Analysis of simplified registration of traditional herbal medicinal products in European Union / 国际中医中药杂志

Europe occupies an important position in the world herbal medicine market. The registration of Traditional Chinese Medicine (TCM) in EU is of great significance to the internationalization of TCM. The European Medicines Agency (EMA) has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products. The promulgation of the DIRECTIVE 2004/24/EC (2004 / 24 / EC) indicates that TCM could enter the EU market through simplified registration. Based on the registration conditions, registration authority and document guideines of Traditional Herbal Medicinal Products (THMPs) in EU, this paper analyzes the application requirements of simple registration of traditional herbal products in EU, and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history, quality requirements and application data format.

A Retrospective Study on the Types and Frequency of Use of Herbal Medicines that were Efficacious in Treating Atopic Dermatitis / 日本東洋医学雑誌

The current study involved 70 patients with atopic dermatitis who were treated with herbal medicine at this hospital’s Oriental Medicine department. This study examined a total of 237 prescriptions with Kampo diagnosis used to treat those patients. Patients who no longer needed to use a steroid ointment preparation were defined as “complete responders” and both these patients and patients whose use of a steroid ointment preparation decreased 50% or more from the level prior to use of herbal medicine were defined as “responders.” The complete response rate was the percentage of complete responders and efficacy rate was the percentage of responders. Among all patients, efficacy was 56.3% for unseiin > 50.0% for tokiinshi > 41.0% for Keigairengyoto > others. The complete response rate was 25.0% for unseiin > 16.7% for tokiinshi > 15.8% for shishihakuhito > 13.1% for Keigairengyoto > others. Among patients with “reddish” atopic dermatitis, unseiin had the highest efficacy and resulted in the highest complete response rate, followed by shishihakuhito and then keigairengyoto. Among patients with “wet” atopic dermatitis, unseiin had the highest efficacy and resulted in the highest complete response rate, followed by shofusan. When Kampo diagnosis is equivocal and herbal medicines are urgently needed, unseiin should be the prescription of first choice. Based on the condition of the skin, shofusan, shishihakuhito, or tokiinshi should be the second-best option.

Future development of Good Agricultural Practice in China under globalization of traditional herbal medicine trade / 中草药·英文版

Traditional herbal medicine (THM) is an important part of the traditional Chinese medicine culture. Due to its high medicinal potential, it should not only serve for the Chinese people's medical use, but also contribute to the world medicine, THM for the international market must be standardized and large-scale, and produced according to the “Good Agriculture Practice” (GAP). The quality of THM directly affects the patient's treatment status and safety of use. Therefore, the quality assurance of THM runs through the entire process of research and development, production and clinical practice. The standardized production and cultivation of THM is the starting point of the THM industry chain and plays a decisive role in the economic development of the THM industry. This article summarizes the development history, limitations and future development of GAP, and clarifies the opportunities for THM in the rapid development of the international and domestic Chinese medicine industry. In addition, analyzing the deficiencies that were existing in the former GAP implementation process and by suggesting science-based quality measures, it is hoped to stipulate improved GAP guidelines in the future and to lay the foundation for a modern THM international trade.

Correlation study on non-volatile ingredients of Menthae Haplocalycis Herba formula granules and traditional herbal pieces by UPLC-MS/MS / 中国中药杂志

To establish the method for determining non-volatile ingredients of neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, caffeic acid, isochlorogenic acid A, rosmarinic acid, ferulic acid, rutin, luteoloside, isoquercitrin, hesperidin, diosmin, diosmetin, luteolin, acacetin and linarin in Menthae Haplocalycis Herba formula granules and traditional herbal pieces by UPLC-MS/MS, and analyze the correlation of non-volatile ingredients in Menthae Haplocalycis Herba formula granules and traditional herbal pieces. Shim-pack GIST C_(18) column(2.1 mm×100 mm, 2 μm) was adopted with acetonitrile-0.1% formic acid aqueous solution as the mobile phase for gradient elution at the flow rate of 0.4 mL·min~(-1). The column temperature was set at 35 ℃. The quantitative analysis was performed using the electrospray ionization source and the multiple reaction monitoring. The linear relationship, resolution, repeatability and recovery of the 16 chemical components all met the requirements. The 16 non-volatile ingredients in traditional herbal pieces of Menthae Haplocalycis Herba could be tracked in formula granules. There were certain differences of the 16 chemical components among Menthae Haplocalycis Herba formula granules of different manufacturers and traditional herbal pieces of different producing areas. The UPLC-MS/MS method was simple, rapid and accurate, and could be used for the quality control of non-volatile ingredients in Menthae Haplocalycis Herba formula granules and traditional herbal pieces.

