In order to support the implementation of the Opinions on Improving the Quality of Traditional Chinese Medicine and Promoting the High-Quality Development of the Traditional Chinese Medicine Industry and fundamentally promote the high-quality development of Chinese materia medica(CMM) industry, this article analyzed the quality and safety issues arising during the transition of CMM from wild harvesting to cultivation. Root causes of these issues were identified, including changes in the habitats of medicinal plants caused by inappropriate field cultivation patterns, excessive use of chemical inputs such as fertilizers and pesticides, and shortened cultivation periods due to rising economic costs. To address the above issues, the following countermeasures and suggestions were proposed to advance the high-quality development of CMM:(1) comprehensively adjust the cultivation patterns, vigorously promote ecological cultivation of CMM, and ensure production quality and safety of CMM from the source;(2) strengthen the breeding of high-quality, stress-resistant CMM varieties, improve cultivation techniques to reduce the use of fertilizers and pesticides, and improve the quality and efficiency of ecological cultivation of CMM;(3) systematically design the production, operation, and supervision models for ecological cultivation of CMM, carry out demonstrations of "high quality with fair price", and ensure the sustainable development of ecological cultivation of CMM.
Drugs, Chinese Herbal/standards* ; Quality Control ; Plants, Medicinal/chemistry* ; Plant Roots/chemistry* ; China ; Fertilizers/analysis* ; Materia Medica/standards* ; Medicine, Chinese Traditional/standards*

Medicinal plants or Chinese materia medica (CMM) are now attracting worldwide attention as they have increasingly prominent advantages over chemical drugs in disease treatment and healthcare. Since the 1990s, World Health Organization (WHO) and International Organization for Standardization established the Technical Committee of Traditional Chinese Medicine (ISO/TC 249) have carried out the development of quality standards on medicinal plants or CMMs respectively, and a considerable number of monographs and international standards have been published. Since the two international organizations adhere to different principles, the standards they develop naturally have different emphasis. Driven by market demand and international trade, ISO mainly takes quality, efficacy and safety into consideration when developing standards, while WHO pays more attention to clinical practice, quality control and medication guidance. Up to now, there is a lack of comparative analysis on the records, background, principles, basic content, and main requirements of quality standards on medicinal plants or CMMs respectively published by WHO and ISO. Therefore, based on international standards of CMM developed by ISO/TC 249 platform and WHO Monographs on Selected Medicinal Plants, this paper systematically compares the purposes, selected principles, standard-developing process, basic content, and main quality requirements to summarize their similarities and differences, and find their merits, aiming to serve as a reference to the development of international standards for CMMs that helps them go global.
Materia Medica/therapeutic use* ; Plants, Medicinal ; Commerce ; Internationality ; Medicine, Chinese Traditional ; Reference Standards ; Drugs, Chinese Herbal/therapeutic use* ; China

Slicing is critical in the processing of Chinese materia medica(CMM) processed product and the specification(thickness) is closely related to the quality of the decoction. On the basis of clarifying the concept and evolution of slicing of CMM processed product by reviewing the Chinese herbal classics of the past dynasties and general rules of local processing standards, this study discussed the development history of slicing specifications in general rules of Chinese Pharmacopoeia(2020 edition), analyzed the current situation and key problems, and proposed the thinking and suggestion on promoting the sound development of slicing of CMM processed product. Since 2000, the slicing thickness of CMM processed product in the general rules of local CMM processed product processing specifications newly revised and issued by 27 provinces, autonomous regions, and municipalities has been consistent with that in the general rules of the Chinese Pharmacopoeia(2020 edition). The standard that the thickness of extremely thin pieces is less than 0.5 mm is rarely retained, and the pieces in 0.5-1 mm thickness have not been found on the market, which is consistent with the provisions of the general rules of the Chinese Pharmacopoeia. This study can provide a historical and modern basis for the rationality of slicing of CMM processed product.
Materia Medica ; Drugs, Chinese Herbal ; Medicine, Chinese Traditional ; Reference Standards

Standards for seeds and seedlings of Chinese materia medica are very important to the production, quality control and management of seeds and seedlings of Chinese materia medica. In this paper, the current standards including international standards, national standards, industry standards, local standards and group standards before 2020, involving relevant standards for seeds and seedlings of Chinese materia medica, were comprehensively and systematically summarized. Relevant standards for seeds and seedlings of Chinese materia medica were analyzed based on the standard issue year, the source and types of Chinese materia medica, and whether they are included in the Pharmacopoeia of the People's Republic of China 2015. It is suggested that the standards for seed and seedling of Chinese materia medica shall be systematic, professional and feasible, so as to ensure the sould and sustainable development of the seed and seedling industry of Chinese materia medica.
China ; Drugs, Chinese Herbal ; Humans ; Materia Medica ; Medicine, Chinese Traditional ; Reference Standards ; Seedlings ; Seeds

Andrographis Herba is a commonly used plant medicine, and has been recorded in pharmacopeias of different countries. However, there are some differences in the quality standards. Based on this, this paper compare the quality standards of Andrographis Herba between Chinese Pharmacopoeia, Hong Kong Chinese Materia Medica Standards, United States Pharmacopoeia, European Pharmacopoeia and Indian Pharmacopoeia, including origin, botanical characteristics, identification(microscopic identification and chromatographic identification), content determination, specific test(such as impurities, loss on drying, extractives, pesticides, heavy metals, mycotoxins, and other items) and storage requirements, so as to provide a reference for studying international quality standards of Andrographis.
Andrographis ; Drugs, Chinese Herbal ; Materia Medica ; Reference Standards

