The Pharmacopoeia of the people's Republic of China (hereinafter referred to as Chinese Pharmacopoeia) is a standard that must be implemented for the production, sale and use of drugs in China. It forms a national drug standard together with the drug standard of the Ministry of health of the people's Republic of China (hereinafter referred to as the "ministerial standard") issued by the former Ministry of health and the drug standard of the people's Republic of China (hereinafter referred to as the "national drug standard") issued by the drug regulatory department of the State Council. For the drugs that have been included in the Chinese Pharmacopoeia, their standards must be implemented according to the Chinese Pharmacopoeia. Therefore, the five-year updating of the Chinese Pharmacopoeia has become a hot spot for drug production and sales enterprises, medical institutions, scientific research institutions and so on.

Traditional Chinese medicine is the raw material for the production of traditional Chinese medicine, and traditional Chinese medicine is the raw material for the production of clinical Decoction and traditional Chinese medicine. Therefore, the revision of the quality standards of traditional Chinese medicine and traditional Chinese medicine is not only directly related to the clinical efficacy and safety of traditional Chinese medicine, but also related to the efficacy and safety of traditional Chinese medicine. Most Chinese medicinal materials come from plants and animals and have the nature of agricultural and sideline products. Their quality is greatly affected by internal and external factors such as germplasm resources, soil, climate, cultivation and processing technology. Due to the complex chemical composition of traditional Chinese medicine, the wide source of some traditional Chinese medicine and the complex origin, as well as the illegal addition and counterfeiting, it has brought great challenges to the formulation of quality standards for traditional Chinese medicine and prepared pieces of traditional Chinese medicine. In order to do a good job in the addition and revision of the quality standards for Chinese medicinal materials and Chinese Herbal Pieces in the 2020 edition of Chinese Pharmacopoeia, the national pharmacopoeia committee solicited opinions from all over the country, and organized Pharmacopoeia members and relevant experts in the field of Chinese medicinal materials and Chinese herbal pieces to trace the source of the collected opinions, suggestions and problems reflected by the media. On this basis, the working ideas for updating the quality standards of Chinese medicinal materials and prepared pieces of traditional Chinese medicine in the 2020 edition of Chinese Pharmacopoeia were formulated. This paper introduces in detail the contents of "Chinese medicinal materials and decoction pieces" in the outline of Chinese Pharmacopoeia 2020 edition, and discusses some problems affecting the quality of Chinese medicinal materials and decoction pieces for reference.

According to the guiding ideology and overall objectives proposed in the preparation outline of Chinese Pharmacopoeia (2020 Edition), fully implement the spirit of the 18th and 19th National Congress of the Communist Party of China, take the establishment of "the most rigorous standards" as the guide, firmly establish the five development concepts of "innovation, coordination, green, openness and sharing", and closely focus on the overall objectives of the "13th five year plan for national drug safety", the National Pharmacopoeia Committee organized Pharmacopoeia members to formulate the overall objectives and work priorities for the preparation of Chinese medicinal materials and decoction pieces.

Based on the clinical practice of traditional Chinese medicine, the quality standards of traditional Chinese medicine and decoction pieces are formulated, and the standard system of traditional Chinese medicine with Chinese Pharmacopoeia as the core body and in line with the characteristics of traditional Chinese medicine is improved; Give full play to the characteristics and advantages of Chinese traditional medicine and decoction pieces, further strengthen international exchanges and cooperation, and realize that the standards of traditional Chinese medicine continue to dominate the formulation of international standards.

In order to ensure the effectiveness and safety of traditional Chinese medicine, revise and improve the quality standard of prepared pieces of traditional Chinese medicine; Strengthen the research on the quality of cultivated and wild cultivated Chinese medicinal materials and processed Chinese medicinal materials in the production area, and revise the relevant testing items and standards of Chinese medicinal materials and Chinese medicinal pieces on the premise of quality assurance; Further strengthen the specific identification and overall quality control of traditional Chinese medicine and decoction pieces; To formulate the limit standards for heavy metals, harmful elements, pesticide residues and mycotoxins in Chinese medicinal materials and decoction pieces.

Traditional Chinese medicine (TCM) is the foundation of TCM clinical practice and TCM industry. It is the foundation of the foundation. Strict, scientific, reasonable and applicable standards must be established.

