• 대한예방한의학회지
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• 제18권1호
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• pp.23-41
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• 2014

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.

• 대한한의학회지
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• 제26권2호
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• pp.152-165
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• 2005

Background: The use of herbal preparations as remedies for various medical conditions has continuously increased in Korea Large proportions of Korean patients use herbal medicinal products, folk remedies, and food supplements. However, studies on the safety of herbal products arc conducted on a less than sufficient basis even in the countries like Korea where herbal medicine is being used extensively. Some of the reports on the safety of herbs were done by the doctors of western medicine but lack of knowledge and misclassification led to misunderstandings. Objecitves: This study aims to review the recent evidences on hepatotoxic events associated with the use of herbal medicinal products, folk remedy, and food supplements. In the process, this review will grasp trends in this field of studies and will direct further researches into the right direction. Methods: Systematic literature searches were performed on MedRic and MEDLIS in Korea. Screening and selection of the articles and the extraction of data were performed independently by two of authors. There were no restrictions regarding the published date. In order to avoid bias, the articles written by medical doctors, not by oriental doctors were selected. 43 journals were chosen for the review. Results: Analyzing the number of journals, studies on the drug-induced liver injury were increased after the year 2000. The proportion of herbal and folk remedy associated hepatotoxic injuries in all drug-induced liver injury was $21.0\%-30.0\%$. But criterion for herbal medicine is rather vague and limited objective data hindered objectiveness. Few of single medicinal herbs and combination preparations were associated with hepatotoxic injuries. But because of lack of objectivity, further researches must be conducted to yield more concrete results. Conclusions: yield more concrete results. Incidence figures are largely unknown, and in most cases a causal attribution is not established. The challenge for the future is to systematically research this area, educate all parties involved, and minimize patient risks.

• 동의생리병리학회지
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• 제37권6호
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• pp.185-192
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• 2023

The purpose of this study is to analyze trends in domestic and international clinical research studies on pharmacopuncture treatment for fractures. We searched five online databases (PubMed, CNKI, RISS, KISS, and OASIS), and selected a total of 13 clinical research studies from Korea and China. Selected studies were analyzed according to publication year, subject, intervention, treatment method, evaluation scale, adverse event, risk of bias, etc. A total of 10 case studies and 3 randomized controlled trials were included. The study subjects were more often female, and the most common type of fracture was vertebral compression fracture. In Korea, herbal medicine preparations and bee venom were used for pharmacopuncture solution, whereas in China, both herbal medicine preparations and Western medicine preparations were used. All studies commonly used local acupoint needling, and in most cases, the treatment period for case study was less than 1 month, and the observation period of randomized controlled trials was diverse. The most frequently used evaluation scale was numeric rating scale, adverse events were mentioned in only three studies, and no adverse events were reported. Overall risk of bias of all included randomized controlled trials was judged "some concerns". According to this study, pharmacopuncture treatment for fractures was found to be relatively effective and safe, but research that complements the limitations of this study is needed.

• 대한한의학방제학회지
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• 제25권3호
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• pp.375-390
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• 2017

Objectives : In order to increase the utilization rate of insurance covered herbal medicines, it is necessary to improve the standard prescription lists of current national health insurance service. Methods : Previous research and discussions have been summarized, the cases of overseas insurance prescription were investigated, and compared with the insurance prescription of Korea. We conducted two questionnaire surveys. From the first email questionnaire survey, response rate was very low. So once again, from december 4, 2014 to december 17, we emailed a questionnaire survey to 17,275 members of the Korean medicine doctors and 890 peoples(5.1%) responded for two weeks. We analyzed prescriptions from previous studies, overseas cases, and surveys. Results : With overseas herbal medicine health insurance lists, prescriptions recommended by the experts committee, the prescriptions results of the first and second surveys, and the prescriptions presented in previous studies, we compared and analyzed all the results and we derived 202 prescriptions for NHIS. Conclusion: We suggest 127 Single extracts and 202 prescriptions to be added for NHI.

