• Title/Summary/Keyword: Drug safety assessment

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Monitoring of Pesticide Residues and Risk Assessment for Fruits in Market (국내 유통 과실류의 잔류농약 모니터링 및 위해성 평가)

  • Ahn, Ji-Woon;Jeon, Young-Hwan;Hwang, Jeong-In;Kim, Jeong-Min;Seok, Da-Rong;Lee, Eun-Hyang;Lee, Seong-Eun;Chung, Duck-Hwa;Kim, Jang-Eok
    • Korean Journal of Environmental Agriculture
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    • v.32 no.2
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    • pp.142-147
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    • 2013
  • BACKGROUND: This study was conducted to monitor residual pesticides in domestic agricultural products and to assess their risk to human health. METHODS AND RESULTS: 123 samples containing both general and environment-friendly certified agricultural products were purchased from traditional domestic markets and supermarkets in six provinces of Korea. Multiresidue analyses of one hundred twenty-two pesticides except for herbicides were performed with gas chromatography-electron capture detector, gas chromatography-nitrogen/phosphorus detector, and high-performance liquid chromatography. Sixteen pesticides were detected in 45 agricultural product samples, which were 38 general, 6 low pesticide and 1 of GAP agricultural product samples and the detection rate was 33.6%. Pesticides detected in agricultural product samples were cypermethrin, lufenuron, fenvalerate, bifenthrin, chlorfenapyr and iprodione. Residual concentration of 18 samples were exceeded the recommended maximum residue limit set by Ministry of Food and Drug Safety and two kinds of unregistered pesticides in korea were also detected in two samples. CONCLUSION(S): In order to do risk assessment by agricultural products consumption, estimated daily intake of residual pesticides were determined and compared to acceptable daily intake, referring to %ADI values. The range of %ADI values was from 0.038% to 2.748%. Taken together, it demonstrates the pesticides found in agricultural products samples were below the safety margin, indicating no effect on human health.

Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna;Eom, Yoon Ji;Kwon, Dohyung;Lee, Jae Hyok;Jung, In Chul;Cho, Eun;Lee, Ji Eun;Cho, Seung-Hun
    • Journal of Oriental Neuropsychiatry
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    • v.32 no.2
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    • pp.81-93
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    • 2021
  • Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

Heavy Metals and Pesticides with Maturing Process of Rehmanniae Radix Preparata (숙지황 제조과정에서 중금속과 잔류농약)

  • Kim, Jung-Ho;Yang, Joon-Young;Moon, Yung-Soo
    • Environmental Analysis Health and Toxicology
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    • v.22 no.3
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    • pp.255-261
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    • 2007
  • To obtain the risk assessment of hazardous materials with maturing process of Rehmanniae Radix Preparata, the residual heavy metals and pesticides in samples are surveyed. Concentration of As, Cd and Pb during the maturing process of Rehmanniae Radix Preparata of Korea are $0.147{\pm}0.007\;mg/L,\;0.025{\pm}0.001\;mg/L\;and\;0.193{\pm}0.021\;mg/L$, respectively. Concentration of As, Cd and Pb during the maturing process of Rehmanniae Radix Preparat of China are $0.0145{\pm}0.014\;mg/L,\;0.023{\pm}0.002\;mg/L\;and\;0.299{\pm}0.013\;mg/L$, respectively. Concentration of As, Cd and Hg remain unchanged during the maturing process of Rehmanniae Radix Preparata. Concentration of As, Cd and Pb in Rehmanniae Radix Preparat on the Korea are 3.53%, 6.66% and 5.16% for Korea Food & Drug Administration (KFDA) advisory level, respectively. The residual pesticides, such as aldrin, $BHC-{\alpha},\;BHC-{\beta},\;BHC-{\gamma},\;BHC-{\delta}$, captan, chlorfenapyr, chlorpyrifos, DDD, DDE, DDT-o,p, DDT-p.p, dieldrin, endosulfan-sulfate, $endosulfan-{\alpha}$, $endosulfan-{\beta}$, fenitrothion, penthoate, permethrin, quintozene, tolyfluanid and vinclozolin, are not detected in Rehmanniae Radix Preparat on the Korea and China. The hazardous materials in Rehmanniae Radix Preparata on the Korea and China are verified the safety of the residual heavy metals and pesticides compare with Korea Food & Drug Administration (KFDA) advistory level.

