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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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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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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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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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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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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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China , Chromatography, High Pressure Liquid/methods , Drugs, Chinese Herbal/chemistry , Flowers/chemistry , Reproducibility of ResultsABSTRACT
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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China , Drugs, Chinese Herbal/standards , Medicine, Chinese Traditional , Pharmacopoeias as Topic , Plants, Medicinal , Quality ControlABSTRACT
ObjectiveTo investigate the compatibility rule of traditional Chinese patent medicines （TCPMs） against liver diseases through network analysis. MethodWith “liver” as the search term， TCPMs against liver diseases were retrieved from volume Ⅰ of Chinese Pharmacopoeia （2020 edition）， and the basic information of them was collected. TCPMs with same Chinese medicinal materials （CMMs）， usage， and indications， but different dosage forms， were unified as one formula. Mutual information entropy （MIE） of CMM couples was calculated to quantify the relationship between them， and the top 25% CMM pairs in MIE were used to construct the compatibility network， with CMM as node and the relationship between CMM pairs as the edge. Key CMM and frequently used CMM combinations were identified based on node centrality and cluster analysis， respectively. The indications of TCPMs related to the CMMs in clusters were recorded. Cytoscape 3.6.1 was employed for visualization and topology analysis of the compatibility network. ResultA total of 179 TCPMs， involving 428 CMMs， were retrieved. Angelicae Sinensis Radix， Paeoniae Radix Alba， and Glycyrrhizae Radix et Rhizoma were identified as key CMMs with high frequency， and Cuscutae Semen-Lycii Fructus， Citri Reticulatae Pericarpium-Cyperi Rhizoma， and Ecliptae Herba-Ligustri Lucidi Fructus combinations had high MIE. Furthermore， the CMMs were clustered into ten groups corresponding to different diseases which， however， all belonged to digestive diseases. ConclusionThis study unveils potential CMM pairs and common CMM combinations against liver diseases， which can serve as a reference for revealing compatibility rules of CMMs and research and development of Chinese medicine.
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In this paper， by consulting the historical herbs and medical classics coupled with related literature in modern research， the historical edition of Chinese Pharmacopoeia and local chronicles of traditional Chinese medicine （TCM） along with the ancient historical evolution of the processing methods of Pinelliae Rhizoma origin as well as the related processing methods of Pinelliae Rhizoma origin from 1959 to 2020 were systematically collated and summarized. It was found that the main processing methods of Pinelliae Rhizoma origin were peeling， decoction washing， lime wrapping and sun-drying. However， stacking， peeling， sun-drying or oven-drying are the primary methods in modern local chronicles of TCM. Meanwhile， washing， peeling， removing fibrous roots and sun-drying are the main methods in Chinese Pharmacopoeia. In addition， there were some changes in the quality evaluation of Pinelliae Rhizoma in different historical periods. Round and white were the best in the quality evaluation of Pinelliae Rhizoma in ancient times， while the evaluation indexes were further refined to size， color， texture， powder property， purity and evenness in modern herbal works. In modern studies， the quality of Pinelliae Rhizoma was mostly evaluated by the chemical components such as alkaloids， total organic acids， polysaccharides， nucleosides， fingerprint and pharmacodynamics. At present， the purification and drying stages of Pinelliae Rhizoma are in the transitional stage between the traditional manual peeling and natural drying methods as well as the modern mechanized and large-scale production. Therefore， a reasonable and feasible modern processing methods and guiding standards of Pinelliae Rhizoma are developed urgently to normalize the processing of Pinelliae Rhizoma and ensure the quality of medicinal materials.
