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이해광,조양하,유규하,박해대,이창형,정호년,노혜원,정광훈,백동헌,장우익,김정구,이해빈 식품의약품안전청 2000 식품의약품안전청 연보 Vol.4 No.-
과학문명의 발전과 더불어 의료기기의 발전 추세는 한 가지 주요 기능 외에 부가적 기능을 겸비하는 다목적인 형태로 발전하고 있다. 이러한 다기능의료기기의 경우 부가기능이 주요 기능의 안전성에 위해를 가할 수 있으며, 또한 동작원리가 서로 다른 의료기기가 준합되어 사용되는 경우에는 전기적인 결합에 의한 간섭 등에 의하여 전기적인 위해의 요소가 증가할 수 있다. 파라서 본 연구에서는 대표적인 다기능 의료기기인 의료용 마취기를 중심으로, 제조사별 제품의 특성과 국제규격과의 조화를 고려하여 안전성 평가를 위한 기술규격을 개발하고자 한다. 또한 개발 확림된 의료용 마취71의 개별기준규격을 고시화하여, 페품의 안전성확보에 관한 기준규격으로의 유웅한 정보제공과 아울러 국제규격과 조화를 이룬 국내 제품의 개발 가능성을 극대화할 것으로 기대된다. The medical devi Purpose Ivhich includes additionalfunctions maf exert a harmful ices in these modern days have a current trend of multi-funci4ions other than major function. However,these additionalnfluence upon a major function such as potential risk of anaccordance with international standards, one of major multi-pumose rrom In)'estlgation ofvarious sl;andards on anaesthetic apparatus toThis standard directilye will be useful information to evaluatdomestic apparatus inharmony with international standards.
이해광,유규하,조양하,노혜원,박해대,이창형,정호년,양원선,김정구 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-
조직긍학은 의학 연구 분야에서 활발한 성장을 보이핀 있늘 분야로 떠오르고 있다. 이러한 조직공f·? 제푿들 대다수는 자연적이거나 생체재료와 조합된 니포구성 성력의 이용에 의존하고 있다. 하지만 쵤근 들어 인공피부, 인긍연골 등 조직긍학 계품이 급슥히 상품화되어 출시될 단계에 있으나 이fl 퍼한 안전성과 유효성 평가피준은 아직 정린되지 못하초 있는 상채이다. 이에 본 연구에서는 믿을만한 의학적 산둘로서 자리 매깅 할 인공연골을-비릇한 조픽공학 재품을 사람에 적용함에 있어 이에 대:한 안전 성쏙 성능 평가를 위한 일반적인 접근을 시도곯였다. 쪼직공학 재품의 쵱가기법과 관련된 제품의 개발 과정베서 반드시 고려리어야 할 분야에 대하여 기쑨하있다. 이에 대한 사항은 다음과 같아 요약될 수 있다 : 1) 세포 및 조직의 유래 ?) 세포 딪 조직의 특서 3; 싱페재료 f,1험 4) 품질보증 5) 픔질관리 6) 비인상 딪 7) 꼴상 펼가가 이엑 해당된다. 로글 코픽공착 제픔 가운데 세포의 유래에 차하여 콩속꼭친 분야왁 독린적인 분야호 영역을 분리하였다. 첫 1,4Fil 길우는 T·11룸의 작용기작이 진체의 극뚜건 부위엑서 구즈쓱 기논의 수복이나 재건을 목적으로 사욧쓴:=7 겄이. 투 껀째 경우는 711품의 작응기각이 진신적으로꺼 껑리학적이나 약리학적으로 활성들 나니내글- 게붐이다. 일반적으초 조직공학 제품의 안진겊곽 성늘 편가를 워한 기법의 개발은 장대적으로 오랜 기간 동안 찬자에게 이식되는 제품에 초점이 딱추어꼭 것이며, 본쳔케서는 제 1단계 사업으로꺼 현Rf 상품화 단끼에 있는 인공연골을 중심으로 안전성쓱 껑능에 패글 기적적인 가이드라인을 )If시하핀자 곡다. 이는 관련 재품의 개발에 도음이 될 것이라 믿는다. Tissue Engineering is a very promising field in biomedical research and development. Guidance of tissue engineered medical devices(TEMDs) is very important for the patients' safety and national welfare. Most of TEMDs consist of natural and/or biomedical polymers and polymer- cell/tissue component mixture. Some TEMDs like artificial skin and cartilage are in the stage of commercialization, however, the evaluation standards and testing methods are not prepared yet. In this study, we have developed a guidance for the function, biocompatibility and safety tests of tissue-engineered cartilage. The guidance contains the essential checking ponits in the development process of TEMDs, which are as follow ; 1) cell or tissue origin 2) cell or tissue characteristics 3) biomaterial test 4) quality assurance 5) quality control 6) non-clinical evaluation 7) clinical evaluation. TEMDs were divided into two categories according to the cell origin. The first category contains the devices used for repair and reconstruction of structural function of impaired tissues. The other category contains the systemic devices with physiological and pharmacological activity. Generally, the guideline for function and safety of TEMDs would be focused on the long-term implants. We believe that adoption of thes guidance of tissue-engineered cartilage sould lead to the products consistent in quality and performance as well as safety.
