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Acceptance criteria and guiding principles for the implementation of standardized planting research projects for traditional Chinese medicinal materials
Release time:2024-07-16  Read: 11 times

The research on the production of traditional Chinese medicine is one of the key links in the research and development of Chinese medicine. The establishment of standards for the production, harvesting and processing of Chinese medicinal materials is of particular significance for ensuring the production of Chinese medicinal materials and even traditional Chinese patent medicines and simple preparations products. Therefore, in the process of modernization and internationalization of traditional Chinese medicine, it is necessary to start with the quality of Chinese medicinal materials. Establish a quality standard specification system for traditional Chinese medicine that conforms to internationally recognized standards and has the characteristics of traditional Chinese medicine, gradually developing into an international standard for the research and development of traditional Chinese medicine, thereby providing institutional guarantees for the modernization and internationalization of traditional Chinese medicine.

The research project on standardized cultivation of Chinese medicinal materials should be guided by the National Good Agricultural Practice (GAP) for the production quality management of Chinese medicinal materials. Through scientific research, standard operating procedures (SOP) for standardized cultivation of each type of Chinese medicinal material should be formulated, and a quality standard system for medicinal material production should be established and improved to produce high-quality Chinese medicinal materials and promote the modernization research and development of Chinese traditional medicine in China. To guide the implementation of standardized planting projects for traditional Chinese medicine, ensuring the smooth completion of the project and achieving the established goals. Our center has formulated project implementation guidelines and acceptance standards based on the requirements of the special contract and after soliciting expert opinions, for reference and implementation by the special project undertakers.

1、 Principles to be followed in project research work

1. Based on the upcoming release of the "Good Manufacturing Practice for Chinese Medicinal Materials" (GAP) by the National Medical Products Administration, various factors affecting the quality of medicinal materials are controlled, and the production process and entire process of medicinal materials are standardized to achieve the goal of "authentic, high-quality, stable, and controllable" medicinal materials.

2. Emphasize the principle of quality of medicinal materials, and the ultimate goal of research work is to produce stable quality Chinese medicinal materials. Therefore, the entire research process must adhere to quality priority.

3. The principle of science and authenticity means that research work must be based on scientific design and implementation, ensuring the authenticity and operability of all conclusions, data, procedures, and standards.

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