• Journal of Physiology & Pathology in Korean Medicine
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• v.18 no.4
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• pp.957-964
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• 2004

Herbal medicines are increasingly used to treat various diseases and lots of studies have been reported that they had benefits in treating and preventing of diseases. But organic toxicity is increasingly recognized as herbal medicines become more popular in industrialized countries. Some herbal products potentially benefit people with lots of diseases, however these benefits remain generally unproved in humans, and a greater awareness for potential adverse effects is required. A herb containing a wide variety of, mostly unknown, substances may well include some with unwanted effects. This review focuses on emerging organic toxicities that have been observed associated with various herbal preparations involving the liver, kidney, and heart, and patterns of organ injury, potential risk factors for organic toxicities. In addition to the potential for organic toxicities, drug drug interactions between herbal medicines and conventional agents may affect the efficacy and safety of concurrent medical therapy. Appropriate reporting and regulatory system to monitor herbal toxicity are required, in conjunction with ongoing scientific evaluation of the potential benefits of phytotherapy.

• Korean Journal of Oriental Medicine
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• v.16 no.1
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• pp.19-27
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• 2010

Objectives & Method : We investigated toxicity, poisoning symptoms, poisoning treatment and prevention against poisoning of mind-tranquilizing herbal medicines(安神藥) in order to use herbal medicines accurately. Result : Cinnabaris(朱砂), Zizyphi Spinosae Semen(酸棗仁), Polygalae Radix(遠志), Ganoderma(靈芝) and Polygoni Multiflori Ramulus(夜交藤) may give rise to some side effects or toxic symptoms in mind-tranquilizing herbal medicines(安神藥). The representative methods of poisoning treatment in western medicines are washing out the stomach, promotion of vomiting, causing diarrhea, supplies of grape sugar and symptomatic treatment, etc. The representative methods of poisoning treatment in oriental medicine take advantage of herbs. And Oriental medical doctor should meet symptoms as patients call for attention. In order to prevent against poisoning of mind-tranquilizing herbal medicines(安神藥), the patients should keep usage, dosage and notes and oriental medical doctors should do processing drugs. Conclusion : We should pay attention to clinical using of Cinnabaris(朱砂), Zizyphi Spinosae Semen(酸棗仁), Polygalae Radix(遠志), Ganoderma(靈芝) and Polygoni Multiflori Ramulus(夜交藤) in mind-tranquilizing herbal medicines(安神藥).

• Toxicological Research
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• v.2 no.2
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• pp.79-87
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• 1986

Water extracts of 21 traditional Korean herbal drugs were prepared, and a dose range of 100 mg/kg to 400 mg/kg was administered orally into mice once a day for five days. Changes of serum enzyme activities of glutamic oxaloacetic transaminase (GOT), glutamic pyruvic transaminase (GPT), blood urea nitrogen (BUN), alkaline phosphatase, body weight changes and histo pathological examination of various organs were investigated. Water extract of Ephedra Herba caused severe body weight loss at a dose of 100 mg/kg and death from a dose level of 200 mg/kg by oral administration. Angelica koreanae Radix and Anthrisci Radix showed a slight body weight loss and damages to liver and kidney.

• The Journal of Korean Obstetrics and Gynecology
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• v.26 no.1
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• pp.59-68
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• 2013

Objectives: This study was conducted to investigate the acute toxicity of Pyungwi-san(Pingwei-san in Chinese) in ICR mice, according to KFDA and OECD guideline. Methods: In the present study, 15 male and female ICR mice administrated singly by gavage at dose levels of 0 and 2000 mg/kg of Pyungwi-san. During the experimental period, no treatment-related death was observed. There were no adverse effects on clinical signs, body weight, and gross findings at all treatment groups. Results: These results showed that the single oral adminstration of Pyungwi-san (Pingwei-san) did not cause any toxic effect at the dose levels of 2000 mg/kg in rats. Conclusions: Taken together, the median lethal dose($LD_{50}$) of Pyungwi-san (Pingwei-san) was considered to be over 2000 mg/kg body for both sexes.