Enlightenment of the European Union ’s Traditional Herbal Medicine Registration System to the Simplified Registration and Monitoring System of Chinese Classical Formulas / 中国药房

OBJECTIVE：To provide refe rence for improving the moni toring system of simplified registration system of Chinese classical formulas. METHODS ：A comparative study was conducted on the simplified registration system of traditional herbal medicines in the European Union and Chinese classical formulas from the aspects of regulatory agencies ，regulatory systems ， simplified registration conditions ，simplified registration catalogs and registration data. On the basis of the experience of the simplified registration system of traditional herbal medicines in the European Union ，some suggestions were put forward to improve the simplified registration system of Chinese classical formulas. RESULTS & CONCLUSIONS ：The European Union establishes special committee on traditional herbal medicine for registration and supervision ；has established a complete regulatory system from directives to specific guidelines ；focuses on the history and conditions of the use of traditional herbal medicine ；has published the European Union monographs and European Union list ，which are used as a basis for safety and effectiveness to further reduce or exempt registration data. In China ，National Medical Products Administration and the National Administration of Traditional Chinese Medicine are jointly responsible for the registration and supervision of classical formulas. At present ，the relevant documents to simplify the registration and approval have been issued ，but there is no corresponding implementation rules and guidelines. China also attaches great importance to the clinical experience of classical formulas ，and emphasizes the consistency of preparation methods and dosage forms with ancient classics. Recently ，China has published the Catalogue of Ancient Classic Formula（the First Batch ），including 100 classical formulas ，and the classic formulas in the catalogue can be exempted from relevant registration materials when applying for registration. Our country can learn from the experience of the European Union and combine the actual situation of classic formulas supervision to establish an expert committee ，focus on quality control and risk control to improve registration and supervision system ，optimize the selection conditions of classic formulas ，and explore the classic formulas monographs ， to further stimulate the innovation vitality of traditional Chinese medicine industry.

Biomonitoring for traditional herbal medicinal products using DNA metabarcoding and single molecule, real-time sequencing

Global concerns have been paid to the potential hazard of traditional herbal medicinal products (THMPs). Substandard and counterfeit THMPs, including traditional Chinese patent medicine, health foods, dietary supplements, etc. are potential threats to public health. Recent marketplace studies using DNA barcoding have determined that the current quality control methods are not sufficient for ensuring the presence of authentic herbal ingredients and detection of contaminants/adulterants. An efficient biomonitoring method for THMPs is of great needed. Herein, metabarcoding and single-molecule, real-time (SMRT) sequencing were used to detect the multiple ingredients in Jiuwei Qianghuo Wan (JWQHW), a classical herbal prescription widely used in China for the last 800 years. Reference experimental mixtures and commercial JWQHW products from the marketplace were used to confirm the method. Successful SMRT sequencing results recovered 5416 and 4342 circular-consensus sequencing (CCS) reads belonging to the ITS2 and regions. The results suggest that with the combination of metabarcoding and SMRT sequencing, it is repeatable, reliable, and sensitive enough to detect species in the THMPs, and the error in SMRT sequencing did not affect the ability to identify multiple prescribed species and several adulterants/contaminants. It has the potential for becoming a valuable tool for the biomonitoring of multi-ingredient THMPs.

