• Title/Summary/Keyword: safety of herbal medicine

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Toxicity Assessment of Cyperi rhizoma Aqueous Extract Orally Administered to Rats for 13 Consecutive Weeks (랫드에서 향부자 추출물의 13주 반복 경구투여 독성평가)

  • Han, So-Ri;Han, Hyoung-Yun;Park, Heejin;Mi, Byung-Sun;Chung, Moon-Koo;Moon, Kyoung-Sik;Jeong, Ja Young;Roh, Hang-Sik;Seok, Ji Hyeon;Kim, Sang Kyum
    • YAKHAK HOEJI
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    • v.57 no.4
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    • pp.258-264
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    • 2013
  • Herbal medicine has been traditionally used in Asian countries for a long time. Many pharmacological effects are identified in the herbs and these herbs are believed to be safe for human. However, the safety or adverse effect of some traditional herbal medicines has not been established. We have chosen Cyperi rhizoma based on the Korea Herbal Pharmacopoeia and which have been widely used for an anti-inflammatory effect in Korea. The object of the study was to evaluate safety of Cyperi rhizoma in rats. The aqueous extract of Cyperi rhizoma was prepared according to the standard hot water extraction method of the Korea Pharmacopoeia. In the sub-chronic study, the aqueous extract of Cyperi rhizoma was orally administered once daily as 0, 125, 250, 500, 1000 and 2000 mg/kg/day to male and female F344 rats for 13 weeks. There were no treatment related abnormalities in mortality, clinical signs, food consumption, ophthalmologic examination, hematology, serum chemistry, urinalysis, gross observation, organ weight and histopathologic examination. In conclusion, The NOAEL (No Observed Adverse Effect Level) for Cyperi rhizoma aqueous extract was determined as more than 2000 mg/kg/day in the present experimental condition.

Assessment of the Forecasting Studies on 12 Traditional Korean Medicine Policy Realization (12개 미래 예측 한의약 정책 과제의 실현 평가 연구)

  • Park, Ju-Young;Shin, Hyeun-Kyoo
    • Journal of Society of Preventive Korean Medicine
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    • v.17 no.1
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    • pp.65-76
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    • 2013
  • Objectives : Aim of this study is to contribute to establishment of the Traditional Korean Medicine (TKM) policies in the future. Final assessment for 12 of the forecasting projects was carried out on the TKM policies that deduced by professionals in 1996 whether or not to realize in 2013. Methods : We investigated governmental and private research projects, reports and papers, and laws and systems on the forecasting projects. We reviewed them through the Traditional Korean Medicine Information Portal OASIS (http://oasis.kiom.re.kr), Korean studies Information Service System (KISS) (http://kiss.kstudy.com/) and DBpia (http://www.dbpia.co.kr/), Akomnews(http://www.akomnews.com/), THE MINJOK MEDICINE NEWS(http://www.mjmedi.com/), Ministry of Government Legislation(http://www.law.go.kr/). Results : Of the 12 forecasting projects, five were judged as 'realization', four were as 'partial realization' and three were as 'un-realization', The realization rate was 75.0%. Three un-realized projects included the TKM insurance coverage for various herbal medicines, leadership secure on medical technicians and commercialization of the TKM managing system on senior medicare policy. Realization of the future forecasting TKM policy projects was decided depending on conditions such as the importance, domestic capability levels, principal agents, methods and restrains. Conclusions : Continuous studies and new developed forecasting projects for the TKM policies will be required to realize the projects in the future.