Determination of Mycotoxins in Agricultural Products Used for Food and Medicine Using Liquid Chromatography Triple Quadrupole Mass Spectrometry and Their Risk Assessment (LC-MS/MS를 이용한 식·약 공용 농산물의 곰팡이독소 분석 및 위해평가)

  • Choi, Su-Jeong;Ko, Suk-Kyung;Park, Young-Ae;Jung, Sam-Ju;Choi, Eun-Jung;Kim, Hee-sun;Kim, Eun-Jung;Hwang, In-Sook;Shin, Gi-Young;Yu, In-Sil;Shin, Yong-Seung
    • Journal of Food Hygiene and Safety
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    • v.36 no.1
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    • pp.24-33
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    • 2021
  • For this study, we surveyed concentrations of 8 mycotoxins (aflatoxin B1, B2, G1, G2, ochratoxin A, fumonisin B1, B2 and zearalenone) in agricultural products used for food and medicine by liquid chromatography-tandem mass spectrometry and conducted a risk assessment. Samples were collected at the Yangnyeong Market in Seoul, Korea, between January and November 2019. Mycotoxins were extracted from these samples by adding 0.1% formic acid in 50% acetonitrile and cleaned up by using an ISOLUTE Myco cartridge. The method was validated by assessing its matrix effects, linearity, limit of detection (LOD), limit of quantification (LOQ), recovery and precision using four representative matrices. Matrix-matched standard calibration was used for quantification and the calibration curves of all analytes showed good linearity (r2>0.9999). LODs and LOQs were in the range of 0.02-0.11 ㎍/kg and 0.06-0.26 ㎍/kg, respectively. Sample recoveries were from 81.2 to 118.7% and relative standard deviations lower than 8.90%. The method developed in this study was applied to analyze a total of 187 samples, and aflatoxin B1 was detected at the range of 1.18-7.29 ㎍/kg (below the maximum allowable limit set by the Ministry of Food and Drug Safety, MFDS), whereas aflatoxin B2, G1 and G2 were not detected. Mycotoxins that are not regulated presently in Korea were also detected: fumonisin (0.84-14.25 ㎍/kg), ochratoxin A (0.76-17.42 ㎍/kg), and zearalenone (1.73-15.96 ㎍/kg). Risk assessment was evaluated by using estimated daily intake (EDI) and specific guideline values. These results indicate that the overall exposure level of Koreans to mycotoxins due to the intake of agricultural products used for food and medicine is unlikely to be a major risk factor for their health.

Assessment of Both Standard and Isolated Vibrio parahaemolyticus on Efficacy of Commercial Sanitizers and Disinfectants (Vibrio parahaemolyticus 표준 및 식품분리 균주에 대한 살균소독제 유효성분별 감수성 평가)

  • Kim, Il-Jin;Kim, Yong-Su;Kim, Hyung-Il;Choi, Hyun-Chul;Jeon, Dea-Hoon;Lee, Young-Ja;Ha, Sang-Do
    • Journal of Food Hygiene and Safety
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    • v.22 no.2
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    • pp.127-131
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    • 2007
  • This study evaluated the bactericidal effect of 10 sanitizers and disinfectants such as ethanol (75 and 95%), iodine (15 and 25 ppm), chlorine (100 and 200 ppm), quaternary ammonium, acid, hydrogen peroxide, and peroxide acetic acid against V. parahaemolyticus. Ten strains of V. parahaemolyticus isolated from Korean foods and 4 strains of standard V. parahaemolyticus were compared for efficacies of various sanitizers and disinfectants by EN 1276 method based on quantitative suspension test. Ethanol (75 and 95%), 25 ppm of iodine, 100 ppm of quaternary ammonium, 145 ppm of hydrogen peroxide and acid showed more than $5log_{10}CFU/mL$ reduction in both clean and dirty conditions. Tests result of chlorine (100 ppm) showed more than $5log_{10}CFU/mL$ reduction in clean condition. Iodine (15 ppm) showed more than $5log_{10}CFU/mL$ reduction except 4 isolated and 1 standard V. parahaemolyticus in clean condition. iodine (15 ppm) also showed under $5log_{10}CFU/mL$ reduction $(0.93{\sim}3.73log_{10}CFU/mL)$ in dirty condition. Eleven hundred ppm of hydrogen peroxide was evaluated as weak sanitizer and disinfectant due to their $0.99{\sim}4.79log_{10}CFU/mL$ reduction on both clean and dirty conditions. Consequently, ethanol, iodine (25 ppm), chlorine (200 ppm), quaternary ammonium, acid and peroxide acetic acid were thought to be effective sanitizer and disinfectant against V. parahaemolyticus.