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In this paper， by consulting the historical herbs and medical classics coupled with related literature in modern research， the historical edition of Chinese Pharmacopoeia and local chronicles of traditional Chinese medicine （TCM） along with the ancient historical evolution of the processing methods of Pinelliae Rhizoma origin as well as the related processing methods of Pinelliae Rhizoma origin from 1959 to 2020 were systematically collated and summarized. It was found that the main processing methods of Pinelliae Rhizoma origin were peeling， decoction washing， lime wrapping and sun-drying. However， stacking， peeling， sun-drying or oven-drying are the primary methods in modern local chronicles of TCM. Meanwhile， washing， peeling， removing fibrous roots and sun-drying are the main methods in Chinese Pharmacopoeia. In addition， there were some changes in the quality evaluation of Pinelliae Rhizoma in different historical periods. Round and white were the best in the quality evaluation of Pinelliae Rhizoma in ancient times， while the evaluation indexes were further refined to size， color， texture， powder property， purity and evenness in modern herbal works. In modern studies， the quality of Pinelliae Rhizoma was mostly evaluated by the chemical components such as alkaloids， total organic acids， polysaccharides， nucleosides， fingerprint and pharmacodynamics. At present， the purification and drying stages of Pinelliae Rhizoma are in the transitional stage between the traditional manual peeling and natural drying methods as well as the modern mechanized and large-scale production. Therefore， a reasonable and feasible modern processing methods and guiding standards of Pinelliae Rhizoma are developed urgently to normalize the processing of Pinelliae Rhizoma and ensure the quality of 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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China , Chromatography, High Pressure Liquid/methods , Drugs, Chinese Herbal , Medicine, Chinese Traditional , Quality Control , SolventsABSTRACT
The origins of 9 species of the Chinese medicinal materials in the 2015 edition of the Chinese pharmacopoeia(ChP) has revised in the 2020 edition of ChP. The revision is based on the investigation and textual research on the problems found after screening the original plants, animals or minerals of all the Chinese medicinal materials in the 2015 edition. Among them the Chinese names of Alismatis Rhizoma, Cassiae Semen, Coicis Semen, Corydalis Bungeanae Herba and Echinopsis Radix all do not match to the Latin scientific names, and also do not match the name of the actual medicinal origins. In addition, Alismatis Rhizoma has the omission of original plant. There is confusion about the Chinese name and the family name of the original insect of Cera Chinensis. The original mineral of Gypsum Fibrosum has the wrong group names. Alumstone and melanterite, the original mineral of Alumen and Melanteritum respectively, of which the group names are missing. To solve these problems, field survey and literature research were conducted on the medicinal materials and their origins. The source of these problems are explored. The correct origins and the Chinese names or Latin names are all determined according to the research results to the situation, in which the Chinese and Latin names of the original plants of the medicinal materials do not match. The correct family name and group name are obtained through textual research by taxonomy if the names are confused or mis-sing. The scientific evidence and correct results of revision in the 2020 edition of ChP are determined at last.
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Animals , China , Coix , Drugs, Chinese Herbal , Medicine, Chinese Traditional , RhizomeABSTRACT
The Chinese Pharmacopoeia 2020 edition was reviewed and approved by the National Medical Products Administration and the National Health Commission of the People's Republic of China in July 2020.The current edition was officially implemented on December 30,2020.The general chapters of the Chinese Pharmacopoeia discuss the general testing methods and guidelines,which are the common re-quirements and basis for the implementation of drug standards in the Chinese Pharmacopoeia.Owing to adherence to the principles of scientificity,versatility,operability,and sustainable development,there is an improvement in the general chapters of the 2020 edition over those of the previous editions.Further,the application of advanced and mature analytical techniques has expanded,the development of testing methods for exogenous pollutants in traditional Chinese medicines has been strengthened,and technical requirements are now better harmonized with international standards.The updated edition provides technical and methodological support to ensure safety,effectiveness,and control of pharmaceuticals in China and will play an important and active role in encouraging the application of advanced technolo-gies,improving the quality control of medicines,and strengthening the means of drug regulation in China.This review provides a comprehensive introduction of the main features of and changes to the general chapters in the Chinese Pharmacopoeia 2020 edition and aims to provide reference for its correct understanding and accurate implementation.
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In order to promote the standardization of traditional medicines in Laos， China and Laos jointly formed a census team to conduct resource survey， market survey， species identification and others of medicinal plants in Laos. According to the principles of nationality， tradition， effectiveness and commonness， 160 medicinal materials and 40 prescriptions were selected and collected into Lao Herbal Pharmacopoeia after recommendation， examination of experts and review by the established expert committee. Moreover， quality standards of traditional medicine and scientific and clear translation methods were formulated in line with the national conditions of Laos， and the contents were finally compiled according to the 2010 edition of Chinese Pharmacopoeia. The promulgation and implementation of Lao Herbal Pharmacopoeia is a successful example of cooperation in the field of health care between China and Laos， which is conducive to promoting mutually beneficial cooperation between China and Association of Southeast Asian Nations （ASEAN） countries in the field of traditional medicine， and making traditional medicine play a greater role in the medical and health services of ASEAN countries.
