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.

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.

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.

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)

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.

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.

Discovery of quality markers of Chinese materia medica based on Chinmedomics / 中草药

The quality of Chinese materia medica (CMM) has become an important factor affecting the inheritance and development of traditional Chinese medicine. However, due to the complexity of CMM ingredients and the specificity of prescription application, the current quality standards of CMM are difficult to guarantee clinical efficacy. Academician Changxiao Liu proposed the concept of the quality marker (Q-marker) of CMM and its basic attributes, which provided a direction for the study of CMM quality standards. Chinmedomics, integrating serum pharmacochemistry and metabolomics technology, under the conditions of correspondence of prescription-syndrome with therapeutic effect, can be used to find the Q-markers of CMM which are related to the clinical efficacy, and reflect the compatibility of prescriptions, and trace the in vivo metabolism and preparation process. The research strategy based on Chinmedomics is an effective method for discovering the Q-markers of CMM, it has been applied to discovery Q-markers of Yinchenhao Decoction, Liuwei Dihuang Pill, NanShi Capsule, AS1350, and other CMM formula as well as the health products.

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.

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.

Simultaneous Determination of 19 Chemical Drugs in Traditional Chinese Medicines and Health Products for Treating Rhinitis by UPLC-MS/MS / 医药导报

Objective To establish a UPLC-MS/MS method for simultaneous determination of 19 chemical drugs in Traditional Chinese Medicines and health products for treating rhinitis. Methods Separation was performed on Waters ACQU-ITY UPLC BEH-C18column(2.1 mm×100 mm,1.7 μm) with 0.1% formic acid acetonitrile solution and 0.1% formic acid aque-ous solution as the mobile phase by gradient elution.The flow rate was 0.3 mL·min-1.The column temperature was set at 35 ℃. The detection was performed by the positive ion electrospray ionization (ESI+) under multiple reactions monitoring (MRM) mode. Results The linear relationships of 19 chemical drugs were good in respective ranges with correlation coefficients higher than 0.995.The average recoveries of the low,medium,and high level were in the range of 84.9%-111.1%,and the RSDs were less than 5.2%.The limits of detection (LOD) and the limits of quantitation (LOQ) were in the range of 0.03-0.78 ng·mL-1 and 0.13-1.82 ng·mL-1,respectively. Conclusion The method is convenient,rapid,accurate,and sensitive,which can be used for the determination of chemical drugs added illegally in traditional Chinese medicines and health products for treating rhini-tis.

Research progress in safety for medicinal and edible Areca catechu / 中草药

Areca catechu is not only Chinese medicinal material but also one of traditional foods in Southeast Asia and China. In this paper, the usage and security were reviewed to discuss the effect of A. catechu on human health. Meanwhile, we put forward suggestions for the security of A. catechu and they may contribute to the medicinal and edible industry of A. catechu in future.

Design ideas of Chinese materia medica health products based on theory and advantages of traditional Chinese medicine / 中草药

Chinese materia medica (CMM) health products play an important position in the field of health products at home and abroad because of its long history of health, unique diet theory, and wealth resources of medicinal herbs. To inherit the theory of traditional Chinese medicine (TCM) and develop the health products with TCM characteristics, this paper has summarized the development status and common problems of CMM health products in recent years, and put forward the design idea based on the theory and advantage of TCM for designing the development model of CMM health products more scientifically and reasonably, which has followed the theory of dialectics of eight aspects, five elements, physique theory, and so on. An effort is made to create health products with TCM characteristics and advantages in order to adapt to the health needs of different people, which would make significant contribution to the people's health and industrial development.

Contents Determination of Catechins Active Components in Lipid-lowering Slimming Health Products by Quantitative Analysis of Multi-Components via Single Marker / 中国药房

OBJECTIVE:To establish the method for contents determination of catechins active components in lipid-lowering slimming health products. METHODS:HPLC method was adopted. Using epigallocatechin gallate(EGCG)as a reference,relative correction factor(RCF)of EGCG to gallocatechin(EGC),catechin(C),epicatechin(EC),gallocatechin gallate(GCG)and gal-loylepicatechin(ECG)were calculated. The contents of EGC,C,EC,GCG and ECG in 5 batches of samples were calculated through RCF. The contents of EGC,C,EC,GCG and ECG determined by external standard method were used as measured value. The similarity of the value determined by external standard method with the value calculated by quantitative analysis of multi-com-ponents via single marker method(QAMS)was evaluated with vector included angle cosine method. RESULTS:The linear ranges of EGCG,EGC,C,EC,GCG and ECG were 0.0065-0.1305 mg/mL(r=0.9998)、0.0005-0.0107 mg/mL(r=0.9997)、0.0020-0.0400 mg/mL(r=0.9999)、0.0153-0.3053 mg/mL(r=0.9998)、0.0008-0.0155 mg/mL(r=0.9998)、0.0040-0.0792 mg/mL (r=0.9999);RSDs of precision,stability and reproducibility tests were all lower than 2.0%.The recoveries were 95.07%-100.35%(RSD=1.94%,n=6)、95.24%-101.87%(RSD=2.79%,n=6)、96.08%-103.86%(RSD=3.01%,n=6)、97.51%-101.06%(RSD=1.45%,n=6)、96.01%-101.66%(RSD=2.27%,n=6)、96.20%-102.89%(RSD=2.71%,n=6),respectively. There was no signifi-cant difference between measured value and calculated value. CONCLUSIONS:The method is simple,precise,stable and repro-ducible,and can be used for contents determination of catechins active components in lipid-lowering slimming health products.

