• 제목/요약/키워드: Minimum detectable concentration

검색결과 48건 처리시간 0.02초

티로프라미드 주사제의 생물학적 동등성 평가를 위한 GC/MS 방법 (Bioequivalence Evaluation of the Tiropramide Formulation by GC/MS)

  • 명승운;김명수;김혜영;곽현태;민혜기;손동렬;홍영훈
    • 분석과학
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    • 제14권3호
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    • pp.221-229
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    • 2001
  • 본 연구에서는 이미 허가되어 시판되고 있는 D제약의 "티로파주"(대조약, 염산티로프라미드로서 1mL당 16.67mg 함유)와 S제약의 "티램주"(시험약)이 생물학적으로 동등한지의 여부를 판정하고자 시행되었다. 두 제제를 건강한 성인 남자 16인의 지원자에게 라틴방격법에 따라서 근육 주사한 후, 고체-액체 추출법으로 추출하여, GC/MS로 티로프라미드의 혈장 중 농도를 측정하고 이로부터 최고 혈장중 농도 (Cmax), 최고 혈장중 농도 도달시간(Tmax), 혈장중 약물농도-시간 곡선하 면적(AUC)에 대하여 식품의약품안정청(이하 식약청이라 함)과 서울대학교 약학대학이 공동 개발한 분산분석 프로그램에 의하여 분산분석을 행하였다. 정량을 위한 검정 곡선의 상관계수는 $R^2=0.998$로 좋은 직선성을 나타내었고, 검출한계는 0.1ng/mL였다.

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지하수와 지표수에서의 라돈 및 우라늄의 실태 조사 (The Study of Radon Activity and Uranium Concentration of Ground Water and Surface Water)

  • 오영미;이종복;신경진;김학철;이재희;황상철;정상기;이상태
    • 한국물환경학회지
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    • 제23권2호
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    • pp.201-205
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    • 2007
  • This paper reports the amount of $^{222}Rn$ and $^{238}U$ in 18 sites of ground water and 30 sites of surface water. The instrument used to count $^{222}Rn$ activity was the liquid scintillation counter (LSC) which could resolute ${\alpha}$ and ${\beta}$ radiations. And $^{238}U$ was analyzed by the inductively coupled plasma (ICP). Radon and Uranium were not detected in raw and treated water which were sampled in a water treatment plant. However, radon ($^{222}Rn$) was high concentration in ground water from Jeon-la, Gang-won. So was uranium ($^{238}U$) in case of ground water from Gang-won, Choong-chung. Radon ($^{222}Rn$) activities were detected less than 15 pCi/L at 5 sampling points, 15~300 pCi/L at 7 sampling points, 300~4000 pCi/L at 6 sampling points. However, Radon ($^{222}Rn$) activities of all ground water samples were less than 4,000 pCi/L, which was bellow American Alternative Maximum Contamination Level (AMCL). Uranium ($^{238}U$) concentrations were less than $0.1{\mu}g/L$ at 5 sampling points, from $0.1{\mu}g/L$ to $20{\mu}g/L$ at 13 sampling points. Uranium was not detected in about 30% of the whole samples, but the concentration ranged from relatively low to high concentrations depending on the sampling point. The minimum detectable activity (MDA) of radon was 15 pCi/L. and the detection limit of uranium was $0.1{\mu}g/L$.

몬테카를로 시뮬레이션에서의 다양한 환경 샘플에 대한 Marinelli 비이커 측정 및 자기 흡수 보정과 적용 (Marinelli Beaker Measurement and Self Absorption Correction and Application for Various Environmental Samples in Monte Carlo Simulation)

