• The Journal of Korean Medicine
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• v.27 no.1 s.65
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• pp.78-90
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• 2006

Background : Traditional herbal medicine is used extensively among the Korean populations, and other Asian countries employ similar therapies as well. In recent years, extensive focus was laid on adulteration of the herbal medicine with liver damage. 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 health food. However, studies on the safety of herbal products are 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. Objectives : This study aims to verify the evidences on safety of frequently used 4 herbal medications (Sipjeondaebo-tang, Bojungikgi-tang, Ohjeok-San, Yukmaijihwang-tang) in the lab animal model. Methods : Sprague-Dawley rats was treated by 4 herbal medications during 31 days. After 1 month, we checked body weight, liver weight, and serum enzyme associated with liver function. Results : There is no significant difference in body weight and liver weight after 1 month of administrations. In all experimental groups, no abnormal findings was observed in histotogical research and lab liver Functions test(AST, ALT etc). Conclusions : These four herbal medications, frequently used in oriental medicine clinics and hospitals, are safe from hepatoxic events in the lab animal model.

• The Journal of Internal Korean Medicine
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• v.35 no.2
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• pp.111-118
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• 2014

Drugs may cause adverse effects, and spontaneous adverse drug reaction (ADR) reports have been used as the main method of drug safety evaluation after drugs have been released. The World Health Organization (WHO) collects ADR data reported from pharmacovigilance organizations in each nations. In China, pharmacovigilance centers operate with hierarchical structure at local, provincial and national levels. Also, Japan and Korea each operate their own respective independent pharmacovigilance organizations. WHO is collecting ADR reports for herbal medicine and 15~20% of all ADRs was related to herbal medicine in China. There are status reports of ADRs for herbal medicine in Japan as well. However, in Korea, there is no ADR reporting system regarding herbal medicine. In light of these overseas cases, a spontaneous ADR reporting system for herbal medicine in Korea should be necessary as well.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.33-44
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• 2015

Objectives: The aim of this study was to understand the characteristics of herbal-drug-associated adverse events (AEs) reported in the internet newspaper articles and to take a countermeasure against the safety issue of herbal drugs. Methods: We searched the internet newspaper articles published from 2010 to 2014 in the 3 major portal sites in Korea, NAVER, DAUM, and GOOGLE. Search terms were the Korean words equivalent of 'herbal drug' and 'side effects'. Informations on the type and characteristics of suspected herbal drugs, AEs, and the patient records were extracted from the articles reporting the herbal-drug-associated AE occurred in Korea. Results: From 8,806 articles, a total of 36 AEs were found. The most frequently reported age group was 20s, and women outnumbered men. Obesity was the most common cause of administration. Doctors of Korean medicine clinic were the most commonly referred prescribers and purchasing route (11 cases). The most frequently mentioned medicinal herb was Ephedra sinica (7 cases) and the most commonly reported AEs were abdominal pain (8 cases), dizziness (6 cases), diarrhea (5 cases), and vomiting (5 cases) were followed in order. Ten cases were judged as serious AEs, and the others were not. Conclusions: Current customers demand health care providers to offer them sufficient information on the safety of herbal drugs. To satisfy their requirements, physicians of Korean medicine should be able to explain, predict, prepare, recognize, and deal with the herbal-drug-associated AEs. We propose an establishment of pharmacovigilance system for herbal medicine, in which doctors of Korean medicine are participated as important personnel, to collect and analyze the related AEs and offer credible information on the safety of herbal drug.

• Herbal Formula Science
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• v.21 no.1
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• pp.111-118
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• 2013

Objectives : Traditional medicine Oryeong-san (ORS) has been prescribed for a long time to treat light fever, thirst, dysuria, and accompanying edema. However, the acute toxicity and safety were not reported. In this study, we evaluated the potent acute toxicity and safety of ORS. Methods : ICR mice were used to evaluate acute toxicity and safety by oral administration of 0, 500, 1,000, 2,000mg/kg of ORS. Mortality, body weight, and clinical symptoms were observed, and organ weight and blood biochemical parameters were analyzed after necropsy. Results : We found no mortality and no toxic or abnormal clinical symptoms by administration of ORS. Comparing with control group, no significant alterations in organ weight and blood biochemical parameters were observed. Conclusions : ORS recognized as safe and non-toxic medicinal material, and median lethal dose considered to be over 2,000 mg/kg in both male and female ICR mice.