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Objective:To analyze the research status of the external use of medicinal materials and decoction pieces in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> （volume 1）， so as to provide reference for the clinical external use research of Chinese medicines. Method:The external function， usage， dosage and other information of medicinal materials and decoction pieces in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> （volume 1） were analyzed and compared. Result:In the 2020 edition of <italic>Chinese Pharmacopoeia</italic> （volume 1）， there were 165 kinds of Chinese medicines that could be used externally， including 25 kinds of Chinese medicines that clearly recorded their functions for external use， such as Euphorbiae Semen， Euphorbiae Semen Pulveratum， Arisaematis Rhizoma， Arisaematis Rhizoma Preparatum， Crotonis Fructus， Crotonis Semen Pulveratum， Nardostachyos Radix et Rhizoma， Artemisiae Argyi Folium， Alumen， Stemonae Radix， Genkwa Flos， Cera Flava， Mel， Psoraleae Fructus， Gardeniae Fructus， Calomelas， Bruceae Fructus， Drynariae Rhizoma， Euphorbiae Ebracteolatae Radix， Cuscutae Semen， Phytolaccae Radix， Meretricis Concha， Talcum， Talci Pulvis and Propolis. The amount of Chinese medicine for external use recorded in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> was mostly appropriate for external use， the amount for external use was not clear. The application method for external use focused on beating powder and applying the affected areas， decocting for fumigation and washing， simmering to paste， etc. Clinical external use was used for the treatment of eczema， tinea pedis， chapped skin and other skin diseases. Conclusion:The number of Chinese medicines recorded in the 2020 edition of <italic>Chinese Pharmacopoeia</italic> for external use is increasing， but the function， dosage and usage of these Chinese medicines for external use still need to be improved.
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Objective:To analyze the functions and indications， formulation， dosage form and medication characteristics of Chinese patent medicines in the 2020 edition of<italic> Chinese Pharmacopoeia</italic> （part Ⅰ） for treating cough of children， and to provide ideas for the clinical rational application and provide reference for the research and development of new cough medicines for children. Method:The name， dosage form， formulation， functions and indications， usage and dosage， and other information of Chinese patent medicines for cough were collected from the 2020 edition of <italic>Chinese Pharmacopoeia </italic>（part Ⅰ）， then relevant information was input into Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine v2.0， and data analysis and mining were carried out through the analysis module of prescription medication rule， VOSviewer 1.6.14 was used to make drug clustering network view of Chinese patent medicines for the treatment of exogenous wind cold， exogenous wind heat and phlegm heat cough. Result:In the 2020 edition of <italic>Chinese Pharmacopoeia </italic>（part Ⅰ）， a total of 75 kinds of Chinese patent medicines for treating cough of children were collected， including 34 kinds of Chinese patent medicines for adults and children， 41 kinds of Chinese patent medicines for children only. There were 7 types of traditional Chinese medicine syndromes， such as wind-cold attacking the lung， wind-heat invading the lung and phlegm-heat obstructing the lung. There were 45 Chinese patent medicines for treating exogenous cough， accounting for 60%， among which 35 kinds were used for exogenous wind-heat cough and 10 kinds were used for wind-cold cough. There were 30 kinds of Chinese patent medicines for treating internal injury cough， including 19 kinds of medicines for phlegm heat obstructing the lung， 4 kinds of medicines for phlegm dampness containing the lung and phlegm food stagnation， 2 kinds of medicines for Yin-deficiency lung heat， 1 kind of medicine for the lung and spleen Qi-deficiency. The formulation analysis showed that Glycyrrhizae Radix et Rhizoma， Platycodonis Radix， Scutellariae Radix， Armeniacae Semen Amarum and Citri Reticulatae Pericarpium appeared frequently， which were mainly cold， bitter and sweet herbs， mainly belonged to the lung and stomach meridians. According to the analysis of administration and dosage forms， 71 kinds of Chinese patent medicines were administered through gastrointestinal tract， including 20 kinds of granules， 15 kinds of oral liquids， others included syrups， pills， capsules， tablets， powers， etc. Only 2 suppositories and 2 injections were administered by nongastrointestinal tract. The usage and dosage of most Chinese patent medicines were not clear. Conclusion:In the 2020 edition of <italic>Chinese Pharmacopoeia </italic>（part Ⅰ）， the main syndromes of Chinese patent medicines for cough of children are exogenous wind-heat and phlegm-heat obstruction in the lung. Most of the Chinese medicines are cold， bitter and sweet， and their meridians are mainly lung and stomach meridians. Scutellariae Radix， Lonicerae Japonicae Flos and Forsythiae Fructus are the most common medicines of exogenous wind heat syndrome. Perillae Folium， Citri Reticulatae Pericarpium and Ephedrae Herba are the most common medicines of exogenous wind cold syndrome. Meanwhile， Scutellariae Radix， Platycodonis Radix and Armeniacae Semen Amarum are the most common medicines of phlegm heat obstructing the lung syndrome. At present， the dosage forms of Chinese patent medicines used for treating cough of children are too few and the dosage labeling is not comprehensive， so it is necessary to further strengthen the research and development of new Chinese medicines suitable for characteristics of children.
