• The Journal of Korean Medicine
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• v.36 no.1
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• pp.61-74
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• 2015

Objectives: The main purpose of this study is to find a solution for modernized classification of herbal medicinal preparations in dual medical systems. Through this study, we expect to provide a reasonable foundation of herbal medicine for public health. Methods: We studied legal or technical terms of herbal medicinal preparations from the past regulations, and through this procedure, we could suggest clear definitions of terms for herbal medicinal preparations. We also investigated documents for approval of herbal medicinal preparation from US, EU(European union), The People's Republic of China, Japan, so that we can refer to them to revise regulation for appropriate use of herbal preparations. Results: In Korea pharmaceutical affairs act, any basis of 'Crude drugs' does not exist. But in some subordinary notifications, the way that they use the 'Natural product medicine' is used as a means of limiting basic rights of doctor or pharmacist of Korean medicine compared to doctor or pharmacist. At the same time, in subordinary notifications, provisions are vague and not enough for scientific evidence of Korean medicine. Thus, we re-categorized herbal medicinal preparations into new drugs, drugs made from herbal medicinal preparations and suggested requirements for drug approval. Conclusions: Instead of using the term 'Crude drug preparations', and we should use term 'Herbal medicinal preparations' in related act and notification. And also we suggest to amend subordinary regulations and documents for approval of herbal medicinal preparations. Through this, we can make herbal medicinal preparations be more industrialized.

• The Journal of Korean Medical History
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• v.27 no.2
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• pp.11-37
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• 2014

Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

• Journal of Korean Medical classics
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• v.27 no.4
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• pp.181-198
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• 2014

Objectives : This study was to analyze definitions of herbal medicinal preparations, crude drug preparations, and new drugs from 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 herbal medicinal preparations, crude drug preparations, and new drugs from 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 : Regarding the current laws and regulations that are relevant to herbal medicinal preparations, we should 1) clarify the boundaries between the duty of physicians and that of pharmacists, 2) limit the principles of Korean Medicine as well as the contents of the related textbooks, 3) find a way to protect the intellectual property rights for herbal medicinal preparations, and 4) establish a separate standard for drug classification regarding herbal medicinal preparations. In case of crude drug preparations, we should 1) clarify the meaning and limitations of the phrase, "the point of view of Western medicine," and 2) establish a classification standard for drugs that are used in Korean Medicine and clarify the boundaries between herbal drug preparations and crude drug preparations. Furthermore, laws and regulations apropos of new drugs from natural products do not actually fit the concept of "new drug," and due to subordinate laws, a supplement to a new drug submission is contradictorily misclassified as a new drug from natural products. Conclusions : The problems of legal definitions of herbal medicinal preparations, crude drug preparations, and new drugs from natural products have emerged in the process of giving approval to drugs that are made of herbs and natural products under the dualistic medical and pharmaceutical System. Laws and regulations that differentiate the process of approving herbs that are used in Korean Medicine and the others should be established.

• Herbal Formula Science
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• v.21 no.2
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• pp.29-43
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• 2013

Objectives : The aim of this study is reviewing the past legal definition and regulations, to provide basis for the future desirable direction of Korean herbal pharmaceutical industry and national herbal drug policies. Methods : We reviewed how concept of herbal medicinal preparation has been utilized and changed along with various national laws and regulations. And this study also reviewed problems related herbal medicinal preparation policies. Results : Since 1990s, especially inauguration of Korea Food & Drug Administration (KFDA) at 1998, the concept of crude drug preparation has constantly expanded and distorted the scope of herbal medicinal preparations. This resulted in decline of herbal medicinal preparation industry. Conclusions : It means policies related herbal medicinal preparation which was driven steadily during this decade have lost their consistency. Also, it restricted the various medical options which can guarantee people's health rights.

• Herbal Formula Science
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• v.23 no.1
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• pp.1-14
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• 2015

Objectives : In Pharmaceutical Affairs Act, herbal medicinal preparations are defined as medicines made by Korean medicine principles. But in Act, Korean medicine principles are vague. Thus, there is a request to explain what the Korean medicine principles are. The aim of this study is to suggest implications of Korean medicine principles in definition of herbal medicinal preparations. Methods : With regard for definition of Korean medicine principles, we referred to the domestic and foreign regulations and literature about the history of herbal medicinal preparations. As a result, the meaning of Korean medicine principles was historically examined from various angles. Results : Through this study, we studied the Korean medicine principles from the past medical history. Due to the broad definition of Korean medicinal principles, we tried to extract general ideas of medicine principles first. We also found that we had scientific formulations based on korean medicine principles which could be used in modern society. In the end, we found that numerous medicine principles which include ‘Four qi and five flavors theory’, ‘Processing of medicinals’, ‘Yin and yang theory’, ‘Five phases theory’, ‘Meridian entry of viscera and bowels theory’, ‘Herb Couplet Interaction theory’, ‘Sovereign, minister, assistant and courier theory’, etc. Conclusions : Innumerable principles used from the past existed. These principles were broad and could be used as modern scientific principles. Based on these facts, we illustrated details of Korean medicine principles, hope this principles be widely shared and Korean herbal medicinal preparations be further developed.