  • 장은성;김양수;이선영
    • 대한방사선기술학회지:방사선기술과학
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    • 제40권4호
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    • pp.605-611
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    • 2017
  • 검출기의 구조를 PENELOPE의 코드를 사용하여 전산모사 하였다. 표준혼합시료(450, 1,000 ml)를 사용하여 다양한 밀도와 높이에 따른 저에너지(59.54 keV)부터 고 에너지(1,836.05)에 대한 측정효율과 PENELOPE 전산모사에서 구한 효율을 비교하였으며, 또한 자체흡수에 대한 효율을 보정하여 다양한 환경시료에 적용하여 검출하한치를 알아보고자 한다. 표준혼합선원의 전체에너지 피크효율 값을 적용하여 높이에 따른 효율변화를 측정치와 PENELOPE의 전산모사 값과 비교하였다. 여기서 구한 값들을 자체흡수 보정하여 구한 효율을 실제 환경시료에 적용하여 검출하한치 값들을 구하였다. 밀도보정인자는 밀도가 $0.4g/cm^3$에서 241Am(59.54 keV)의 밀도보정인자는 1.15, PENELOPE 전산모사에서는 1.153, 137CS(661.66 keV) 에서는 $1.06g/cm^3$, PENELOPE 전산모사에서는 1.064, 88Y(1,836.04 keV)에 대한 밀도보정인자는 1.03, PENELOPE 전산모사에서는 1.033으로 불확도는 1% 이내에서 잘 일치함을 확인하였다. 환경 시료의 밀도에 따른 방사능 농도는 시료량이 많을수록, 측정시간이 증가할수록 MDA(Minimum Detectable Activity) 값이 감소함을 확인할 수 있었다.

의암호 퇴적물 내 인공방사성동위원소 (134Cs, 137Cs, 239+240Pu) 분포특성 연구 (A Study on Artificial Radionuclides(134Cs, 137Cs and 239+240Pu) Distribution in the Sediment from Lake Euiam)

  • 김성환;이상한;오정석;최종기;강태구
    • Journal of Radiation Protection and Research
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    • 제40권4호
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    • pp.223-230
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    • 2015
  • 공공수역 내 방사성물질 분포특성 파악을 위하여 춘천시 의암호 퇴적물 내 인공방사성핵종인 $^{134}Cs$, $^{137}Cs$, $^{239+240}Pu$과 자연방사성동위원소인 $^{210}Pb$을 분석하였고, 퇴적물 내 유기물의 특성을 파악하기 위하여 총 유기탄소(total organic carbon, TOC)를 분석하였다. 의암호 퇴적물 내 $^{134}Cs$ 농도는 4지점 모두 minimum detectable activity(MDA) 미만으로 나타났으며, $^{137}Cs$ 농도는 $MDA{\sim}8.79Bq{\cdot}kg^{-1}-dry$으로 나타났다. 표층 내 $^{137}Cs$의 농도는 $2.4{\sim}4.2Bq{\cdot}kg^{-1}-dry$의 범위를 나타냈고, St. 4에서 최소값, St. 3에서 최대값을 보였다. 의암호 퇴적물 내 $^{239+240}Pu$ 농도는 $0.049{\sim}0.47Bq{\cdot}kg^{-1}-dry$의 농도를 보였고, St. 2에서 최소값이, St. 3에서 최대값이 나타났다. $^{239+240}Pu$$^{137}Cs$ 농도의 상관관계 (r)는 0.54~0.97로 이들 두 핵종의 퇴적물 내 거동과 기원이 유사한 것으로 사료된다. $^{134}Cs$의 농도가 MDA 미만으로 검출된 점과 $^{239+240}Pu/^{137}Cs$의 평균값 0.041이 과거 대기 핵실험기원의 농도 비와 비슷한 값이 나타나는 점으로 의암호 퇴적물 내 인공방사성동위원소 ($^{134}Cs$, $^{137}Cs$, $^{239+240}Pu$)의 기원은 후쿠시마 사고가 아닌 과거 핵실험에 인한 낙진의 영향으로 사료된다. 의암호 퇴적물 내 $^{210}Pb$의 결과를 이용하여 퇴적물의 퇴적률을 산출한 결과, St. 2에서 $0.31{\pm}0.06cm{\cdot}y^{-1}$의 퇴적률을 나타냈으며, 이는 $^{137}Cs$의 퇴적물 내 peak를 1963년으로 가정하였을 때 측정된 퇴적률, $0.41{\pm}0.05cm{\cdot}y^{-1}$와 불확도($2{\sigma}$)의 범위에서 유사한 값으로 나타내었다. 의암호 퇴적물 내 TOC는 0.20~13.01%의 값이 나타났으며, 퇴적물 내 TOC와 $^{137}Cs$의 상관관계는 St. 1에서 다른 지점에 비해 높게 나타났다.

