1亿粒年阿莫西林硬胶囊车间工艺设计

1 亿粒/年阿莫西林硬胶囊车间工艺设计摘 要 阿莫西林胶囊为新型半合成青霉素类药，具有吸收快、血药浓度高、杀菌力强、毒性极低、副作用小以及广泛的抗菌谱，对多种细菌的杀菌作用迅速而强等特点。硬胶囊剂系将一定量的药物加辅料制成均匀的粉末或颗粒，充填与空胶囊中，或将药物粉末直接填充与空胶囊中制成，是目前除片剂之外应用最为广泛的一种固体剂型。装入胶壳的药物可分为粉末、颗粒、微丸、片剂及胶囊，甚至液体或半固体糊状物。硬胶囊的生物利用度高，能够达到速释、缓释或控制释药等多种目的。 此外，胶囊生产工艺过程相对简单，且能够弥补其他固体剂型的不足。由于胶壳具有掩味作用，因此能够有效地隔离药物的不良气味。 本设计为 1 亿粒/年阿莫西林硬胶囊车间生产工艺的设计。在 GMP 的相关规定指导下，根据生产需要，进行物料衡算，完成工艺流程设计，厂房车间的设计，设备平面布置的设计，总平面布置设计，干净级别设计，人物流走向设计。关键词：阿莫西林 硬胶囊剂 车间设计 100 million/year hard capsules amoxicillin Process Design WorkshopAbstract Amoxicillin is a new semi-synthetic penicillin drugs, with the absorption of fast, high plasma concentration, bactericidal ability, low toxicity, side effects and wide antibacterial spectrum, bactericidal action of bacteria on a variety of quick and strong features. Department of hard capsules will be a certain amount of drug plus percipients into a homogeneous powder or granules, filled with empty capsules, or directly to the drug powder into capsules filled with air, is the most widely used than tablets outside a kinds of solid dosage forms. Drugs into the plastic shell can be divided into powder, granules, pellets, tablets and capsules, liquid or semi-solid or paste. Hard capsule bioavailability, can achieve rapid release, sustained release or controlled release, and other purposes. In addition, capsule production process is relatively simple, and can make up for lack of other solid dosage forms. The plastic shell wi...