• Title/Summary/Keyword: drug safety

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Study Analysis of Isocycloseram and Its Metabolites in Agricultural Food Commodities

  • Ji Young Kim;Hyochin Kim;Su Jung Lee;Suji Lim;Gui Hyun Jang;Guiim Moon;Jung Mi Lee
    • Korean Journal of Environmental Agriculture
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    • v.42 no.1
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    • pp.71-81
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    • 2023
  • An accurate and easy-to-use analytical method for determining isocycloseram and its metabolites (SYN549431 and SYN548569) residue is necessary in various food matrixes. Additionally, this method should satisfy domestic and international guidelines (Ministry of Food and Drug Safety and Codex Alimentarius Commission CAC/GL 40). Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS) was used to determine the isocycloseram and its metabolites residue in foods. To determine the residue and its metabolites, a sample was extracted with 20 mL of 0.1% formic acid in acetonitrile, 4 g magnesium sulfate anhydrous and 1 g sodium chloride and centrifuged (4,700 G, 10 min, 4℃). To remove the interferences and moisture, d-SPE cartridge was performed before LC-MS/MS analysis with C18 column. To verify the method, a total of five agricultural commodities (hulled rice, potato, soybean, mandarin, and red pepper) were used as a representative group. The matrix-matched calibration curves were confirmed with coefficients of determination (R2) ≥ 0.99 at a calibration range of 0.001-0.05 mg/kg. The limits of detection and quantification were 0.003 and 0.01 mg/kg, respectively. Mean average recoveries were 71.5-109.8% and precision was less than 10% for all five samples. In addition, inter-laboratory validation testing revealed that average recovery was 75.4-107.0% and the coefficient of variation (CV) was below 19.4%. The method is suitable for MFDS, CODEX, and EU guideline for residue analysis. Thus, this method can be useful for determining the residue in various food matrixes in routine analysis.

Development of a LC-MS/MS method for simultaneous analysis of 20 antihistamines in dietary supplements (LC-MS/MS를 이용한 건강기능식품 내 항히스타민 20종 동시분석법 개발)

  • Do, Jung-Ah;Kim, Jung Yeon;Choi, Ji Yeon;Lee, Ji Hyun;Kim, Hyung Joo;Noh, Eunyoung;Cho, So-Hyun;Yoon, Chang-Yong;Kim, Woo-Seong
    • Analytical Science and Technology
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    • v.28 no.2
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    • pp.86-97
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    • 2015
  • Recently, the consumption of dietary supplements has increased because of people’s greater interest in health. Unfortunately, the sales of dietary supplements containing unauthorized substances such as drugs have also increased. We developed a rapid, accurate method for the simultaneous determination of antihistamines using liquid chromatography tandem mass spectrometry with a multiple reaction monitoring mode. The limit of detection (LOD) and limit of quantification (LOQ) of the instrument used in this method were in the ranges 0.0003-0.3 and 0.0009-0.6 µg mL−1, respectively. The linearity of the method was > 0.99. The precision levels of the method were 0.1-9.8% (intra-day) and 0.3-9.6% (inter-day), and the levels of accuracy of the method were 82.7-115.0% (intra-day) and 84.3-113.0% (inter-day). The mean of recovery of the method was in the range of 83.9-117.9% and the RSD of the stability was less than 5.9%.

Neurotoxicity of Synthetic Cannabinoids JWH-081 and JWH-210

  • Cha, Hye Jin;Seong, Yeon-Hee;Song, Min-Ji;Jeong, Ho-Sang;Shin, Jisoon;Yun, Jaesuk;Han, Kyoungmoon;Kim, Young-Hoon;Kang, Hoil;Kim, Hyoung Soo
    • Biomolecules & Therapeutics
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    • v.23 no.6
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    • pp.597-603
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    • 2015
  • Synthetic cannabinoids JWH-018 and JWH-250 in 'herbal incense' also called 'spice' were first introduced in many countries. Numerous synthetic cannabinoids with similar chemical structures emerged simultaneously and suddenly. Currently there are not sufficient data on their adverse effects including neurotoxicity. There are only anecdotal reports that suggest their toxicity. In the present study, we evaluated the neurotoxicity of two synthetic cannabinoids (JWH-081 and JWH-210) through observation of various behavioral changes and analysis of histopathological changes using experimental mice with various doses (0.1, 1, 5 mg/kg). In functional observation battery (FOB) test, animals treated with 5 mg/kg of JWH-081 or JWH-210 showed traction and tremor. Their locomotor activities and rotarod retention time were significantly (p<0.05) decreased. However, no significant change was observed in learning or memory function. In histopathological analysis, neural cells of the animals treated with the high dose (5 mg/kg) of JWH-081 or JWH-210 showed distorted nuclei and nucleus membranes in the core shell of nucleus accumbens, suggesting neurotoxicity. Our results suggest that JWH-081 and JWH-210 may be neurotoxic substances through changing neuronal cell damages, especially in the core shell part of nucleus accumbens. To confirm our findings, further studies are needed in the future.