액체크로마토그래프법에 의한 사람 혈장 중 테라조신의 정량 및 테라토닌® 정의 생물학적 동등성 (Determination of Terazocin in Human Plasma by Liquid Chromatography and Bioequivalence Study of Teratonin® Tablets)

  • 조은숙;강성하;전인구
    • Journal of Pharmaceutical Investigation
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    • 제32권2호
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    • pp.119-125
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    • 2002
  • A rapid, selective and reproducible high-performance liquid chromatographic method has been developed for the determination of terazocin in human plasma. Terazocin plus the internal standard, prazocin hydrochloride, were extracted from alkalified plasma with tert-butylmethyl ether, back-extracted into 0.05% phosphoric acid. Fifty ${\mu}l-portions$ of extract were injected onto a octadecylsilane column and eluted with a mixture of acetonitrile, water and triethylamine (30 : 70 : 0.1 v/v, adjusted to pH 5.0 with dilute phosphoric acid) at a flow rate of 1.0 ml/min. The fluorescence intensity of column eluents was monitored at excitation wavelength of 250 nm and emission wavelength of 370 nm. No interference peaks were observed. The practical limit of quantitation was 5 ng/ml for terazocin. The average intraday and interday coefficients of variation were 4.15 and 3.54%, respectively. Also intraday and interday precisions over the range $5{\sim}60\;ng/ml$ were $0.49{\sim}2.92\;and\;0.38{\sim}5.12%$, respectively. The bioequivalence of two terazosin tablets, the $Hytrine^{\circledR}$ (Il Yang Pharmaceutical Co., Ltd.) and the $Teratonin^{\circledR}$ (Sam-A Pharmaceutical Co., Ltd.), was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers $(24.6{\pm}2.0\;years\;old)$ were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 2 mg of terazosin was orally administered, blood was taken at predetermined time intervals and the concentration of terazosin in plasma was determined with a HPLC method using spectrofluorometric detector. AUC was calculated by the linear trapezoidal method. $C_{max}\;and\;T_{max}$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) was utilized for the statistical analysis of the parameters. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between the two preparations were 0.21 %, 5.53% and 8.82%, respectively. The powers $(1-{\beta})\;for\;AUC_t,\;C_{max}\;and\;T_{max}$ were >99%, 97.49%, and 33.26%, respectively. Minimum detectable differences $({\Delta},\;%)\;at\;{\alpha}=0.1\;and\;1-{\beta}=0.8$ and the 90% confidence intervals were all less than ${\pm}20%$ except for $T_{max}.\;AUC_t\;and\;C_{max}$ met the criteria of KDFA for bioequivalence, indicating that $Teratonin^{circledR}$ tablets are bioequivalent to $Hytrine^{circledR}$ tablets.

메바코 정 (로바스타틴 20 mg)에 대한 로바로드 정의 생물학적 동등성 (Bioequivalence of Lovaload Tablet to Mevacor Tablet (Lovastatin 20 mg))