• Journal of Society of Preventive Korean Medicine
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• v.15 no.3
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• pp.141-152
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• 2011

Objective : This study was carried out to investigate the acute toxicity and safety of Insampaedok-san and Fermented Insampaedok-san. Methods : SPF ICR male and female mice were administered orally with Insampaedok-san and Fermented Insampaedok-san. of 0(control group), 1,250, 2,500 and 5,000 mg/kg. After single administration, we daily examined number of deaths, clinical signs, gross findings and changes of body weight for 14 days. Hematological parameters and isolated organ weights were determined after 14 days of administration. Results : No dead animal and no significant changes of body weights were found during experimental period. In addition, no differences were found between control and all of treated groups in clinical signs, organ weights, hematology, and other findings. Conclusions : Insampaedok-san and Fermented Insampaedok-san. did not show any toxic effects and oral $LD_{50}$ values of the extracts was over 5,000 mg/kg in ICR mice.

• Journal of Pharmacopuncture
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• v.18 no.2
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• pp.67-75
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• 2015

Objectives: This study was carried out to analyze the single-dose toxicity of ShinYangHur (SYH) herbal acupuncture injected into the muscles of Sprague-Dawley (SD) rats. Methods: The SYH herbal acupuncture was made in a clean room at the Korean Pharmacopuncture Institute (KPI, Korea-Good Manufacturing Practice, K-GMP). After the mixing process with sterile distilled water, the pH was controlled to between 7.0 and 7.5. Then, NaCl was added to make a 0.9% isotonic solution by using sterilized equipment. All experiments were conducted at Biotoxtech, an institution authorized to perform non clinical studies under the regulations of Good Laboratory Practice (GLP). SD rats were chosen for the pilot study. Doses of SYH herbal acupuncture, 0.25, 0.5, and 1.0 mL, were administered to the experimental groups, and a dose of normal saline solution, 1.0 mL, was administered to the control group. This study was conducted under the approval of the Institutional Animal Ethics Committee. Results: No deaths or abnormalities occurred in any of the four groups. No significant changes in weight, hematological parameters or clinical chemistry between the control group and the experimental groups were observed. To check for abnormalities in organs and tissues, we used microscopy was used to examine representative histological sections of each specified organ; the results showed no significant differences in any of the organs or tissues. Conclusion: The above outcomes suggest that treatment with SYH herbal acupuncture is relatively safe. Further studies on this subject are needed to yield more concrete evidence.

• Journal of Society of Preventive Korean Medicine
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• v.12 no.1
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• pp.73-87
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• 2008

In recent years, there has been a globally increasing application of herbal medicines and dietary supplements to treat various chronic diseases and to promote health. However, there are increasing clinical reports on the organ toxicities associated with consumption of herbal medicines. In general, most xenobiotics are metabolized by Phase I reaction(the main enzyme : cytochrome P450) and Phase II reaction. However, reactive oxygen species, free radicals and electrophils are produced inevitably during xenobiotics metabolism. These toxic species and metabolites are increased whenever the endogenous substances and enzymes for Phase II reaction not available. In addition, herbal-drug interactions are pharmacokinetic, with most actually or theoretically affecting the metabolism of the affected product by way of the cytochrome P450 enzymes. This review updated the knowledge on metabolic activation of herbal components and its clinical and toxicological implications. Also, the possible way for preventing the side-effects by herbal-medicine use was suggested.