Web Accessibility of Healthcare Websites of Korean Government and Public Agencies: Automated and Expert Evaluations (정부 및 공공기관의 보건 관련 웹 사이트의 웹 접근성 - 자동 및 전문가 평가 -)

  • Yi, Yong Jeong
    • Journal of the Korean BIBLIA Society for library and Information Science
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    • v.26 no.4
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    • pp.283-304
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    • 2015
  • The purpose of this study was to identify Web accessibility issues of healthcare websites of the Korean government and public agencies by evaluating these websites' accessibility in accordance with the Korean Web Contents Accessibility Guideline. This study conducted both automated and expert testing to assess the accessibility of a total of 27 health-related websites. The results of the assessment which was conducted in two stages indicated that institutions such as the National Hospital and National Rehabilitation Center demonstrated almost no Web accessibility error. In addition, the Korea Health Insurance Review and Assessment Service, the Ministry of Health and Welfare, the Health Services Agency, the Ministry of Food and Drug Safety, and the Korea Medical Dispute Mediation and Arbitration Agency attained very high web accessibility. However, the results of an expert evaluation highlighted that there were considerable errors in providing appropriate alternative text, which was not found in the automated test, and the color contrast of the text content did not comply with Web accessibility standard. Therefore, these websites did not support web accessibility for the sight-impaired. Furthermore, the present study found that it was difficult to deliver accurate information to users due to errors in the default language display and markup, and also, issues of skipping repeated content, content linearization, and compliance with keyboard use were considered as challenges that might arise for people with sight, cognitive and mobility impairments with respect to Web accessibility. It is the first study that evaluated accessibility of healthcare websites of the Korean government and public agencies based on the Korean Web Contents Accessibility Guideline. The present study made a contribution to research on Web accessibility by conducting expert testing, which provided a more complete assessment that identified the degree and specific issues of accessibility errors when compared to automated testing.

Toxicity Assessment and Establishment Acceptable Daily Intake of Penthiopyrad (펜티오피라드(Penthiopyrad)의 독성평가와 일일섭취허용량 설정)

  • Jeong, Mi-Hye;Hong, Soon-Sung;Park, Kyung-Hun;Kim, Chan-Sub;Park, Jae-Eup;Hong, Moo-Ki;Im, Moo-Hyeog;Kim, Young-Bum;Han, Bum-Seok;Han, Jeung-Sul
    • The Korean Journal of Pesticide Science
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    • v.14 no.4
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    • pp.478-489
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    • 2010
  • Penthiopyrad is a fungicide agent in types of pyrazole which is showing the effect of prevention in fungal disease and powdery mildew. In order to register this new pesticide, reports of acute toxicity and chronic toxicity by animal study were examined to set acceptable daily intake to evaluate hazards of consumers. Acute toxicity was low in toxic, and it did not have the effect of acute dermal toxicity, acute eye irritation, or skin sensitization. As the result of the study in chronic toxicity, the common effect of chemical appeared in the liver and thyroid which was proven as a toxic effect. Two-generation reproduction toxicity, genotoxicity, and prenatal development toxicity were not proven. As the result of carcinogenic study, increase of thyiroid follicular adenoma in the rat and the frequency of liver hepatocellar adenoma in mice were also increased. However, it was decided that the threshold value on the effect in chemicals could be controlled through study liver enzyme induction. Therefore, the ADI for penthiopyrad is 0.081 mg/kg/ bw/day, based on the NOAEL of 8.10 mg/kg bw/day of twelve-months dogs study and applying an uncertainty factor of 100.

Assessment of the Abuse Liability of Synthetic Cannabinoid Agonists JWH-030, JWH-175, and JWH-176

