1亿粒年阿莫西林硬胶囊车间工艺设计.doc

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，吸收快血药浓度高杀菌力强毒性极低副作用小广泛的抗菌谱，对多种细菌的杀菌作用迅速而强。?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，洁净级别设计，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 Workshop Abstract 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 with a taste masking effect, so the drug can effectively isolate the bad smell. The design for the 100 million / year hard capsules amoxicillin workshop production process design. The relevant provisions of the GMP guidance, based on production needs, the material balance, complete the process design, plant design, equipment layout design, general layout design, clean-level design, logistics to human designs Keywords: amoxicillin hard capsules Workshop Design 目录 第一章文献综述 1 1.1生产产品的基本情况 1 1.1.1阿莫西林胶囊的概述 1 1.1.2阿莫西林的剂型 3 1.2生产剂型的基本情况 6 1.2.1胶囊及硬胶囊剂的概况 6 1.2.2硬胶囊剂的特点 6 1.2.3适合制成胶囊剂的药物 7 1.2.4硬胶囊剂的国内外发展现状 7 1.2.5硬胶囊剂的制备 8 1.2.6空胶囊的规格和质量要求。 9 1.2.7硬胶囊剂的填充 10 1.3硬胶囊剂的GMP车间建设 11 1.3.1制剂GMP车间的基本要求 11