长 春 工 业 大 学毕 业 设 计年产5000万支恩必普注射剂车间工艺设计Annual Output of 50Million Butylphthalide InjectionWorkshopProcess Design学 院：化学工程专 业：制药工程班 级：110607姓 名：解 亚 楠指导教师：胡 江 磊2015年 6 月 3 日长春工业大学学士学位论文摘 要恩必普（丁苯酞注射剂）是一种多靶点抗脑缺血药物，目前主要用于轻、中度急性缺血性脑卒中的治疗。是一种具有保护线粒体和改善微循环的独特作用的化学合成药物。3-(3-羟基丁基)异苯丙呋喃-(3H)-酮是恩必普在动物体内的主要代谢产物，不仅含量高，同时还具有改善脑能量代谢、增加血流量、改善脑缺血、缩小脑梗塞面积、保护和修复缺血区神经细胞、抗血栓和抗血小板等药理活性。恩必普具有起效迅速可靠、生物利用度高、副作用极小等优点。恩必普是我国原创的抗脑缺血新化学实体药物，属于国家类新药。本设计包括恩必普注射剂的性质，恩必普注射剂的工艺路线选择及工艺流程设计，恩必普注射剂的工艺计算（物料衡算、能量计算、设备计算及其选型等），绘制工艺流程图建筑设计要求及说明。其中，生产工艺设计和车间设计是本设计的重点环节。提取车间与制剂车间是本设计的重点车间。安瓿洗烘封联动机组是本设计的重点设备。本设计采用现代化的设备和生产方法，确保了提高药品质量和降低成本。要求符合中国药典标准，对年产5000万支恩必普注射剂车间进行设计。关键词：恩必普注射剂，疗效，化学合成药物，生产工艺设计，车间设计长春工业大学学士学位论文AbstractButylphthalide and Sodium Chioride Intection is a multiple target drug for thetreatment of acutemild to moderate ischemic cerebral stroke. Its that has anti-cerebralischemic effect through mitochondrial protection and micro-circulation improvementchemical synthesis drug.3-（3-hydroxybutyl)-isobenzofuran-（3H)-one was reported as oneof the main metabolites of Butylphthalide which has many pharmacological activities,suchas improving cerebral brain energy metabolism, increasing blood flow,improving cerebralischemia, reducing infarct size, protecting and repairing neural cells, antithrombotic andantiplatelet activities. Butylphthalide has the advantage that it has a rapid onset, reliable,high bioavailability and little side effect. Butylphthalide is a class innovative drug ofnewchemicalentities inChina.The design includes prescription injections Butylphthalide introduced its nature, theprocess route selection and process design Butylphthalide injections, process calculationButylphthalide injections (material balance, energy calculation, calculation and selection ofequipment, etc.), architectural design requirements for drawing flow chart and description.Among them, the production process design and plant design are key aspects of the design.Extraction workshop and preparation workshop is focused on the design workshop. Sealedampoulewashing drying equipment linkage unitis thefocus ofthisdesign.This design uses modern equipment and production methods to ensure that the drugsimprove quality and reduce costs. The design requirements in line with the ChinesePharmacopoeia standards, the annual output of 50 million Butylphthalide injectionsworkshop design.Keywords: Butylphthalide injection, effect, chemical synthesis drug, production processdesign, plant design长春工业大学学士学位论文目录1概述.11.1恩必普注射剂各方面内容简介.11.1.1恩必普注射剂的背景及来源.11.1.2恩必普的作用与特点.21.1.3制备恩必普注射剂的意义.21.1.4恩必普注射剂存在的主要问题.21.2.恩必普注射剂的药理性质.21.3产品方案.31.3.1产品方案的要求和安排.31.3.2恩必普的来源依据.31.3.3恩必普具体功效.31.4产品设计.41.4.1设计要求.41.4.2生产规模.41.4.3设计产品规格.41.4.4班产量和人员.42 生产方法及工艺流程.42.1工艺流程设计的原则.42.2工艺路线概述.52.3各部分生产工艺内容.