论文部分内容阅读
目的研究提高他克莫司胶囊含量均一性的工艺。方法在普通湿法制粒机增设弯管式定位加料系统控制加料位置和流速、选用合适的辅料与工艺参数制得他克莫司胶囊,用HPLC测定含量。结果他克莫司胶囊含量均一性良好,中间体粉末RSD<2.0%,含量均匀度A+1.80S<15,溶出度>85%。结论使用弯管定位加料,选用乳糖G200及合适的工艺参数,制备的他克莫司胶囊含量均一,适合产业化生产。
Objective To study the technology to improve the homogeneity of tacrolimus capsules. Methods An elbow positioning and feeding system was added to the ordinary wet granulator to control the feeding position and flow rate. Tacrolimus capsules were prepared by using appropriate auxiliary materials and process parameters, and the content was determined by HPLC. Results The content of tacrolimus capsule was good. The RSD of intermediate powder was less than 2.0%, the content uniformity was A + 1.80S <15 and the dissolution rate was> 85%. Conclusion The use of elbow positioning feed, the choice of lactose G200 and the appropriate process parameters, the content of tacrolimus capsules prepared uniform, suitable for industrial production.