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한의학임상에 기초를 둔 천연물신약 연구과정에 대한 소고 -역사적 근거 발굴부터 천연물신약 임상시험계획승인신청까지-
엄석기 ( Seok Ki Eom ),김세현 ( Se Hyun Kim ),김경석 ( Kyung Suk Kim ),박상재 ( Sang Jae Park ),어완규 ( Wan Kyu Eo ),최원철 ( Won Cheol Choi ) 대한한의학원전학회(구 대한원전의사학회) 2010 대한한의학원전학회지 Vol.23 No.4
Purpose: To propose various types of clinical research which is feasible for botanical new drug (IND) development processes, and suggest essential steps to development of study protocol for IND. Methods: Literature-based discussions and one research group`s experience is given regarding domestic act, regulation, and system. Results: In order to get an approval of IND for botanical drug in Korea there are several types of clinical research to conduct. In quality control steps for standardized medicinal herbs, case reports or case series can be conducted, and for good manufacturing practice(GMP) steps, we can conduct case reports, case series, and retrospective cohort studies. In addition, as long as we gathered good laboratory practice(GLP) data we can conduct up to quasi-experimental studies and clinical trials including investigator initiated trials. In order to conduct these studies development of study protocol is essential. First, we obtain historical evidence including target disease and indication, efficacy, safety, and endpoints by reviewing medical classics. Second, we obtain clinically and statistically important data by conducting non-clinical studies, observation studies, and quasi-experimental studies. Third, we generate research hypotheses and purposes and explore methodologies, endpoints, clinical practice guidelines, cost-effectiveness, and commercial potential. Finally, we develop study protocol with aid of biostatistician or expert in contract research organization. Discussions and conclusions: This study have obvious limitations in that most thoughts, suggestions, and proposes are from one research group`s experience. Therefore, we hope to see various types of research in this topic and process from other research group as well.
엄석기(Seok Ki Eom),김세현(Se Hyun Kim) 한국의사학회 2015 한국의사학회지 Vol.28 No.1
Objectives : The purpose of this study is to analyze and identify the problems of current laws and regulations regarding preparation and processing of herbal medicines at hospitals of Korean Medicine. Possible solutions are proposed in the end Methods : Based on the status of hospitals of Korean Medicine and characteristics of Korean Medicine and Korean Medicine industry, I analyze the laws and regulations in regards to preparation and processing of herbal medicines and propose possible solutions. Results : Regulations for the agents, places, and cautions in respect of preparation and processing of herbal medicines are inadequate. Meanwhile, the definition of drug preparation in the Pharmaceutical Affairs Act does not apply to processing and preparation of herbal Medicines at hospitals of Korean Medicine, since herbal medicines accompanies chemical and physical change. Discussions & Conclusions : New regulations for on-site preparation at hospitals of Korean Medicine are necessary. Also, the definition for herbal medicines preparation, which states possible chemical and physical changes of herbal medicines, should be specified in Pharmaceutical Affairs Act.
엄석기(Seok-Ki Eom),강봉석(Bong-Seok Kang),권순조(Soon-Jo Kwon) 한국의사학회 2013 한국의사학회지 Vol.26 No.2
Purpose : The purpose of this study was to analyze the history and characteristics of laws and regulations of the medical and pharmaceutical system in Korea-focusing on the Korean (Oriental) medical and pharmaceutical system-from the modern period to the early days of the Republic. We reviewed how traditional notions and categories of Oriental medicine, which were regarded as experiential and conventional, became part of the current dualistic medical and pharmaceutical system, and examined problems and effects during the course of positioning. Methods : We classified the development of the medical and pharmaceutical laws and regulations chronologically, from the Korean Empire to the beginning of the Republic. The abolishment of the traditional medical system that was based on laws and regulations of the Joseon Dynasty, the implementation of dualistic medical system in the Korean Empire, the attempt to demolish Korean (Oriental) medicine under the Japanese colonial rule, and the process of developing a statute-based continental law system were thoroughly reviewed. Results : Although the dualistic medical system was specified in legislation via the enactment of the National Medical Services Law in 1951, we found that it was actually enacted in 1963, when the laws and systems regarding the educational institution of Korean (Oriental) medicine were stably established. Moreover, the dualistic pharmaceutical system was specified in legislation through the partial amendment of the Pharmaceutical Affairs Act in 1994, but we concluded that the actual enactment was rather in 2000, when the first Korean (Oriental) pharmacist was produced. Discussions and conclusions : An effort to establish a dualistic medical system of Korean (Oriental) medicine and Western medicine during the Korean Empire bore fruit a few decades later, after the Republic of Korea was founded. It means the basis for the legal system finally took shape in spite of the numerous attempts during the Japanese colonial era and the beginning of the Republic to abolish Korean (Oriental) medical and pharmaceutical system.