Subacute Toxicity Study on Sagunja-tang(Sijunzi-tang) in SD Rats (SD 랫트를 이용하여 사군자탕(四君子湯)의 아급성 독성에 관한 연구)

  • Ma, Jin-Yeul;Yu, Young-Beob;Ha, Hye-Kyung;Huang, Dae-Sun;Shin, Hyun-Kyoo
    • Korean Journal of Oriental Medicine
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    • v.13 no.3
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    • pp.151-156
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    • 2007
  • Sagunja-tang(Sijunzi-tang) has been traditionally prescribed as a restorative. The present study was undertaken to determine the possible toxic effects of Sagunja-tang on SD rats. In this study, we investigated the subacute toxicity of water-extracted Sagunja-tang(Sijunzi-tang) on SD rats. Twenty rats were orally adiministered Sagunja-tang for 28 days at a dose of 0 mg/kg(control group) or 1500mg/kg(treated group), respectively. All of subjects was survived. No significant difference in abnormal clinical signs, related to hematological values, serum biochemical values, water and feed intake, coagulation time, autopsy analysis, organ weight, tissue microscopically, funduscopy, urine intake and urinalysis, was detected. Compared with the control group, we could not find any subacute toxic alteration in treated group (1500mg/kg) for 28 days. This result suggests that Sagunja-tang(Sijunzi-tang). a herbal medicine prescription, is a safe prescription to body.

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A 90 Day Repeated Dose-Oral Toxicity Study of Extracts from Astragalus membranaceus-Aboveground Parts in Rats (랫드를 이용한 황기의 지상부 추출물에 대한 90일 반복경구투여 독성시험)

  • Park, Yeong Chul;Lee, Ji Sun;Kim, Dong Yoon;Son, Hye Young;Lee, Jung Woo;Cheoi, Yu Soon;Kim, Kwang Ki;Yu, Chang Yeon;Chung, Ill Min;Im, Moo Hyeog;Lee, Kyung Jae;Choi, Ri Na;Shim, Hoon Seob;Lim, Jung Dae
    • Korean Journal of Medicinal Crop Science
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    • v.21 no.6
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    • pp.474-485
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    • 2013
  • Pharmacological studies and clinical practices have indicated that Radix Astragali, a dried root of Astragalus membranaceus possesses a lot of biological activities, including antioxidant, hepatoprotective, anti-diabetic, tonic, diuretic, antimicrobial, antiviral, and immunological activities. These biological activities approved by the modern pharmacological studies are mainly due to the constituents of Astragalus membranaceus including polysaccharides, saponins, flavonoids, amino acids, and trace elements. In resent, the main constituents in the root part showing a lot of biological activities has been isolated also from the aboveground parts such as leaves and sprouts in our laboratory. However, the safety evaluation for the aboveground parts of Astragalus membranaceus should be checked before expanding their application as one of food. In the study, a 90-day rat oral gavage study has been conducted with the extracts from Astragalus membranaceus-above-ground parts at doses of 1000, 3000, and 5000mg/kg/day. The following endpoints were evaluated: clinical observations, body weight, gross and microscopic pathology, clinical chemistry, and hematology. Based on the analysis of these endpoints, it was estimated that NOEL (no observed effect level) for male rats and NOAEL (no observed adverse effect level) for female rats are 5000mg/kg/day of the water-extracts from Astragalus membranaceus-aboveground parts.

Dissipation Pattern of a Fungicide Mandipropamid in Korean Cabbage at Different Harvest Times under Greenhouse Conditions (시설재배 엇갈이배추 중 살균제 Mandipropamid의 수확시기별 잔류 특성)

  • Choung, Myoung-Gun;Ahn, Kyung-Geun;Kim, Gi-Ppeum;Hwang, Young-Sun;Kwon, Chan-Hyeok;Kang, In-Kyu;Lee, Young Deuk
    • Horticultural Science & Technology
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    • v.34 no.4
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    • pp.644-654
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    • 2016
  • Supervised residue trials for mandipropamid in Korean cabbage(Brassica campestris L.) were conducted to establish its pre-harvest residue limit (PHRL), a criterion to ensure the safety of the terminal pesticide residue during cabbage production. Tissues of Korean cabbage were collected at 0, 1, 3, 5, 7, and 10 days after mandipropamid application and subjected to residue analysis. The analytical method was validated by recoveries ranging from 88.2-92.2% at two levels (0.4 and $2.0mg{\cdot}kg^{-1}$), and a limit of quantitation (LOQ) of $0.04mg{\cdot}kg^{-1}$. Mandipropamid residues in Korean cabbage gradually decreased over time. The dissipation rate of the residue would be affected by intrinsic degradation of the compound along with dilution resulting from the fast growth of Korean cabbage. The decay pattern was well fitted by simple first-order kinetics. Biological half-lives of mandipropamid in Korean cabbage ranged from 3.9-4.0 days in two field conditions. Calculated by the regression curve of mandipropamid dissipation, the PHRLs of mandipropamid in Korean cabbage were recommended as 11.07-12.19 and $5.76-6.05mg{\cdot}kg^{-1}$ for 10 and 5 days prior to harvest, respectively.

