• Herbal Formula Science
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• v.20 no.2
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• pp.187-197
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• 2012

Objectives : The purpose of this study is to find a reasonable solution to a current status of drug classification between the drugs of western conventional (allopathic) medicine and Korean medicine. A clear and distinct concept on the drugs of allopathic medicine and Korean medicine based on reasonable concepts and broad consensus is a pressing issue in Korea, and will facilitate the development of herbal medicinal products and pharmaceutical industry. Methods : Considering the issue of drug classification from domestic and international regulations, we reviewed the current Drug Law of Korea and China, Guidance for Industry, Botanical Drug Products of USA, Directive 2004/24/EC of the European parliament and of the council. Results : In Korea, the drug classification of allopathic medicine and Korean medicine is quite vague even though differential licensure system is enforced for the clinicians of allopathic medicine and Korean medicine field. According to the definition in the Drug Law, the scope of Korean medicine drug is so broad that even a drug made of single-compound material, as well as herbal extract of crude mixture, is regarded as a drug of Korean medicine, as long as the material may be separated from medicinal herbs, animal tissues, or mineral resources. Only new compound not found in natural resources are outside of the scope of Korean medicine drug. In USA and EU, medicinal products manufactured from herbs are approved by separate regulations for the herbs with special waivers. In China, the category of new medicine and the definition of allopathic medicine and traditional chinese medicine are clearly specified and classified. Conclusions : As medicines are validated therapeutic materials for efficacy and toxicity, we suggest that generally the concept of conventional medicines is based on a single compound that has been synthesized and individually validated and that of Korean medicines is based on a compound extracted from natural materials or a complex of compounds that has been validated as a whole in its totality.

• Journal of Physiology & Pathology in Korean Medicine
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• v.33 no.4
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• pp.207-218
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• 2019

It is necessary to investigate the efficacy of commercial Korean herbal medicine for cognitive disorder. The purpose of this study is to select candidates among licensed herbal medicines that are expected to be effective in the treatment of cognitive disorders and can be used in future clinical trial. From laboratory experiments, we first found individual single herbal drugs that could be effective for cognitive disorder, and then through experts recommendation, selected five priorities of single herbal drug and obtained the information of the best herb as a combination of each herbal drug. To derive the final herbal prescriptions, we searched the KFDA drug information system for licensed herbal medicines containing each drug and its combination. As a result of laboratory experiments and experts recommendation, we found that the five effective single herbal drugs for cognitive disorders. They are Ginseng Radix, Acori Graminei Rhizoma, Cyperi Rhizoma, Coptidis Rhizoma, Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata(Pinelliae Rhizoma, Hoelen cum Pini Radix, and Rehmanniae Radix Preparata were tied for $5^{th}$). And licensed herbal prescriptions derived from the planned search are Palbohoichoon-tang, Taehwa-hwan, Bosim-hwan, and so on. Among these, in consideration of the feasibility of research and possibility of success in development, Yukgunja-tang, Samhwangjichul-hwan can be selected as future study subjects. Through experimental studies and expert recommendations, we have derived herbal prescriptions that can be effective in treating cognitive disorders from licensed herbal medicines.

• 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.

• 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.

• Journal of Sasang Constitutional Medicine
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• v.22 no.4
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• pp.40-48
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• 2010

1. Objectives Herbal Extracts are used in Korean Oriental Medicine clinics. The sixty eight kinds of single herbal extracts and fifty six kinds of mixed herbal extracts has been using since the first year of execution of Korean medicine national insurance policy in 1987. This paper was performed to make a guideline of using herbal extracts. Single herbal extracts and mixed herbal extracts were discussed and classified according to Sasang constition. 2. Methods The sixty eight single herbal extracts were classified into four categories according to Sasang Constitution and fifty six mixed herbal extracts were classified by six Korean oriental medical doctors. Mixed herbal extracts were considered in terms of drug roles[sovereign, minister, assistant and courier(君臣佐使)] or most included ingredient herb. 3. Results Sasang constitutions which were suitable for fifty six mixed herbal extracts were Soeumin(46.4%), mixed constitution(39.2%) and Soyangin(8.9%), Taeeumin(5.3%). Sasang constitutions which were suitable for sixty eight single herbal extracts were Soeumin(47.1%), Soyangin(32.4%) and Taeeumin(20.6%). 4. Conclusions The rate of Soeumin herbal extracts was the most highest among all constitutions. It is regarded that warming and enforcing herb medicine were most used in all prescriptions.

