摘 要

斯皮仁诺胶囊别称是伊曲康唑（Itraconazole）胶囊，是三唑类衍生物，具有广谱抗真菌活性。斯皮仁诺胶囊用于AIDS患者隐球菌病的长程治疗和中性粒细胞减少症患者真菌感染的预防。国内外目前已经对此药物的药理学作用进行过临床组织形态学等的研究并证实，伊曲康唑具有很高的研究和药用价值。

本设计的目的是通过对斯皮仁诺胶囊生产工艺的研究，设以GMP中相关规定为指导，利用计算机辅助，设计出符合《药品生产质量管理规范》(GMP)要求的斯皮仁诺胶囊生产车间蓝图。进一步理解GMP在对于药品生产质量的控制，以及其生产厂房、设施、建筑、设备、仓储、生产过程、工艺卫生等诸多方面的规范指导，增加对制药企业规范化设计生产的了解。

关键词：斯皮仁诺胶囊；抗真菌药；生产工艺；洁净车间设计；GMP

Abstract

Spiraxel capsules are known as Itraconazole capsules and are triazole derivatives with broad spectrum antifungal activity. Spearing Capsules are used to prevent long-term treatment of cryptococcal disease in AIDS patients and fungal infections in patients with neutropenia. At home and abroad has been the pharmacological effects of this drug had clinical histomorphology and other studies and confirmed that itraconazole has a high research and medicinal value.

The purpose of this design is to study the production technology of Spiraxel capsules, and to use the relevant provisions of GMP as a guide, the use of computer-aided design to meet the "Pharmaceutical Production Quality Management Practice" (GMP) requirements of spiram Production workshop blueprint. To further understand the GMP in the control of the quality of pharmaceutical production, as well as its production plants, facilities, construction, equipment, warehousing, production processes, process hygiene and many other aspects of standardized guidance to increase the standardization of pharmaceutical production and production understanding.

Keywords: spirauren capsules; antifungal agents; production process; design of workshop ; GMP

目 录

第1章 绪论 .................................................................................................................................1

1.1斯皮仁诺胶囊概述 .............................................................................................................1

1.1.1斯皮仁诺的药理作用 ......................................................................................................2

1.1.2斯皮仁诺的毒理作用................................................ .......................................................2

1.2斯皮仁诺的研究现状与发展前景.......................................................................................3

1.3设计目的及意义...................................................................................................................3

第2章 简述硬胶囊剂...................................................................................................................4

2.1胶囊及硬胶囊剂的概况.......................................................................................................4

2.2硬胶囊剂的制备...................................................................................................................4

2.2.1空胶囊壳的制备................................................................................................................4

2.2.2空胶囊的规格和质量要求................................................................................................5

2.2.3硬胶囊剂的填充................................................................................................................6

2.2.4硬胶囊剂的质量评定、包装与贮存................................................................................7

第3章 硬胶囊剂的GMP车间建设............................................................................................8

3.1制剂GMP车间的基本要求................................................................................................8

3.1.1洁净室的选择....................................................................................................................8

3.1.2人员与物料净化处理........................................................................................................8

3.1.3设备的清洗........................................................................................................................9

3.2制剂GMP对制药工业车间的要求....................................................................................9

3.3制剂GMP对设备布置的要求及管理................................................................................9

3.3.1 车间设备布置满足GMP要求........................................................................................9

3.3.2车间设备布置满足工艺要求..........................................................................................10

第4章 车间布置.........................................................................................................................11

4.1车间布置的原则.................................................................................................................11

4.2车间布置及人流、物流概述.............................................................................................11

第5章 厂址的选择与总体车间排布.........................................................................................12

第6章 生产工艺.........................................................................................................................13

6.1生产目标及工艺流程.........................................................................................................13

6.2 物料衡算............................................................................................................................13

6.2.1 每天制剂工序各工序物料的需求量.............................................................................14

6.2.2包装材料的消耗量..........................................................................................................15

6.3 主要工艺设备选用说明....................................................................................................17

6.3.1 选用原则.........................................................................................................................17