Detection of 10 anti-rheumatic constituents illegally added in Chinese traditional medicine and health products by UPLC-MS/MS / 药物评价研究

Objective To establish a UPLC-MS/MS method for determination of 10 anti-rheumatic constituents illegally added in Chinese traditional medicine and health products preparation.Methods The column was ACQUITY UPLC BEHC18 (50 mm× 2.1 mm,1.7 μm),The mobile phase was acetonitrile-Ammonium acetate solution (containing 0.1％ Acetic acid) with gradient elution at a flow rate of 0.3 mL/min.The ion source was electrospray ionization (ESI),Multiple-reaction monitoring (MRM) was performed to identify and quantify 10 anti-rheumatic constituents.Results 10 linear calibration curves were obtained with r ≥ 0.996 1.The recoveries were determinated at three concentration and ranged from 92.5％ to 101.8％.The precision of the method was shown by RSD (n =5) ranged from 0.9％ to 3.1％.The ranges of limit of detection were from 0.001 5 to 0.018 μg,and quantitation were from 0.004 5 to 0.55 μg.The illegally added chemicals were detected with 10 batches of 27 batches of samples.Conclusion The method were simple,sensitivity,accurate,and can be used to detect Anti-rheumatic constituents illegally added in Chinese traditional medicine and health products.

Determination of 5 Heavy Metal Elements in Spirulina Health Products by ICP-MS / 中国药师

Objective:To establish a method for the determination of Cu,As,Cd,Hg and Pb in spirulina health products. Meth-ods:The samples were digested by microwave and determined by ICP-MS. Results: The minimum detection limits of Cu,As,Cd,Hg and Pb was 6. 72,6. 25,3. 12,0. 331 and 8. 78 ng·g-1 , respectively, and showed good linear relationship within respective concentra-tion range (r >0. 999 7) with the average recovery of 110.4%,96.6%,93.1%,102.8%, 101.4% and RSD of 3.2%,4.2%, 2. 5%,2. 9%,3. 0%(n=9), respectively. Conclusion:The method is sensitive, simple and accurate, and can be used to determine the harmful elements in spirulina health products.

Status, Opportunities and Challenges for the Regulation of Traditional Chinese Medicine (TCM) in Canada / 国际中医中药杂志

It has been 4 years since Natural Health Products Regulations(NHPRs)was enforced by Health Canada in January of 2004.In the past time,how will it affect the marketed Traditional Chinese Medicines(TCM) in Canadian market? Recently,The two TCM products Carditionic Pill (Fufang Danshen Diwan)and Chaihu Pill from Tasly have been newly certificated by Health Canada recently.Taking them as examples,this article introduces the current status.opportunities and challenges for the regulation of TCM in Canada.and suggests that the domestic TCM corporations push the product registration as soon as possible.

A Recommendation for the Acquisition of Knowledge of Natural Health Products (NHP) for Physicians and Paramedical Staff / 日本補完代替医療学会誌

The number of people that use Natural Health Products (NHP), not only as a complementary medical treatment, but also for disease prevention and health maintenance, has increased considerably in recent years. Although classified as a food, NHPs can have various pharmacological effects, leading to situations that cannot be ignored by healthcare administrators. However, the level of knowledge and awareness of NHPs are inadequate among healthcare professionals. The Medical Supplement Advisor (MSA) Certification Course that is introduced here is an advanced level course intended for medical professionals only, which examine NHPs, categorized by specific diseases, based on EBM. The contents and arrangement of this course allow clinical physicians and pharmacists to learn and acquire more effectively the knowledge and tools of NHPs and has also been designed with special attention to the clinical application of that knowledge. In order to maximize convenience, the entire course is offered on-line and a CBT system is utilized for the qualification exam. It is essential for healthcare administrators in the future to be able to critically assess information about NHPs and to play a guiding role in health management programs and comprehensive medical care that incorporate Natural Health Products.<br>