• 대한한의학방제학회지
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• 제30권3호
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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.

• 대한본초학회지
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• 제28권2호
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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.

• 대한한방내과학회지
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• 제33권4호
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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.

• 대한한방소아과학회지
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• 제34권3호
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• pp.18-36
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• 2020

Objectives The purpose of this study is to analyze Chinese randomized controlled trials (RCTs), and to evaluate the effectiveness and safety of the oral herbal medicine treatment for pediatric chickenpox. Methods We searched RCTs after 2000s from the China National Knowledge Infrastructure (CNKI). Afterwards, the year of publication, demographic information, duration of chickenpox, intervention, treatment duration, outcome measure, results and adverse events were investigated and analyzed for this study. Results 21 RCTs out of 219 studies were collected and analyzed. Although each composition of the herbal medicine was different, they have common ingredients such as 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風 in order to make efficacy of 清熱解毒, 散結消腫, 疏散風熱, 涼血解毒, 解表散風. The oral herbal medicine showed better efficacy and safety to improve clinical symptoms such as total efficacy, cure rate, antipyretic time, antipruritic time, scab time, anti-rash time, hospitalization period and herpes recovery time compared to the western medicine treatment. Conclusions These results show that the oral herbal medicine treatment on chickenpox in children may be more effective in reducing of clinical symptoms compared to the western medicine treatment.

• 한국식품위생안전성학회지
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• 제32권3호
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• pp.187-192
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• 2017

현대인들의 건강에 대한 관심이 커짐에 따라 한약재 소비량이 지속적으로 증가하고 있다. 그러나 최근 기후변화와 국내 한약재의 높은 수입 의존도에 따라 유해물질에 대한 오염 위험이 높아지고 있다. 곰팡이독소는 한약재 중 안전성을 평가하는 주요한 항목 중 하나이다. 본 연구에서 498 건의 한약재에 대해 곰팡이독소 모니터링을 진행하였다. 면역컬럼을 이용해 한약재 중 아플라톡신을 추출하였으며, 추출한 아플라톡신은 HPLC-FLD 방법을 통해 분석하였다. 직선성, 회수율, LOD 및 LOQ를 통해 본 연구에 이용한 실험법 검증을 실시하였다. 39건에서 평균 $7.670{\mu}g/kg$의 아플라톡신이 검출되었으며, $0.610{\sim}77.452{\mu}g/kg$의 검출범위를 보였다. 특히 현호색은 국내 아플라톡신 기준이 없으나, 시험에 사용된 39건 중 5건에서 $14.9{\pm}4.1{\mu}g/kg$의 높은 아플라톡신 농도를 보였다. 즉, 현호색에 대한 기준 설정이 시급히 요구되어지며, 선제적 관리를 위한 지속적인 모니터링이 필요할 것으로 사료되어진다.

• 대한한의학방제학회지
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• 제27권1호
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• pp.31-44
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• 2019

Objective : Herbal dispensaries, where medications are prepared for patients, require specific preparation and operations management for safe herbal medicines. This study aims to propose improvements in the herbal medicine preparation and operation of the herbal dispensaries as series study of the "A Survey on the Management Status of Extramural Herbal Dispensaries" Methods : We first checked current management regulations. In addition, we compared and analyzed related laws which are "State management norm of Traditional Chinese Medicine dispensaries", "Enforcement Rule of Medicinal Product Safety" and " Hazard Analysis and Critical Control Point(HACCP)", to introduce the assessment items of herbal dispenses evaluation and certification system. Results : In this study, we found that the current regulations, "Guideline on Installation and Utilization of Extremal Herbal Pharmaceutical Facility and Shared-use of Herbal Dispensary", are insufficient to ensure the quality and safety of herbal medicines. We suggested articles for the proper management of herbal dispensaries and these were introduced to the Herbal dispensary evaluation and certification system. Conclusion : We recommend evaluation articles in Herbal dispensary evaluation and certification systems need to be popular among herbal dispensaries, then Korean herbal medicine could restore credibility from the people.

• 대한한방내과학회지
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• 제44권4호
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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.