• 대한본초학회지
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• 제31권3호
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• pp.29-35
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• 2016

Objectives : Ijung-tang (IJT) is a traditional herbal formula and has been used to treat digestive diseases such as abdominal pain, vomiting, and diarrhea. IJT consists of four herbal medicines, Ginseng radix, Atractylodis rhizoma alba, Zingiberis rhizoma, and Glycyrrhizae radix et rhizoma, containing various bioactive compounds. Quality assesment of IJT preparations was performed by analytical method for determining marker compounds.Methods : Determination of seven marker compounds in IJT preparations was quantitatively conducted by high-performance liquid chromatography equipped with a diode-array detector. The marker compounds were separated on a reversed-phase C18 column and the analytical method was successfully validated. Chemometric analysis was performed to compare IJT water extracts and commercial IJT granules.Results : Limit of detection and limit of quantification values were in the ranges of 0.093-2.649 μg/mL and 0.283-8.027 μg/mL, respectively. Precisions were 0.30-3.87% within a day and 0.23-2.35% over three consecutive days. Recoveries of the marker compounds ranged from 87.35-107.05%, with relative standard deviation (RSD) values < 6.15%. Repeatabilities were < 1.20% and < 1.71% of RSD value for retention time and absolute peak area, respectively. The results from quantitative analysis showed that the quantities of seven marker compounds of IJT samples varied, as were found in principal component analysis and hierarchical clustering analysis.Conclusions : The analytical method developed in the present study was precise and reliable to simultaneously determine marker compounds of IJT. Therefore, it can be used for the quality assessment of IJT preparations.

• 대한한의학방제학회지
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• 제18권1호
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• pp.43-56
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• 2010

Objective : There is a growing need to expand or adjust insurance coverage of herbal prescriptions in National Health Insurance. The purpose of this study was to provide basic data for expansions or adjustments of 56 herbal prescriptions in the National Health Insurance. Method : We surveyed lists of 56 insurance-covered herbal prescriptions, non-covered company-produced herbal medicines and self-prepared herbal medicines in 531 traditional korean medical clinics by mail from 6/1/2008 to 12/9/2008. Result : Among the 56 Prescriptions, Ojeok-san was stocked in 66.7% of clinics (1st), Samso-eum ranked 2nd, Socheongnyong-tang ranked 3rd, Gumiganghwal-tang was 4th, Hyangsapyeongwi-san ranked 5th. Among the non-covered company-produced herbal medicines, Danggwisu-san ranked 1st, Gwakyangjeonggi-san ranked 2nd, Oryeong-san was 3rd, Bangpungtongseong-san was 4th, Maengmundong-tang ranked 5th. Among the self-prepared herbal medicines, Gongjin-dan ranked 1st, Soche-hwan was 2nd, Gyejibongnyeong-hwan was 3rd, Yeongsin-hwan was 4th, Palmi-hwan ranked 5th. Conclusions : It is reasonable to select frequently used company-produced or self-prepared herbal prescriptions in this stock rate survey for improvement of National Health Insurance coverage.

• Toxicological Research
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• 제21권3호
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• pp.255-261
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• 2005

Gami-Samhwang-San, a herbal prescription for obesity treatment, is composed of seven crude herbs such as Rehmanniae Radix Preparata, Ephedrae Herba, Scutellariae Radix, Acori Gramineri Rhizoma, Polygalae Radix, Typhae Pollen, Armeniacae Semen, Menthae Herba. In this study, marker substances in n-butanol fraction (SH-21-B) from Gami-Samhwang-San were analyzed by high performance liquid chromatography (HPLC) and acute toxicity of standardized SH-21-B was evaluated by good laboratory practices (GLP) guideline of Korea Food and Drug Administration. Therefore we confirmed that there were baicalin of 15.92%, amygdalin of 6.57% and ephedrine of 2.49% in SH-21-B. SH-21-B was administered in rats at dose of 0 mg/kg, 2,000 mg/kg, and 5,000mg/kg. Clinical signs of both sexes of rats were observed daily for 14 days after single oral administration. Two female rats one administered at 2,000 mg/kg and the other administered at 5,000 mg/kg, died, but no dead animal was observed among male rats. Therefore $LD_{50}$ in the female rat is observed to be 8,710 mg/kg, and MLD (Minimun Lethal Dose) of the male rat is observed to be more than 5,000 mg/kg.