Research and practice on readability test of Danshen Capsule for registration as THMPs in EU / 中草药

The package leaflet is a legal document relevant with drug information, which plays an important role for instructing the rational use of the medicinal product for the patient population. During the registration application in the EU countries, the patient readability test on package leaflet is the essential requirement to ensure the leaflet information easy-to-understand and avoid any risk caused by misunderstanding. The readability research on package leaflet can improve its quality and drug use safety to patients. Currently, CFDA does not publish any regulation/guidance on the drug application in China. By the successful case of registration application of Danshen Capsule as the herbal medicine in the EU, this paper not only discusses the relevant requirements of readability test in the EU, but also offers the regulatory advice on future regulations of readability research of the pharmaceutical products in China.

Tribes in Karnataka: Status of health research.

The south Indian State of Karnataka, once part of several kingdoms and princely states of repute in the Deccan peninsula, is rich in its historic, cultural and anthropological heritage. The state is the home to 42,48,987 tribal people, of whom 50,870 belong to the primitive group. Although these people represent only 6.95 per cent of the population of the State, there are as many as 50 different tribes notified by the Government of India, living in Karnataka, of which 14 tribes including two primitive ones, are primarily natives of this State. Extreme poverty and neglect over generations have left them in poor state of health and nutrition. Unfortunately, despite efforts from the Government and non-Governmental organizations alike, literature that is available to assess the state of health of these tribes of the region remains scanty. It is however, interesting to note that most of these tribes who had been original natives of the forests of the Western Ghats have been privy to an enormous amount of knowledge about various medicinal plants and their use in traditional/folklore medicine and these practices have been the subject matter of various scientific studies. This article is an attempt to list and map the various tribes of the State of Karnataka and review the studies carried out on the health of these ethnic groups, and the information obtained about the traditional health practices from these people.

Comparative Study of Clinical Efficacy of Ultrafine Extracted Granule Preparation and Traditional Herbal Decoction of Li Zhong Tang / 中国中医药信息杂志

Objective To compare the clinical efficacy of different doses of ultrafine extracted granule preparation (EGP) and traditional herbal decoction (THD) of Li Zhong Tang in treatment of epigastric pain. Methods Sixty cases of epigastric pain patients in accordance with the diagnostic criteria of deficiency and cold pattern of spleen and stomach in TCM were randomly divided into THD group, 1/3 dose group and 1/5 dose group, and were given THD, 1/3 dose of ultrafine EGP and 1/5 dose of ultrafine EGP, respectively. The clinical efficacy of the three groups after one course of medication was comparatively analyzed. Results There were no significant differences in age, course of disease, symptom score before treatment, epigastric pain efficacy and syndrome curative effect among the three groups, the differences had no statistical significance (P>0.05). The severity, frequency and duration of epigastric pain were all reduced in the three groups, with significant differences between before and after treatment (P<0.05). Conclusion There are no significant differences in the clinical efficacy on epigastric pain among THD, 1/3 dose of ultrafine EGP and 1/5 dose of ultrafine EGP. In addition, the effect of 1/3 dose group is very close to the THD group.

An ethnobotanical study of plants used for the treatment of livestock diseases in Tikamgarh District of Bundelkhand, Central India

<p><b>OBJECTIVE</b>To explore and document the information regarding usage of ethnoveterinary medicinal plants utilized by rural farmers and traditional herbal healers for livestock healthcare in Tikamgarh District of Bundelkhnad, Central India.</p><p><b>METHODS</b>The remote villages of Tikamgarh district were regularly visited from July 2011 to June 2012. Following the methods of Jain and Goel (1995) information regarding the usage of ethnoveterinary medicinal plants was collected.</p><p><b>RESULTS</b>A total of 41 plant species in 39 genera and 25 families were used traditionally with various plant parts and their combinations for the treatment of more than 36 diseases in the studied area. Trees (17 species) were found to be the most used Ethnoveterinary medicinal plants followed by herbs (15 species), shrubs (6 species) and grasses (3) in descending order. The most common diseases cough, diarrhoea and fever were treated by 04 ethnoveterinary medicinal plant species.</p><p><b>CONCLUSIONS</b>The present study recommended that the crop and medicinal plant genetic resources cannot be conserved and protected without conserving/managing of the agro-ecosystem or natural habitat of medicinal plants and the socio-cultural organization of the local people. The same may be applied to protect indigenous knowledge, related to the use of medicinal and other wild plants. Introduction of medicinal plants in degraded government and common lands could be another option for promoting the rural economy together with environmental conservation, but has not received attention in the land rehabilitation programs in this region.</p>