• 대한한의학회지
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• 제29권2호
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• pp.41-46
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• 2008

Objective: To build a basis of strategy for development of herbal drug as a preventive medicine during dynamic innovation of Korean Oriental medicine. Methods: Via telephone interview, 101 subjects prescribed with deer antler were asked to provide us their reflections about five topics: points of satisfaction, physical improvement, improved symptoms, annual times of taking restorative herbal medicine, and aspect of complaints about taking the herbal drugs. Results: Around 68% of subjects usually take a restorative herbal medicine with deer antler less than once per year. 63% of subjects were satisfied with herbal restoratives. They answered the physical energetic feeling (52%) as the most benefit while expensive price (43%) as the most frequent complaint. Conclusion: Scientifically designed restorative herbal medicine needs to be developed for competitiveness of Korean Oriental medicine as a preventive medicine. In addition, more reasonable price and confirmative data for safety and quality control should be equipped in Korean Oriental medical market.

• 대한한의학회지
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• 제40권3호
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• pp.139-176
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• 2019

Objectives: This study aims to review the herbal medicines containing substances banned by World Anti-Doping Agency(WADA), and to consider criteria for the using of herbal medicines. Methods: Using foreign(Pubmed, Cochrane, Embase, Google Scholar, WANFANG, CiNii) and domestic databases (NDSL, OASIS, RISS), we analyzed the content and pharmacokinetics of the prohibited substances in herbal medicines. Results: Herbal medicines containing the prohibited substances proposed in Korea, China, and Japan are Ephedrae Herba, Cannabis Semen, Strychni Semen, Strychni Ignatii Semen, Pinelliae Tuber, Rhizoma Pinelliae, Chelidonii Herba, Papaveris Fructus Deseminatus, Liriopis Tuber, Rehmanniae Radix Recens, Cistanchis Herba, Ponciri Fructus Immaturus, Aurantii Fructus Immaturus, Moschus, Testudinis Plastrum, Otariae Testis et Penis, and Hominis Placenta. Of these, when using Ephedrae Herba, Cannabis Semen, Strychni Semen, Moschus, Strychni Ignatii Semen, and Otariae Testis et Penis, caution is needed in relation to the doping test. Other herbal medicines are considered safe for the doping test. In addition, by analyzing data related to higenamine added to the WADA's prohibited list of doping since 2017, we don't recommend using Nelumbinis Plumula. And in the case of the other herbal medicines containing higenamine, it is considered that care should be taken in doping test depending on the amount of usage. Conclusions: As a result of analyzing the herbal medicines which are in prohibited list about doping, we were able to know the criteria and precautions to use when prescribing the herbal medicines. Further research will be needed about common used herbal medicines and the amount of detection depending on extraction and boiling method.

• 대한약침학회지
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• 제17권4호
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• pp.55-60
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• 2014

Objectives: This study was designed to evaluate the efficacy and the safety of constitutional herbal tea for treating chronic fatigue with no diagnosed cause, which is called Mibyeong in Korea. Methods: Males and females with ages between 40 and 59 years who had complained of fatigue for 1 month consistently or for 6 months intermittently without a definite cause were recruited. At the same time, a Chalder fatigue scale (CFS) score of 19 was essential for participation in this study. Sixty five subjects completed the entire process, including blood tests and tests with medical devices. Five assessments of health status were accomplished over 8 weeks by using the CFS and the visual analogue scale (VAS). To ensure that the constitutional herbal tea was being safely used, we conducted and analyzed renal function and liver function tests. For the diagnosis of the Sasang constitution, the Sasang Constitutional Analysis Tool (SCAT) was used, and a specialist in Sasang constitutional medicine made the final diagnosis based on the SCAT result. Constitutional herbal tea was served four weeks after the first visit. The subjects took the constitutional herbal tea twice a day for one month. Results: The results are as follows: The CFS and the VAS scores were significantly improved for the subjects in the constitutional herbal tea. No abnormalities were found on the blood tests to evaluate safety after taking the constitutional herbal tea. The improvements in the CFS and the VAS scores due to the constitutional herbal tea had no significant differences according to the Sasang constitution. Conclusion: Constitutional herbal tea may be used to reduce fatigue and improve health and has no adverse effect on either the kidney or the liver.