가축질병의 진단과 치료를 위한 유전자기술의 활용에 관한 법적 쟁점

왕승혜(Wang Seung hye) 충북대학교 법학연구소 2016 과학기술과 법 Vol.7 No.2

Regulation of gene technology should be applied differently depending on contents of individual genetic technology, its scope of application, and effect. At this time, it is desirable to establish the legislations that specify the content, method, and degree of differentiated regulation according to the characteristics of genetic technology by delegated administrative legislation or the rules of the specialized agencies, taking into consideration the characteristics of each genetic technology applied to veterinary health. The European Parliament is now restructuring the regulation of veterinary medicine in 2015. March 18, 2015, European Parliament’s Environmental Health Food Safety Committee (Environment, Public Health and Food Safety (ENVI) committee) hold a meeting on the European Union Regional Animal Pharmaceutical market regulation to simplify and comprehensively readjust it for amendment to the agreement. The background of regulatory change is designed to separate the regulatory sysstem into dual system, human medicine and veterinary medicine. Until the European Union has maintained in parallel system the human medicine and the veterinary drug. But human medicines and veterinary medicine was recognized as a needed separated regulatory object. However, the European Parliament recognized the problem of law enforcement based on the type of guidelines and decisions adopted inside the European Commission s revised guidelines for medicines in 2009 for animals. In the decision it proposed to the European Commission, while strengthening the supervision of animal food veterinary medicine remaining in the system at the same time restructuring the norms so as not to discourage the availability of veterinary medicine. Efforts of these changes has been promoted for the past five years the drug regulatory system for animals in the future. Our country also needs to develop regulatory tools how to manage separately human medicine and veterinary medicine so as to promote public health protection, while ensuring the possibility of appropriate use of medicines and medical devices applied with genetic technology for animals.

LC/MS를 이용한 수산물 중 다양한 잔류물질 분석

김효정 ( Hyo Jeong Kim ),이다희 ( Da Hee Lee ),류경열 ( Kyung Yoal Ryu ),송지영 ( Ji Young Song ),노기미 ( Ki Mi No ),이지혜 ( Ji-hye Lee ),윤고은 ( Goeun Yun ),최소희 ( So-hee Choi ),장은영 ( Eun Young Jang ),서수경 ( Soo Kyung S 한국환경농학회 2022 한국환경농학회 학술대회집 Vol.2022 No.-

Fishery products are involuntarily exposed to many harmful substances like a pesticide and veterinary drugs. Especially, contamination of pesticide and veterinary drugs on fishery products could be derived from the aquatic environment and the accumulation of residues causes undesirable effects on human health. In this study, we estimated a multi-residue analysis method for the determination of 115 pesticides and 76 veterinary drugs in fishery products using liquid chromatography-tandem mass spectrometry (LC-MS/MS). Matrix-matched calibrations of 76 veterinary drugs were performed at MRL (0.5 MRL, 1 MRL, 2 MRL) or LOQ (1 LOQ, 2 LOQ, 10 LOQ) on flatfish, eel, and shrimp. This study was conducted 2 g of each sample. The accuracy, precision, and linearity were satisfied with the intra-laboratory level according to the Codex Guidelines (CAC/GL-40) in terms of accuracy (recoveries between 60 and 120%) and precision (relative standard deviation below 20%). It shows that the proposed method is acceptable for the multi-residue analysis of 76 veterinary drugs in fishery products. Further studies are required to apply for the simultaneous determination of target pesticides and to enlarge several fishery products.

인천 유통 수산물 중 잔류동물용의약품 조사

장진섭(Jin-Seob Jang),허명제(Myong-Je Hur),김명희(Meyong-Hee Kim),한영선(Young-Sun Han),권성희(Sung-Hee Kwon),여은영(Eun-Young Yeo),홍성희(Seong-Hee Hong),김지선(Ji-Sun Kim),이승리(Seung-Ri Lee) 한국환경보건학회 2018 한국환경보건학회지 Vol.44 No.5

