• 제목/요약/키워드: safety of herbal medicine

검색결과 603건 처리시간 0.029초

ICR 마우스를 이용한 누룩 고체 발효 쌍화탕의 급성독성에 관한 연구 (Acute Toxicity Study on Ssanghwa-tang Fermented with Nuruk in ICR Mice)

  • 이지혜;엄영란;마진열
    • 한국한의학연구원논문집
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    • 제16권3호
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    • pp.149-154
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    • 2010
  • Objective : Ssanghwa-tang has been used as herbal medine, favorite beverage or health beverage. This study was performed to evaluate the acute toxity and safety of fermented Ssanghwa-tang extract in ICR mice. Methods : 0(control group), 1250, 2500 and 5000 mg/kg of Ssanghwa-tang and fermented Ssanghwa-tang extracts were orally administered to 35 male and 35 female ICR mice. After single administration, we observed number of death, clinical signs, changes of body weight for 14 days. After 14 day of administration, all mice were sacrificed and major organ were observed. Results : Compared with the control group, we could not find any toxic alteration in all treated groups (1250, 2500 and 5000 mg/kg). Conclusions : These results suggest that Sssanghwa-tang fermented with nuruk extracts might be safe to ICR mice.

만성 골반염의 한약 치료에 대한 무작위 대조 임상시험 연구 분석 (Review of Randomized Controlled Trials of Traditional Herbal Medicine for Chronic Pelvic Inflammatory Disease)

  • 노언지;안수연;김동철
    • 대한한방부인과학회지
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    • 제34권4호
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    • pp.46-61
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    • 2021
  • Objectives: The purpose of this review is to overview the studies of traditional herbal medicine for chronic pelvic inflammatory disease. Methods: We searched relevant studies using seven databases (The Journal of Korean obstetrics & gynecology, National Digital Science Library (NDSL), Research Information Sharing Service (RISS), Oriental Medicine Advanced Searching Integrated System (OASIS), Pubmed, Cochrane, Chinese National Knowledge Infrastructure (CNKI)). Data retrieval was carried out on April 5, 2021 and the papers published from January 1, 2015 to March 31, 2021 were included. The risk of bias was assessed by using Cochrane's risk of bias tool. Results: 524 studies were searched in domestic and foreign databases, and 7 studies were finally selected. In all studies, the treatment group was treated with oral traditional herbal medicine and the control group was treated with western medicine. Although the evaluation index was slightly different for each study, all studies used total efficacy rate index. In all 7 studies, the treatment group was more effective than the control group. Conclusions: Traditional herbal medicine can be an effective option in treating chronic pelvic inflammatory disease. Further high quality studies which include large number should be carried out to confirm the evidence and safety of traditional herbal medicine treatment.

Analysis for Individual-authorization of Functional Food Materials in Korea

  • Son, Chang-Gue
    • 대한한의학회지
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    • 제36권4호
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    • pp.35-41
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    • 2015
  • Objectives: This study aimed to provide basic information for the trend of individual-authorization on functional food materials in Korea to side of Korean medicine. Methods: Approval of materials for individual-authorized functional food in Korea was analyzed from 2004 to August 2015 using database from Ministry of Food and Drug Safety (MFDS), regarding the kinds of function, materials and their functional level by year. Results: Korean functional food market has rapidly grown to 1.56 trillion Won in 2014, with about 10% of annual growth rate. In particular, the increase of individual-authorized functional food is worth of notices, in detail 313 kinds of functional materials covering 31 body functions have been approved by August 2015. 15.7% of individual-authorized functional foods have used the herbal materials. This quantitative and qualitative expansion of functional foods, especially of individual-authorized functional foods, will affect the herbal drug industry negatively. Conclusion: This study figured out the current pattern of material approval for individual-authorized functional food in Korea, which would be essential in development of strategies by Korean medicine community in order to overcome such conditions.

원산지별 국내 유통 한약재의 이산화황 잔류실태 조사 (Monitoring of Sulfur Dioxide Residues in Commercial Herbal Medicines at Domestic by Geographical Origins)