In order to ensure the relative stability of the varieties of Chinese medicinal materials in the 2020 edition of Chinese Pharmacopoeia, in principle, it is not easy to add new varieties of medicinal materials and new sources of medicinal materials. For the varieties and new sources that really need to be added, strict revenue principles are formulated: 1) for the varieties of Chinese medicinal materials with large demand for clinical drugs, extensive use areas, solid basic research and rich resources (wild and cultivated), appropriate consideration can be given. 2) For the Chinese Pharmacopoeia (2015 Edition) containing or to be included in the prescription flavor of Chinese patent medicines, the original medicinal materials are not included in the Chinese Pharmacopoeia (commonly known as "upside down varieties"), according to the use of the flavor in the prescription of Chinese patent medicines, appropriate consideration can be given; At the same time, in the selection of Chinese patent medicine varieties that are included in Chinese Pharmacopoeia, try to select the varieties whose prescription drug flavor is included in Chinese Pharmacopoeia, so as to reduce the generation of "upside down varieties" from the source. 3) In principle, the newly added base source of existing Chinese medicinal materials shall be applied for registration according to the "newly discovered Chinese medicinal materials". After approval, it can be considered as a new base source to be included in Chinese pharmacoeia. The varieties that have been proved by herbal research to be historical misuse and need to be corrected are not included.

Chinese Pharmacopoeia has also established a withdrawal system for drug quality standards. For the Chinese medicinal materials with exhausted wild resources, lack of commodities and obvious safety, ethics and other problems, such as the varieties of Chinese medicinal materials whose original plants and animals are included in Appendix I of the Convention on international trade in wild fauna and flora, the varieties of Chinese medicinal materials derived from fossils, human placenta, animal feces and other Chinese medicinal materials, as well as the standards of Chinese medicinal materials with weak basic research, they will not be added or included in the 2020 Chinese Pharmacopoeia.

The increase or non inclusion of the quality standards for Chinese medicinal materials needs to be evaluated by the medical professional committee and the pharmaceutical professional committee.

The names, sources or medicinal parts of Chinese medicinal materials contained in Chinese Pharmacopoeia are determined according to the textual research, clinical medication and the actual production of Chinese medicinal materials. As a national drug code, Chinese Pharmacopoeia maintains a relatively stable standard in principle.

Due to the continuous deepening of basic research, the continuous improvement of scientific understanding and the different taxonomic views of some researchers, the taxonomic status and Latin scientific names of some primitive plants (animals) of Chinese medicinal materials have changed. For example, flora of China has revised the taxonomic location and Latin scientific names of many plants, resulting in differences in the taxonomic status and Latin scientific names of some primitive plants of Chinese medicinal materials contained in Chinese Pharmacopoeia and flora of China; At the same time, due to historical reasons, there are differences between the source of a few Chinese medicinal materials and the actual use of drugs.

In order to maintain the authority and scientificity of the Pharmacopoeia, the 2020 edition of Chinese Pharmacopoeia will sort out and standardize the names, sources and medicinal parts of Chinese medicinal materials. If the family, genus, species and Latin scientific name of the original plant (animal), the category, family and ore name of the original mineral are different from those in other literatures, Pharmacopoeia Committee members and experts (including biological taxonomic experts) from abroad will be organized to conduct in-depth analysis and textual research. For changes that have formed a consensus or conclusion at home and abroad, the relevant contents of Chinese Pharmacopoeia will be revised; For changes or opinions that have not yet reached a consensus and conclusion, Chinese Pharmacopoeia will not be revised accordingly for the time being. If there are differences between the current actual medication and Chinese Pharmacopoeia, systematic herbal textual research will be carried out, and the names, sources and medicinal parts of relevant Chinese medicinal materials will be deeply analyzed and studied in combination with the actual clinical medication and production of Chinese medicinal materials. If there are problems in Chinese Pharmacopoeia, the 2020 version of Chinese Pharmacopoeia will be revised and standardized accordingly.

At present, with the rapid development of traditional Chinese medicine agriculture, many commonly used medicinal materials have been planted and cultivated on a large scale, and the collection and processing have been relatively concentrated and gradually mechanized; In particular, some larger roots, rhizomes and stems of medicinal materials have developed from natural drying of original medicinal materials to drying or drying of fresh slices, which has shortened the drying time and effectively prevented mildew. These are the inevitable trends of the progress of Chinese herbal medicine production and industrial development. It is normal for cultivated medicinal materials to have variation due to natural phenomena in the plant world, so it is necessary to fully collect relevant data, and on the basis of relatively stable variation, carry out research on the relevant characters and microscopes of the standards for Chinese medicinal materials contained in Chinese Pharmacopoeia, and gradually improve the standards; There may be some differences between the characters of the slices processed in the producing area, especially the fresh slices directly dried, and those of the traditional raw medicinal materials directly dried.

