沙普西肠溶微囊的研制及质量控制

Preparation and Quality Control of SAPC Enterosoluble Microcapsules

采用聚丙烯酸树脂Ⅲ号为囊材，研制成新的马沙拉嗪前体药物沙普西肠溶微囊，制备工艺成熟、质量稳定、成囊效果好，制备温度４０～４５℃，转达７００～８００ｒｐｍ，成囊ｐＨ为５～６。采用紫外分光光度法测定含量，操作快速简便，结果准确，重现性好，测定波长３５９ｎｍ，γ＝０．９９９９，回收率９９．８０％，ＲＳＤ＝０．３３％（ｎ＝５）。

SAPC enterosoluble microcapsule, a new precursor of 5-ASA, was prepared at temperature of 40～45℃,700～800 rpm and pH 5～6 using polypropenoic acid resin as the material of microcapsule. The content of SAPC in the microcapsule was determined by UV-spectrophotometry at wavelength of 359nm. The linear relationship between the concentration and absorbance appeared well. The correlation coefficient was 0.9 999, the average recovery 99.80%, RSD 0.33%(n=5). The results show that the method of determination is simple, rapid and accurate.