• 한국한의학연구원논문집
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• 제1권1호
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• pp.441-459
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• 1995

To study stability of distilled herbal medicine, we chose changes in UV spectrum, pH, conductivity, and HPLC chromatogram. Aconiti Lateralis preparata Radix and Scutellariae Radix were selected and studied. There ws no consistancy in UV spectrums of preparatons and in duration. The changes in pH and conductivity were not correlated to those in UV spectrums. HPLC chromatograms were also compared each other depending on the preparations. One interesting peak of distilled Aconiti solution was appeared at 40 min retention time which was not identified yet. Ingeneral, UV spectrum, pH, conductivity measurements are pretty poor tool to study stability of herbal medicine although HPLC analysis should be studied further.

• 분석과학
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• 제24권2호
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• pp.127-134
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• 2011

본 연구에서는 기존 대한약전외 일반시험법 중 파라옥시안식향산에스텔 및 그 염류의 함량시험법의 이동상의 조성을 acetonitrile water (containing 1% glacial acetic acid) mixture (30:70 v/v)로 변화시켜 첨가제로 사용된 보존제성분과 제품에서 기인하는 방해물질과의 완전한 분리를 통하여 액상한약제제 분석의 효율성을 기하였다. 유통되고 있는 한약제제 중 액상제품 총 47품목을 대상으로 안식향산나트륨, 디히드로 초산나트륨, 파라옥시안식향산메칠, 파라옥시안식향산에칠, 파라옥시안식향산프로필 등 5종의 함량을 모니터링 하였다. 그 결과 액상한약제제 37품목 중 보존제가 표시된 31품목은 보존제가 표시된 함량에 맞게 함유되어 있었다. 안식향산과 디히드로초산이 함유된 7품목 중 6품목은 디히드로초산이 표시량에 비해 낮게 검출되었거나 검출되지 않았다. 보존제가 미표시된 10품목 중 3품목에서 보존제가 검출되었다. 3건 모두 안식향산이 검출되었고 그 중 2건에서 디히드로초산이 검출되었으며 1건에서 메틸파라벤이 검출되었다.

• Journal of Pharmaceutical Investigation
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• 제36권4호
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• pp.253-262
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• 2006

This study was performed to investigate the effects of treatment for dermatitis using the herbal gel preparations. Scutellariae Radix(SR) and Zingiberis Rhizoma(ZR) were used for the purpose of herbal preparations. Baicalin, baicalein are the ingredients of SR, having biological effects like anti-inflammatory, anti-oxidative, anti-bacterial and antiallergic action. 6-Gingerol is one of the ingredients of ZR having biologicai effects like anti-inflammatory and analgesic action. The three types of hydrogels(SRE, SRH, SZH) were formulated with Carbopol 940, Labrasol, Triethanolamine etc. Baicalin was hydrolysed to baicalein by $\beta$-glucuronidase for the purpose to increase rate of skin permeation. Content of ingredients by HPLC determination, rate of skin permeation using Franz type diffusion cell, anti-oxidative activity for the free radical, hydroxyl radical, superoxide, anti-inflammatory by using carrageenan injection, efficacy on the dermatitis induced by 2,4-dinitro-chlorobenzene(DNCB) were experimented. Baicalein showed higher permeability than baicalin, so it is considered that baicalein was more suitable form than baicalin for transdermal absorption by its lipophilic property. In the anti-oxidative experiments, SZH gel was the most effective scavenging activity than the other gels in all experiments. In anti-inflammatory test, SRM and SZH gel more decreased edma rapidly than SRE gel. In case of using SZH gel, treatment period for the dermatitis was more declined than that of other gel groups. These results suggests that the SZH hydrogel could be suitable preparations for the treatment of dermatitis.