• Natural Product Sciences
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• v.22 no.3
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• pp.162-167
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• 2016

Peucedani Radix is the root of Angelica decursiva Franchet et Savatier (=Peucedanum decursivum Maximowicz) or Peucedanum praeruptorum Dunn in several Asian countries. The coumarins contained in Peucedani Radix were quantitatively analyzed using HPLC-DAD to develop a simultaneous determination for the quality control of A. decursiva and P. praeruptorum. For quantitative analysis, four major coumarins contained in these medicinal plants were assessed. Nodakenin (1), nodakenetin (2), praeruptorin A (3), and praeruptorin B (4) were separated with a Phenomenex Luna C18 column ($5{\mu}m$, $4.6{\times}250mm$) under the gradient conditions using distilled water with 0.1% phosphoric acid and acetonitrile with 0.1% phosphoric acid as the mobile phase, at a flow rate of 1.0 ml/min and a detection wavelength of 330 nm. This method was fully validated for linearity, accuracy, precision, recovery, and limit of detection and quantification. As a result, A. decursiva and P. praeruptorum were clearly classified by the quantification of four major coumarins in extracts. Also, the pattern recognition analysis based on HPLC indicates that all of the samples were largely clustered into two groups. Therefore, it is possible to distinguish between A. decursiva and P. praeruptorum and contribute to quality control.

• The Korea Journal of Herbology
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• v.27 no.2
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• pp.25-29
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• 2012

Objectives : This article reviews a solution preventing the illegal distribution of herbal medicine in common use for food and medicine and risks on public health by conducting safety management of food and medicine. Also, this article would like to contribute to improvement of public health treating diseases in compliance with accurate diagnosis and prescription of Oriental Medicine Doctor("OMD")'s. Methods : An approach in this research can be categorized into two : first, to examine the current administrative situation and problems of herbal medicine in common use for food and medicine based on policy documents of Ministry of Health and Welfare and Korea Food and Drug Adminstration("KFDA") and academic articles of the herbal medicine;second, to find reasonable administrative solutions to solve the problems. Solutions : A solution is to strengthen the management level of herbal medicine in common use for food and medicine by selecting 117 items as target items requiring concentrated management. In case herbal medicine is imported for food, KFDA strengthens the quality management level of herbal medicine by making use of inspection frequency at random, collecting and verifying herbal medicine on the market. However, KFDA decides to maintain current different quality specification system of food and medicine reflecting a civil complaint that quality specification of food and medicine should separately managed according to the purpose of use. Herbal medicine as medicine that is functioned as treating diseases and alleviating symptoms, unlike herbal medicine for food, can cure all kinds of diseases by recovering inner balance of human body, making use of other properties of herbal medicine. Medicine has its own properties. If a doctor uses properties of medicine appropriately, he cures diseases. If a doctor uses herbal medicine inappropriately. he may damage human body. Thus, whether side effects of medicine depend on a doctor who uses herbal medicine. Conclusions : All herbal medicine will be supplied into the market after strict safety control of manufacturers of herbal medicine according to the revised Pharmaceutical Affairs Act, beginning in April, 2012. Thus, people can take safer and more reliable herbal medicine through strengthening safety management of herbal medicine and improving quality and transparency in the distribution system. Herbal medicine should appropriately be prescribed by licensed OMD because herbal medicine is used to treat diseases and alleviate symptoms, unlike herbal medicine for food.

• Journal of Physiology & Pathology in Korean Medicine
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• v.22 no.6
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• pp.1390-1396
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• 2008

The aim of this study is to analyze literatures researching changes of liver function parameters after administration of herbal medicine and the safety of herbal medicine on hepato-biliary system. Eight Korean databases were searched for researches on the safety of oriental herbal medicine. According to inclusion criteria, nineteen studies were selected and analyzed. As a result, seventy outcomes in five parameters(aspartate transaminase, alanine transaminase, gamma(${\gamma}$)-glutamyl transferase, alkaline Phosphatase, total bilirubin) were obtained. After administration, parameters decreased or sustained in fifty seven outcomes. In thirteen outcomes, parameters slightly increased. In two outcomes, parameters increased but not severely. The change of liver function parameters after administration of herbal medicine is expected to be harmless. But it requires additional large scale studies and modification in method to corroborate the safety of herbal medicine.