  • 이아름;장설;이아영;최고야;김호경
    • 한국식품위생안전성학회지
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    • 제29권2호
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    • pp.152-157
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    • 2014
  • 국내에 유통되고 있는 국산과 수입산 한약재 11종 116건을 대상으로 잔류이산화황에 대한 모니터링을 수행한 결과 108건(93.1%)은 불검출이었고 6건(5.2%)는 이산화황 허용기준치 30 mg/kg을 초과하였고 2건은 30 mg/kg 미만으로 검출되었다. 116건의 이산화황 평균함량은 $17.6{\pm}144.2mg/kg$이고 최대 검출량은 구기자(1,546.3 mg/kg)이었고 중국산 현호색(66.6%)의 이산화황 검출 빈도가 가장 높게 나타났다. 국내산 한약재는 71건 중 1건(1.4%), 수입산 한약재는 45건 중 7건(15.6%)에서 이산화황이 검출되었고 국내산 1건(36.7 mg/kg)과 수입산 5건(118.1 mg/kg)이 허용기준치를 초과하여 국내산보다 수입산 한약재에 이산화황 잔류량이 많았다. 본 연구를 통해 이산화황 허용기준을 초과하는 부적합율은 다소 낮아지고 있지만 이산화황 허용기준을 초과하는 한약재들 중 일부 한약재에서는 잔류이산화황 함량이 높게 나타났고, 특히 국내산 약재에 비해 수입산 약재는 부적합율이 높게 나왔다. 한약재는 일반적으로 수세 및 가열과정을 거치므로 실제 섭취하는 형태의 탕액에서는 원재료보다 이산화황의 잔류량이 크게 감소하지만 완전히 제거되지는 않으므로 유통되는 한약재의 안전성 확립이 절실히 요구되어진다. 강화된 기준이 정착하여 안전한 한약재가 유통될 수 있도록 수입통관시 특별관리가 요구되며, 보다 적극적인 검사 요주의 품목에 대한 지속적인 잔류이산화황 모니터링이 필요할 것으로 사료된다.

폐암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰 (Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer])

  • 한가진;조민지;박은주;성신;김성수;김관일;정희재;이범준;임정태
    • 대한한의학회지
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    • 제40권1호
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    • pp.153-173
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    • 2019
  • Objectives: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer" by analyzing the existing guidelines and clinical trials. Methods: The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer". Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: 'lung neoplasm', 'herbal medicine', 'Medicine, Korean traditional', 'Medicine, Chinese Traditional' etc. Results: There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test. Conclusions: Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of "Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer".

환아 보호자 대상으로 실시한 한약 용기 선호도 조사 (Preference of Herbal Medicine Packagings for Caregivers)

  • 정아람;이혜윤;천진홍;김기봉
    • 대한한방소아과학회지
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    • 제28권4호
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    • pp.71-84
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    • 2014
  • Objectives The aim of this study is to investigate preferred herbal medicine packaging. Methods The study used questionnaires for the caregivers, who have administered their children herbal and western medicine. 106 of them were visited the Department of Pediatrics, the Oriental Medicine Hospital of ${\bigcirc}{\bigcirc}$ University, during the period between in 2014. We used PASW Stastics 18.0 to analyze different dosing methods, and preferred packaging and drug formulations. Results 1. 77.4% answered that they use cups to administer medications, 9.4% transferred it to other plastic bottles, 8.5% used straw to drink from the pouch, 4.7% drank as it is inside the pouch. Method of taking it was not very significant depending on the age. 2. Compare to pills and capsules, 48 responders answered that pills and capsules are easier to take, 11 answered herbal medication is easier to take. 32 answered that there were no significant difference. 3. 45.3% reported vinyl pouch was preferable, 44.3% answered spout pouch was preferred, 5.7% answered bottles are convenient, and another 5.7% responders thought cup was fine. Others include syrup bottles had 1 person. These varying preferences were not depending on the age variations. 4. 56.3% answered that price was the main reason why they prefer one over the other. Others 29.2% stated convenience, 12.5% reported safety, and 10.4% people answered ease of administration as their main reason for their preferences. Conclusions Based on this study, numbers of parents felt inconvenient administering herbal medicine as a vinyl pouch, and felt necessary to improve this. However, price and other reasons made vinyl pouch still more preferable option. Vinyl pouch that we are using today didn't show any safety issues. Therefore, it is recommended to still use vinyl pouch, but with caps on top to improve administration and distinguishing issues.

2021년도 인천광역시 한의약 난임 지원 사업에 관한 결과 연구 (A Study on the Results of the Incheon Metropolitan City Korean Medicine Infertility Support Program in 2021)

  • 권나연;이동녕;성현경;박장경
    • 대한한방부인과학회지
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    • 제35권4호
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    • pp.143-160
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    • 2022
  • Objectives: This study aimed to lay the foundation for the Korean medicine infertility treatment support program to be implemented in the future by analyzing the results of the Korean medicine infertility treatment support program implemented by Incheon metropolitan city. Methods: 224 patients applied for the Korean medicine infertility treatment support program conducted by Incheon metropolitan city and had three months of herbal medicine treatment and three months of follow-up time. Information on general, demographic, and infertility-related characteristics of patients before treatment was collected. Information on treatment contents performed by Korean medical doctors during treatment, and information on results and satisfaction after treatment was collected. In order to evaluate the safety of treatment, blood tests were performed before and after treatment, and abnormal reactions were monitored. Results: Of 224 patients, 211 ended treatment, of which 45 (21.33%) succeeded in pregnancy. The characteristics of the successful and failure groups of pregnancy were found to be statistically significant differences in age, therapeutic history, parity, anti-müllerian hormone test results, and type of infertility of the patients and spouses. The most common pattern identification was kidney deficiency, and the most widely used prescription was Jogyeongjongok-tang. Patients were highly satisfied with the treatment of Korean medicine infertility. As a result of the safety evaluation, herbal medicine treatment was confirmed to be a safe treatment. Conclusions: In this study, clinical information on the Incheon metropolitan city Korean medicine infertility treatment support program was obtained. Based on this study, it is expected that the Korean medicine infertility treatment program in the future will guarantee more extensive treatments such as extending the treatment period or supporting korean herbal medicine to spouses.

