• 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.28 no.1 s.69
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• pp.1-10
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• 2007

Background : There has been renewed interest in complementary alternative medicine around the world far a decade. On the other hand, the issue of safety of herbal medicine in Korea has been continuously questioned. Issues raised have included not only chemical residue or heavy metals caused by pollution, but also the toxicity of herbal medicine itself. Objectives : The purpose of this study was to review some herbal medicines subject to controversy of toxicity and figure out what kind of problems they evidence. Methods : In this review, PubMed was used to search medical journals. Keywords such as 'herb, or herbal medicine', 'safety, or adverse events, or adverse effect, or toxicity, or liver injury' were applied. Journals were selected by four inclusion criteria, as objectives should be human, researchers should be medical doctors, literature written in the English language, and types of journals should be meta-analysis or practice guideline or reviews. Finally, 9 cases from 60 journals were included in this review. Results : We reviewed 13 herbal medicines for controversy of toxicity such as ephedra(Mahuang), Arisolochia fangchi, Aristolochia manshuriensis, licorice, skullcap , germander, Syo-saiko-to(Xiao-chai-hu-tang), Chelidonium majus, mistletoe, Dictamnus dasycarpus and madder. Conclusions : It suggested that 'who it is prescribed for' is one of the most important factors to identify the causes of toxicity in herbal medicine and dietary supplements, under specific conditions in Korea.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.35 no.3
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• pp.48-65
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• 2022

Objectives : This study was conducted to find out the effectiveness and safety of herbal medicine eye drops on conjunctivitis. Methods : We searched randomized controlled trials on conjunctivitis through 10 DBs from the start to April 27, 2022. Study collection and data extraction, and evaluation of risk of bias were conducted by two independent researchers. The evaluation of the risk of bias in included RCTs was carried out by using Cochrane risk-of-bias tool. And the data synthesis was conducted by using Review Manager(RevMan, ver.5.4). Results : Total of 106 studies are researched and 7 studies of them are finally included. 1. The herbal medicine eye drops are more effective on than the western medicine eye drops, but the heterogeneity was very high. So we conducted sensitivity analysis and compared to the herbal medicine eye drops and the western medicine eye drops, the total effective rate was higher in the herbal medicine eye drops and the heterogeneity was somewhat reduced. 2. In the subgroup analysis, Fufang Xiongdan eye drops and Houttuynia cordata Thunb eye drops are more effective than the western medicine. It may represent substantial heterogeneity. 3. In the subgroup analysis, the herbal medicine eye drops are more effective than antibiotic and antiviral eye drops on acute bacterial conjunctivitis, but showed high heterogeneity. On the other hand, the herbal medicine eye drops are more effective than antibiotic and antiviral eyed drops on acute viral conjuctivitis and showed low heterogeneity. 4. In the subgroup analysis, we compared the effectiveness of herbal and western medicine eye drops according to total effectiveness rate evaluation methods. When comparing the studies calculating the total effective rate by the sum of 'Cured', 'Significantly Impaired', and 'Improved', the effective rate of the herbal medicine eye drops was higher than that of the western medicine eye drops, and the heterogeneity was very low. 5. In most studies, side effects of herbal medicine eye drops were absent or mild. Conclusions : This study shows that herbal medicine eye drops may be more effective than western medicine eye drops and have safety. But further researches are needed to resolve the heterogeneity of this study.

• Korean Journal of Oriental Medicine
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• v.15 no.1
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• pp.79-83
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• 2009

In this study, we investigated the single dose toxicity and safety about water-extracted Galgeuntang. To evaluate single dose toxicity, 20 male and 20 female ICR mice were observed survival rates, general toxicity, changes of body weight for 14 days after single oral administration of 0 (control group), 1250, 2500 and 5000mg/kg Galgeuntang. And after 14 day, We observed autopsy. Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). LD50 of Galgeuntang might be over 5000mg/kg and it is very safe to ICR mice.