PLGA미립구의 크기에 따른 인간디스크세포의 증식 및 표현형 분석
소정원,김순희,백미옥,임지예,노혜원,이나리,김문석,유규하,조양하,이승진,민병현,강길선,이해방 한국조직공학과 재생의학회 2007 조직공학과 재생의학 Vol.2 No.1
The PLGA microspheres can create an environment conductive to promising candidate as an injectable system for tissue engineered intervertebral disc(IVD). The final goal of this study was to investigate the condition of PLGA microspheres as microcarriers for IVD cells. We prepared PLGA microspheres using oil-in-water(O/W) solvent evaporation method and investigated the size variation of the microspheres(180~425 μm). Human disc cells were used in a prospective study of attachment, proliferation, and gene expression within various size of PLGA microspheres. Mophology of cell attached on the microspheres was studied using scanning electron microscopy (SEM). Cellular behavior in response to various size of PLGA microspheres was analyzed using MTT assay and reverse transcriptase - polymerase chain reaction(RT-PCR). SEM showed that cells could be bridge between microspheres with elongated shapes. MTT assay revealed that the cells could be attach, proliferate and spread on PLGA microspheres, in particular on the ones having size below 250 μm. In RT-PCR results, we observed strongly specific gene expression of type collagen at more 250 μm microsphere. In conclusion, this result will be used to injectable system for disc regeneration.
양원선,조은정,신채민,오현주,노혜원,백성인,김민아,정정자,유규하,오현진,조양하 한국생체재료학회 2009 생체재료학회지 Vol.13 No.4
Acrylic resin bone cement is designed to fix artificial joints and implants onto bones. As such, bone cement functions to fill spaces between an implant and a bone, evenly disperse the pressure on the implant across the bone, and deliver antibiotics. This study surveyed the use status and development trends of acrylic resin bone cement and researched into various standards and literature in an effort to induce standard criteria for acrylic resin bone cement. Bone cement consists of powder and liquid; powder contains PMMA, polymerization initiators, and radiopaquer materials, and the liquid consist mainly of MMA monomers. Bone cement polymerization constitutes exothermic reaction, and the physical and mechanical properties of bone cement change according to polymerization conditions. Bone cement aims to couple implants with bones, but in the case of acrylic resin bone cement, tissue necrosis problems are being raised in association with not only such osteoconduction but also exothermic reaction; thus various research institutes are recently striving to develop diverse bioactive materials-based products in a bid to maintain the strength of bone cement and boost the adhesion of cement and bone. These products are producing good results with animal experiments, but, compared with existing PMMA products, they offer inconsistent manipulation and physical properties, and other problems such as unconfirmed internal side effects. A survey of bone cement standards in various nations indicated that there are such standards as ISO, ASTM, FDA Guidance and KS; ISO, ASTM, and KS offer similar test methods and test standards, while the FDA Guidance offers various methods designed to analyze physical, chemical and mechanical properties of bone cement. With an analysis of these standards, this study tested bone cement's compressive strength, bending strength, bending modulus, maximum temperature, and setting time by conducting physical and mechanical tests of bone cement. An extractable test was also conducted through chemical tests. In addition, for the verification of biological safety, pyrogen test, intracutaneous test, and acute toxicity test were conducted. Various test methods specified in each standard thus were verified, and finally the bone cement standards were determined. The suggested standards for bone cement offer results of the test of acrylic resin bone cement's physiochemical and mechanical properties, and biological safety, and the research findings are intended to lend themselves to the public notification of medical device standards in an effort to be used in reviewing technical files.
