Requirements and thinking on quality management of Natural Health Products in Canada / 国际中医中药杂志

Introduces the regulatory requirements of the Natural and Over-the-Counter Health Products Administration on the quality of natural health products, and adopts the literature research method to translate and interpret Health Canada's "Guidelines for the Quality of Natural Health Products" on the quality management and quality control of natural health products. Policy documents, from the perspective of stakeholders, provide requirements for the detection methods and standards of natural health products, such as characterization, identification experiments, component content, pollutants and impurity content detection, etc. To achieve natural health Quality management and quality control in the whole process of product production. Familiar with and understand the requirements for the quality management of natural health products in Canada will help to promote the legal and compliant management of product quality in the production process of Traditional Chinese Medicine (TCM) products after registration in Canada, and promote the production and sustainable development of TCM products. At the same time, it provides a reference for further improving my country's drug quality management system normative system documents, and assists the effective connection between the registration-related standards of Chinese patent medicines and international standards.

Introduction and analysis of the registration process of Traditional Chinese Medicine as a natural health product in Canada / 国际中医中药杂志

At present, the registration process of Traditional Chinese Medicine (TCM) in Canada is refering to the requirements of Natural Health Products (NHPs). In terms of registration material, both NHPs and TCM include plants, animals and minerals with medicinal components, but the fundamental difference between them is that TCM is guided by the basic theory of TCM. As for the registration classification of TCM in Canada, first of all, judge whether the product to be applied for is NHPs; Secondly, we should clarify the types and ways of registration, mainly including simple application, traditional application and non-traditional application, and provide application forms, label texts, summary reports, evidence, animal tissue forms, finished product specifications and other materials according to different requirements. At present, the successful registration experience of TCM products in Canada mainly mainly includes applying for superior varieties, selecting appropriate application channels, communicating with local health management units and providing sufficient scientific evidence and good clinical application records. The regulations on the registration of NHPs in Canada have not fully considered the particularity of TCM and the registration of TCM products is still facing some difficulties. In the future, we can learn from the registration process and requirements of the Health Canada, promote the interconnection and mutual recognition of the Pharmacopoeia of the People's Republic of China and the NNHPD monographs in Canada, reduce the obstacles to the local application for registration of TCM, and promote the further improvement of the international standards of TCM.

Marco Jurídico-Legal de la Homeopatía en México: análisis histórico y conceptual de los artículos 28 y 50 del reglamento de insumos para la salud / Juridical-Legal Framework of Homeopathy in Mexico: historical and conceptual analysis of articles 28 and 50 of the regulation of health supplies

El interés por diseñar un marco jurídico específico para la práctica de la Homeopatía ha generado diversos criterios alrededor del mundo, debido a la nomenclatura establecida por la Organización Mundial de la Salud (OMS). Este organismo, de una visión sociológica y antropológica, incluye a la Homeopatía en el concepto de medicina alternativa y/o complementaria (MAC o CAM, por sus siglas en inglés), pero, al mismo tiempo, señala que cada país es autónomo para reglamentar y formular políticas acordes a sus circunstancias. El caso de México merece una mención especial, pues a finales del siglo XIX formalizó la institucionalización, profesionalización e inclusión de la Homeopatía en el Sistema Nacional de Salud como parte de la medicina. A pesar de ello, la existencia del término "homeópata" en la legislación sanitaria ha generado un debate por más de dos décadas entre médicos homeópatas y homeópatas no médicos que buscan reglamentar su práctica mediante legislaciones hechas a modo. Dentro de este contexto, se analiza el proceso histórico y conceptual del término "homeópata" en la legislación sanitaria mexicana mediante el estudio de leyes y reglamentos desde su introducción, en 1850, permitiendo afirmar que dicho término reconoce a los médicos homeópatas formados en escuelas y facultades de medicina y no a homeópatas no médicos.

