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Background: Chinese patent medicines are specialty preparations in China that are produced using traditional prescriptions processed by modern pharmaceutical technology. They contain complex ingredients and much attention is paid to their clinical safety. Demonstrating the clinical safety of Chinese patent medicines containing toxic ingredients in modern pharmacological studies has become one of the urgent issues to be solved for the safe use of clinical medicines. Objectives: The aim of this research is to evaluate the safety of Chinese patent medicines containing toxic ingredients by applying the risk-benefit assessment method. Additionally, a database of 'toxic ingredients-toxic Chinese herbal medicines-adverse reactions' will be established to explore the relationship between toxic ingredients and adverse reactions. This will lay the foundation for the rational clinical use of Chinese patent medicines containing toxic ingredients. Methods: 1) Establish a database of 'toxic Chinese herbal medicines-toxic ingredients-toxic Chinese patent medicines' to count the Chinese patent medicines containing toxic ingredients in the 2020 edition of Chinese Pharmacopoeia. 2) Filtered the clinical studies, extracted the drug-related ADEs, and analyzed the characteristics and correlations of these ADEs. 3) Finally, this section summarizes the causes of ADEs related to Chinese patent medicines containing toxic ingredients and extracts the main risk factors to provide a reference for further study. Outcomes: 1) There are four main types of Chinese patent medicines containing toxic ingredients. These include medicines with diester aconitine metabolites, mineral composition, Araceae metabolites, and hydrogen cyanide. 2) Digestive system, skin and its appendages, and allergic reactions were the main types of ADEs related to four types of Chinese patent medicines containing toxic ingredients. 3) There are four primary risk factors associated with the clinical use of Chinese patent medicines containing toxic ingredients: medicine, medication, individual and regulatory factors.

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In pharmaceutics, ingredients are classified as active ingredients and excipients. In topical/transdermal phytomedicines, an ingredient may serve both functions. Published information on these dual-purpose ingredients and their pharmacological relevance is limited. An intriguing scenario arises in traditional Chinese medicine (TCM) formulations, where active ingredients and excipients are undifferentiated. This study analyzes ingredients in TCM topical/transdermal formulations, aiming at harmonization of understanding of TCMs. The most commonly recorded ingredients from such formulations in the Chinese pharmacopoeia 2020 (ChP 2020) are reviewed, aiming at developing innovative topical/transdermal phytomedicines. Current editions of Chinese historical documents were reviewed to explore the principles underlying the use of these ingredients. TCM formulations containing botanical drugs for topical/transdermal application were selected from the ChP 2020. The use of botanical materials in TCM formulations is guided by the "Jun-Chen-Zuo-Shi" principle rooted in Yin-Yang and the five elements' theories. In the ChP 2020, 155 botanical drugs, along with 40 excipients (from the "procedure" section, focusing on processing and technical parameters), were identified from 34 botanical formulations intended for topical/transdermal application. Pungent and aromatic botanical materials were the most frequently recorded. Adhesive plasters were the most commonly recorded TCM dosage form, employing specific matrix blends. This new perspective of study reveals the prevalence of pungent and aromatic botanical materials, the common use of adhesive plasters, multifunctional properties of botanical oils, and formulation adaptability in TCM topical/transdermal products. These insights should inform novel formulation designs for both pharmaceutical and phytopharmacological research.

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The traditional Chinese medicine(TCM) single preparation refers to the innovative TCM made from the whole or the effective part(including the effective ingredient) extract of a TCM single herb by modern technology. They have a long history of applications, definite effects and few side effects. It is an indispensable part of the research of innovative TCM. In recent years, with the optimization of national policies, the development of TCM single preparation shows a positive trend. However, because of the imbalance in the composition ratio, the need for expansion of indications, the need for further basic research, and the low conversion rate of existing patent achievements in universities and institutes, the TCM single preparation still has significant development space. In this review, we analyze and study the current situation, characteristics and difficulties of TCM single preparation, as well as relevant clinical application, basic research, industrialization and patent application information through statistical analysis of TCM single preparations in the Chinese Pharmacopoeia, which helps to provide direction for the development and research of single preparation of TCM.