An ethnobotanical study of plants used for the treatment of livestock diseases in Tikamgarh District of Bundelkhand, Central India

Objective: To explore and document the information regarding usage of ethnoveterinary medicinal plants utilized by rural farmers and traditional herbal healers for livestock healthcare in Tikamgarh District of Bundelkhnad, Central India. Methods: The remote villages of Tikamgarh district were regularly visited from July 2011 to June 2012. Following the methods of Jain and Goel (1995) information regarding the usage of ethnoveterinary medicinal plants was collected.Results:various plant parts and their combinations for the treatment of more than 36 diseases in the studied area. Trees (17 species) were found to be the most used Ethnoveterinary medicinal plants followed by herbs (15 species), shrubs (6 species) and grasses (3) in descending order. The most common diseases cough, diarrhoea and fever were treated by 04 ethnoveterinary medicinal plant species.Conclusions:The present study recommended that the crop and medicinal plant genetic A total of 41 plant species in 39 genera and 25 families were used traditionally with resources cannot be conserved and protected without conserving/managing of the agro-ecosystem or natural habitat of medicinal plants and the socio-cultural organization of the local people. The same may be applied to protect indigenous knowledge, related to the use of medicinal and other wild plants. Introduction of medicinal plants in degraded government and common lands could be another option for promoting the rural economy together with environmental conservation, but has not received attention in the land rehabilitation programs in this region.

Study result of some treatment effects in collagen induced arthritis mouse model / Монголын Анагаах Ухаан

IntroductionRheumatoid Arthritis (RA) is chronic systemic inflammatory autoimmune disorder that still remains a disease of unknown etiology and complex disease without a single treatment that is dominated by serious and debilitating sequalae resulting from synovial membrane, cartilage and progressive joint destruction involvement. There is a one major obstacle in elucidating the early events in the pathogenesis of RA has been the lack of definition of the initial features of the disease. To overcome these difficulties, various animal models have been developed. But Collagen Induced Arthritis (CIA) mouse model is known to be the most valuable animal model to explore the pathogenic process, molecular and cellular mechanisms of joint destruction, to discover the immune system respond and activation and to develop new effective treatment methods and useful drugs [1].Materials and Methods:Within this study we have used 40 male mice at age 6-8 weeksfor 0-60 days and divided into following 4 groups which are:I group–CIA induced mouse group treated with Derveger Jirgeruu (Saposhnicovia divaricata) (n=12) II group–CIA induced mouse group treated with Natriisalicylas (10%) (n=12) III group–Healthy control mouse group (n=8) IV group–CIA inducedcontrol mouse group (n=8). To induce CIA model, we have used standard method of Murali /2005/’s design. Standard drug Natriisalicylas (10mg/ 20gr), one of the often used drug anti-inflammatory and Mongolian herbal plant Derveger jirgeruu (Saposhnicovia divaricate) (0.26mg/20gr) were daily administered by orally, starting on day 21 until day 60.To evaluate and compare 2 drug’s anti-inflammatory effect, we have done clinical score evaluation (Kim W.U, 2002), laboratory testing and histological examination of the joints using standard methods.ResultTo summarize the research result, both medications have proven to be as a medication which has anti-inflammatory effect that decreased the signs and symptoms of RA by it is histological and laboratory analysis.Conclusions:1. CIA model was effectively induced, which have proven by clinical signs, laboratory result and histological examination.2. Within this study it has proven that traditional herbal medicine Derveger Jirgeruu (Saposhnicovia divaricate) (0.26mg/20g) have anti-inflammatory effect on CIA induced mouse model of Rheumatoid Arthritis, which have had similar effect asstandard non-steroid medicine Natriisalicylas (10mg/20g).