The interest in designing a specific legal framework for the practice of homeopathy has generated diverse criteria around the world; due to the nomenclature established by the World Health Organization (WHO). The WHO, from a sociological and anthropological perspective includes homeopathy in the concept of Alternative and / or Complementary Medicine (MAC or CAM, for its acronym in English); however, at the same time it indicates that each country has the autonomy to regulate and formulate policies according to its circumstances. The case of Mexico deserves a special mention, since at the end of the 19th century it formalized the institutionalization, professionalization and inclusion of homeopathy in the National Health System as a part of formal medicine. Despite this, the term "Homeopath" in health legislation has generated a debate for more than two decades between homeopathic doctors and non-medical homeopaths who seek to regulate their practice through legislation made for this manner. Within this context, the historical and conceptual process of the term "Homeopath" in Mexican health legislation is analyzed through the study of the laws and regulations since its introduction in 1850, which confirms that said term recognizes Homeopathic Doctors trained in schools and colleges of medicine and not non-medical homeopaths.

Formulation regularity and thinking of adjuvant sleep-improving Chinese medicinal health products / 中国中药杂志

To summarize and analyze the current adjuvant sleep-improving Chinese medicinal health products,this study retrieved the information on health products with the sleep-improving effect published by the Department of Special Food Safety Supervision and Management,State Administration for Market Regulation( SMAR),which was statistically analyzed with Microsoft Excel and TCMISS for the characteristics of formulations. A total of 435 sleep-improving health products were collected,including 344 ones containing Chinese herbal medicines. Among them,413 health products were not suitable for adolescents,neither 194 for pregnant women. Ten Chinese herbal medicines showed a frequency of use ≥40,with 1 095 times( 73. 1%) in use. Through unsupervised hierarchical entropy-based clustering of the above Chinese herbal medicines of health products( degree of support of 45 and confidence coefficient of0. 7),12 new formulas were obtained. The composition of Chinese herbal medicines was consistent with the principles of improving sleep in traditional Chinese medicine( TCM) theories,i. e.,replenishing the heart and spleen,nourishing blood,calming the nerves,nourishing Yin,reducing internal heat,communicating the heart and kidney,replenishing Qi,relieving convulsions,clearing heat,resolving phlegm,regulating the middle warmer,soothing the liver,relieving heat,and calming the heart. According to TCM theories,syndrome differentiation was performed based on the existing sleep-improving health products,followed by data mining and analysis according to the formulation regularity,aiming to provide new ideas for the development of new Chinese medicinal health products. In particular,attention should be attached to the requirements of special populations to provide a basis for follow-up studies,exert the advantages of TCM,and lay a foundation for Chinese medicinal health products to service the public.

Analysis on formulation regularity and characteristics of acne-relieving Chinese medicinal health products and Chinese patent medicines / 中国中药杂志

This study summarized and analyzed the current acne-relieving Chinese medicinal health products and Chinese patent medicines,aiming at providing references for the formulation and development of acne-relieving health products. The information on acne-relieving health products published by the Department of Special Food Safety Supervision and Management,the State Administration for Market Regulation( SAMR) was retrieved,and the Chinese patent medicines on DRUGDATAEXPY were searched. Microsoft Excel and the Traditional Chinese Medicine Inheritance Support System V2. 5( TCMISS) were employed to statistically analyze the characteristics of formulations. Forty-three acne-relieving health products were obtained,including 40 ones containing Chinese herbal medicines. Six Chinese herbal medicines showed a usage frequency ≥8,with 61 times in use totally,including Salviae Miltiorrhizae Radix et Rhizoma( 13),Lonicerae Japonicae Flos( 12),Taraxaci Herba( 11),ALOE( 9),Carthami Flos( 8),and Rhei Radix et Rhizoma( 8). A total of 29 Chinese patent medicines with similar efficacy were collected in DRUGDATAEXPY. Nine Chinese herbal medicines showed a usage frequency ≥6,with 63 times in use,including Rhei Radix et Rhizoma( 10),Glycyrrhizae Radix et Rhizoma( 8),Scutellariae Radix( 8),Lonicerae Japonicae Flos( 7),Angelicae Sinensis Radix( 6),Paeoniae Radix Rubra( 6),Astragali Radix( 6),Paeoniae Radix Alba( 6),and Gardeniae Fructus( 6). Through unsupervised hierarchical entropy-based clustering of the above-mentioned Chinese medicinal health products and Chinese patent medicines,five and three new formulas were obtained,respectively. The selection of Chinese herbal medicines was consistent with the principles of traditional Chinese medicine( TCM) theories in relieving acne,i. e.,dispelling exterior wind,ventilating lungs,clearing heat,dissipating mass,promoting diuresis,relaxing bowels,removing toxin,activating blood,resolving stasis,eliminating phlegm,and regulating Qi. According to the " lung governing skin and body hair" and " interior-exterior relationship between lung and large intestine" in TCM theories,the idea that acne could be treated by relieving constipation was proposed,which provided new methods and references for the research and development of Chinese medicinal health products.