• The Journal of Korean Obstetrics and Gynecology
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• v.18 no.3
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• pp.127-138
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• 2005

Purpose : This study was designed to establish safety and efficacy of using herbal medicine in pregnancy and to investigate patient's treatment satisfaction. Methods : We investigated general pregnancy outcomes of twenty-five gynecological outpatients who visited Dongguk univ. Kangnam Oriental Hospital, from July 1, 2002 through December 31, 2004 and have taken herbal medicine in pregnancy. Additionally we investigated newborn's growth status and patient's treatment satisfaction. Results : The rate of normal delivery of patients used herbal medicine for diseases that possibility of abortion is not high was 100% and there was no malformation in normally delivered 21 cases. Most of Newborn's growth status was normal and the average score of patient's satisfaction was 3.5(absolutely satisfied=5). Conclusion : The results of this study show safety and efficacy of using herbal medicine in pregnancy. And In the future, It is thought that more exactly constructed clinical survey need to be carried out.

• The Journal of Korean Medicine
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• v.28 no.2 s.70
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• pp.93-113
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• 2007

Objective : To research Trends of studies about anti-inflammation and pain relief, obesity, and safety of herbal acupuncture therapy by analyzing domestic theses, published since 2001, about herbal acupuncture therapy. Methods : Domestic theses, published since 2001, mentioning anti-inflammation or pain relief, obesity, or safety of herbal acupuncture therapy were reviewed and analyzed. These theses were then classified by university, year, and subject. Results : The following results were obtained in this study. 1. Among published theses related to anti-inflammation effects of herbal-acupuncture, studies about arthritis comprised the most part, 52. In theses relating to causes of arthritis, 16 were about adjuvant, which was the most, followed by Type II collagen, LPS and carrageenan. Blood test, reactions of inflammation and revelation of cytokine and immune cellswere methods for evaluating anti-inflammation effect. The tendency of experimental methods was to focus on molecular biologic method. 2. In theses related to pain relief, many clinical attempts with herbal injection were carried out, and Carthami Flos and Scolopendrawere used most. Observing reduction of pain inducing factor and checking behavioral change were methods for evaluating pain relief. 3. In theses related to obesity, research focused on effects in association with spots on the body suitable for acupuncture. There were also attempts comparing effectiveness between single injections and complex injections. Astraball Radix, Angelica Gigantis Radix, Coicis Semen and Taeumjowetang were used. Evaluation of anti-obesity effects were by weight loss, food efficiency, blood lipid profile and evaluation of liver function. 4. In theses related to safety of herbal-acupuncture, Herba Chelidonii Chaenonelis Fructus, Clematis Florida Thunb, Corydalidis Tuber, Paeoniae Radix, and Carthami Flos which marked 2 theses each were most studied. Methods of evaluating safety were mostly by observing liver and kidney functions based on blood test, and by applying herbal injections to clinical treatment. Conclusion : Herbal acupuncture is being used in various ways associating with its anti-inflammation, pain relief and anti-obesity effect. Studies on efficacy and mechanism of herbal acupuncture are being conducted even at the molecular biology level.

• Journal of Society of Preventive Korean Medicine
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• v.17 no.1
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• pp.117-124
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• 2013

Objectives : This study was carried out to investigate the acute toxicity and safety of Palmultang and Fermented Palmultang Extract in Mice. Methods : To evaluate their acute toxicity and safety, 0 (control group), 2000 mg/kg of Palmultang and Fermented Palmultang Extracts were orally administered to 15 male and 15 female ICR mice. After a single administration, we observed survival rates, behavioral pattern, clinical sign, body weight. The results of biochemical analysis and hematological analysis were no any significant change. Results : Compared with the control group, we could not find any toxic alteration in all treated mice. Conclusions : Overall, the results suggest that, the oral administration of Palmultang and Fermented Palmultang extracts did not produce significant toxic effect in mice. Hence, the fermented extract can be utilized for herbal therapy.