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目的 以聚乳酸或乳酸 乙醇酸共聚物为载体材料制备雌二醇缓释微囊。方法 实验中采用乳化 溶剂萃取法制备微囊 ,考察了影响微囊特性以及体外释药的各种因素 ,采用单因素试验方差分析进行因素影响的显著性检验 ,并在此基础上采用T方法进行两两间多重比较 ,进一步考察因素各水平间差异的显著性。结果 结果表明 ,粒径和加水萃取速度对雌二醇微囊的包封率有显著性影响 (P <0 0 1) ;随油相载体的浓度以及加水萃取速度对微囊的粒径影响显著 (P <0 0 1)。体外释药研究表明 ,加水萃取速度和载体的型号和分子量对微囊释药影响显著 (P <0 0 1)。但这些影响因素的各水平之间的差异性并不都具有显著性。结论 通过改变处方以及制备工艺可以得到具有不同性质的雌二醇聚乳酸类缓释微囊
OBJECTIVE To prepare estradiol sustained-release microcapsules by using polylactic acid or lactic-co-glycolic acid as carrier material. Methods In the experiment, the microcapsules were prepared by the emulsified solvent extraction method. Various factors affecting microcapsule characteristics and in vitro release were investigated. One-factor test analysis of variance was used to test the significance of the factors. Based on this, the T method Multiple comparison between two or two further examines the significance of the differences between the factors. The results showed that the particle size and water extraction rate significantly affected the entrapment efficiency of estradiol microcapsules (P <0.01). With the concentration of oil carrier and the extraction speed of water, the particle size of microcapsules was significantly affected (P <0 0 1). In vitro release studies showed that water extraction speed and carrier type and molecular weight significantly affected microcapsule release (P <0.01). However, the differences between the levels of these factors are not significant. Conclusion Different formulations of estradiol polylactic acid sustained release microcapsules can be obtained by changing the prescription and preparation process