中药材生产研究是中药研究与开发的关键环节之一。建立中药材的生产、采收、饮片加工的规范标准，对于保证中药材产品以至中成药产品具有特别重要的意义。因此，在中药现代化、国际化进程中，首先必须从中药材的质量抓起，建立符合国际通用标准规范，并具有中医药特点的中药材质量标准规范体系，逐步发展为传统药物研究和开发的国际标准，从而为中药现代化、国际化提供制度保障。

The research on the production of Chinese medicinal materials is one of the key links in the research and development of traditional Chinese medicine. Establishing standardized norms for the production, harvesting and processing of decoction pieces of Chinese medicinal materials is of particular significance for ensuring the quality of Chinese medicinal materials products and even Chinese patent medicines. Therefore, in the process of modernization and internationalization of traditional Chinese medicine, it is first necessary to start from the quality of Chinese medicinal materials, establish a quality standard and specification system for Chinese medicinal materials that conforms to international common standards and norms and has the characteristics of traditional Chinese medicine, and gradually develop it into an international standard for the research and development of traditional drugs, thereby providing institutional guarantees for the modernization and internationalization of traditional Chinese medicine.

中药材规范化种植研究项目应在国家中药材生产质量管理规范（GAP）的指导下，通过科学研究工作，制订每种中药材的规范化种植标准操作规程（SOP），建立和完善药材生产的质量标准体系，生产出高质量的中药材，推进我国中药的现代化研究与发展。为指导中药材规范化种植项目的实施，确保项目顺利完成并达到既定目标，我中心根据专题合同要求，经征求专家意见制订项目实施指导原则及验收标准，供专题承担者参照实施。

The research project on standardized cultivation of Chinese medicinal materials should be carried out under the guidance of the National Good Manufacturing Practice (GAP) for Chinese Medicinal Materials. Through scientific research, it should formulate standard operating procedures (SOP) for the standardized cultivation of each type of Chinese medicinal material, establish and improve the quality standard system for medicinal material production, produce high-quality Chinese medicinal materials, and promote the modernization research and development of traditional Chinese medicine in China. To guide the implementation of the standardized cultivation project of Chinese medicinal materials and ensure its smooth completion and achievement of the set goals, our center, in accordance with the requirements of the special topic contract and after soliciting expert opinions, has formulated the project implementation guidelines and acceptance standards for the reference and implementation of the project undertaers.

项目研究工作应遵循的原则

The principles that project research work should follow

1．以国家药品监督管理局即将发布的"中药材生产质量管理规范"(简称中药材GAP)为基本原则，控制影响药材质量的各种因子，规范药材各生产环节乃至全过程，以达到药材"真实、优质、稳定、可控"的目的。

1. Based on the "Good Manufacturing Practice for Chinese Medicinal Materials "(referred to as GAP for Chinese medicinal materials) to be released by the National Medical Products Administration soon, various factors affecting the quality of medicinal materials should be controlled, and all production links and even the entire process of medicinal materials should be standardized to achieve the goal of" authenticity, high quality, stability and controllability "of medicinal materials.

2．突出药材质量**的原则，研究工作的较终目的是生产出质量稳定的中药材，因此整个研究过程必须坚持质量优先。

2 The principle of highlighting the quality of medicinal materials should be emphasized. The ultimate goal of the research work is to produce Chinese medicinal materials with stable quality. Therefore, the entire research process must adhere to quality first.

3．科学、真实的原则，研究工作必须建立在科学设计、科学实施的基础上，确保所有结论、数据、规程、标准的真实性和可操作性。

3 The principles of science and truth must be adhered to. Research work must be based on scientific design and implementation to ensure the authenticity and operability of all conclusions, data, procedures and standards.

4．鼓励新技术的应用。

4 Encourage the application of new technologies.