Chinese Pharmacopoeia will face these problems directly and gradually study and improve the corresponding quality standards of traditional Chinese medicine under the premise of corresponding management regulations. On the premise of ensuring the quality, the 2020 edition of Chinese Pharmacopoeia carried out research on the properties and microscopic characteristics, harvesting and processing methods and the properties of some cultivated or cultivated Chinese medicinal materials. Specific ideas: 1) formulate the evaluation methods and guiding principles for the collection and processing technology of traditional Chinese medicine, and bring the collection and processing of traditional Chinese medicine into a scientific and legal track. 2) Collect and standardize the processing method of direct drying of fresh slices of traditional Chinese medicine. The collected varieties must meet the requirements of the above guiding principles, which are limited to some traditional Chinese medicinal materials with backward collection and processing methods, which are difficult to dry and easy to mildew or cause significant decline in components during the long-term drying process, as well as the traditional Chinese medicinal materials that use sulfur fumigation instead of sulfur free processing in the production area. 3) We will study the sources and properties of Chinese medicinal materials processed in the above-mentioned relevant places, encourage the application of advanced technologies, and improve and ensure the quality of Chinese medicinal materials. For those that can be directly used as decoction pieces of traditional Chinese medicine after processing in the place of origin, the standards shall be established according to the decoction pieces of traditional Chinese medicine, and the processing conditions shall also comply with the production regulations of decoction pieces of traditional Chinese medicine, and shall be managed according to the production management of decoction pieces of traditional Chinese medicine. 4) For Chinese medicinal materials with obvious origin dependence and strict requirements on growth years, the origin, harvest time and harvest years should be specified.

The research and revision of Chinese materia medica and Chinese herbal pieces should be consistent with the current laws and regulations on drug administration.

The safety of traditional Chinese medicine has always been the focus of international attention, and it is also the new requirement of "healthy China 2035". Traditional Chinese medicine is the source of traditional Chinese medicine, and its safety must be controlled from the source. To this end, the 2020 Chinese Pharmacopoeia further improved the safety testing methods for Chinese medicinal materials. According to the "guidelines for the limit of harmful residues in Chinese medicinal materials" in the Chinese Pharmacopoeia, it organized the research on the limit standards for heavy metals and harmful elements, pesticide residues, mycotoxins in moldy Chinese medicinal materials, etc. in particular, a unified limit standard must be formulated for the pesticides banned and restricted by the state. Through strict limit standards, the chaos of pesticide abuse in the source planting and breeding stage must be curbed, and the safety of the quality of Chinese medicinal materials must be strictly controlled.

Study the toxic traditional Chinese medicinal materials collected in Chinese Pharmacopoeia and the medicinal materials that have been reported to have liver and kidney toxicity and other potential safety hazards. Through systematic toxicological research, determine the main toxic components, establish detection methods, and formulate reasonable limits and guiding principles.

Due to the wide variety of Chinese medicinal materials, different medication habits in different regions, chaotic market circulation, artificial addition and counterfeiting, the establishment of exclusive identification of Chinese medicinal materials has always been the focus of the revision of Chinese Pharmacopoeia. The 2020 edition of Chinese Pharmacopoeia continues to supplement and improve the microscopic identification and TLC identification of plant medicinal materials, and compiles the corresponding atlas; For the medicinal materials that lack specificity identification, precious and fine medicinal materials and medicinal materials with confused sources, continue to study the specificity identification methods, and if necessary, adopt the methods such as characteristic map and DNA molecular identification; Focus on the research and application of the control extract for identification. On the basis of formulating the corresponding guiding principles, promote the TLC identification or characteristic map identification with the control extract as the control.

Traditional Chinese medicine has complex chemical components and extensive functions. According to different functions and indications, the pharmacodynamic components of the same medicinal material may be different. The purpose of quality control of Chinese medicinal materials and pieces of traditional Chinese medicine is to ensure the relative stability of its material base, that is, the internal chemical components. Therefore, the establishment of overall control of chemical components is an inevitable trend of quality control of Chinese medicinal materials and pieces of traditional Chinese medicine. The 2020 edition of Chinese Pharmacopoeia plans to carry out fingerprint and multi-component content determination research on 50 bulk Chinese medicinal materials with solid research foundation and basically clear pharmacodynamic components, so as to comprehensively improve the effectiveness control level of common Chinese medicinal materials.
Chinese Pharmacopoeia (2020 Edition) quality standards for Chinese medicinal materials and Chinese herbal pieces (Part 2)

Source: Modern Chinese Medicine
Author:Tupengfei   School of pharmacy, Peking University

Huangluqi traditional Chinese medicine resource center of Chinese Academy of traditional Chinese Medicine

Chenwansheng Naval Medical University of the Chinese people's Liberation Army

Chenshilin Institute of traditional Chinese medicine, Chinese Academy of traditional Chinese Medicine

Cao     Hui School of pharmacy, Jinan University

Qian Zhongzhi, national pharmacopoeia committee, etc