Prevenção quaternária, reforma curricular e educação médica / Quaternary prevention, curricular reform and medical education / Prevención cuaternaria, reforma curricular y educación médica

Desde uma perspectiva crítica e de enfrentamento à problemática da sobremedicalização, a prevenção quaternária (P4) emergiu como um conceito inovador, propondo alternativas para prevenir os eventos iatrogênicos e otimizar os custos da saúde. O presente ensaio foi elaborado a partir de uma revisão histórico-conceitual da P4 e dos modelos de educação médica, visando compreender como a P4 poderia se constituir como um elemento estratégico para remodelar a educação médica. O artigo aprofunda aspectos conceituais da P4; aborda a educação médica a partir de uma perspectiva histórica; aponta as interligações dinâmicas entre a P4, as práticas de saúde e a educação médica; e, por fim, expõe os motivos pelos quais a P4 pode se tornar um elemento central da educação médica.(AU)

From a critical perspective that tackles the problem of overmedicalization, quaternary prevention (P4) emerged as an innovative concept, proposing alternatives to prevent iatrogenic events and to optimize healthcare costs. This essay provides a historical-conceptual review of P4 and of medical education models, aiming to understand how P4 can become a strategic element to remodel medical education. The article addresses conceptual aspects of P4, approaches medical education from a historical perspective, and shows the dynamic interconnections between P4, health practices and medical education. Finally, it explains the reasons why P4 can become a central element of medical education.(AU)

Desde una perspectiva crítica y de enfrentamiento a la problemática de la sobremedicalización, la prevención cuaternaria (P4) surgió como un concepto innovador, proponiendo alternativas para prevenir los efectos iatrogénicos y optimizar los costos de la salud. El presente ensayo se elaboró a partir de una revisión histórico-conceptual de la P4 y de los modelos de educación médica, con el objetivo de entender cómo la P4 podría constituirse como un elemento estratégico para remodelar la educación médica. El artículo profundiza aspectos conceptuales de la P4, aborda la educación médica a partir de una perspectiva histórica, señala las interconexiones dinámicas entre la P4, las prácticas de salud y la educación médica. Finalmente, expone los motivos por los cuales la P4 puede convertirse en un elemento central de la educación médica.(AU)

Research progress on superfine grinding technique in field of Chinese materia medica / 中草药

With the continuous development of the modernization of Chinese materia medica (CMM), the superfine grinding technology has been continuously applied to the basic and applied research of raw materials and preparations, which has become an important way to improve and enhance the quality of traditional Chinese medicine decoction pieces and traditional preparations. This paper introduces the concept, the equipment, working principle and characteristics of superfine grinding, and expounds the general situation of application of superfine grinding technology in Chinese materia medica (CMM). The prospective application of superfine grinding technology in the field of CMM was analyzed and prospected. The problems that should be paid attention to in the future research and application of superfine grinding of CMM were put forward.

