口服缓控释制剂设计与应用资料.pptVIP

* 流化床工艺制备微丸通常需要空白丸芯作为母核, 将药物以适合的方式包裹至丸芯形成载药微丸, 我们一般称为上药过程, 根据药物的剂量,溶解性和稳定性等性质,上药方法可以分别为溶液 / 混悬液 / 粉末上药三种方法. 上药完成后通常会采用水溶性的聚合物如HPMC作为包衣材料对微丸进行隔离层包衣, 这样可以避免药物在进一步包衣过程可能产生的迁移, 也可以降低微丸的脆碎度.一般我们会在隔离层包衣结束后测定微丸含量并清洗设备, 避免设备里一些游离的药物粉末可能进入功能型包衣膜. 功能包衣是改变微丸释药特性的主要过程,达到缓释 / 肠溶 / 脉冲释放的目的, 衣膜厚度和衣膜质量直接决定微丸的释药行为. 微丸功能包衣后根据需要还可以进行外层包衣着色, 同时避免微丸在储存过程中可能产生的粘连. 所以从结构上流化床制备的包衣微丸通常具有丸芯/药物层/隔离层包衣层/功能包衣层/外层包衣等多层结构. * 实验设备采用7“ 的底喷装置, 丸芯投料4公斤 * 中试设备采用18”底喷装置, 丸芯投料40kg, 隔圈面积为7” 装置的6倍, 所以从7”到18”, 进风风量和喷液速率都按6倍来放大 This is an 18 Wurster insert which is fitted with the HS nozzle because we did not have the capability to use the earlier version Schlick nozzle which is in use in the 32 Wurster. The partition diameter is 219 mm, or approximately 6 times that of the 7 Wurster. If the same face velocity is to be used across the orifice plate, then the increase in spray rate, if based on drying capacity alone, would be about 6 times. * 生产设备采用32”流化床. 丸芯投料180 kg, 喷枪和隔圈数分别都是三个, 隔圈面积和18” 相同, 因此进风风量和喷液速率按可以按照18” 流化床的三倍放大. Although the photograph shows a tapered or conical insert, the one which was available to us for these trials was an older version, and cylindrical. The 32 Wurster does not use a single partition, but 3 based on the 18 Wurster. The partition diameter is the same, and this makes several of the process variables the same in scale up. Typically the same nozzle would be used as in the 18 Wurster, so that the atomization air pressure and volume as well as the spray rate would identical per partition as that used in the 18 Wurster. Also, the up and down bed orifice plates are selected such that the process air volume used in the 18 Wurster is the same per partition in the 32. It must be stressed that the selection of orifice plates is very critical to success in multi-partition equipment. If the air is not uniformly distributed across the plate, the bed surface will be tilted, and mixing, or coating distribution uniformity may be compromised. * 对于流化床工艺的原理是通过进风气流的推动, 使物料悬浮在气流中进行包衣