Objectives: This study was carried out to provide safe seafood to the public through simultaneous analysis rapid inspections for residual veterinary drugs in 150 fishery products in 2016. Methods: Quinolones (9), Sulfonamides (14), Penicillins (2), Cephalosporins (3), Tetracyclines (4), Macrolides (4), Lincosamides (2), Pleuromutilin (1), Phenicols (4), benzylpyrimidines (2), Others (1) Malachite green (2), and Melamine (1) were analyzed for 49 species using by HPLC and HPLC-MSMS. Results: There were six unsuitable samples, five among fish and one for crustaceans. Within the standard detection were five fish. The antibiotics found were Quinolones (50%), Tetracyclines (33%) and Penicillins (17%). Conclusions: As a result of the experiment, there were six unsuitable samples, five for fish and one for crustaceans. The most prevalent antibiotics were Quinolones. The quinolone antibiotics are highly persistent in fish tissues, so they require more time than the withdrawal period for other common veterinary drugs. Careful attention is required when they are used in fish farms.

Development of a simultaneous multi-residue analysis for screening and confirmation of 7 veterinary drugs in bovine milk by LC-MSMS

김민경,김남선,권현정,하성용,김희선,김종원 한국예방수의학회 2019 예방수의학회지 Vol.43 No.2

A simple and fast analytical method based on liquid chromatography-tandem mass spectrometry was developed for detection of the veterinary drugs acetanilide, anthranilic acid, antipyrine, cyproheptadine, diphenhydramine, DLmethylephedrine, and phenacetin in bovine milk. The target analytes were extracted from milk samples by using acetonitrile followed by clean-up with C18 and liquid-liquid purification with saturated n-hexane. A reverse-phase analytical column was employed with a mobile phase comprising (A) 0.1% formic acid in distilled water and (B) 0.1% formic acid in acetonitrile to achieve the best chromatographic separation. Matrix-matched calibration curves (r2 ≥ 0.9986) were constructed using six concentrations (1, 2, 5, 10, 20, and 40 μg/kg) of drugs in the milk matrix. Recoveries at three drug-spiking levels (5, 10, and 20 μg/kg) ranged from 71.2% to 103.8% with intra-day and inter-day relative standard deviation (RSD) values of ≤ 8.6%. The calculated limits of quantification (LOQ) were 0.19-7.1 μg/kg.

Development of a simultaneous multi-residue analysis for screening and confirmation of 7 veterinary drugs in bovine milk by LC-MSMS

MinKyoung Kim,NamSun Kim,HyunJung Kwon,SungYong Ha,HeeSun Kim,JongWon Kim 한국예방수의학회 2019 예방수의학회지 Vol.43 No.2

A simple and fast analytical method based on liquid chromatography-tandem mass spectrometry was developed for detection of the veterinary drugs acetanilide, anthranilic acid, antipyrine, cyproheptadine, diphenhydramine, DLmethylephedrine, and phenacetin in bovine milk. The target analytes were extracted from milk samples by using acetonitrile followed by clean-up with C18 and liquid-liquid purification with saturated n-hexane. A reverse-phase analytical column was employed with a mobile phase comprising (A) 0.1% formic acid in distilled water and (B) 0.1% formic acid in acetonitrile to achieve the best chromatographic separation. Matrix-matched calibration curves (r2 ≥ 0.9986) were constructed using six concentrations (1, 2, 5, 10, 20, and 40 μg/kg) of drugs in the milk matrix. Recoveries at three drug-spiking levels (5, 10, and 20 μg/kg) ranged from 71.2% to 103.8% with intra-day and inter-day relative standard deviation (RSD) values of ≤ 8.6%. The calculated limits of quantification (LOQ) were 0.19-7.1 μg/kg.

Marbofloxacin-encapsulated microparticles provide sustained drug release for treatment of veterinary diseases

Lee, J.,Kwon, H.J.,Ji, H.,Cho, S.H.,Cho, E.H.,Han, H.D.,Shin, B.C. Elsevier S.A. 2016 Materials Science and Engineering C Vol. No.