Advances in immunoregulatory effects and bioactive compounds of polysaccharides from Dendrobium officinale / 中草药

Based on the previous studies in recent years, this advances made a summary of immunoregulatory effects from Dendrobium officinale. And the research advances on related bioactive compounds of polysaccharides in extraction, separation and purification, structural composition and content determination were systemically reviewed. This paper intended to provide a theoretical basis for reasonable research and exploitation of related health foods of D. Officinale.

New situation and new strategies——research and development and internationalization of new drugs and health products of traditional Chinese medicine / 中国药理学与毒理学杂志

The 2017 China (Lianyungang) International Medical Technology Conference was held in Lianyungang,Jiangsu Province during November 15-17,2017.During this conference,the Division for Traditional Chinese Medicine and Natural Products Pharmacology of Chinese Pharmacological Society (CNPHARS) and Jiangsu Kanion Pharmaceutical Co. Ltd.jointly held the Forum on R&D and Interna-tionalization of New Drugs and Health Products of Traditional Chinese Medicine.The forum was co-chaired by Professor ZHANG Yong-xiang, President of CNPHARS, Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS,and Chair of the Natural Product Section of Inter-national Union of Basic&Clinical Pharmacology(IUPHAR), Professor DU Guan-hua,former President of CNPHARS and Vice-Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS,and Dr.XIAO Wei,Chairman of the Board of Jiangsu Kanion Pharmaceutical Co. Ltd. And Vice-Chair of Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS. More than 70 scholars attended the forum, including four foreign experts [Michael SPEDDING, Secretary-General of IUPHAR; Professor Valérie B. SCHINI-KERTH, Vice-Chair of the Natural Product Section of IUPHAR; Professor Cherry WAINWRGHT, Director of Centre for Natural Product Drugs of Robert Gordon University; Professor InKyeom KIM, Director of the Korean Society of Pharmacology], members of the Division for Traditional Chinese Medicine and Natural Products Pharmacology of CNPHARS and leading researchers at Jiangsu Kanion Pharmaceutical Co.,Ltd.GU Jin-hui,Director of the Division of National Science and Technology Major Project for Drug Innovation,Department of Health Science,Technology and Education,National Health and Family Planning Commission of the People's Republic of China was also invited to attend the forum. Representatives discussed the R&D and internationalization of new drugs and health products of traditional Chinese medicine.The summary of views and advice of some experts was published here for the purpose of promoting domestic and overseas academic exchange, and playing an active role in improving the level of R&D and internationalization of new drugs and health products of traditional Chinese medicine in China.

Analysis of development trend of Chinese medicine health products based on history of western health products development / 中国药理学与毒理学杂志

Because of the rapidly rhythm of modern society, fast food and take-out become the main dining methods for most of young people,while the outside foods always have few types of foods and nutrition is not complete. Nutrient imbalances may cause many diseases such as gastrointestinal diseases,cardiovascular diseases,diabetes,obesity,and cancer.In this environment,health products have emerged.At present,there are a wide variety of health care products at home and abroad,which are broadly divided into three categories:traditional vitamins,emerging nutrient products,and extracts of natural plant active ingredients.In the early 1970s,the sales of health products in the United States had reached 170 million dollars.At present,it has nearly 100 billion dollars,which is almost 1/3 of the total food sales, people's demand for health products is increasing rapidly. In recent years, Chinese medicine health products become more popular in western,in fact, Chinese medicine health products have a long history of application in China and have a good reputation in the folk. Obviously, Chinese medicine health products have great potential for development.So this article mainly compared the de-velopment and state of health products between China and west countries.Based on the development of health products in western countries, this article analyzes the development trend and prospects for the development of Chinese medicine health products. It is roughly divided into three parts. The first part introduces the development reasons and history of western health products development.The sec-ond part introduces the history of Chinese health products and the current situation of Chinese medi-cine health products. The third part guesses the development trend of Chinese medicine health prod-ucts and provides some development ideas. The purpose of this airticle is to provide reference and ideas for the future research and development of traditional Chinese medicine health products.