阿莫西林胶囊内容物成柱的因素分析与控制

Analysis and Control of Main Factor That Granules Show Columnar in Amoxicillin Capsules

在阿莫西林胶囊生产中,干法制粒时常出现内容物成柱现象,不符合药典规定内容物为粉末状的性状要求。我们通适大量的实验与生产实际,总结出主要影响阿莫西林胶囊内容物成柱的主要因素和控制方法。结果:颗粒密度是导致阿莫西林胶囊内容物成柱的主要因素,通过调节干挤机压力、送料速度与干挤轮转速控制颗粒密度,以保证阿莫西林胶囊性状符合要求。结论:干挤机压力控制在1.5kg～2.1kg,送料速度与干挤轮转速协调一致即可解决其内容物成柱问题。

During production of Amosicillin capsules,when pelletizing by dry-extruding peI letization,often find granules show columnar,which don't conform to the appearance requirement in Pharmacopoeia of the Peoples Republic of China.Through a mass of tests and production prac- tices,we found grain density is the main factor that granules show columnar in Amosicillin cap- sules.And we could control grain density by adjusting pressure,speed of material feeding and wheel rotary speed of dry extrusion machine should be harmonious,and so that could solve the problem that granules show columnar in Amoxicillin capsules.