摘 要

急性气管-支气管炎是由微生物感染、物理刺激、化学性刺激或过敏因素等引起的气管、支气管黏膜的急性炎症，是临床最常见、发病率很高的疾病之一，临床表现以咳嗽为主，多由病毒感染所致^[1]。急性气管-支气管炎长期不愈可转变为慢性气管-支气管炎，对罹患慢性心、肺基础疾病者，气管-支气管炎症状可导致缺氧或通气不足等问题，对患者产生极大危害^[2]。芩贝止咳颗粒是生物医药领域中天然药物的研究与开发的一种治疗急性气管-支气管炎的中药新药，由黄芩，浙贝母，鱼腥草，苦杏仁，百部，前胡，连翘，甘草8味中药组成。本品主要药效学研究表明其具有良好的抗炎、抗菌作用以及解热、镇咳、祛痰功效，特别适用于风热外邪导致的急性气管炎-支气管炎的治疗^[3][4]。本设计旨在设计出一种洁净有保障、生产可操作的年产100万袋芩贝止咳颗粒中药前处理车间，为芩贝止咳颗粒的大生产工艺提供参考。

设计中采取的工艺路线为：连翘、鱼腥草、前胡三味药材用水蒸气蒸馏法提取挥发油，药液另器收集，挥发油备用；浙贝母、百部加12倍量70%乙醇回流1次2小时，回流液备用；以上两次药渣与其余黄芩等3味药材加10倍量水煎煮2次，每次2小时。合并煎液及提取挥发油的药液，滤过，滤液浓缩至相对密度为1.15~1.20（80℃测），加乙醇使含醇量为65%，搅匀，静置24小时，滤过，滤液与回流液合并后回收乙醇并浓缩至相对密度为1.30~1.35（80℃测），低温干燥成细粉，送往制剂车间。

设计内容主要包括：芩贝止咳颗粒的产品介绍、处方分析和提取工艺流程叙述；以物料衡算、能量衡算和工艺计算为前提的生产批次，设备选型，车间总布局的合理设计；带控制点的工艺流程图，车间平立面布置图，管线平、立面布置图，主要设备装配图；劳动安全保护、环境保护以及“三废”治理的简要说明。

关键词：急性气管-支气管炎；芩贝止咳颗粒；前处理；车间设计

Abstract

Acute tracheitis-bronchitis is an acute inflammation of tracheal and bronchial mucosa caused by microbial infection, physical stimulation, chemical stimulation or allergic factors. It is one of the most common diseases with high incidence. Cough is the main clinical manifestation, mostly caused by viral infection^[1]. Acute tracheitis-bronchitis can be converted into chronic tracheitis if it does not heal for a long time. For patients suffering from chronic heart and lung basic diseases, the symptoms of tracheitis can lead to problems such as anoxia or insufficient ventilation, which have great harm to patients^[2]. Qinbei Zhike Granules is a new traditional Chinese medicine drug for the treatment of acute tracheitis-bronchitis developed by the research and development of natural drugs in the field of biomedicine. It is composed of 8 traditional Chinese medicines including Scutellariae Radix, Bulbus Fritillariae Thunbergii, Herba Houttuyniae, Semen Armeniacae Amarum, Radix Stemonae, Radix Peucedani, Fructus Forsythiae and Glycyrrhrizae Radix. The main pharmacodynamics research shows that the product has good anti-inflammatory and antibacterial effects and antipyretic, antitussive and expectorant effects, and is especially suitable for the treatment of acute tracheitis-bronchitis caused by wind-heat exogenous pathogens^[3][4]. The purpose of this design is to design a clean, safe and operable TCM pretreatment workshop with an annual output of 1 million bags of Qinbei Zhike Granules, which provides a reference for the large-scale production process of Qinbei Zhike Granules.

The process route adopted in the design is as follows: the three medicinal materials of forsythia suspensa, houttuynia cordata and peucedanum praeruptorum are distilled by steam to extract volatile oil, and the liquid medicine is collected in another device for later use; Reflux Bulbus Fritillariae Thunbergii and Radix Stemonae with 12 times the amount of 70% ethanol once for 2 hours for standby; The residue of the above two times and the other three herbs such as scutellaria baicalensis Georgi are added with 10 times of water and decocted twice for 2 hours each time. Mixing decoctions and liquid medicine for extracting volatile oil, filtering, concentrating the filtrate to a relative density of 1.15-1.20 (measured at 80 DEG C), adding ethanol to make the alcohol content 65%, stirring, standing for 24 hours, filtering, recovering ethanol after the filtrate is combined with reflux, concentrating to a relative density of 1.30-1.35 (measured at 80 DEG C), drying at low temperature to obtain fine powder, and sending to a preparation workshop.

The design content mainly includes: product introduction, prescription analysis and extraction process description of Qinbei Zhike Granules; Process flow based on material balance calculation, energy balance calculation and process calculation, equipment selection and reasonable design of the overall layout of the workshop; Process flow chart with control points, workshop elevation layout, pipeline layout and main equipment assembly drawing; Brief description of labor safety protection, environmental protection and "three wastes" treatment.

Key Words: acute tracheitis-bronchitis; Qinbei Zhike Granules; pretreatment; workshop design

目 录

第一章 绪论 1

1.1 芩贝止咳颗粒产品介绍 1

1.2 处方和处方分析 1

1.2.1 处方 1

1.2.2 处方分析 2

第二章 生产任务及设计依据 3

2.1 生产任务 3

2.2 设计依据 3

2.3 设计原则 3

第三章 生产工艺与流程叙述 4

3.1 生产工艺 4

3.2 流程叙述 5

3.2.1 预处理 5

3.2.2 乙醇提取剂配制 5

3.2.3 水蒸汽蒸馏工序 5

3.2.4 醇提工序 6

3.2.5 水提工序 6

3.2.6 一次浓缩工序 6

3.2.7 醇沉工序 7

3.2.8 二次浓缩与收膏工序 7

3.2.9 干燥工序 7

第四章 物料衡算 8

4.1 衡算依据 8

4.2 物料衡算 8

4.2.1 产量 8

4.2.2 物料用量 8

4.2.3 浸膏量 9

4.2.4 废渣量 10

4.3 衡算结果汇总表 11

4.4 各工序收率指标 11

第五章 能量衡算 12

5.1 衡算依据 12

5.1.1 热量平衡方程式 12

5.1.2 各项热量的计算 12

5.2 水蒸气蒸馏工序 13

5.2.1 Q₁和Q₄的计算 13

5.2.2 Q₃的计算 14

5.2.3 Q₆的计算 14

5.2.4 Q₂的计算 14

5.2.5 加热蒸汽量的计算 14

5.3 醇提工序 15

5.3.1 Q₁和Q₄的计算 15

5.3.2 Q₃的计算 15

5.3.3 Q₆的计算 15

5.3.4 Q₂的计算 15

5.3.5 加热蒸汽量的计算 16

5.4 水提工序 16

5.4.1 Q₁和Q₄的计算 16

5.4.2 Q₃的计算 16

5.4.3 Q₆的计算 16

5.4.4 Q₂的计算 16

5.4.5 加热蒸汽量的计算 17

5.5 一次浓缩工序 17

5.6 二次浓缩与收膏工序 18

第六章 主要设备工艺计算及选型 19

6.1 预处理工序 19

6.1.1 洗药机 19

6.1.2 润药罐 19

6.1.3 切药机 20

6.1.4 热风循环烘箱 20

6.2 水蒸气蒸馏工序 21

6.2.1 提取罐 21

6.2.2 储罐 21

6.3 醇提工序 21