• Analytical Science and Technology
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• v.34 no.4
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• pp.160-171
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• 2021

Synthetic azo dyes are used extensively in herbal medicines to render the medicines more visually attractive to consumers. This study developed and validated a rapid high-performance liquid chromatography (HPLC) method to determine whether synthetic colorants such as Tartrazine, Auramine O, Metanil yellow, Sunset yellow, and Orange II are used extensively in Typha orientalis. To increase the recovery of the synthetic dyes, this method employed containing 50 mM ammonium acetate in 70 % methanol at first extraction and 100 mM HCl in 70 % methanol at second extraction. Five synthetic pigments in Typha orientalis were separated by gradient elution with a mobile phase consisting of acetonitrile and 50 mM ammonium acetate in distilled water at ultra-violet (UV) detection 428 nm or 500 nm. Additionally, this study established the liquid chromatography tandem mass spectrometry (LC-MS/MS) method to confirm positive samples suspected by HPLC results. The HPLC-UV method had good linearity, indicating r²> 0.999. The recoveries of the samples spiked with three different concentration ranged from 73.8~91.5 %, and relative standard deviation values indicated 0.2~5.2 %. The established LC-MS/MS could successfully identify the synthetic pigments in herbal medicine samples. The study demonstrates that Typha orientalis adulterated by yellowish synthetic dyes can be successfully distinguished when using the HPLC-UV method.

• Journal of Society of Preventive Korean Medicine
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• v.12 no.3
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• pp.9-20
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• 2008

The purpose of this study is to investigate the actual conditions of herbal medicine products for the establishment of drug utilization review system. To accomplish of the purpose, we investigated medical treatment pay of insurance and consumption of herbal medicine products in pharmacy at jeollabuk-do, two oriental hospital etc. To gain valid and reliable the actual conditions of herbal medicine products, it needed close relationship with oriental hospital, society for manufacture of herbal medicines etc and further study classify herbal medicines by Korean Medicine.

• Korean Journal of Pharmacognosy
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• v.38 no.3 s.150
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• pp.205-216
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• 2007

South Korea is the representative consumption country of herbal medicines and most of herbal medicines circulating in Korea have been importing from the developing countries of Southeast Asia such as China, Vietnam, Indonesia and so forth. Domestic hygiene and safety are continuously proposed because herbal medicines which are circulating have the possibility could remain contaminants or residues. Physicochemical contaminants such as heavy metals, persistent organic pollutants, radionucleosides, microbial toxins, biological contaminants such as microorganisms and animals, agrochemical residues such as pesticides, substances used for fumigation, antiviral agents, and solvent residues are classified as major contaminants and residues in herbal medicines from 2005 September WHO.$^{1)}$ Currently our administration have established a permission standard and the inspection criteria against the heavy metal, the residual pesticides and a residual sulfur dioxide. Furthermore our administration is continuously monitoring and conducting researches for the policies and their scientific ground against herbal medicines. But the appearances or discoveries of the harmful new species due to environmental and industrial developments are becoming social problems. Therefore it may be necessary to continuously consider and investigate regarding hereupon. Recently, the contamination of the mycotoxins against foods such as cereals, nuts and the powdered red pepper have developed and started became problematic issue, and possibility of contamination against the herbal medicine is proposed. And since populations who are using the herbal medicines very limited to several nations, recognition and researches about contamination of mycotoxins in herbal medicines are very insufficient. Therefore it will be need to more focus on the international regulation of quality control and safety for herbal medicines. Now on, we are going to introduce the importance, occurrence, characteristic properties, World-wide research trends and detoxification of aflatoxins, which is known as the most potent mutagen, carcinogen and teratogen mycotoxins.

• 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.

• 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.

• 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.

• The Journal of Internal Korean Medicine
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• v.33 no.4
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• pp.485-497
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• 2012

Objectives : The aim of this study was to systematically investigate herbal-drug-associated adverse drug reactions (herbal ADRs) reports submitted by a single oriental hospital and to analyze the general characteristics, causative agents, clinical manifestations, severity and types of herbal medicines which caused herbal ADRs. Methods : This study proceeded with IRB approval. The data on herbal ADR were collected prospectively from January 2008 to February 2012 by EMR of Dongguk University Ilsan Oriental Hospital. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to determinate causality for each herbal ADR. WHO-Adverse Reaction Terminology (WHO-ART) System Organ Class (SOC) code and WHO severity category were also used in this study. Results : A total of twenty eight cases were reported. Twenty two cases were assessed to have over possible relations with herbal medication. The gender ratio of these cases were 64.6 percent female and 36.4 percent male, demonstrating no statistical significance. Patients aged over 60 were 59.1%. Gastro-intestinal system was reported to be the most frequently affected organ (38.8%), and followed by psychiatric system (22.4%), and integumentary system (22.4%). The most common clinical symptom was headache (12.2%), followed by diarrhea (10.2%), and pruritus (10.2%). The severity of most cases was assessed to be mild (89.8%). The percentage of moderate ones was 10.2%, and there were no severe cases. Conclusions : Progressive study and further analysis on herbal ADRs are warranted for safety in the clinical use of herbal medicines.

• Korean Journal of Pharmacognosy
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• v.44 no.2
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• pp.168-175
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• 2013

Aldose reductase (AR) plays a central role in the development of the diabetic complications. Eighty one Korean herbal medicines have been investigated for inhibitory activities on AR. Among them, fourteen herbal medicines exhibited a significant inhibitory activity compared with 3,3-tetramethyleneglutaric acid (TMG) as positive control. Particularly, Xanthium strumarium (fruit, whole plant), Ilex cornuta (stem and leaf), Vitex rotundifolia(stem), Sophora flavescens (whole plant), Platycarya stobilacea (flower) showed two times more potent inhibitory activity than 3,3-tetramethyleneglutaric acid (TMG).

• Korean Journal of Pharmacognosy
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• v.45 no.4
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• pp.354-358
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• 2014

Aldose reductase (AR) has been demonstrated to play important role in the development of the diabetic complications such as diabetic retinopathy, diabetic neuropathy and diabetic nephropathy. To discover novel treatments for diabetic complications from natural sources, 69 Korean herbal medicines have been investigated for inhibitory activities on AR. Among them, 7 herbal medicines, Eleutherococcus sessiliflorus (stems), Artemisia japonica (whole plants), Wisteria floribunda (leaves), Eurya japonica (stems, twigs and leaves, leaves), Ampelopsis brevipedunculata (stems) exhibited a significant inhibitory activity compared with 3,3-tetramethyleneglutaric acid as positive control.

• Korean Journal of Pharmacognosy
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• v.45 no.4
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• pp.359-365
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• 2014

Aldose reductase (AR) is the key enzyme of the polyol pathway in the development of the diabetic complications. Sixty seven Chinese herbal medicines have been investigated for inhibitory activities on AR. Among them, 7 herbal medicines, Buddleja crispa (twigs and leaves), Taiwania flousiana (twigs and leaves), Sloanea hemsleyana (fruits), Euphorbia nemetocypha (whole plants), Photinia glomerata (twigs and leaves), Vitex yunnanensis (twigs and leaves) exhibited a significant inhibitory activity against AR. Particularly, S. hemsleyana and V. yunnanensis showed 1.2-4.5 times more potent inhibitory activity than the positive control, 3,3-tetramethyleneglutaric acid (TMG).