Single Oral Dose Toxicity Test of Jeopgoltang Extracts in Sprague-Dawley Rat (접골탕(接骨湯) 2.0의 Sprague-Dawley 랫드를 이용한 단회경구투여 독성시험)

  • YoungJin Choi;HyoJung Kim;Se-Jin Kim;JunSub Kim;Jiwoon Jeong;HyunHee Leem;BoGyung Jang;YuJin Park;Jungtae Leem;Gi-Sang Bae;Bitna Kweon;Dong-Uk Kim
    • The Korea Journal of Herbology
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    • v.39 no.2
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    • pp.19-25
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    • 2024
  • Objectives : Jeopgoltang (JGT) is a new Korean herbal medicine formulation that is used to treat bone fractures. Although JGT is frequently used in clinical practice, there is a lack of scientific evidence on its safety. This study aimed to evaluate the preclinical toxicity of JGT using a single oral dose toxicity test in Sprague-Dawley (SD) rats. Methods : Five male and female rats per group were orally administered 1,250, 2,500, or 5,000 mg/kg of JGT after fasting for 12 h. Mortality and changes in clinical signs, body weight, and necropsy findings were monitored for 14 days according to the guidelines of the Korean Ministry of Food and Drug Safety and Organisation for Economic Co-operation and Development (OECD). Results : No significant clinical signs or mortality were observed after a single administration of up to 5,000 mg/kg. In addition, no significant necropsy findings related to JGT administration were observed. Conclusions: In conclusion, these results suggest that approximate Lethal Dose (ALD) of JGT on SD rats is over 5,000 mg/kg.

The Content and Risk Assessment of Heavy Metals in Herbal Medicines used for Food and Drug (식약공용 농·임산물의 유해중금속 분석 및 위해도 평가)

  • Cho, In-Soon;Kim, Su-Jin;Park, Ae-Suk;Kim, Jin-Ah;Jang, Jung-Im;Lee, Sung-Deuk;Yu, In-Sil;Shin, Yong-Seung
    • Journal of Food Hygiene and Safety
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    • v.35 no.4
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    • pp.354-364
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    • 2020
  • For this paper we analyzed heavy metals including lead, cadmium, arsenic and mercury, and conducted risk assessment on 171 types of herbal medicines used as foods and drugs distributed in Seoul's Yangnyeongsi and Kyungdong (Gyeongdong) herbal medicine markets. The concentrations of the heavy metals were measured by the ICP-MS and a mercury analyzer. The detection ranges of the lead, cadmium, arsenic and mercury were found to be ND-4.719 mg/kg, ND-1.019 mg/kg, 0.002-8.696 mg/kg and ND-0.058 mg/kg, respectively. Artemisiae Capillaris Herba exceeded the standards of the MFDS (Ministry of Food and Drug Safety) for cadmium items, and Actinidiae Ramulus et Fulium et Fructus Vermicultus exceeded the standards for arsenic items. The non-carcinogenic risk assessment showed that there were no items exceeding 1 and that they were safe. The risk of carcinogenicity to lead was below 10-6 in all items and was evaluated as safe. The risk of carcinogenicity of arsenic was almost all in the range of 10-4 to 10-6. All %PTWI are considered to be safe below 100.