<P>Fluoroquinolone antibiotics with concentration-dependent killing effects and a well-established broad spectrum of activity are used commonly to treat infectious diseases caused by bacteria. However, frequent and excessive administration of these antibiotics is a serious problem, and leads to increased number of drug-resistant bacteria. Thus, there is an urgent need for novel fluoroquinolone antibiotic formulations that minimize the risk of resistance while maximizing their efficacy. In this study, we developed intramuscularly injectable polymeric microparticles (MPs) that encapsulated with marbofioxacin (MAR) and were composed of poly(D,L-lactide-co-glycolic acid) (PLGA) and poloxamer (POL). MAR-encapsulated MP (MAR-MP) had a spherical shape with particle size ranging from 80 mu m to 120 mu m. Drug loading efficiency varied from 55 to 85% (w/w) at increasing amount of hydrophilic agent, POL. Drug release from MAR-MP demonstrated a significant and sustained increase at increased ratios of POL to PLGA. These results indicate that MAR-MP is an improved drug delivery carrier for fluoroquinolone antibiotics, which can reduce the number of doses needed and sustain a high release rate of MAR for 2-3 days. As a novel and highly effective drug delivery platform, MAR-MP has great potential for use in a broad range of applications for the treatment of various veterinary diseases. (C) 2015 Published by Elsevier B.V.</P>

반려동물애호가 대상 동물의약품 사용 및 동물약국 이용 현황 조사

안화영,김현지,허지선,여승언,김유환,천영주,임성실,Ahn, Hwa Young,Kim, Hyun Ji,Heo, Ji Seon,Yeo, Seung Eun,Kim, Yu Hwan,Cheon, Young Ju,Lim, Sung Cil 한국임상약학회 2022 한국임상약학회지 Vol.32 No.1

Background: In modern society, the number of households raising companion animals increases, and the market for veterinary medicines is expanding even more. This study aims to investigate the perception of companion animal lovers' veterinary medicines, the necessity of specific guidance by pharmacists for veterinary medicines, the role of pharmacists at veterinary pharmacies, and ways to fulfill that role. Methods: This study evaluated veterinary medicines and medication guidance through Google online questionnaire targeting pet-lovers from December 20, 2021, until January 19, 2022. The questions consist of 1) characteristics of petlovers, 2) purchase history and drug recognition of veterinary drugs, 3) use of veterinary vaccines, 4) use of diagnostic kits, and 5) guidance of veterinary medicines by local pharmacists. Results: The respondents' experience purchasing veterinary drugs was as high as 94.4%. The most purchased drug was heartworm-preventing products, and vaccination was performed mainly at veterinary clinics (veterinarians). The respondents primarily purchased veterinary medicines for companion animals at veterinary hospitals and did not know the name of the drugs which they bought. In addition, respondents expected to receive specific information on veterinary medicines from pharmacists. Conclusion: As the number of veterinary pharmacies in the community will increase with the expansion of the companion animal market, pharmacists should play their role as experts in veterinary medicines through systematic and continuous professional education.

자료 : 식품 중 잔류동물용의약품의 안전관리

오재호 ( Jae Ho Oh ),권찬혁 ( Chan Hyeok Kwon ),전종섭 ( Jong Sup Jeon ),최동미 ( Dong Mi Choi ) 韓國環境農學會 2009 한국환경농학회지 Vol.28 No.3