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ObjectiveThe angiosperm phylogeny group （APG） Ⅳ system is currently the latest angiosperm classification system. The APG system based on DNA sequence can more naturally reflect the phylogeny and evolution of plants， which has been widely recognized and applied in scientific research and teaching of plants in other countries. Through the comparison between the changes in the APG Ⅳ system and the traditional plant classification system， the changes in the taxonomic status of the original plants of traditional Chinese medicine （TCM） in the 2020 edition of Chinese Pharmacopoeia were reviewed. MethodBy referring to the literature in China and abroad， the changes in the taxonomic status of the original plants of TCM recorded in Chinese Pharmacopoeia were sorted out according to the basic groups of angiosperms in the APG Ⅳ system， including the basal group of ANA， the magnoliid and chloranthales， the basal groups of monocots and eudicots， the superrosids， and the superasterids. ResultThere are about 72 species of TCM in the 2020 edition of Chinese Pharmacopoeia. A total of 76 species of the original plants change in family grade according to the APG Ⅳ system. There are 22 species of TCM belonging to the dicotyledon class， involving 26 species of the original plants. It should be placed in front of the differentiation of monocotyledons and eudicotyledons according to the APG Ⅳ system. ConclusionThis paper largely clarifies the change in the taxonomic status of the original plants of TCM in Chinese Pharmacopoeia according to the APG Ⅳ system， which is helpful to the reviewing literature in China and abroad for the original plants of TCM and facilitates the international academic exchange for TCM. It provides a reference for the revision of textbooks such as Botany and Medicinal Botany in Chinese colleges and universities and will lay the foundation for updating the content of Chinese Pharmacopoeia in the future.

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ObjectiveTo statistically analyze the efficacy and application characteristics of animal-derived drugs in the 2020 edition of the Pharmacopoeia of the People's Republic of China （referred to as Chinese Pharmacopoeia）， and provide data references for the research and application of animal-derived drugs. MethodAnimal-derived drugs included in the 2020 edition of the Chinese Pharmacopoeia were selected and screened. Information such as the classification， nature and flavor， meridian tropism， usage， dosage， toxicity or contraindications of single animal-derived drugs were statistically analyzed. The efficacy and clinical application analysis of externally applicable Chinese medicinal preparations containing animal-derived drugs， the dosage forms of preparations containing animal-derived drugs， and the contraindications of their use were also analyzed. The above information was recorded in an Excel spreadsheet for statistical analysis. ResultThe 2020 edition of the Chinese Pharmacopoeia clearly records a total of 51 types of animal-derived drugs. Among them， liver-calming and wind-relieving drugs and deficiency-tonifying drugs are the most common in the efficacy classification of animal-derived drugs. The properties are mainly categorized as neutral and salty， with meridians including liver， kidney， heart， and lung meridians with a frequency of >10 times. Most animal-derived drugs are used in decoctions and pills， with the decoction method being the primary method for decoction. The common dosage of animal-derived drugs is 3-9 g， 5-10 g， or 3-6 g， and animal-derived drugs are used externally in appropriate amounts. In addition to mentioning the toxicity of drugs， the most common precautions for animal-derived drugs are caution and prohibition for pregnant women. Externally applicable Chinese medicinal preparations containing animal-derived in the Chinese Pharmacopoeia are widely used in various departments such as pediatrics， gynecology， orthopedics and traumatology， stomatology， internal medicine， surgery， dermatology， ophthalmology， and otorhinolaryngology， with extensive clinical applications. The dosage forms of preparations containing animal-derived drugs are mainly pills， capsules， tablets， and capsules. Animal-derived drugs are mainly in the form of fine powder before use. The precautions for use in preparations mainly focus on the contraindications for pregnant women and children. ConclusionThe clinical application of animal-derived drugs included in the 2020 edition of Chinese Pharmacopoeia is extensive and has unique efficacy. However， there are still problems such as imperfect quality standards and unclear mechanisms of action for animal-derived drugs， which require further research to better utilize the advantages of internal and external use of animal-derived drugs. In addition， non-medicinal parts of animals also have development and utilization value， which should be fully explored and utilized to achieve the green development of animal-derive drug resources.