• The Korea Journal of Herbology
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• v.36 no.1
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• pp.9-17
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• 2021

Objectives : Tetrapanacis Medulla and Akebiae Caulis are one of the most frequently adulterated herbal medicines because of their confusability of terms in the ancient writings and the similarity of morphological features of dried herbal products. The major adulterant is Aristolochia manshuriensis (Guanmutong) which has a serious safety concern with its toxicity. To ensure the safety and quality of the two herbal medicines, it is necessary to discriminate the toxic adulterant from authentic species. The aim of this study is to develop SCAR markers and to establish the multiplex-SCAR assay for discrimination of four plant species related to Tetrapanacis Medulla and Akebiae Caulis. Methods : ITS regions of fifteen samples of four species (Tetrapanax papyrifer, Fatsia japonica, Aristolochia manshuriensis, and Akebia quinata) collected from different sites were amplified and sequenced. Fifteen obtained ITS sequences were aligned and analysed for the detection of species-specific sequence variations. The SCAR markers were designed based on the sequence alignments and then, multiplex-SCAR assay enhancing rapidity was optimized. Results : ITS sequences clearly distinguished the four species at the species level. The developed SCAR markers and multiplex-SCAR assay were successfully discriminated four species and detected the adulteration of commercial product samples by comparison of the amplified DNA fragment sizes. Conclusions : These SCAR markers and multiplex-SCAR assay are a rapid, simple, and reliable method to identify the authentic Tetrapanacis Medulla and Akebiae Caulis from adulterants. These genetic tools will be useful to ensure the safety and to standardize the quality of the two herbal medicines.

• Journal of Environmental Health Sciences
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• v.41 no.1
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• pp.30-39
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• 2015

Objectives: This study was conducted to determine the heavy metal contents in commercial herbal medicines in Korea. Methods: Monitoring of lead, arsenic, cadmium and mercury was carried out on 116 samples of eleven types of herbal medicines. Among the total samples, 71 samples were domestic and 45 were imported. The samples were digested using the microwave method. The heavy metal contents were measured by inductively coupled plasma atomic emission spectrometry (ICP-AES) and a mercury analyzer. ICP-AES was used to analyze lead, arsenic cadmium. Mercury was analyzed by the amalgamation method. Results: The mean values of the heavy metal contents in the herbal medicines were Pb 0.64mg/kg, As 0.26mg/kg, Cd 0.07mg/kg and Hg 0.004mg/kg. Of the total samples, one violated the MFDS (Ministry of Food and Drug Safety) regulatory guidance on heavy metals in herbal medicines. Lead was detected at more than 5mg/kg in one sample. The measured values of arsenic, cadmium and mercury in the herbal medicines showed levels lower than the recommended levels for herbal medicines in MFDS regulatory guidance. In the comparison of domestic samples with imported herbal medicines, it was found that one domestic sample surpassed the maximum residue limits for lead. Conclusion: These results will be used to establish the regulation and control of heavy metal contents in herbal medicines. In addition, continuous monitoring is needed to ensure confidence in and the safety of these herbal medicines.

• The Journal of Internal Korean Medicine
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• v.23 no.2
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• pp.222-227
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• 2002

Although there are a few reports concerning the side effects and toxicity of herbal medicines, there has not yet been any report concerning their causes, mechanisms or prevention. We investigated the internal reports concerning the side effects and toxicity of herbal medicines. In the findings, liver disorder (hepatic injury) was found in 7 cases, kidney disorders (nephropathy) were found in 12 cases, heart disorders were found in 4 cases and mineral-caused diseases were found in 2 cases. Besides, we found the major cause of the side effects and toxicity was drug abuse, such as over-dosage and long term medication. So, we hope this report brings more attention to the safety and toxicity of herbal medicines.