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As an important branch of medicine,Traditional Chinese Medicine(TCM)has been applied for the treatment of diseases for thousands of years in China and other countries in East Asia.The Chinese Pharmacopoeia(ChP)is a drug code formulated by the Chinese government,and it includes a special volume for the monographs of TCM,which plays an important role in ensuring the quality of drugs.The use of quality control technology has always been a complex and important factor in TCM.Owing to the chemical diversity of TCM,chromatography technology has been proven to be a comprehensive strategy for the assessment of the overall quality of TCM and has become the main analytical method in the ChP.This article provides an overview of the classical and modern chromatographic technologies applied in the ChP,and summarizes the advantages and disadvantages of each technique in the TCM monographs.In 2020,the new edition of the ChP(the 2020 edition)has been implemented at the end of 2020.This paper also contains a brief introduction about the application of chromatographic technologies in the new edition of the ChP.
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Thin layer chromatography, high performance liquid chromatography and multivariate statistical analysis were integrated in current study to provide a basis for the quality evaluation and the standard improvement of Paridis Rhizoma(Chinese name: Chong-lou). The results demonstrated that the primary saponins in the two authorized sources of Paridis Rhizoma were polyphyllinsⅠ, Ⅱ and Ⅶ, while the rhizome of Trillium tschonoskii an adulterant of Paridis Rhizoma was rich of polyphyllin Ⅵ. Therefore, the apparent content of polyphyllin Ⅵ plays a determinant role towards the source authentication of raw materials and decoction slices of Paridis Rhizoma, whose adulterants frequently occur in the market. Moreover, the contents of polyphyllin Ⅵ in the two authorized sources could meet the requirements of Chinese Pharmacopoeia. Therefore, we suggested that polyphyllin Ⅵ should not be omitted from the quality standard of Paridis Rhizoma in the Chinese Pharmacopoeia, and on the other side, polyphyllinsⅠ, Ⅱ and Ⅶ should be the eligible quality indicators. The study aims to sound information and evidences for the quality evaluation of Paridis Rhizoma, and also to provide a theoretical basis for the standard revision of Paridis Rhizoma in the future Chinese Pharmacopoeia.
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Chromatography, High Pressure Liquid , Drugs, Chinese Herbal , Rhizome , Saponins , TrilliumABSTRACT
OBJECTIVE: To establish the system suitability standard for N-glycan profile analysis of monoclonal antibodies. METHODS: LC-MS was used to characterize the N-linked glycoform of the system suitability standard, and the stability was evaluated. The acceptance criteria of system suitability was set according to the method property and the data from method validation. RESULTS: The data of accelerated and long-term stability test indicated that the system suitability standard was stable under storage condition. The N-glycoform of this standard was representative, which covered the main glycoform of monoclonal antibodies. The acceptance criteria of system suitability set for the three analytical METHODS: were as below: the detected chromatogram should be visually similar to representative chromatogram; the resolution between G1F(1, 6) and G1F(1, 3), and G0F percentage should meet the specific requirements; the RSD of G0F retention time should be ≤4%. CONCLUSION: The standard substance for system suitability test and acceptance criteria for three N-glycan profile analytical METHODS are established.
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OBJECTIVE: To analyze the general situation of pharmaceutical excipients standard in Chinese Pharmacopoeia 2020 edition and understand the standards accurately. METHODSE: This article focuses on the overall information of standard, the changes of working mechanism, the framework of the standard system and the characteristics of all pharmaceutical excipients standards in the 2020 edition of Chinese Pharmacopoeia. RESULTS: It has significantly improved that the number of standards, the standard system and the standard formation mechanism of the 2020 edition of China Pharmacopoeia. CONCLUSION: The Chinese Pharmacopoeia will continue to strengthen the construction of a standard system for pharmaceutical excipients, promote industrial upgrading and improve supervision efficiency.