呋喃唑酮片制备的工艺优化

Optimization on the Preparation of Furazolidone Tablets

为了使呋喃唑酮片溶出度及可压性等指标均符合质量标准要求,对制备工艺进行考察及优化.以溶出度为指标,对原料药粒径、黏合剂用量、崩解剂内外加比例、表面活性剂种类进行了考察,原料药 D50 为1.860μm,黏合剂用量为0.6 %,崩解剂内外加比值为 75 %,选择吐温-80 为表面活性剂呋喃唑酮片溶出效果最佳;以可压性为指标,对湿颗粒干燥过程中翻盘次数进行考察,湿颗粒干燥过程中翻盘 2 到 3 次,可满足呋喃唑酮片可压性要求.研究结果表明:原料药粒径、黏合剂、崩解剂、表面活性剂、湿颗粒干燥过程中的翻盘次数均是影响呋喃唑酮片质量的重要指标.

In order to make the dissolution and compressibility of furazolidone tablets meet the requirements of quality standards,the preparation was investigated and optimized.With dissolution as an index,the particle size of APIs,the amount of binder,the ratio of disintegrants internal and external,and the types of surfactants were investigated.The D50 was 1.860μm,the amount of binder was 0.6%,the ratio of disintegrants internal and external was 75%,Tween-80 was chosen as surfactant;compressibility was used as an index,the frequency of turn in the drying process of wet granules was investigated.The results showed that the compressibility of furazolidone tablets could be satisfied by turning the plate 2 to 3 times during the drying process of wet granules.The particle size of APIs,adhesives,disintegrants,surfactants and the frequency of turn in the drying process of wet granules are all important indicators affecting the quality of furazolidone tablets.