Guideline for Bioequivalence Studies of Controlled Release Products (서방성 제제의 생물학적동등성시험을 위한 가이드라인)

  • Seo, Hyun-Ok;Kim, So-Hee;Ahn, Mee-Ryung;Ahn, Choong-Yul;Park, Hye-Jin;Oh, Eun-Kyung;Lee, Eun-Ju;Kim, Bo-Yeon;Kim, Min-Jeong;Woo, Na-Ry;Seo, Hee-Won;Chung, Soo-Youn
    • Journal of Pharmaceutical Investigation
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    • v.40 no.1
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    • pp.63-66
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    • 2010
  • The "Guidance Document for Bioequivalence Study" was revised for adding to bioequivalence studies of controlled-release products after meal(Korea Food & Drug Administration Notification #2008-22, 2008.5.7). The bioequivalence study design for controlled-release products is $2{\times}2$ crossover under fast and fed condition in respect. For studies of controlled-release products under fed study, the same high-fat diet should be taken within 20 minutes in at least a 10-hour fasting state. The drug products should be administered 30 minutes after the meal started. A high-fat(more than 35 percent of total caloric content of the meal) and high-calorie(over 900 calories) meal is recommended as a test meal for fed BE studies.

Dependence Potential of Quetiapine: Behavioral Pharmacology in Rodents

  • Cha, Hye Jin;Lee, Hyun-A;Ahn, Joon-Ik;Jeon, Seol-Hee;Kim, Eun Jung;Jeong, Ho-Sang
    • Biomolecules & Therapeutics
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    • v.21 no.4
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    • pp.307-312
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    • 2013
  • Quetiapine is an atypical or second-generation antipsychotic agent and has been a subject of a series of case report and suggested to have the potential for misuse or abuse. However, it is not a controlled substance and is not generally considered addictive. In this study, we examined quetiapine's dependence potential and abuse liability through animal behavioral tests using rodents to study the mechanism of quetiapine. Molecular biology techniques were also used to find out the action mechanisms of the drug. In the animal behavioral tests, quetiapine did not show any positive effect on the experimental animals in the climbing, jumping, and conditioned place preference tests. However, in the head twitch and self-administration tests, the experimental animals showed significant positive responses. In addition, the action mechanism of quetiapine was found being related to dopamine and serotonin release. These results demonstrate that quetiapine affects the neurological systems related to abuse liability and has the potential to lead psychological dependence, as well.

Development of Primer Sets for the Detection of Polygonum multiflorum, Cynanchum wilfordii and C. auriculatum (유전자 마커를 이용한 하수오, 백수오 및 이엽우피소 종 판별법 개발)

  • Kim, Kyu-Heon;Kim, Yong-Sang;Kim, Mi-Ra;Lee, Ho-Yeon;Lee, Kyu Ha;Kim, Jong Hwan;Seong, Rack Seon;Kang, Tae Sun;Lee, Jin-Ha;Jang, Young-Mi
    • Journal of Food Hygiene and Safety
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    • v.30 no.3
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    • pp.289-294
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    • 2015
  • The aim of this study was to develop rapid screening method for the identification of Chinese herbal medicine species with similar appearance, Polygonum multiflorum, Cynanchum wilfordii and C. auriculatum, by using genetic markers. As a genetic marker, psbA-trnH gene in chloroplast was selected due to differences in sequence among the three species. Species-specific primers were designed based on the sequences of the marker gene of P. multiflorum, C. wilfordii, and C. auriculatum, and the expected size of PCR products was 160, 147, and 119 bp, respectively. Under the developed conditions, cross-reaction was not detected among these three plant species. To confirm the efficiency of our species-specific primers, the optimized method was applied to a variety of processed products composed of mostly P. multiflorum and C. wilfordii, demonstrating that our method was a rapid and easy screening assay. Our findings suggest this screening method can be utilized to prevent the distribution of economically motivated adulteration food and to improve consumer's right.

Total Diet Studies as a Tool for Ensuring Food Safety

  • Lee, Joon-Goo;Kim, Sheen-Hee;Kim, Hae-Jung;Yoon, Hae-Jung
    • Toxicological Research
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    • v.31 no.3
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    • pp.221-226
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    • 2015
  • With the diversification and internationalization of the food industry and the increased focus on health from a majority of consumers, food safety policies are being implemented based on scientific evidence. Risk analysis represents the most useful scientific approach for making food safety decisions. Total diet study (TDS) is often used as a risk assessment tool to evaluate exposure to hazardous elements. Many countries perform TDSs to screen for chemicals in foods and analyze exposure trends to hazardous elements. TDSs differ from traditional food monitoring in two major aspects: chemicals are analyzed in food in the form in which it will be consumed and it is cost-effective in analyzing composite samples after processing multiple ingredients together. In Korea, TDSs have been conducted to estimate dietary intakes of heavy metals, pesticides, mycotoxins, persistent organic pollutants, and processing contaminants. TDSs need to be carried out periodically to ensure food safety.