한경문,김진호,조수열,심선보,이진희,이지현,황인선,김성일,조양하,채갑용,권순재,이준호 한국식품위생안전성학회 2011 한국식품위생안전성학회지 Vol.26 No.2
Melamine has raised international concerns for its catastrophic health effects from tainted infant formula. This report concerns the developmental validation of a sensitive HPLC/MS/MS and GC/MS methods about melamine and cyanuric acid in human urine and serum. Analytical detection ranges of LC/MS was from 0.2 to 5.0 ng/mL and 2.0 to 60.0 ng/mL about melamine and cyanuric acid, respectively. The limits of quantification and confirmation are 0.2 ng/mL for both analytes in human urine and serum by LC/MS/MS. The range of recovery was 91.6%, and 107.6% for cyanuric acid and melamine in urine, respectively. The range of precision coefficient variation was from 2.0%, to 11.8% for cyanuric acid and melamine in urine. The range of recovery was from 94.9%, to 119.0% about cyanuric acid and melamine in serum, respectively. The range of precision coefficient variation from was 3.7%, and 13.5% about cyanuric acid and melamine in serum. Analytical detection ranges of GC/MS were 5.0 to 100.0 ng/mL about melamine and cyanuric acid, respectively. The limits of quantification and confirmation are 5.0 ng/mL for both analytes in human urine and serum by GC/MS. The range of recovery was from 83.7%, to 114.5% for cyanuric acid and melamine in urine, respectively. The range of precision coefficient variation was 3.5%, and 10.7% for cyanuric acid and melamine in urine. The range of recovery was 94.4%, and 110.7% for cyanuric acid and melamine in serum,respectively. The range of precision coefficient variation from was 3.9%, and 13.8% for cyanuric acid and melamine in serum. Several changes were taken to optimize performance by this method.
LC/TOFMS를 이용한 생체시료의 내인성 대사체 분석법 개발
이인선,김진호,조수열,심선보,박혜진,이진희,이지현,황인선,김성일,이정희,조수현,최돈웅,조양하 한국식품위생안전성학회 2010 한국식품위생안전성학회지 Vol.25 No.4
Metabolomics aims at the comprehensive, qualitative and quantitative analysis of wide arrays of endogenous metabolites in biological samples. It has shown particular promise in the area of toxicology and drug development, functional genomics, system biology and clinical diagnosis. In this study, analytical technique of MS instrument with high resolution mass measurement, such as time-of-flight (TOF) was validated for the purpose of investigation of amino acids, sugars and fatty acids. Rat urine and serum samples were extracted by selected each solvent (50% acetonitrile, 100% acetonitrile, acetone, methanol, water, ether) extraction method. We determined the optimized liquid chromatography/time-of-flight mass spectrometry (LC/TOFMS) system and selected appropriated columns, mobile phases, fragment energy and collision energy, which could search 17 metabolites. The spectral data collected from LC/TOFMS were tested by ANOVA. Obtained with the use of LC/TOFMS technique, our results indicated that (1) MS and MS/MS parameters were optimized and most abundant product ion of each metabolite were selected to be monitorized; (2) with design of experiment analysis, methanol yielded the optimal extraction efficiency. Therefore, the results of this study are expected to be useful in the endogenous metabolite fields according to validated SOP for endogenous amino acids, sugars and fatty acids.