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BACKGROUND: Ethnobotanical studies in metropolitan areas and urban ethnic markets have grown considerably in recent years as large cities have demonstrated to be significantly rich in biocultural diversity and in driving its evolution, as human populations migrate from one region to another. Urban spaces also represent important places of rich multicultural and multilingual interaction and exchange, where ethnobotany can act as a bridge between research and action. The purpose of this study is to present a case study on how to use ethnobotany in multicultural urban settings by studying people-plant interactions and the larger implications and applications to promote biocultural learning in these areas. METHODS: We inventoried the botanical composition of fresh and dry products sold in most food stores owned by Chinese immigrants in Fondo, a neighbourhood of Barcelona's metropolitan area, in Santa Coloma de Gramenet municipality (Barcelonès county, Catalonia, Iberian Peninsula), pharmacologically validating the obtained list with the Chinese Pharmacopoeia. We also participated in multiple dissemination activities and materials (non-academic and academic), along with exchanges with the broader community in relation to this research. RESULTS: In total, 103 plants were identified at the species level, pertaining to 88 genera and 46 botanical families. Including the infraspecific level, a total of 113 plant taxa were inventoried. One algal and six fungal species were also recorded, but not included in the analyses. Brassicaceae (12.4%) and Fabaceae (10.6%) were the most predominant families inventoried, followed by Cucurbitaceae (7.1%) and Poaceae (7.1%). Over three-quarters of all the taxa have an Asian origin (76.11%), indicating a high conservation of the use of Asian taxa. Over one-third (36.89%) of the plant parts pertain to species contained in the Chinese Pharmacopoeia, showing the relevance of medicinal plants in local stores and the preponderance of Eastern Asian food-medicine continuums. To promote ethnobotanical education programmes, over 50 dissemination activities and educational materials were produced from this study and shared with the local urban community in different fora. CONCLUSIONS: Further research in these and similar settings can provide significant ethnographic information to better understand anthropological processes and phenomena underlying migration and transculturation that can be used in an umbrella of applications, from adequate nomenclature and labelling of foreign products in local languages to multicultural integration and social cohesion programmes along with educational activities on biocultural topics.

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ObjectiveTo analyze the functions， formulae， dosage forms， and methods of administration of the menstruation-regulating Chinese patent medicines included in the 2020 edition of the Chinese Pharmacopoeia， so as to provide reference for rational clinical use. MethodThe relevant Chinese patent medicines were recorded one by one， and the efficacy， dosage forms， methods of administration， and contraindications were counted， classified， and summarized. Further， we analyzed the Chinese medicines used in these Chinese patent medicines， identified the high-frequency Chinese medicines for menstrual regulation， and analyzed their natures， tastes， meridian tropism， and functions， aiming to guide the clinical use. ResultA total of 142 Chinese patient medicines for menstrual disorders were included in this study. They were classified into 12 categories according to their efficacy， mainly for regulating menstruation and blood， tonifying， activating blood， and eliminating mass. The representative Chinese patent medicines were Bazhen Yimu pills， Shaofu Zhuyu pills， Lyujiao Buxue granules， and Guizhi Fuling pills， which are in line with the principles of moving Qi and blood and regulating liver and spleen. Menstruation-regulating Chinese patents medicines are mostly in pills and capsules and are mainly taken with yellow wine or ginger decoction. Pregnancy was the contraindication with the highest frequency， followed by menstruation and dietary precautions. The high-frequency Chinese medicines mainly had the functions of tonifying， activating blood， resolving stasis， and clearing heat， with the top three being Angelicae Sinensis Radix， Paeoniae Radix Alba， and Chuanxiong Rhizoma. These medicines mainly had warm nature， sweet， bitter， and pungent tastes， and tropism to liver and spleen meridians. ConclusionThe treatment of menstrual disorders should focus on nourishing and activating blood， regulating Qi， tonifying kidney， supporting spleen， nourishing liver， and harmonizing stomach. The appropriate dosage form should be selected according to the patient's specific conditions. The medicinal guide and the method of administration should be selected on the basis of syndrome differentiation with attention to the contraindications. In summary， the Chinese patient medicines for menstrual regulation should be chosen based on the patient’s syndrome under guidance of the theory of traditional Chinese medicine.