Development of a Quantitative Analytical Method for Determining the Concentration of Human Urinary Paraben by LC-MS/MS

  • Lee, Seung-Youl;Son, Eunjung;Kang, Jin-Young;Lee, Hee-Seok;Shin, Min-Ki;Nam, Hye-Seon;Kim, Sang-Yub;Jang, Young-Mi;Rhee, Gyu-Seek
    • Bulletin of the Korean Chemical Society
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    • v.34 no.4
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    • pp.1131-1136
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    • 2013
  • Parabens, the esters of p-hydroxybenzoic acid, have been widely used as antimicrobial preservatives in cosmetic products, drugs, and processed foods and beverages. However, some parabens have been shown to have weak estrogenic effects through in vivo and in vitro studies. Because such widespread use has raised concerns about the potential human health risks associated with exposure to parabens, we developed a simultaneous analytical method to quantify 4 parabens (methyl, ethyl, propyl, and butyl) in human urine, by using solid-phase extraction and high-performance liquid chromatography coupled with triple quadrupole mass spectrometry. This method showed good specificity, linearity ($R^2$ > 0.999), accuracy (92.2-112.4%), precision (0.9-9.6%, CV), and recovery (95.7-102.0%). The LOQs for the 4 parabens were 1.0, 0.5, 0.2, and 0.5 ng/mL, respectively. This method could be used for quick and accurate analysis of a large number of human samples in epidemiological studies to assess the prevalence of human exposure to parabens.

Establishment of Analytical Method for Residues of Ethychlozate, a Plant Growth Regulator, in Brown Rice, Mandarin, Pepper, Potato, and Soybean Using HPLC/FLD

  • Kim, Jae-Young;Lee, Jin Hwan;Lee, Sang-Mok;Chae, Young-Sik;Rhee, Gyu-Seek;Chang, Moon-Ik
    • Korean Journal of Environmental Agriculture
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    • v.34 no.2
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    • pp.111-119
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    • 2015
  • BACKGROUND: Ethychlozate (ECZ) is a plant growth regulator of synthetic auxin for agricultural commodities (ACs). Accurate and sensitive method to determine ECZ in diverse ACs on global official purpose is required to legal residue regulation. As the current official method is confined to the limited type of crops with poor validation, this study was conducted to improve and extend the ECZ method using high-performance liquid chromatography (HPLC) in all the registered crops with method verification. METHODS AND RESULTS: ECZ and its acidic metabolite (ECZA) were both extracted from acidified samples with acetone and briefly purified by dichloromethane partition. ECZ was hydrolyzed to form ECZA and the combined ECZA was finally purified by ion-associated partition including hexane-washing. The instrumental quantitation was performed using HPLC/ FLD under ion-suppression of ECZA with no interference by sample co-extractives. The average recoveries of intra- and inter-day experiment ranged from 82.0 to 105.2% and 81.7 to 102.8%, respectively. The repeatability and reproducibility for intra- and inter-day measurements expressed as a relative standard deviation was less than 8.7% and 7.4%, respectively. CONCLUSION: Established analytical method for ECZ residue in ACs was applicable to the nation-wide pesticide residues monitoring program with the acceptable level of sensitivity, repeatability and reproducibility.

Determination of streptomycin in kiwifruit samples using LC-ESI-MS/MS (LC-ESI-MS/MS를 이용한 키위 중 streptomycin 분석)

  • Do, Jung-Ah;Lee, Mi-Young;Cho, Yoon-Jae;Chang, Moon-Ik;Hong, Jin-Hwan;Oh, Jae-Ho
    • Analytical Science and Technology
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    • v.28 no.4
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    • pp.299-307
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    • 2015
  • In May 2012, a safety hazard issue arose because some kiwifruit growers in New Zealand had sprayed streptomycin to prevent kiwifruit canker. Therefore, for food safety management, analytical methods to determine streptomycin residues in kiwifruits are required. We developed an analytical method to determine streptomycin residues in kiwifruit samples using liquid chromatograph tandem mass spectrometer (LC-ESI-MS/MS). Streptomycin residues in samples were extracted using 1% formic acid in methanol, centrifugation for 10 min, and subsequent supernatant filtration. Purified samples were subjected to LC-ESI-MS/MS to confirm presence of and quantify streptomycin residues. Average streptomycin recoveries (6 replicates each sample) were in the range of 94.8%-110.6% with relative standard deviations of <10%. The linearity of the concentration range of 0.01-5.0 mg/kg using a matrix-matched calibration gave R2 = 0.9995. The limit of quantification (LOQ) was 0.01 mg/kg. Results showed that our analytical method is rapid, simple, and sensitive, with easy sample preparation.