摘 要
中药质量控制体系构建与实践旨在应对中药产业面临的质量问题，随着中医药现代化进程加快及国际贸易需求增加，建立科学有效的质量控制体系成为保障中药安全有效、稳定可控的关键。本研究以提升中药质量为目标，基于现代分析技术与传统鉴别方法相结合的原则，构建了涵盖药材种植、采收加工、炮制生产到成品检测的全过程质量控制体系。创新性地引入了指纹图谱技术用于中药材及其制剂的质量评价，实现了定性定量一体化分析；建立了多指标成分含量测定方法，确保了产品质量均一性；制定了严格的内控标准高于现行国家标准。通过对多个典型中药品种的实际应用验证，该体系能够显著提高产品合格率，增强市场竞争力。研究结果表明，所构建的质量控制体系不仅适用于单味药材，还可推广至复方制剂，为中药标准化生产提供了理论依据和技术支持，对促进中医药产业发展具有重要意义。
关键词：中药质量控制体系；指纹图谱技术；多指标成分含量测定；内控标准；全过程质量控制
Abstract
The construction and implementation of a quality control system for traditional Chinese medicine (TCM) aims to address the quality issues faced by the TCM industry. As the modernization of traditional Chinese medicine accelerates and international trade demands increase, establishing a scientifically effective quality control system has become crucial for ensuring the safety, efficacy, stability, and controllability of TCM products. This study focuses on enhancing the quality of TCM by integrating modern analytical techniques with traditional identification methods, thereby developing a comprehensive quality control system that covers the entire process from herbal cultivation, harvesting, processing, preparation production to finished product testing. Innovatively, fingerprinting technology has been introduced for the quality evaluation of TCM materials and their preparations, achieving integrated qualitative and quantitative analysis; multiple-index component content determination methods have been established to ensure product uniformity; and stringent internal control standards exceeding current national standards have been set. Through practical application verification of several typical TCM varieties, this system can significantly improve product qualification rates and enhance market competitiveness. The research results indicate that the constructed quality control system is not only applicable to single herbs but can also be extended to compound preparations, providing theoretical basis and technical support for standardized TCM production, which holds significant importance for promoting the development of the TCM industry.
Keywords：Traditional Chinese Medicine Quality Control System；Fingerprinting Technology；Multi-index Component Content Determination；Internal Control Standards；Whole Process Quality Control
目 录
摘 要 I
Abstract II
引 言 1
第一章 中药质量控制体系的理论基础 2
1.1 中药质量控制的重要性 2
1.2 中药质量控制的历史发展 2
1.3 现代中药质量控制的基本原则 3
第二章 中药材源头质量管理 4
2.1 中药材种植规范 4
2.2 中药材采收与初加工 4
2.3 中药材质量检测技术 5
第三章 中药生产过程质量控制 6
3.1 生产工艺标准化 6
3.2 关键工序质量监控 6
3.3 生产环境与设备管理 7
第四章 中药质量评价与监管体系 9
4.1 质量标准制定依据 9
4.2 质量评价方法研究 9
4.3 监管机制与政策保障 10
结 论 11
参考文献 12
致 谢 13
