阿莫西林胶囊生产工艺设计.docVIP

阿莫西林胶囊生产工艺设计 [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，洁净级别设计，人物流走向设计。 [关键词] 阿莫西林；胶囊；生产工艺 Production process design of Amoxicillin Capsules [Abstract] Amoxicillin capsule is a new semi-synthetic penicillin drug. It has the characteristics of fast absorption, high blood concentration, strong bactericidal activity, low toxicity, small side effects and extensive antimicrobial spectrum. It has a rapid and strong bactericidal effect on a variety of bacteria. Hard capsule is a kind of solid dosage form which can make a certain amount of drugs and excipients into uniform powder or granules, fill in empty capsules, or directly fill in empty capsules. It is the most widely used solid dosage form besides tablets. Drugs loaded into shells can be divided into powder, granules, pellets, tablets and capsules, or even liquid or semi-solid pastes. Hard capsules have high bioavailability and can achieve rapid, sustained or controlled release. In addition, the capsule production process is relatively simple, and can make up for the shortcomings of other solid dosage forms. Because of the masking effect of shells, they can effectively isolate the bad odor of drugs. The design of amoxicillin hard capsule workshop production process design. Under the guidance of relevant provisions of GMP, material balance is carried out according to production needs, process flow design, workshop design, equipment layout design, general layout design, cleanliness level design, and people flow direction design are completed. [Key words] Amoxicillin; Capsules; Production Technology 目 录 TOC \o 1-3 \h \z \u [摘 要] 1 [Abstract] 2 [ 2 第一章 绪论 1 1.1 指导思想 1 1.2 设计原则 1 第