• Journal of Society of Preventive Korean Medicine
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• v.21 no.2
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• pp.15-22
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• 2017

Objectives : This study was conducted to identify awareness and satisfaction of herbal medicine preparations in Korean medicine doctor(KMD). Methods : The questionnaire consisted of three professors of Korean medicine based on previous researches and reports. The pilot survey was conducted to five KMDs who work in local clinic to get face validity. Based on the results of the pilot survey, three professors of Korean medicine completed the final version. Online surveys was conducted to member of the association of Korean medicine from march 25 to april 6 in 2016. Results : The proportion of patients who prescribe herbal medicine was not significantly correlated to gender (p=0.346), but significantly correlated to age(p<0.01), specialty(p=0.017), monthly income(0.022), and clinical experience(p<0.001). The most common reason for using the herbal preparations which is covered by NHI (National Health Insurance) was due to patient's payment(39.3%). Likewise, the most common reason for using the herbal preparations which is not covered by NHI was various kind of prescription(34.1%). Conclusions : The utilization of herbal preparations could be enhanced by expansion of NHI cover range of herbal preparations.

• The Korea Journal of Herbology
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• v.21 no.4
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• pp.1-10
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• 2006

Objectives : Recently, the total medical expenses of the korean oriental medical service in national health insurance is on the increase every year. Herbal medicines are one of the major methods of the medical treatment. But the expenses of these herbal preparations that can receive benefits from insurance system are decreasing. Methods : In this research, we obtained statistical data of the benefit states of herbal preparations in herbal heath insurance during year 2001-2003 from Health Insurance Review Agency. We analyzed top twenty main diseases in herbal health insurance and mainly used prescription in these diseases. Results : There were wide differences in the application of prescriptions among diseases. For example, musculoskeletal diseases occupied an important position and Ojucksan took more than 50 percentage. Conclusion : We hope that this study could be a basic data for improving the benefit system of herbal health insurance and further studies should be carried out subsequently.

• Journal of Society of Preventive Korean Medicine
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• v.22 no.3
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• pp.31-44
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• 2018

Objectives : The aim of this study was to investigate the Korean medicine doctor's perception of the extension and activation of herbal medicine preparations insurance benefits. Methods : The sample of Korean medicine doctors' panel pool which is extracted by examining the square root quota of city location of Korean medicine clinics was used. In case of a vacancy in some participants, the number of Korean medicine doctors were supplemented and placed for investigation. Results : It has 54.0% awareness of the separation of prescribing and dispensing herbal preparations, 87.0% agreed on the need to be insured, but the separation as a necessary condition for being insured was only 60.3% agreed. When a large number of herbal preparations are being insured, it was expected that 30% to 50% of patients(30.3%) will be prescribed herbal preparations and the number of new patients will increase by 5 to 15 for the purpose of prescriptions only(49.3%). Increase amount of medical expense(?3,000) as a result of the separation of prescribing and dispensing herbal preparations are insufficient(54.3%). Conclusions : From the results of this study, extension of national health insurance to cover herbal preparations must be needed to activate herbal medicine preparations and improve Korean medical services.

• Journal of The Korean Society of Clinical Toxicology
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• v.6 no.2
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• pp.110-116
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• 2008

Purpose: Acute toxic hepatitis is a common cause of acute liver failure (ALF). We investigated the causes, clinical manifestation, and outcomes of ALF patients who underwent liver transplantation due to acute toxic hepatitis caused by herbal medicines and preparations. Methods: Between January 1992 and May 2008, we retrospectively reviewed the medical records of 24 patients who were transplanted due to acute toxic hepatitis caused by herbal medicines and preparations. We applied the RUCAM score to patients with acute toxic hepatitis and assessed the relationship between herbal preparations and liver injury. We studied the patients' medication history, liver function tests, and clinical outcomes. Results: The type of liver injury was divided into three groups: hepatocellular type, 14 patients (58.3%); cholestatic type, 4 patients (16.7%); and mixed type, 6 patients (25%). Polygonum multiflorum Thunberg (3 cases) was the most common cause of acute toxic hepatitis, followed by Acanthopanax senticosus (2 cases), pumpkin juice (2 cases), Dictamnus dasycarpus Turcz (2 cases), Hovenia dulcis (1 case), Phellinus linteus (1 case), and Artemisia capillaries (1 case). One year survival after liver transplantation was 76%. Conclusion: We identified the herbal preparations leading to acute liver failure. Many patients consider herbal remedies to be completely free of unwanted side effects. However, we found that many herbal products have biological activities that can lead to severe hepatotoxicity.

• Journal of Dental Anesthesia and Pain Medicine
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• v.22 no.6
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• pp.419-426
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• 2022

Topical anesthetics are routinely used in dental practice for various purposes. They are usually available at higher dosages and have serious potential adverse reactions, such as seizures, anaphylaxis, and acquired methemoglobinemia. To date, the scope of application of herbal plants and their extracts, which have medicinal properties, has been elaborated in the field of dentistry. The growing interest in herbal medication can be attributed to the increased safety profile of herbal agents, in contrast to synthetic preparations that have a higher risk of systemic complications. Herbal preparations can induce topical anesthesia with minimal side effects. Recently, many studies have reported the use of topical herbal preparations. The current review aimed to evaluate data from various articles comparing the capacity of herbal topical anesthetic formulations and conventional synthetic anesthetics in reducing pain perception when used as local anesthesia before dental procedures.