Worth of Traditional Herbal System of Medicine for Curing Ailments Prevalent Across the Mountain Region of Uttarakhand, India.

The present study deals with 40 medicinal plant species used to cure a variety of ailments through traditional health care system by the local healers (Vaidyas). These plants were checked and verified from the available literature which revealed that the uses of these plants were newly recorded. Depth studies of 40 new recorded medicinal plants were documented with their different parts being used in herbal medicines. It was also found that one species or some times more species were used for curing one or many diseases together. The nature and type of symptoms of diseases reported of human beings were found varying across the region. All these different kinds of diseases were grouped in to three categories i.e. serious, moderate and common based on the risk factor and seriousness of disease in consultation with doctors practicing different streams of treatment i.e. Vaidyas, Ayurvedic and Allopathic. About more than 40% of local inhabitants were consulted, so as to reveals their perceptions on ranking of 10 common ailments prioritized by the local people based on their preference for opting herbal system of treatments. The traditional herbal system of medicine is one of the most important prevailing systems in the area where modern health care centre are rare or in very poor conditions.

The suggestions on the entry of Chinese medicines into European Community monographs for traditional herbal medicinal products / 国际中医中药杂志

Directive 2004/24/EC of the European Parliament and the Council entered into force on April 30th, 2004. After 7 years, there is no Chinese medicine to be registered successfully in European market as traditional herbal medicinal products. The thesis gives some ideas to tackle this problem. Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products (EMEA/HMPC/182320/2005) published by European Medicines Agency is an important guidance for traditional herbal products to enter European Community monographs. The thesis introduces and details the procedure as well as gives feasible suggestions about the procedure. It suggests that Chinese medicines enter European Community monographs first, and then apply the registration according to the directive 2004/24/EC. This is an easier access to European market.

The regulatory developments of traditional herbal medicinal products in European Union / 国际中医中药杂志

The transient period of 7 years which is regulated in 2004/24/EC Director is due to 2011. This paper discussed the changing of traditional herbal drug regulation, the increasing of herbal monographs and lists, extending the scope of the simplified registration procedure in European Union. The purpose was to promote traditional Chinese medicine to enter the market.

Uso de las plantas medicinales por pobladores de Artemisa / Use of medicinal plants by the inhabitants of Artemisa

OBJETIVO: identificar aspectos relacionados con el uso de las plantas medicinales por quinientos pobladores de Artemisa, provincia La Habana, quienes accedieron de forma voluntaria y con consentimiento informado previo a la aplicación del instrumento, se analizaron variables de interés. MÉTODOS: se realizó un estudio descriptivo, prospectivo, transversal. RESULTADOS: los artemiseños conocen acerca del tema investigado, utilizan un sin número de plantas, muchas de las cuales no tienen su uso autorizado por el MINSAP, no existe un modo de preparación distinguido, la mayoría las emplea para combatir las enfermedades o dolencias ligadas al uso místico-religioso y el principal prescriptor fue el curandero. CONCLUSIONES: se demostró una vez más el poder resolutivo que desde la antigüedad le confieren los humanos a las plantas, ligadas a los rituales místico-religiosos, en nuestra localidad ha llegado hasta nuestros días. El uso de las plantas descritas en el presente trabajo influye de forma directa sobre la vida cotidiana, las costumbres y la salud de la comunidad(AU)