Through market investigation, the adulteration of Zaocys dhumnades on markets was found out, and samples of authentic and adulterated Z. dhumnades on markets were collected. The origin and properties of the adulterated Z. dhumnades were studied in order to provide reference for the identification of Z. dhumnades. The counterfeit Z. dhumnades sold on markets were as follows: Ptyas korros, P. mucosus, Najanaja atra, Sinonatrix annularis, Dinodon septentrionalis, etc. It is found that there existed a obvious difference between the traits of the Z. dhumnades and counterfeits. Genuine Z. dhumnades with "sword ridge" "iron tail", strongly ribbed scales and other features, is the key point to identify the difference from adulterants.
Animals ; Drug Contamination ; Materia Medica ; standards ; Snakes

The quality evaluation of Chinese materia medica(CMM) is an important and difficult topic research in traditional Chinese medicine, due to its inherent complexity, and incompatibility of evaluation patterns and their key techniques. To solve the issue, it is necessary to break the limit of conventional evaluation, and establish the evaluation pattern and its key techniques about CMM quality related to clinic. Hence, with the strategy- "originating from clinic, validating by experiments and returning to clinic", a novel academic concept is proposed which is termed as "bio-characteristic profiling related to clinic of CMM". A series of key techniques should be established including living-cell dynamic monitoring, enzyme bioactivity dynamic monitoring, electric chemistry dynamic monitoring and isothermal titration dynamic monitoring, etc. Besides, the quality fluctuation of CMM(products) which is hard to control and assess could be evaluated when associated with clinical efficacy and safety(exemplified by Chinese herbal injection, animal medicine and joint use of drugs in clinic). It is expected to form the novel evaluation system for CMM quality based on bio-characteristic profiling related to clinic and its key techniques, which provides novel ideas and techniques for improving quality and clinical efficacy, and promotes the modernization and internationalization of CMM.
Animals ; Materia Medica ; standards ; Medicine, Chinese Traditional ; standards

Deer is valuable all over the body,which is rich in nutritional value and medicinal value. Deer breeding and processing are very advanced in North America and New Zealand where many related standards have been published. The development of Chinese deer industry lack standard and normal management,neither standards' number nor coverage area formed complete frame structure. The international standards like Panax ginseng and P. notoginseng were more lacked. This paper makes a classification statistics on standardization organizations at home and abroad,foreign standards,Chinese national standards,industry standards,local standards and enterprise standards. The classes,contents,ages,implementation and promotion and demonstration area construction of standards were compared and analyzed. We found Chinese deer industry standards were deficient in coverage,uniformity,innovation,repeatability and support. And we give advises for the construction of industry quality standard system,organizational mobility and ideology of consumers,hoping to boost the standard construction and promote international competitiveness of Chinese deer industry.
Animals ; China ; Deer ; Industry ; Materia Medica ; standards

Health food containing Chinese materia medica has many advantages in health preservation and reducing the risk of disease occurrence,which meets people's demands for " great health" and " preventive treatment of disease". However,due to its complex ingredients,diverse quality of raw materials,as well as the vagueness and lack of integrity for existing quality standards,chaos is caused in the health food market,which restricts its healthy development and also poses new challenges to the quality control of healthy food. At present,the total component content or single component content is determined in most functional/marker component examinations. Safety and microbial detection methods fail to cover the contamination range of the raw materials of Chinese materia medica.Therefore,it is impossible to meet the purpose of ensuring authenticity,safety and efficacy. In recent years,a lot of Chinese materia medica extracts have been used as raw materials for food products,but many extracts lack standards. The author believes that the quality control of health food containing Chinese materia medicas should start with the quality control of Chinese materia medica extracts. In this way,product quality is controlled from source to ensure product consistency; secondly,the overall quality control should be strengthened to ensure the authenticity of the products; the scope of safety inspection shall be expanded to fundamentally ensure the safety of products. At the same time,we should strengthen the quality control of whole process and strengthen the overall quality control of raw materials to produce health food of high quality.
Food ; standards ; Materia Medica ; standards ; Medicine, Chinese Traditional ; Quality Control ; Research Design

Ginger juice， a commonly used adjuvant for Chinese materia medica， is applied in processing of multiple Chinese herbal decoction pieces. Because of the raw materials and preparation process of ginger juice， it is difficult to be preserved for a long time， and the dosage of ginger juice in the processing can not be determined base on its content of main compositions. Ginger juice from different sources is hard to achieve consistent effect during the processing of traditional Chinese herbal decoction pieces. Based on the previous studies， the freeze drying of ginger juice under different shelf temperatures and vacuum degrees were studied， and the optimized freeze drying condition of ginger juice was determined. The content determination method for 6-gingerol， 8-gingerol， 10-gingerol and 6-shagaol in ginger juice and redissolved ginger juice was established. The content changes of 6-gingerol， 8-gingerol， 10-gingerol， 6-gingerol， 6-shagaol， volatile oil and total phenol were studied through the drying process and 30 days preservation period. The results showed that the freeze drying time of ginger juice was shortened after process optimization; the compositions basically remained unchanged after freeze drying， and there was no significant changes in the total phenol content and gingerol content， but the volatile oil content was significantly decreased(<0.05). Within 30 days， the contents of gingerol， total phenol， and volatile oil were on the decline as a whole. This study has preliminarily proved the feasibility of freeze-drying process of ginger juice as an adjuvant for Chinese medicine processing.
Adjuvants, Pharmaceutic ; Chemistry, Pharmaceutical ; methods ; Drugs, Chinese Herbal ; standards ; Freeze Drying ; Ginger ; chemistry ; Materia Medica ; standards