한약, 한약재, 생약과 천연물의 법규상 개념 및 정의의 문제점과 개선안
엄석기 ( Seok Ki Eom ) 대한한의학원전학회(구 대한원전의사학회) 2014 대한한의학원전학회지 Vol.27 No.2
Objectives : This study was to analyze the definitions of herbs, herbal drugs, crude drugs and natural products in the relevant laws and regulations, understand the related problems, and propose directions for improvement. Methods : I analyzed the legal definitions in respect of herbs, herbal drugs, crude drugs and natural products in relevant laws and regulations since 1945, explained the problems, and suggested the solution-considering the academic stance of Traditional Korean Medicine and the dualistic medical and pharmaceutical system. Results : Herbs are defined as “refined things that are cut and dried in their most original state.” The definition of crude drugs includes herbs and the “cell contents, secretion, extracts, minerals and other parts of animals and plants that are used medicinally.” The concept of natural products is expanded to adding tissue cultures to the definition of crude drugs. Conclusions : The definition of herbs should at least include all products that are “processed, extracted and prepared” as well as contents that consist of various forms of hospital-prepared herbs. The term “herbal drug” corresponds to a traditional term of “drug,” and this should be established as a concept to explain “drugs in raw materials that are used to prepare herbs and/or manufacture herbal medicine.” The legal definition of herbs should include the concept of crude drugs. Herbal drug preparations and crude drugs should be included in the definition of herbal drugs
"기사망사(其死亡者) 삼분유이(三分有二) 상한십거기칠(傷寒十居其七)"에 대한 소고(小考) -상한(傷寒)에 의한 질환(疾患)-특이(特異) 사망율(死亡率)을 중심(中心)으로-
엄석기 ( Seok Ki Eom ),김세현 ( Se Hyun Kim ),어완규 ( Wan Kyu Eo ) 대한한의학원전학회 ( 구 대한원전의사학회 ) 2008 대한한의학원전학회지 Vol.21 No.4
Based on the sentence "The number of my family member and relatives reached around 200, but since the first year of Geonan(建安) era, two thirds of them died and seven out of ten died of cold damage in less than ten years" in Sanghanjapbyeongron(Treatise on Cold Damage and Miscellaneous Diseases), which is allegedly known to be written by Jangnunggyeong(張仲景), we analyzed the sentence by three factors of time, location and people. These factors are used in the investigation of the disease outbreak, and through this analysis, following conclusions were made. 1. Approximate 10 year crude mortality rate since A.D 196(the first yea of Geonan era) in Jangsa(長沙) province was 67 out of 100 in the population. Approximate 10 year disease-specific mortality rate of cold damage since A.D 196(the first yea of Geonan era) in Jangsa(長沙) province was 47 out of 100 in the population. Regardless of age, gender or other demographic variables, approximate 10 year proportionate mortality ratio since A.D 196(the first yea of Geonan era) in Jangsa province was 70.2%, which lead to the assumption that 70% of death is cold-damage related. 2. Increased disease-specific mortality rate by cold damage in Jangsa(長沙) province for about 10 years since A.D 196(the first yea of Geonan era), and followed increased crude mortality rate in the population, threatened the stability of nation or local government. This is due to the repeated war in late Han Dynasty with political chaos and repeated flood caused by geographical disadvantage in Jangsa province.
엄석기,Eom, Seok-Ki 대한예방한의학회 2014 대한예방한의학회지 Vol.18 No.1
Objective : The purpose of this study was to lay the groundwork for understanding the details and scope of the legal definition of medicinal products, following the changes in the relevant laws and regulations. This will let readers properly understand the origins of the ongoing conflicts on herbal drugs and new drugs from natural products that are present in the medical field and the medical industry. Possible solutions are proposed in the end. Method : I analyzed the changes in definition of medicinal products since 1945 that have been used in relevant laws and regulations(i.e. Pharmaceutical Affairs Act) and drug approval process(i.e. New Drug Application and Investigational New Drug Application). Results : Legal definition of medicinal products has changed in accordance with the changes in the pharmaceutical industry, such as the establishment of dualistic medical and pharmaceutical System and the introduction of the substance patent. Due to those changes, boundaries of Western medicinal products and health food expanded, while those of herbal medicine products relatively downscaled. Conclusion : Legal definition of medicinal products-i.e. Herbal Drugs, Crude Drugs, and New Drugs from Natural Products-should be reestablished according to academic legitimacy and dualistic medical and pharmaceutical System.