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Strengthening the standard formulation and quality management of traditional Chinese medicine（TCM） dispensing granules is an important part of the strategic planning for the development of TCM in China. In order to examine the clinical application and overall quality control of the existing national standards for TCM dispensing granules， this study classified and summarized the varieties in the existing standards， analyzed their clinical applicability， and discussed the characteristics of the test methods for identification， content determination and specific chromatogram/fingerprint. It was found that the coverage of the existing standards was inadequate in terms of quantity， and it was even weaker in the aspects of therapeutic efficacy， herb family， processing method and preparation method of TCM dispensing granules. It was concluded that the characteristics of national standards in test methods were summarized as follows：guided by clinical application， based on the reference system， taking specific chromatogram as a breakthrough， so as to improve the overall quality control of TCM dispensing granules. It is suggested that the coverage of national standards should be subsequently expanded to meet the needs of market development. In order to enhance clinical applicability， the content of national quality standards should be increased， including increasing variety diversity to meet the needs of clinical application， raising the standard requirements to improve the clinical medication experience， and strengthening effectiveness research to highlight clinical efficacy. At the same time， the accessibility of regulatory inspection is enhanced， the rules for the management of varieties without national standards are promulgated to lay the foundation for the healthy and orderly development of TCM dispening granule industry.

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By reviewing the relevant literature of ancient herbal works and modern codices， this paper sorted out the historical evolution and developmental venation of processing of Notoginseng Radix et Rhizoma. On this basis， the modern research of processed products of Notoginseng Radix et Rhizoma was used as the breakthrough point to analyze the literature in terms of processing technology， chemical composition changes and changes in pharmacological effects before and after processing. According to the research status of processing of Notoginseng Radix et Rhizoma， some existing problems were analyzed in this paper， such as not many ancient processing methods used in modern time， lack of standardized research on processing technology. And saponins， polysaccharides， amino acids， flavonoids and other chemical components in Notoginseng Radix et Rhizoma may change to different degrees before and after processing， which was the main reason for the difference of efficacy before and after processing. However， the current research on the pharmacological effects of Notoginseng Radix et Rhizoma mainly focuses on raw products， resulting in a lack of in-depth research on the transformation mechanism of Notoginseng Radix et Rhizoma in processing difference， and the scientific connotation of "Shengxiao Shubu" has not been clearly elaborated， which is not conducive to the standardized clinical use of drugs. Therefore， it is necessary to further analyze the material basis of Notoginseng Radix et Rhizoma and its processed products， and to explore the change rule of chemical components before and after processing and its correlation with pharmacodynamic activity， so as to clarify the processing mechanism for providing scientific basis for its standardized processing， quality control and clinical rational use.

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Chinese Pharmacopoeia is an important part of drug standards in China, and it is also a legal basis that must be strictly followed in drug development, production, operation, application, and management. The information on prescriptions, preparation methods, properties, identification, inspection, content determination, functions and indications, usage and dosage, precautions, specifications, and storage of Chinese patent medicine preparations included in the Chinese Pharmacopoeia(Vol.Ⅰ) was clarified. The "Preparation Method" section describes the preparation process of Chinese patent medicine from decoction pieces to finished preparations in detail and specifies the preparation production methods and parameters, which has a good guiding and standardizing effect on the production of Chinese patent medicine in China. The present study summarized the preparation methods of Chinese patent medicine preparations and single drug preparations contained in the Chinese Pharmacopoeia(2020 edition, Vol.Ⅰ) in stages and analyzed the common preparation methods and technical parameters of Chinese patent medicine preparations, which is helpful to understand the current situation of Chinese patent medicine production technology in China and can provide references for the development of new Chinese medicine, the transformation of large varieties of Chinese patent medicine, and the optimization of preparation process of Chinese patent medicine in the market.