• Journal of Society of Preventive Korean Medicine
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• v.15 no.2
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• pp.131-143
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• 2011

Objective : The aims of this study are to investigate the trend of internet journalism about the toxicity and safety of the herbal medicine, and to suggest the regulatory solution of the issue. Method : In this study, we had searched the internet news article published from 2001 to 2011 in the five major portal sites-NAVER, DAUM, Nate, Google Korean, and Yahoo Korean. The search terms were 'herbal medicine', 'adverse event', 'toxicity'. If the articles described the same event in the same form and tone, the articles were considered overlapping. The overlapped articles were excluded. The articles were categorized by the form and tone. The form categories were straight news, interpretative story, editorial, interview, and the tone categories are the positive, the negative, and the neutral. The regulations were searched about the negative issue. Result : Total 56 articles were reviewed. There were 19 positive articles, 29 negative articles, 8 neutral articles. Most negative issues have the proper regulations, but insufficient measures for the adverse event reporting system. Conclusion : The herbal medicine specified adverse event reporting system is essential.

• Journal of Physiology & Pathology in Korean Medicine
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• v.21 no.6
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• pp.1646-1654
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• 2007

The aim of this study was to investigate the effects of several herbal prescriptions in patients with allergy or atopic disease, such as atopic dermatitis, asthma and allergy rhinitis and others, on the blood immunological parameters and to verify the safety of long-term use of herbal medicine. Eighty one patients with allergy or atopy disease who taken herbal medicine at least for 2 months were compared with patients who taken same medicine with no allergy & atopy disease (n=14) and normal healthy subjects (n=22). According to the comparison of immunological parameters change, the data showed that herbal medicine decreased IgE (P=0.003), Eosinophil ratio (P<0.001) and count (P<0.001) of White Blood Cell (WBC) and did not affect to the liver cell enzymes in blood. This results indicated that herbal medicine decreased immune hypersensitivity and improved chronic inflammation related to blood immunological parameters of allergy or atopy diseases. In addition, herbal medicine seemed to be safe to the liver function for long-term use.

• The Journal of Internal Korean Medicine
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• v.26 no.2
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• pp.440-452
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• 2005

Objective: In the winter of 2002, severe acute respiratory syndrome(SARS) began to spread throughout the world. More than 5,000 cases were reported in China, including over 1,700 cases in Hong Kong Special Administrative Region(Hong Kong SAR). The total number of cases reported from Canada and Singapore was more than 200. The total number of SARS cases world-wide reached 8,437 with incidences in 29 counties. Mortality from SARS is estimated at $10{\sim}12%$. When the SARS outbreak occurred in China, the State Administration of Traditional Chinese Medicine of China immediately initiated clinical research projects on the use of integrated herbal medicine and Western medicine for treating SARS. and, in Hong Kong SAR, research on the use of herbal medicine for the prevention and treatment of SARS. Reports were released during convalescence. The objective of this study is to overview twelve clinical SARS reports of WHO on the treatment of SARS with herbal medicine and evaluate the efficacy and safety of treatment of SARS with herbal medicine, and further to share experiences and knowledge of the treatment of SARS. Methods: Twelve clinical reports about SARS from the WHO were selected, overviewed and evaluated for efficacy and safety of treatments of SARS. Results and Conclusion: Twelve clinical reports about SARS showed that the integrated treatment may have advantages, and the advantages are reflected in the following findings: Firstly, herbal medicine is not targeted only at a specific etiology or a certain pathological link, but also at the pathological status of the patients at that particular time. Therefore, comprehensive readjustment was made through various angles, targets and channels to restore the balance of the body. Secondly, there are advantages in the differentiation of the disease and the treatment. Based on the various symptoms, herbal medicine enables the physician to adopt the most suitable principle, provide individual treatment, and to administer medicine in accordance with the actual process and nature of the illness. Thirdly, there are advantages in the results of the treatment; herbal medicine can relieve symptoms, promote absorption of lung inflammation, improve the degree of blood oxygen saturation, regulate immunological functions, reduce the required dosage of glucocorticoid and other Western medicines, and reduce case fatality rate, in addition to lowering the cost of treatment.