동물용의약품은 가축의 질병예방 및 치료, 성장 촉진 등 생산성을 높이는 목적으로 사용되는 의약품임에도 불구하고 무분별하게 과용 또는 남용되면 축·수산물에 잔류하게 되고 장기간 노출될 경우 인체에 유해할 수 있기 때문에 관리가 필요한 물질이다. 국내 동물용의약품의 관리는 국립수의과학 검역원에서 국내 사용되는 동물용의약품의 허가를 담당하고 있으며, 식품의약품안전청은 해당 동물용의약품의 잔류자료, 일일섭취허용량, 식품섭취량 및 국민평균체중 등을 이용하여 위해평가를 실시하고 그에 알맞은 잔류허용기준을 고시하고 있다. 현재 국내의 동물용의약품에 대한 잔류허용기준은 116개가 고시되어 있으며, 2009년 말까지 총 142종에 대하여 기준이 설정될 예정이다. 또한 2010년 1월 1일부터 축수산물(유, 알 포함) 및 벌꿀에서 기준 미설정 항생제 및 합성항균제가 검출될 경우 0.03 mg/kg의 일률기준을 적용함으로써 축·수산물에 대한 안전관리가 강화하게 된다. 현재 동물용의 약품의 기준관리는 이미 선진국 수준으로 운영되고 있으며, 잔류분석법도 또한 국제적 수준에 맞게 개선할 예정이다. Veterinary drugs have been used to prevent livestock diseases for many years. In spite of having advantages, sometimes indiscriminate application, overdose and abuse may cause risk for human. Therefore, management and risk assessment of veterinary drugs become essential to ensure food safety. So the National Veterinary Research & Quarantine Service (NVRQS) impose on registration for use of veterinary drugs also Korea Food and Drug Administration (KFDA) fixed the maximum residue limits (MRLs) for veterinary drugs in food. Basically, KFDA set MRLs based on the veterinary drugs residual data. Moreover, KFDA estimates the theoretical maximum daily intake (TMDI) with food consumption data and population mean body weight. Recently, 116 veterinary drug MRLs including banned veterinary drugs have been established and other 32 veterinary drugs MRLs will be established within 2009. In 2010, MRLs among antibiotics and synthetic antibacterial agents in livestock fishery products (including milk and eggs) and honey (including royal jelly and propolis) which have not been set in Korea Food Code and Codex Alimentarius Commission (CAC) will be regulated as uniform limit (0.03 mg/kg). In future, veterinary drugs will be controlled strictly to strengthen public health by improving analytical method.

충남지역에서 생산되는 양식수산물의 잔류 동물용의약품 모니터링

이강범,김남우,김동욱,신명희,이미영 한국식품위생안전성학회 2020 한국식품위생안전성학회지 Vol.35 No.5

For this study, we conducted a simultaneous multiresidue analysis of veterinary drugs in cultured fishery products in Chungnam Province in 2018. A total of 115 fishery product samples were obtained from fish farms and fishery production sites located in the province. In all, 29 residual veterinary drugs in the samples were analyzed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. As a result, veterinary drug residues were only detected in a small number of the 106 samples (92.2%), and the detection rate was 7.8% (9 of 115 samples). The amounts were also below maximum residual limit (MRL) for fishery products, although one sample exceeded the MRL allowed by the Ministry of Food and Drug Safety and was detected in loach. The nine residual veterinary drugs were detected in 8 samples: loach, eel, catfish, freshwater bream, flatfish, rockfish and shrimp. The detected veterinary drugs were oxolinic acid, enrofloxacin, ciprofloxacin, sulfadiazine, flumequine and oxytetracycline. The most frequently detected antibiotic was oxolinic acid, and enrofloxacin exceeded the MRL in loach sample. Residues of most veterinary drugs were either not detected or were below the MRL, and while the status of fishery products is seen as safe overall, current surveillance efforts over veterinary drugs should be continued.

Reducing Veterinary Drug Residues in Animal Products: A Review

Md Shohel Rana,Seung Yun Lee,Hae Jin Kang,Sun Jin Hur 한국축산식품학회 2019 한국축산식품학회지 Vol.39 No.5

A survey we conducted suggests that the ingestion of veterinary drug residues in edible animal parts constitutes a potential health hazard for its consumers, including, specifically, the possibility of developing multidrug resistance, carcinogenicity, and disruption of intestinal normal microflora. The survey results indicated that antibiotics, parasitic drugs, anticoccidial, or nonsteroidal anti-inflammatory drugs (NSAIDs) are broadly used, and this use in livestock is associated with the appearance of residues in various animal products such as milk, meat, and eggs. We observed that different cooking procedures, heating temperatures, storage times, fermentation, and pH have the potential to decrease drug residues in animal products. Several studies have reported the use of thermal treatments and sterilization to decrease the quantity of antibiotics such as tetracycline, oxytetracycline, macrolides, and sulfonamides, in animal products. Fermentation treatments also decreased levels of penicillin and pesticides such as dimethoate, malathion, Dichlorodiphenyldichloroethylene, and lindane. pH, known to influence decreases in cloxacillin and oxacillin levels, reportedly enhanced the dissolution of antimicrobial drug residues. Pressure cooking also reduced aldrin, dieldrin, and endosulfan in animal products. Therefore, this review provides updated information on the control of drug residues in animal products, which is of significance to veterinarians, livestock producers, and consumer health.