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As China is implementing the policy of "Announcement on Ending the Pilot Work of Chinese medicine formula gra-nules", the standard of Chinese medicine formula granules has gradually become the focus of industry development. Up to now, 196 national drug standards for Chinese medicine formula granules have been published by China, which guaranteed the production quality of Chinese medicine formula granules. However, there are still several challenges such as the rational application of national drug standards and the enrichment and improvement of varieties. The basic content of the issued national drug standards for Chinese medicine formula granules was analyzed and compared with the quality standard provisions of the corresponding decoction pieces in the Chinese Pharmacopoeia(2020 edition) in this paper. This paper discussed the main characteristics of paste-forming rate of each medicinal raw materials, "quantity-quality" transformation, equivalent ratio, and so on, and clarified the characteristics of the national standard for Chinese medicine formula granules. This paper provided references for achieving the unified quality control and meeting the overall quality requirements of Chinese medicine formula granules.

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Ziziphi Spinosae Semen(ZSS), a precious bulk Chinese medicinal, has long been used for nourishing heart and tonifying liver, calming the heart and tranquilizing the mind. Based on materia medica records, medical classics, and relevant literature, this study summarized the evolution and development of the processing methods of ZSS, verified the purposes of ancient processing and efficacy of ZSS, checked whether the decoction pieces of ZSS had been included in national and provincial standards, and concluded the research progress on processing mechanism of ZSS. A total of 9 processing methods have been recorded, such as plain stir-frying and stir-frying with adjuvants. It was a common view that ZSS was endowed with a different purpose after being processed in ancient times. However, in modern times, different views, such as ZSS and processed ZSS for the same purpose, and processing enhancing the efficacy of ZSS, emerge. At the moment, processed ZSS are included in 10 editions of Chinese Pharmacopoeia and the processing methods of ZSS can be retrieved in 22 provincial specifications on processing. Plain stir-frying is currently the mainstream processing method. The chemical components, such as flavonoids, saponins, and fatty acids, in the medicinal, change after processing, but ZSS and the stir-fried ZSS show no significant difference in tranquilizing mind, improving learning and memory, and alleviating anxiety. The problems in the research on ZSS processing were analyzed in this study. In addition, the author also discussed the inheritance of ancient methods, the scientific connotation of processing, and the improvement of decoction pieces standards, hoping to provide new ideas for the clinical rational use and the decoction pieces standard improvement of ZSS.

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Background and aim: Chinese Materia Medica (CMM) is subject to changes over time. Investigating changes in botanical ingredients, applications, plant parts used as well as name changes over time, contribute to the understanding of the history and development of CMM. Materials and methods: This study compares four historic collections of CMM, located in Europe, compiled between 1700 and the late 19th century, with a list of contemporary CMM marketed in Europe. Results: More than 1700 specimens within these five collections. The dominant families are Fabaceae (5.3-7.2%) and Asteraceae (4.1-5.7%), while half of the medicinal parts are represented by roots or rhizomes and fruits and/or seeds. Their importance has been stable in a time span of 300 years. The proportion of animal and mineral drugs gradually decreased over time. 14 plant species appeared in all five collections. A total of 47 species are shared between the three more recent collections and the modern trade list. Among these common species, most medicinal parts remain unchanged, but for several species the used plant parts changed or new medicinal plant parts appeared. All common species have unanimously been used in ancient classical TCM formulae and/or Chinese patent medicines. Conclusions: Over more than 300 years, the main body of CMM has hardly changed, with regard to plant taxa and plant parts used. The most prominent changes are related to conservation issues of threatened species, health safety and the discovery of new pharmacological applications of well-known species. Analyzing physical specimens from historic CMM collections complements literature-based research.

