lactic-co-glycolic acid) nanoparticles.