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In recent years, National Medical Products Administration has successively issued special documents such as “Several Measures to Further Strengthen the Scientific Regulation of Traditional Chinese Medicine(TCM) and Promote the Inheritance, Innovation and Development of TCM”, “Special Regulations on Registration and Management of TCM” and “Special Regulations on the Management of TCM Standards”, which put forward new requirements for the research, formulation and management of TCM standards, and is of great significance for the comprehensive construction of a new system for the management of TCM standards, the establishment of the most rigorous TCM standards, and the promotion of high-quality development of TCM industry. Due to the natural source of TCM, the complex composition of drug components, the unique theoretical system and the safety and effectiveness derived from clinical practice, it is difficult to objectively evaluate and effectively control the quality of TCM preparations based on qualitative and quantitative quality control models based on chemical components and the quality standards established thereby. How to realize the advanced characterization and objective identification of TCM quality based on the characteristics of TCM, and to study and establish the corresponding quality standard of TCM preparation has become an important content of TCM quality research, the focus and difficulty of TCM supervision scientific research, and the bottleneck of TCM quality improvement and standard formulation. At present, the quality control of TCM preparations has established a whole process quality control system from TCM crude drugs, decoction pieces to preparations, and formed a quality standard system of TCM preparations based on the characteristics of TCM consisting of the standards of TCM crude drugs, decoction pieces, extracts and preparations. By sorting out the development history of TCM quality standards, this paper analyzs the problems and challenges in the research of TCM quality standards, and discusss the strategies and methods for the research of TCM preparation quality standards based on the characteristics of TCM in combination with the scientific research results of TCM regulatory science in recent years, and the actual research and development and review of TCM, so as to provide reference for colleagues in the industry.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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