摘 要

咳嗽是一种常见的、发病率高的呼吸道病症，由于气管、支气管黏膜或胸膜受炎症、异物、物理或化学性刺激引起，表现先是声门关闭、呼吸肌收缩、肺内压升高，然后声门张开，肺内空气喷射而出，通常伴随声音^[1]。咳嗽具有清除呼吸道异物和分泌物的保护性作用。但如果咳嗽不停，由急性转为慢性，常给患者带来很大的痛苦，如胸闷、咽痒、喘气等^[2]。一旦出现咳嗽，最受人们青睐的莫过于中药止咳口服液、糖浆、膏滋之类^[3].虽然每种止咳中成药都标有"止咳化痰"、"镇咳平喘"等功效，但由于中医讲究辨证施治，所以在选药时应避免盲目和随意性^[4]。

芩贝止咳颗粒是一种由传统中药复方经现代制剂工艺研制而成的中药颗粒剂新药，由黄芩、浙贝母、百部、鱼腥草、苦杏仁、前胡、连翘、甘草等八味中药材制成，功能为清热宣肺、化痰止咳‚具有解热、镇咳、祛痰、抗炎、抗菌等药理作用，临床上可以用于急性支气管炎所致的咳嗽、痰黄黏稠、苔黄或兼腻、脉数等症^[5]。

本文旨在设计出一种可行的芩贝止咳颗粒固体制剂车间工艺设计，设计内容主要包括：处方分析和固体制剂工艺流程叙述；以物料衡算、能量衡算和工艺计算为前提的工艺流程，设备选型，车间总布局的合理设计；带控制点的工艺流程图、车间平面布置图、管线布置图、主要设备装配图；定员定岗、环境保护以及“三废”治理的简要说明。

关键词：固体制剂；芩贝止咳颗粒；颗粒剂；生产车间；工艺设计

Abstract

Cough is a common and high-risk respiratory illness. It is caused by inflammation, foreign body, physical or chemical irritation of the trachea, bronchial mucosa or pleura. The performance is first the closure of the glottis, the contraction of the respiratory muscles, and the increase in lung pressure The glottis opens and the air in the lungs ejects, usually accompanied by sound. Coughing has the protective effect of removing foreign bodies and secretions from the respiratory tract. However, if the cough keeps changing from acute to chronic, it often brings great pain to the patient, such as chest tightness, itching, and gasping. Once a cough occurs, the most popular is the traditional Chinese medicine Zhike oral liquid, syrup, ointment and the like. Although each Chinese medicine for cough is marked with "cough and phlegm", "antitussive and asthma", but because of Chinese medicine Treatment is based on syndrome differentiation, so blindness and randomness should be avoided when choosing drugs.

Qinbei Zhike Granules is a new medicine of traditional Chinese medicine granules developed by traditional Chinese medicine compound through modern preparation technology. It consists of Scutellaria baicalensis, Fritillaria thunbergii, Hundred Department, Houttuynia cordata, bitter almond, Qianhu, Forsythia, Licorice etc. It is made of Chinese herbal medicine with the functions of clearing away heat and expelling lung, reducing phlegm and relieving cough. It has antipyretic, antitussive, expectorant, anti-inflammatory, antibacterial and other pharmacological effects. It can be used clinically for acute cough caused by acute bronchitis and thick yellow phlegm , Yellow fur or greasy, pulse number embolism.

This article aims to design a feasible Qinbei Zhike granules solid preparation workshop process design, the design content mainly includes: prescription analysis and solid preparation process flow description; the process flow on the premise of material balance calculation, energy balance calculation and process calculation, Equipment selection, reasonable design of the overall layout of the workshop; process flow chart with control points, workshop floor plan, pipeline layout, main equipment assembly drawings; brief descriptions of staffing and post, environmental protection and "three wastes" treatment.

Keywords: solid preparation; Qinbei Zhike granules; granules; production workshop; process design

目录

摘要 3

Abstract 4

第一章 绪论 7

1.1芩贝止咳颗粒研究概况 7

1.2处方及处方分析 7

1.2.1法定处方 7

1.3 生产任务 8

1.4 设计依据 8

1.5 设计原则 8

第二章 生产工艺与流程叙述 8

1.生产工艺流程框图 9

2.生产工艺流程 10

2.1干膏粉领料称量 10

2.2制粒与整粒 10

2.3总混 10

2.4内包装 10

2.5外包装 10

第三章 物料衡算 11

3.1原辅料用量 11

3.1.1任务 11

3.1.2 原辅料物料计算 11

3.1.3原辅料实际投料量汇总 12

3.1.4各工序收率指标 13

3.2 包装材料用量 13

3.2.1包装办法 13

3.2.2材料用量计算 13

3.3.3包装材料用量汇总 14

第四章 能量衡算 14

4.1 能量衡算的依据 15

4.2颗粒干燥过程的能量衡算 15

第五章 设备选型 16

5.1湿法制粒机 16

5.2摇摆制粒机 17

5.3热循环烘箱 19

5.4 V型混合机 20

5颗粒包装机 21

第六章 定员定岗 22

6.1岗位定员法 22

6.2定员定岗 23

6.3岗位定员安排 23

第七章 车间布置设计 24

7.1 车间布局设计 24

第八章 三废处理 26

参考文献 27

致谢 28

第一章 绪论

1.1芩贝止咳颗粒研究概况

芩贝止咳颗粒由黄芩、浙贝母、百部、鱼腥草、苦杏仁、前胡、连翘、甘草等中药材，加上甜菊素、糊精等辅料配制而成^[6]。

芩贝止咳颗粒是由传统中药复方经现代制剂工艺研制而成的一种治疗急性气管-支气管炎的中药新药，功能为清热宣肺、化痰止咳‚临床上可以用于急性支气管炎所致的咳嗽、痰黄黏稠、苔黄或兼腻、脉数等症^[7]。目前，芩贝止咳颗粒的前期工作已完成提取工艺与制剂工艺研究、质量标准研究、初步稳定性实验研究、药效研究、急性毒性试验及长期毒性试验研究，并获得了国家食品药品监督管理局颁发的临床试验批件^[8]。

我通过在学校期间学习的天然药物化学相关知识，在咨询相关老师，联系实际之后，认为芩贝止咳颗粒这一中药新药将是未来药品市场上新的止咳药潮流。因此，研究设计该药品的固体制剂车间工艺设计是十分及时且必要的。本课题研究年产100万袋芩贝止咳颗粒的固体制剂车间工艺设计，为芩贝止咳颗粒实现工业化生产提供一定的理论支持。

1.2处方及处方分析

1.2.1法定处方

表1.1芩贝止咳颗粒处方表

1.2.2处方分析