OBJECTIVE: To identify aspects related to the use of medicinal plants by five hundred inhabitants of Artemisa, Havana province, that volunteered to and gave their previous informed consent for the application of the instrument. Some variables of interest were analyzed. METHODS: A descriptional, prospective and cross-sectional study was conducted. RESULTS: The inhabitants of Artemisa know about the research topic. They utilize a great number of plants, whose use is not authorized by the Ministry of Public Health. There is no a specific way to prepare them. Most of them take these plants to fight diseases or ailments related to the mystic-religious use. The healer was the main prescriber. CONCLUSIONS: Once more, it was proved that the resolving power human beings have conferred to plants, linked with mystic-religious rituals, since ancient times, has come to our days in our locality. The use of the plants described in this paper influence directly on the daily life, the customs and the health of the community(AU)

Chinese herbal medicinal products in Europe:sales prospect and legal issues / 中华中医药杂志

In general EU legislation on pharmaceutical products for human use also applies to herbal medicines.In 2004 EU adopted a Directive to introduce a new pathway for marketing traditional herbal medicinal products,the "simplified registration" procedure.Subject to satisfying certain conditions,it allows the registration of traditional herbal medicinal products without requiring particulars and documents on tests and trials on safety and efficacy,provided that there is sufficient evidence of a minimum 30 years medicinal use,including at least 15 years in the EU.Accordingly pharmaceutical companies should to be able in theory to save considerable expenditure of time,effort and money when applying for marketing authorization.But in practice the new pathway doesn't work out as smoothly as expected.This article analyze the various pieces of European legislation that affect the development of both modern and traditional herbal medicine,the continued growth of their demand,EU's response to the latest market trend,and how Chinese herbal medicine companies should grasp the opportunities to penetrate into the European market.It also stresses the fact that publication of Chinese medicine scientific research articles in international medical journals will be the key to the sector's future success.

Traditional Medicine under Japanese Rule after 1930s / 의사학

Japan, which occupied Korean from 1910 through the end of World War II, transformed traditional medicine. Japanese colonialists propagandized the "benefits of modern civilization such as western medicine" and rejected the advantages of traditional medicine. This bias against Korean traditional medicine mirrored the government's rejection of its own traditional medicine. So, Korean traditional medicine was marginalized in the national health care system traditional doctors were excluded from public institutions and references to traditional medicine were purged from school textbooks and newspapers. The wars that Japan waged between 1931 and 1944 effected a favorable change toward traditional medicines, however. The wars created a severe shortage of drugs and medical personnel. Thus the colonial government was eager for Koreans to cultivate and gather herbal drugs it also built a large research institute for herbalism at the Keijo Imperial University in 1938. The colonial government made pharmacopoeia for traditional herbal drugs including plant and animal drugs from 1937 to 1942, independently from Japan. Under these conditions the prestige of traditional medicine was greatly improved. Influential newspapers and magazines covered the traditional medicine, and public lectures on traditional medicine drew large audiences. The wartime government abandoned its opposition to traditional medicine and appointed a traditional practitioner to the staff of the public hospital in 1934. Moreover, the government allowed the association of the traditional medical doctors in Seoul to train three hundred more practitioners between 1937 and 1942. Japanese colonial policy toward traditional medicine reflected the contradiction between modernizing ideology and the reality of poor colonial medical care. Japanese propaganda promised that the colonial regime would provide more advanced medicine to Korea, but the promise was an empty one. In this situation, traditional medical doctors and herbalists once again shouldered the main responsibility for the health of the Korean people.

Effect of Administration of Chinese Traditiional Herbal Preparation for Invigorating Spleen and Strengthening Immunity on Immune Function and Exercise Capacity of Endurance Athletes / 中国运动医学杂志

Objective The effects of administration of Chinese traditional herbal preparation for invigorating spleen and strengthening immunity (ISSI) on immune function and exercise capacity of endurance athletes were observed. Methods Thirty-three elite cyclists and runners were randomly divided into two groups: ISSI group and control group. 200ml per dose of ISSI preparation were separately given to each athlete every morning and evening before meals for 1 month. Th 1/Th 2, NK cytotoxic activity, sIL-2R, IgG, IgA, IgM, serum testosterone (T) and cortisol (C), and VO 2max were measured. Results After 1 month of treatment, the immune function of ISSI group including NK cell activity, Th 1/Th 2 and IgG increased significantly (P