• The Korea Journal of Herbology
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• v.28 no.2
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• pp.61-65
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• 2013

Objectives : Samchulgeonbi-tang (shenzhujianpi-tang) has been prescribed as one of traditional herbal medicine for treatment of stomach diseases since ancient time in Korea. Samchulgeonbi-tang extract was fermented by Lactobacillus spp. for improving the effect. However, the toxicity and safety of fermented Samchulgeonbi-tang (FS) extract were not confirmed. Therefore, this study was performed to evaluate the acute toxicity and safety of FS extract. Methods : To evaluate the acute toxicity and safety of FS extract, several doses of FS extract, 0, 500, 1000 and 2000 mg/kg, were orally administered to 20 male and 20 female ICR mice, respectively. After treatment with FS extract, we observed mortality, general toxicity, behavior and change of body weight for the 14 days. After 14 days of oral administration, all mice were sacrificed and hematological parameters were analyzed from blood serum. Results : In present study, the toxic signs such as mortality or abnormal behaviors by FS extract were not observed. There are no significant differences between FS-treated group and control group in body weight, organ weights, and hematological parameters. Conclusions : The remarkable adverse effects by FS extract were not observed in ICR mice. Also, any death was not occurred at all treated FS doses, 500, 1000 and 2000 mg/kg. Therefore, the approximate lethal dose (ALD) of FS extract may be more than 2000 mg/kg.

• Journal of Pharmacopuncture
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• v.21 no.3
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• pp.203-206
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• 2018

Objectives: There is an increasing number of complex diseases that are progressively more difficult to be controlled using the conventional "single compound, single target" approach as demonstrated in our current modern drug development. TCM might be the new cornerstone of treatment alternative when the current treatment option is no longer as effective or that we have exhausted it as an option. Orthogonal stimulus-response compatibility group study is one of the most frequently employed formulas to produce optimal herbal combination for treatment of multi-syndromic diseases. This approach could solve the relatively low efficacy single drug therapy usage and chronic adverse effects caused by long terms administration of drugs that has been reported in the field of pharmacology and medicine Methods: The present review was based on the Science Direct database search for those related to the TCM and the development of antihypertensive TCM herbal combination using orthogonal stimulus-response compatibility group studies approach. Results: Recent studies have demonstrated that the orthogonal stimulus-response compatibility group study approach was most frequently used to formulate TCM herbal combination based on the TCM principles upon the selection of herbs, and the resulting formulated TCM formula exhibited desired outcomes in treating one of global concerned complex multi-syndromic diseases, the hypertension. These promising therapeutic effects were claimed to have been attributed by the holistic signaling mechanism pathways employed by the crude combination of herbs. Conclusion: The present review could serve as a guide and prove the feasibility of TCM principles to be used for future pharmacological drug research development.

• 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.

• The Korea Journal of Herbology
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• v.27 no.3
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• pp.95-100
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• 2012

Objectives : This study was carried out to investigate the acute toxicity and safety of $Leejung$-$tang$($Lizhong$-$tang$) and fermented $Leejung$-$tang$($Lizhong$-$tang$) extract. Methods : To evaluate their acute toxicity and safety, 0(control group), 1250, 2500 and 5000 mg/kg of $Leejung$-$tang$($Lizhong$-$tang$) and fermented $Leejung$-$tang$($Lizhong$-$tang$) extracts were orally administered to 35 male and 35 female ICR mice. After a single administration, we observed survival rates, general toxicity, changes of body weight, and autopsy. Results : Compared with the control group, we could not find any toxic alteration in any of treated groups (1250, 2500 and 5000 mg/kg). Conclusions : $LD_{50}$ of $Leejung$-$tang$($Lizhong$-$tang$) and fermented $Leejung$-$tang$($Lizhong$-$tang$) were over 5000 mg/kg and it is very safe to ICR mice.

• The Journal of Internal Korean Medicine
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• v.44 no.4
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• pp.635-644
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• 2023

Objectives: This study analyzed laboratory serum data results before and after patients took herbal medicine to confirm the clinical safety of herbal medicine. In addition, in the event of liver damage, the case was analyzed to confirm the characteristics of liver damage and the possibility of liver damage caused by herbal medicine. Methods: A retrospective chart review of the effects of herbal medicine on liver function in patients diagnosed with functional dyspepsia was conducted. The electronic medical records of 128 patients in a single hospital were reviewed. Results: The statistical analysis revealed a statistically significant decrease in liver function-related laboratory serum data after taking herbal medicine (p<0.05). In addition, among 128 patients, there were two cases of drug-induced liver injury (DILI) (1.56%). Conclusion: Taking herbal medicine prescribed by experts does not significantly affect liver function in patients with functional dyspepsia. Rather, the liver levels of the subjects showed a significant decrease after taking herbal medicine. To support these results, further large-scale multicenter prospective studies are necessary.