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本文采用乳化-溶剂挥散法制备了醋酸纤维素水分散体,并在研究该水分散体特点的基础上,选择增塑剂浓度、固化时间、固化温度、包衣增重量等四个因素,通过正交实验设计制备了硫酸沙丁胺醇控释片。分别考察了上述因素对于控释片体外释放度的影响以及药物释放机制。实验结果表明,各个实验因素对于药物释放趋势影响大小依次为:包衣增重量>增塑剂浓度>固化时间>固化温度;醋酸纤维素水分散体在增塑剂的作用下,具有良好的成膜性能,所制备的控释片在8小时内呈现良好的零级释放趋势;体外释药机制研究表明,药物的释放速度主要受释放介质渗透压的影响。
In this paper, the aqueous dispersion of cellulose acetate was prepared by emulsification-solvent volatilization method. Based on the study of the characteristics of the aqueous dispersion, four factors, plasticizer concentration, curing time, curing temperature and coating weight, Salbutamol sulfate controlled release tablets were prepared by orthogonal design. The effects of the above factors on the in vitro release of controlled release tablets and the mechanism of drug release were investigated. The experimental results showed that the influence of each experimental factor on the drug release tendency was as follows: weight gain of coating> concentration of plasticizer> curing time> curing temperature; aqueous dispersion of cellulose acetate had a good effect under the action of plasticizer The performance of the prepared controlled release tablets showed good zero-order release within 8 hours. The in vitro drug release mechanism showed that the drug release rate was mainly affected by the osmotic pressure of the release media.