  • Tampus, Reinholdgher;Yoon, Seong Shoon;Pena, June Bryan de la;Botanas, Chrislean Jun;Kim, Hee Jin;Seo, Joung-Wook;Jeong, Eun Ju;Jang, Choon Gon;Cheong, Jae Hoon
    • Biomolecules & Therapeutics
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    • v.23 no.6
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    • pp.590-596
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    • 2015
  • The emergence and use of synthetic cannabinoids have greatly increased in recent years. These substances are easily dispensed over the internet and on the streets. Some synthetic cannabinoids were shown to have abuse liability and were subsequently regulated by authorities. However, there are compounds that are still not regulated probably due to the lack of abuse liability studies. In the present study, we assessed the abuse liability of three synthetic cannabinoids, namely JWH-030, JWH-175, and JWH-176. The abuse liability of these drugs was evaluated in two of the most widely used animal models for assessing the abuse potential of drugs, the conditioned place preference (CPP) and self-administration (SA) test. In addition, the open-field test was utilized to assess the effects of repeated (7 days) treatment and abrupt cessation of these drugs on the psychomotor activity of animals. Results showed that JWH-175 (0.5 mg/kg), but not JWH-030 or JWH-176 at any dose, significantly decreased the locomotor activity of mice. This alteration in locomotor activity was only evident during acute exposure to the drug and was not observed during repeated treatment and abstinence. Similarly, only JWH-175 (0.1 mg/kg) produced significant CPP in rats. On the other hand, none of the drugs tested was self-administered by rats. Taken together, the present results indicate that JWH-175, but not JWH-030 and JWH-176, may have abuse potential. More importantly, our findings indicate the complex psychopharmacological effects of synthetic cannabinoids and the need to closely monitor the production, dispensation, and use of these substances.

Determination of Heavy Metal Concentration in Herbal Medicines by GF-AAS and Automated Mercury Analyzer

  • Kim, Sang-A;Kim, Young-Jun
    • Journal of Food Hygiene and Safety
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    • v.36 no.4
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    • pp.281-288
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    • 2021
  • This study was conducted to analyze and compare the concentrations of heavy metals in 430 different products of 20 types of herbal medicines available in the domestic market in Korea by Graphite Furnace-Atomic Absorption Spectrometry (GF-AAS) and automated mercury analyzer. The accuracy for lead (Pb), arsenic (As), cadmium (Cd), and mercury (Hg) was in the range 92.67-102.56%, and the precision was 0.21-6.00 relative standard deviation (RSD%), which was in compliance with the Codex acceptable range. Furthermore, the Food Analysis Performance Assessment Scheme (FAPAS) quality control (QC) material showed a recovery range of 96.7-102.0% and 0.33-4.93 RSD%. The average contents (㎍/kg) of Pb, As, Cd, and Hg in herbal medicines were 254.9 (not detected (N.D.)-2,515.2), 171.0 (N.D.-2,465.2), 99.2 (N.D.-797.1), and 6.0 (N.D.-83.6), respectively. Based on the quantitative analysis results, the heavy metal contents of 20 types of herbal medicines distributed in Korea are within the acceptable range according to the standards issued by the Ministry of Food and Drug Safety (MFDS). By using the manufacturer of herbal products as the standard for QC, the Pb, As, Cd, and Hg contents were investigated in the packaging process just before distribution to determine the actual conditions of residual heavy metals in herbal medicines. Thus, these result may contribute to monitoring the QC of herbal medicines distributed in Korea and could provide basic data for supplying safe herbal medicines to the public.

Development and evaluation of next-generation cardiotoxicity assay based on embryonic stem cell-derived cardiomyocytes

  • Ryu, Bokyeong;Choi, Seong Woo;Lee, Seul-Gi;Jeong, Young-Hoon;Kim, Ukjin;Kim, Jin;Jung, Cho-Rok;Chung, Hyung-Min;Park, Jae-Hak;Kim, C-Yoon
    • BMB Reports
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    • v.53 no.8
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    • pp.437-441
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    • 2020
  • In accordance with requirements of the ICH S7B safety pharmacology guidelines, numerous next-generation cardiotoxicity studies using human stem cell-derived cardiomyocytes (CMs) are being conducted globally. Although several stem cell-derived CMs are being developed for commercialization, there is insufficient research to verify if these CMs can replace animal experiments. In this study, in vitro high-efficiency CMs derived from human embryonic stem cells (hESC-CMs) were compared with Sprague-Dawley rats as in vivo experimental animals, and primary cultured in vitro rat-CMs for cardiotoxicity tests. In vivo rats were administrated with two consecutive injections of 100 mg/kg isoproterenol, 15 mg/kg doxorubicin, or 100 mg/kg nifedipine, while in vitro rat-CMs and hESC-CMs were treated with 5 μM isoproterenol, 5 μM doxorubicin, and 50 μM nifedipine. We have verified the equivalence of hESC-CMs assessments over various molecular biological markers, morphological analysis. Also, we have identified the advantages of hESC-CMs, which can distinguish between species variability, over electrophysiological analysis of ion channels against cardiac damage. Our findings demonstrate the possibility and advantage of high-efficiency hESC-CMs as next-generation cardiotoxicity assessment.