RESUMO
Chinese materia medica (CMM) is indispensable component of Traditional Chinese Medicine (TCM) therapy. With the widespread of TCM around the world, the quality control and safe use of CMM become a major concern. This paper introduces the role of ISO standards for industrial development and current development status of CMM standards in ISO/TC 249. Through the comparison of similarities and differences between CMM standards in ISO/TC 249 and pharmacopoeias of main stakeholders, this paper suggests strengthening standard formulation in the following areas to provide more appropriate documents to facilitate the international trade and promote the industrial development of CMM: (1) Develop standards to fill the blanks among the whole industry chain of CMM; (2) Develop standards for new forms of CMM and services; (3) Develop specification and grade standards for CMM with large quantity and high value.
Assuntos
Medicamentos de Ervas Chinesas/normas , Materia Medica/normas , Medicina Tradicional Chinesa/normas , China , Comércio/normas , Humanos , Internacionalidade , Controle de QualidadeRESUMO
As Traditional Chinese Medicine (TCM) becomes widely used in many countries around the world, global demand for intelligent and modernized medical devices of TCM is increasing. Medical devices of TCM have played an important role in diagnosis and treatment of disease. Standardization on medical devices of TCM cannot only be beneficial to ensuring the life safety of patients, but also to enhancing the effectiveness of diagnosis and treatment. This paper includes (1) classification and trends in medical devices of TCM; (2) status review on international standardization of medical devices of TCM; (3) key technical factors in developing international standards for medical devices of TCM and (4) prospects for international standardization development of medical devices of TCM.
Assuntos
Equipamentos e Provisões , Medicina Tradicional Chinesa/instrumentação , China , Técnicas e Procedimentos Diagnósticos/instrumentação , Técnicas e Procedimentos Diagnósticos/normas , Desenho de Equipamento , Equipamentos e Provisões/normas , Humanos , Internacionalidade , Medicina Tradicional Chinesa/normasRESUMO
As Traditional Chinese Medicine (TCM) transcends its cultural boundaries and becomes widely used in many countries around the world, one of the major risks to the growing use of TCM internationally is the damage caused to its reputation and to community safety when TCM practitioners are not adequately trained. Ensuring the quality and competency of TCM practitioners is a fundamental requirement. This paper covers (1) the current level of regulation of education and training of TCM practitioners particularly in countries with well developed health systems; (2) the progress of self regulatory standards for education and training developed by international organizations and (3) the potential role of ISO/TC 249 in assisting these initiatives.
Assuntos
Acupuntura/educação , Competência Clínica , Educação Médica , Pessoal de Saúde/educação , Medicina Tradicional Chinesa , Acupuntura/normas , Terapia por Acupuntura , Competência Clínica/normas , Currículo , Educação Médica/normas , Pessoal de Saúde/normas , Humanos , Medicina Tradicional Chinesa/normas , Segurança do Paciente , Formulação de Políticas , Melhoria de Qualidade , Indicadores de Qualidade em Assistência à SaúdeRESUMO
PURPOSE: Traditional Chinese medicine (TCM) has fully engaged and played an essential role in the prevention and treatment of Coronavirus Disease 2019 (COVID-19). This study compares relevant standards on high-frequent Chinese Materia Medicia (CMM) used in this pandemic aiming at reaching a global consensus and ensuring the use of Chinese medicines safely. METHODS: 141 representative Chinese formulas and Chinese Patent Medicines from the National Protocol and the most of Provincial Protocols for controlling COVID-19 in China have been collected to statistical analyze the composition and characteristics of CMM. Among them, the domestic and international standards of 47 varieties with the frequency usage over 10 times were selected to compare their quality requirements in the mainstream pharmacopoeias and international standards. RESULTS: The quality requirements of used CMM for fighting COVID-19 on the terms of overall quality control, marker compounds, and safety indicators showed different patterns in these mainstream pharmacopoeias and international standards. The uniformed and scientific quality standards of CMM were urgently needed to promote global acceptation and trade. CONCLUSIONS: These findings will provide evidence for building unified quality and safety standards that can adapt to the characteristics of CMM and promote international trade, and also will be stated that it is of the highest priority for ISO/TC 249 to formulate high-quality standards that consolidate international consensus to ensure quality and safety of the urgently needed CMM.
Assuntos
Infecções por Coronavirus/prevenção & controle , Infecções por Coronavirus/terapia , Medicamentos de Ervas Chinesas/normas , Medicamentos de Ervas Chinesas/uso terapêutico , Materia Medica/normas , Medicina Tradicional Chinesa/normas , Pandemias/prevenção & controle , Pneumonia Viral/prevenção & controle , Pneumonia Viral/terapia , COVID-19 , Infecções por Coronavirus/tratamento farmacológico , Composição de Medicamentos , Medicamentos de Ervas Chinesas/efeitos adversos , Humanos , Materia Medica/efeitos adversos , Materia Medica/uso terapêutico , Segurança do Paciente , Farmacopeias como Assunto , Saúde Pública , Controle de Qualidade , Tratamento Farmacológico da COVID-19RESUMO
The trade of Chinese medicines (CMs) has developed rapidly worldwide. There is an urgent need for international standards of CMs in international trade. A newly established technical committee TC249 in the International Organization for Standardization (ISO) provides a platform for developing the international standards of traditional Chinese medicine. This article introduces the overview and development strategy of the international standardization of CMs. A quality assurance system for the entire industrial chain was well designed in the fields of seedlings, medicinal materials, and manufactured products. The general standards, testing method standards, and standards for single herbal medicines meet the urgent needs of the market and should be developed with high priority to promote the international trade of CMs and guarantee the quality and safety of clinical use. This article also introduces the significance, classification, and procedures for developing international standards of CMs and helps us better understand the international standardization work of CMs.
Assuntos
Indústria Farmacêutica/normas , Indústria Farmacêutica/tendências , China , Comércio , Medicamentos de Ervas Chinesas/normas , Humanos , Internacionalidade , Controle de Qualidade , Padrões de ReferênciaRESUMO
Africa is home to two major floral kingdoms: the Paleotropical kingdom of central Africa and the Capensis kingdom of the Western Cape province of South Africa, the latter of which consists of approximately 10,000 species, representing about 20% of Africa's floral 'gold mine', better known as the Cape herbal medicine. Needless to say, such rich flora comes with numerous plants with a potential to cause poisoning to humans. This review document reports important toxic medicinal plants and their toxic ingredients for plant species resident in the southern African region. These include important medicinal uses and pharmacological properties ranging from antimicrobial, antiviral, anticancer, anti-inflammatory as well as those that are used as aphrodisiacs and for maternal health care.