각종(各種) 소화기(消化器) 증상(症狀)에 대(對)한 HPS-A의 임상(臨床) 치험(治驗)

  • Mun Gu;Kim Se-Gil
    • Journal of Oriental Neuropsychiatry
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    • v.3 no.1
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    • pp.91-106
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    • 1992
  • The effectiveness, the safety and the usefulness of HPS-A(An Jung San with Chyag Yag Kam Cho Tang), herbal digestive, was examined on 32 patients complained digestive symptoms. This medicine was administered 1 package per 1 time 3 times per 1 day, during 2 weeks. From the examination of the improvemnt and the safety mainly by subjective symptoms, the usefulness was gained. The results were as follows ; 1. In the improvement rate of susbjective symptoms, high rate symptoms was gastric distension, anorexia, heart burn, gastric discomport, dyspepsia, acrid eructation, indigestion, nausea. 2. The improvment over moderate effective was 85.7% after 1 week 96.4% after 2 weeks. The 4 cases breaked medicine during experimental period were all over moderate offectiveness. 3. There weren't any cases complaind particular problem about safety except for 1 case complained mild pushing up of heat. There weren't also any side effect of medicine on common blood count, blood chemistry and urinalysis. 4. In the dicision of usefulness, 19cases(59.4%) were usefulnesss, 12cases(37.5%) were moderate usefulness, 1 case was uselessness(3.1%). So the cases over moderate usefulness were 31 and rate was 96.9%. 5. The usefulness rates according to physical features were all over 95.5% in sturdiness, middle feature and infirmity. So the rates were no relations with the features. 6. The usefulness rates over moderate usefulness according to total seriousness were all over 90% in high, middle, and mild cases. So the rates were no relations with the seriousness. Totally HPS-A was a medicine that was highly effective, safe and useful to patients complained various digestive symptomes.

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Studies on Pesticide Residues in Ostrici Radix (한국산 강활(羌活)의 잔류농약에 대한 연구)

  • Na, Seung-Young;Kim, Hong-Jun;Choi, Go-Ya;Jeong, Seung-Il;Ju, Young-Sung;Oh, Seo-Jin
    • The Korea Journal of Herbology
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    • v.21 no.4
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    • pp.37-41
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    • 2006
  • Objectives : This study has been conducted to investigate the amount of residual pesticide in herbal medicine of Osterici Radix which are purchased on Kwangju(Hanyaksarang). Methods : In order to analyze many pesticides in Osterici Radix, simultaneous multi-residue analysis of pesticides by GC-ECD/NFD was used. Results : But the amount of residual pesticide in Osterici Radix, simultaneous multi-residue analysis of pesticides by GC-ECD/NFD was used. Conclusion : These results indicate that Osterici Radix in current has safety. In future, it is considered the results of this study will be furnished the basis to succeeding studies and it is needed to extensive comparative study for the same genus-degree of relatedness.

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Saenghwa-tang Treatment on Postpartum Prolonged Lochia and Uterine Subinvolution: a Systematic Review and Meta-Analysis (산후 오로부절 및 자궁 복구 불완전에 대한 생화탕(生化湯) 치료의 효과 : 체계적 문헌고찰과 메타분석)

  • Ji-Youn Song;Dong-Chul Kim
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.4
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    • pp.121-139
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    • 2023
  • Objectives: This study was performed to analyze randomized controlled trial, which studied the effect of Saenghwa-tang treatment on postpartum prolonged lochia and uterine subinvolution. Methods: Researchers searched for randomized controlled trial of based on postpartum prolonged lochia, uterine subinvolution and Saenghwa-tang. The paper search was conducted through 6 online databases on August 10, 2023. Results: 8 studies were included after selection and exclusion criteria. 5 studies compared Saenghwa-tang alone with western medicine. 3 studies compared combined treatment of Saenghwa-tang and western medicine, with western medicine alone. Comparing with control group, the treatment group showed statistically significant improvement on total effective rate, uterine involution, serum fibrinogen, D-dimer, viscosity of blood and plasma, Erythrocyte aggregation, and various symptoms. Conclusions: This study suggests that Saenghwa-tang has benefit for treating prolonged lochia and uterine subinvolution. For reliable evidence, further research is needed to establish safety of Saenghwa-tang, standardize diagnosis criteria and specify the treatment course.