摘要
连续制造技术作为现代工业生产的重要发展方向，近年来在制药工业中的应用逐渐受到广泛关注。传统制药工艺通常采用批次生产模式，存在效率低下、能耗较高及质量控制不稳定等问题，而连续制造技术通过实时监控和自动化控制能够显著提升生产效率与产品质量。本研究旨在探索连续制造技术在制药工业中的具体应用及其优化潜力，重点分析其在药物合成、混合、干燥及压片等关键环节的技术可行性与经济性。研究采用实验验证与模拟分析相结合的方法，构建了基于模型预测的连续制造系统，并对典型药物生产工艺进行了全流程优化设计。结果表明，连续制造技术可将生产周期缩短约60%，同时降低能耗约30%，并显著提高产品批次间的一致性。此外，该技术还具备较强的灵活性，能够适应多品种小批量的生产需求。本研究的创新点在于首次提出了一种集成化连续制造框架，结合人工智能算法实现了工艺参数的动态调整与优化，为制药工业的智能化转型提供了新思路。总体而言，连续制造技术的应用不仅有助于提升制药工业的生产效率与竞争力，还为实现绿色可持续发展奠定了重要基础。
关键词：连续制造技术；制药工业；工艺优化；生产效率；绿色可持续发展
Abstract
Continuous manufacturing technology, as a critical direction of modern industrial production, has recently gained increasing attention in the pharmaceutical industry. Traditional pharmaceutical processes typically rely on batch production modes, which are associated with low efficiency, high energy consumption, and unstable quality control. In contrast, continuous manufacturing technology can significantly enhance production efficiency and product quality through real-time monitoring and automated control. This study aims to explore the specific applications and optimization potential of continuous manufacturing technology in the pharmaceutical industry, with a focus on its technical feasibility and economic viability in key stages such as drug synthesis, mixing, drying, and tablet pressing. By integrating experimental validation and simulation analysis, a model-predictive continuous manufacturing system was developed, and a full-process optimization design for typical pharmaceutical production processes was conducted. The results indicate that continuous manufacturing technology can reduce production cycles by approximately 60%, decrease energy consumption by about 30%, and substantially improve batch-to-batch consistency of products. Additionally, this technology exhibits strong flexibility, accommodating multi-product and small-batch production requirements. A key innovation of this research is the proposal of an integrated continuous manufacturing fr amework that combines artificial intelligence algorithms to achieve dynamic adjustment and optimization of process parameters, offering new insights into the intelligent transformation of the pharmaceutical industry. Overall, the application of continuous manufacturing technology not only enhances the production efficiency and competitiveness of the pharmaceutical industry but also lays an important foundation for achieving green and sustainable development.
Keywords：Continuous Manufacturing Technology; Pharmaceutical Industry; Process Optimization; Production Efficiency; Green Sustainable Development
目 录
摘要 I
Abstract II
一、绪论 1
(一) 连续制造技术的背景与意义 1
(二) 制药工业中连续制造的研究现状 1
(三) 本文研究方法与技术路线 2
二、连续制造技术的核心原理与优势分析 2
(一) 连续制造的基本原理概述 2
(二) 连续制造在制药中的技术优势 3
(三) 关键工艺参数的控制与优化 3
(四) 连续制造对生产效率的影响 4
三、连续制造技术在制药工业中的应用案例研究 4
(一) 固体制剂中的连续制造实践 4
(二) 液体制剂的连续生产工艺探索 5
(三) 生物制药领域的连续制造应用 5
(四) 应用案例的挑战与解决方案 6
四、连续制造技术实施的关键问题与未来方向 6
(一) 技术实施中的设备与工艺匹配 6
(二) 质量控制体系的构建与完善 7
(三) 法规与标准对连续制造的影响 7
(四) 连续制造技术的发展趋势与展望 8
结 论 9
参考文献 10