목향 추출물의 항비만 활성 효과 (Anti-obesity Activity of Extract from Saussurea lappa)

  • 윤태숙;성윤영;장자영;양원경;지윤의;김호경
    • 한국약용작물학회지
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    • 제18권3호
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    • pp.151-156
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    • 2010
  • Obesity has become one of the main public health problems. Saussurea lappa (Asteraceae), syn Aucklandia lappa and Saussurea costus, is a well-known herbal medicine that has been used for treating various ailments, such as inflammatory and gastrointestinal diseases. The present study examined the anti-obesity effect of S. lappa extract (SLE) in 3T3-L1 adipocytes and high fat diet (HFD)-induced obese mouse model. SLE significantly inhibited the differentiation from preadipocytes to adipocytes of cultured 3T3-L1 in dose-dependent manner. In addition, SLE significantly decreased the body weight gain and the food efficiency ratio of mice fed HFD during 9 weeks. Further study must be performed for the pharmacological mechanism and safety of SLE as well as the identification of active compound in SLE. Our results revealed that S. lappa suppresses the adipogenesis in cultured cells and the obesity in rodent models. Therefore, S. lappa may be useful toward the development of new potent anti-obesity drugs.

한약재 13종의 hERG 채널 관련 심장독성 평가 (hERG Channel-Related Cardiotoxicity Assessment of 13 Herbal Medicines)

  • 하혜경;이시온;김동현;서창섭;신현규
    • 대한한의학회지
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    • 제42권3호
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    • pp.44-55
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    • 2021
  • Objectives: As the use of herbal medicinal products (HMPs) increases worldwide, systematic verification of the safety of HMPs is required. The induction of cardiotoxicity is one of the major factors in post-approval withdrawal of medicinal products, and drug-induced cardiotoxicity assessment is emerging as an important step in drug development. In the present study, we evaluated human ether-à-go-go-related gene (hERG) potassium channel-related cardiotoxicity to predict the risk of cardiac arrhythmia in thirteen herbal medicines known to have cardiac toxicity. Methods: We measured the inhibition rate of hERG potassium channel activity of 13 medicinal herbal extracts in hERG-expressing HEK 293 cells using an automated patch-clamping system. Quinidine was used as a positive control for inhibition of hERG activity. Results: Extracts of Evodiae Fructus, Strychni Semen, and Corydalis Tuber potently inhibited the activity of hERG, and IC50 values were 3.158, 19.87, and 41.26 ㎍/mL, respectively. Cnidi Fructus, Ephedra Herba, Lithospermi Radix, Polygoni Multiflori Radix, Visci Ramulus et Folium, Asiasari Radix et Rhizoma, and Scolopendra weakly inhibited hERG activity, and the IC50 value for each herbal medicine was more than 400 ㎍/mL. Aconiti Kusnezoffii Tuber and two types of Aconiti Lateralis Radix Preparata (Po and Yeom) had weak inhibitory activity against hERG, and the IC50 values were more than 700 ㎍/mL. The IC50 value of quinidine against hERG was 1.021 𝜇M. Conclusion: Evodiae Fructus, Strychni Semen, and Corydalis Tuber acted as potent inhibitors against hERG. These herbal medicines may cause cardiac arrhythmia through QT prolongation, so care should be taken when taking them.

삼정환의 랫드를 이용한 단회 경구투여 독성시험 (Single Oral Dose Toxicity Study of Modified Samjung-Hwan in Sprague-Dawley Rats)

  • 김민지;이명종;김호준
    • 한방비만학회지
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    • 제17권2호
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    • pp.96-100
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    • 2017
  • Objectives: Samjung-hwan (SJH) is a Korean herbal formula that has been used for antilipidemic, antioxidant, and antidepressant effects. As a part of safety evaluation, single oral dose toxicity study of modified SJH in Sprague-Dawley (SD) rats was carried out. Methods: Modified SJH extract was administered orally in male and female SD rats at dose of 5,000 mg/kg. After single oral administration of modified SJH, we monitored the changes of mortalities, clinical signs, and body weight daily for 14 days. Gross necropsy findings were also evaluated at the end of the experiment. Results: Modified SJH extract did not induce any toxic signs in the changes of mortalities, clinical signs, and body weight. There were also observed no gross necropsy findings in rats. Conclusions: As results, the approximate lethal dose of modified SJH extract in SD rats was considered to be over 5,000 mg/kg. This suggests that modified SJH is safe herbal formula for the treatment with.