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This study discovered that the resolution of 3,5-O-dicaffeoylquinic acid(isochlorogenic acid A) in the content determination method of Chrysanthemi Flos in Chinese Pharmacopoeia(ChP)(2020 edition) was poor, which affected accurate quantification. We tested the method in ChP with chromatographic columns of seven brands to clarify the problems in the existing method, optimized the chromatographic conditions by adjusting the mobile phase composition and elution ratio and replacing the chromatographic column packing, and carried out the reproducibility assay for the new method. The two methods were compared for the content determination results of Chrysanthemi Flos prepared from six different varieties. As evaluated by the resolution based on different chromatographic columns of seven brands, the existing method failed to separate isochlorogenic acid A and isochlorogenic acid D well. The peaks of the two components were not completely separated on three chromatographic columns, and isochlorogenic acid A and isochlorogenic acid D generated a co-effluent peak in the other four columns. Isochlorogenic acid A and isochlorogenic acid D could be completely separated under the optimized chromatographic conditions. The difference in the peak areas of isochlorogenic acid A+isochlorogenic acid D obtained by the optimized method and the method in ChP was not significant, with deviation less than 3.0%, which further proved that the result measured by the method in ChP was the co-effluent of isochlorogenic acid A and isochlorogenic acid D. The optimized method can ensure the accurate quantification of isochlorogenic acid A. The existing content determination method of Chrysanthemi Flos has the problem of poor resolution. It is recommended to revise the chromatographic conditions for the content determination method of Chrysanthemi Flos to improve the resolution of isochlorogenic acid A and ensure its accurate quantification.

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The Chinese Pharmacopoeia began to apply fingerprints (specific chromatogram) to quality control of traditional Chinese medicine in its 2010 edition, and in its 2015 and 2020 editions, new fingerprints (specific chromatogram) were added for improvement of the Pharmacopoeia-based national standards for drugs. This review analyzes the traditional Chinese medicine fingerprints (specific chromatogram) in Chinese Pharmacopoeia (2010-2020) in terms of the number of varieties listed, application of fingerprints (specific chromatogram), selection of evaluation method, determination method, the selection of extraction or preparation solvents of the test samples. With the expansion of the application of fingerprints (specific chromatogram), the evaluation indicators are constantly improving. The future development of the fingerprints (specific chromatogram) is also discussed in light of the selection of appropriate extraction or preparation solvents to obtain effective substances, which is the basis for the establishment of the fingerprints; multiple fingerprints for one drug based on different functional indications or basic sources, which expands the application of the fingerprints; addition of technical guidelines for traditional Chinese medicine fingerprints to standardize the use of the fingerprints; and the regular revision, update and application expansion of the fingerprints to ensure its essential role in quality control of traditional Chinese medicine.

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Chinese herbal medicines (CHMs) have unique advantages in the prevention and treatment of diseases, which are widely recognized in the world. More and more CHMs are becoming increasingly popular in the international markets. However, the quality control of CHMs is a significant issue for their acceptance and recognition in the international market. This review mainly focuses on the quality requirements for CHMs to enter the European Union (EU) market. Both Chinese and European regulations and quality controls are compared. Firstly, the EU medicinal regulatory system and relevant regulations were reviewed. Secondly, the key factors of the quality control of CHMs, including Chinese herbal drugs, extracts and products were compared with those of European herbal medicines in the EU market. Subsequently, three main registration routes for herbal medicinal products including Chinese herbal medicinal products entering the EU were introduced. Furthermore, the legal status of traditional Chinese medicine granules in the EU was also discussed. Through the comparison of the key quality factors for CHMs in China and the EU, the similarities and differences in terms of quality requirements and regulations are addressed, which provides a reference for the development of CHMs into the EU market.