• Herbal Formula Science
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• v.30 no.3
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• pp.191-203
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• 2022

Purpose : In 『Herbal Formula Science in Korean Medicine (HFSKM)』, the weight unit of Shanghanlun '1 Liǎng (一兩)' is mostly converted to 3 g. We tried to confirm whether the usages of the Shanghanlun prescriptions of HFSKM are valid in the view of safety and efficacy. Method : The toxicity of herbs in Shanghanlun were summarized. The prescriptions of HFSKM including herbs recorded by weight in Shanghanlun were compared with the pharmacopoeia usage. Domestic clinical case studies were analyzed to confirm the clinical evidence for safety and efficacy. Results : Glycyrrhizae Radix, Rhei Radix et Rhizoma, Persicae Semen, Ephedrae Herba, Pinelliae Tuber, Aconiti Lateralis Radix Preparata, Asiasari Radix et Rhizoma, Armeniacae Semen and Scutellariae Radix have been reported to have toxicity. As a result of analyzing the 39 Shanghanlun prescriptions of HFSKM, 26 prescriptions were identified when they were within the pharmacopoeia usage, and 13 prescriptions were found in excess. As a result of analyzing the domestic clinical research papers, symptoms considered to be side effects were not mentioned, and improvement of the diseases was confirmed. As a result of measuring the actual weight, it was confirmed that the usage greatly exceeded the pharmacopoeia usage, such as 57.23 g for Pinelliae Tuber and 45.77 g for Armeniacae Semen. Conclusion : The composition of the prescription for Shanghanlun proposed in HFSKM is considered to be a reasonable dose, but continuous review and standard supplementation are necessary.

• The Journal of Korean Medicine
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• v.44 no.3
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• pp.189-200
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• 2023

Objectives: The purpose of this study is to analyze the current state of quantitative literature evidence for the prescription of 56 herbal medicines covered by health insurance that have been studied in Korea for the past 30 years, to evaluate the reliability of the evidence, and to find out the research direction of herbal medicine prescription in the future. Methods: 56 kinds of herbal medicine prescriptions were searched in domestic literature search databases OASIS, DBpia, and overseas PubMed, classified into chemistry, toxicity, cells, animals, clinical cases, and clinical trial studies, and built into an EBM pyramid structure. Results: When classified according to research contents, there were 61 cases (7.5%) of physicochemical analysis to identify constituent substances, 80 cases (9.8%) of toxicity evaluation, and 672 cases (82.7%) of efficacy evaluation. The efficacy evidence was classified according to the evidence-based medical pyramid structure: 196 cell trials (29.1%), 372 animal trials (55.4%), 89 case and case reporting series (13.3%), 7 comparative case studies (1.1%), and 8 randomized control clinical trials (1.2%). In the pyramid composition, the basis for the validity of 56 kinds of herbal medicines prescribed was 568 cases (84.5%) in cell and animal units, which could not be said to be highly reliable. There was no relationship between the ranking of quantitative literature evidence for herbal medicine prescriptions and the ranking of salary administration. Conclusions: In an era that continues to require scientific evidence for herbal medicine, traditional herbal medicine should secure the basis for safety validity even for the 10th most frequent prescription among 56 herbal medicine prescriptions for consumers. In particular, traditional herbal medicine should increase the quantitative and qualitative level of case reports on related herbal medicine prescriptions, focusing on each clinical society, and move toward comparative case studies and randomized clinical trial so that traditional herbal medicine is positioned as Evidence-based medicine.

• Herbal Formula Science
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• v.19 no.2
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• pp.93-108
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• 2011

Objectives : Angelica sinensis has been used extensively in Korean traditional medicine. Although thorough clinical trials are lacking, Various pharmacological actions for Angelica sinensis has been identified newly using animal models. In addition, it was reported that reactive intermediates, potentially causing toxic effects, was isolated from components in Angelica sinensis. In this article, it was purposed for explanation and introduction of new studies for Angelica sinensis. in terms of Pharmacological action and Toxicity. Methods : New studies for Angelica sinensis were reviewed and summarized in terms of pharmacological action and toxicity. Results and Conclusions : Angelica sinensis and its components including phthalide, phthalide dimers, polysaccharides, polyacetylenes, ligustilide와 butylidenephthalide as well as organic acid showed a variety of pharmacological actions on uterine, cardiovascular system and immune system. In addition, it was identified that three components of such as ligustilide, caffeic acid and safrole was biotransformed to reactive intermediates causing possibly toxicity.