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The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials. The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards. According to the statistical analysis, in 499 types of plant medicinal materials, harvest period standards are recorded under 486 types, accounting for 97.4%, and are lacking in the remaining. Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year. The standards of the harvest season and phenological period are recorded under 233 types, accounting for 46.7%. For 237 types, only harvest season is specified, accounting for 47.5%, and for 15 types, only harvest phenological period is specified, accounting for 3.0%. Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation, only 11 types are recorded with harvest period of cultivated products. Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately. The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow. The main problems about the harvest period standards are discovered. Specifically, no harvest period standards are recorded under 13 types of plant medicinal materials. Almost all perennial cultivated medicinal materials are not recorded with harvest year standard. No phenological period standard is found under 250 types of plant medicinal materials. There is no clear distinction between the harvest period standards of cultivated and wild products. The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient. As a result, it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.

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The Chinese Pharmacopoeia began to apply fingerprints (specific chromatogram) to quality control of traditional Chinese medicine in its 2010 edition, and in its 2015 and 2020 editions, new fingerprints (specific chromatogram) were added for improvement of the Pharmacopoeia-based national standards for drugs. This review analyzes the traditional Chinese medicine fingerprints (specific chromatogram) in Chinese Pharmacopoeia (2010-2020) in terms of the number of varieties listed, application of fingerprints (specific chromatogram), selection of evaluation method, determination method, the selection of extraction or preparation solvents of the test samples. With the expansion of the application of fingerprints (specific chromatogram), the evaluation indicators are constantly improving. The future development of the fingerprints (specific chromatogram) is also discussed in light of the selection of appropriate extraction or preparation solvents to obtain effective substances, which is the basis for the establishment of the fingerprints; multiple fingerprints for one drug based on different functional indications or basic sources, which expands the application of the fingerprints; addition of technical guidelines for traditional Chinese medicine fingerprints to standardize the use of the fingerprints; and the regular revision, update and application expansion of the fingerprints to ensure its essential role in quality control of traditional Chinese medicine.

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Objective To improve the standardization and legitimacy of the quality control for traditional Chinese medicine (TCM) by analyzing the microscopic identification quality standard of TCM in Chinese Pharmacopoeia 2020 edition (Volume 1). Methods Through the analysis of the standard items of microscopic identification in Chinese Pharmacopoeia 2020 edition (Volume1), the problems in the standard was summarized and classified , and suggestions for revision were provided. Results The standardization and consistency have the room to improve in TCM microscopic identification standard in Chinese Pharmacopoeia 2020 (Volume 1). Conclusion The TCM microscopic identification standard needs to be improved, and the formulation for the standard should be more specific and practical.

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The improvement of the harvest period standards is critical in the quality control of Chinese medicinal materials. The present study statistically analyzed the harvest period standards of plant medicinal materials in the 2020 edition of Chinese Pharmacopoeia(Vol.Ⅰ) and put forward the existing problems and suggestions based on herbal records and modern research to provide references for the improvement of the standards. According to the statistical analysis, in 499 types of plant medicinal materials, harvest period standards are recorded under 486 types, accounting for 97.4%, and are lacking in the remaining. Only one medicinal material(Stellariae Radix) is recorded with the standard of the harvest year. The standards of the harvest season and phenological period are recorded under 233 types, accounting for 46.7%. For 237 types, only harvest season is specified, accounting for 47.5%, and for 15 types, only harvest phenological period is specified, accounting for 3.0%. Among 222 types mainly derived from cultivation and 51 types from wild resources and cultivation, only 11 types are recorded with harvest period of cultivated products. Only Stellariae Radix is recorded with the harvest period standards for the wild and cultivated products separately. The harvest period standards of plant medicinal materials with different medicinal parts have certain rules to follow. The main problems about the harvest period standards are discovered. Specifically, no harvest period standards are recorded under 13 types of plant medicinal materials. Almost all perennial cultivated medicinal materials are not recorded with harvest year standard. No phenological period standard is found under 250 types of plant medicinal materials. There is no clear distinction between the harvest period standards of cultivated and wild products. The evidence for harvest period standards of 26 types of plant medicinal materials that can be harvested all year round is insufficient. As a result, it is proposed to strengthen basic research in response to the above-mentioned problems and improve the harvest period standards as soon as possible to ensure the quality of Chinese medicinal materials.

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