  • 송우헌;김정민;조성완;김재현;임종래;신희종;최영욱
    • Journal of Pharmaceutical Investigation
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    • 제28권4호
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    • pp.283-288
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    • 1998
  • Lovastatin, one of the potent cholesterol-lowering agents, is an inactive lactone prodrug which is metabolized to its active open acid, lovastatin acid (LVA). Bioequivalence study of two lovastatin preparations, the test drug ($Mevacor^{\circledR}$: Chungwae Pharmaceutical Co., Ltd.) and the reference drug ($Lovaload^{\circledR}$: Chong Kun Dang Pharmaceutical Co., Ltd.), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Fourteen healthy male volunteers, $23.9{\pm}3.9$ years old and $67.6{\pm}8.0$ kg of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 160 mg as lovastatin in a $2{\times}2$ crossover study. Plasma concentrations of lovastatin acid were analysed by HPLC method for 12 hr after administration. The extent of bioavailability was obtained from the plasma concentration-time profiles of total lovastatin acid after alkaline hydrolysis of the plasma samples. By alkaline hydrolysis, trace amounts of unmetabolized lovastatin were converted to lovastatin acid. The $AUC_{0-12hr}$ was calculated by the linear trapezoidal rule method. The $C_{max}$ and $T_{max}$ were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there were no differences in AUC, $C_{max}$, and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 7.07, 5.77 and 1.18% for AUC, $C_{max}$, and $T_{max}$, respectively). Minimum detectable differences(%) between the formulations at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 17.2, 15.1, and 15.9% for AUC, Cmax, and Tmax, respectively). The 90% confidence intervals for these parameters were also within ${\pm}20%$ (e.g.. $-5.20{\sim}19.3$, $-5.00{\sim}16.5$, and $-10.2{\sim}12.5%$ for AUC, $C_{max}$, and $T_{max}$, respectively). These results satisfied the bioequivalence criteria of KFDA guidelines, indicating that the two formulations of lovastatin were bioequivalent.

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일부 제조업 사업장의 사무 및 공장동에서의 라돈농도 수준 및 유효선량 평가 (Evaluation of Effective Dose and Exposure Levels of Radon in Office and Plant Buildings)

  • 정은교;김기웅
    • 한국산업보건학회지
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    • 제27권1호
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    • pp.38-45
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    • 2017
  • Objectives: Radon may be second only to smoking as a cause of lung cancer. Radon is a colorless, tasteless radioactive gas that is formed via the radioactive decay of radium. Therefore, radon levels can build up based on the amount of radium contained in construction materials such as phospho-gypsum board or when ventilation rates are low. This study provides our findings from evaluation of radon gas at facilities and offices in an industrial complex. Methods: We evaluated the office rooms and processes of 12 manufacturing factories from May 14, 2014 to September 23, 2014. Short-term data were measured by using real-time monitoring detectors(Model 1030, Sun Nuclear Co., USA) indoors in the office buildings. The radon measurements were recorded at 30-minute intervals over approximately 48 hours. The limit of detection of this instrument is $3.7Bq/m^3$. Also, long-term data were measured by using ${\alpha}-track$ radon detectors(${\alpha}-track$, Rn-tech Co., Korea) in the office and factory buildings. Our detectors were exposed for over 90 days, resulting in a minimum detectable concentration of $7.4Bq/m^3$. Detectors were placed 150-220 cm above the floor. Results: Radon concentrations averaged $20.6{\pm}17.0Bq/m^3$($3.7-115.8Bq/m^3$) in the overall area. The monthly mean concentration of radon by building materials were in the order of gypsum>concrete>cement. Radon concentrations were measured using ${\alpha}-track$ in parallel with direct-reading radon detectors and the two metric methods for radon monitoring were compared. A t-test for the two sampling methods showed that there is no difference between the average radon concentrations(p<0.05). Most of the office buildings did not have central air-conditioning, but several rooms had window- or ceiling-mounted units. Employees could also open windows. The first, second and third floors were used mainly for office work. Conclusions: Radon levels measured during this assessment in the office rooms of buildings and processes in factories were well below the ICRP reference level of $1,000Bq/m^3$ for workplaces and also below the lower USEPA residential guideline of $148Bq/m^3$. The range of indoor annual effective dose due to radon exposure for workers working in the office and factory buildings was 0.01 to 1.45 mSv/yr. Construction materials such as phospho-gypsum board, concrete and cement were the main emission sources for workers' exposure.

Development of Self-Questionnaire for Internal Dose Assessment by Food Ingestion

  • JiEun Lee;Hyo Jin Kim;Yong-Uk Kye;Dong-Yeon Lee;Wol Soon Jo;Chang-Geun Lee;Jung-Ki Kim;Yeong-Rok Kang
    • Journal of Radiation Protection and Research
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    • 제47권4호
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    • pp.204-213
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    • 2022
  • Background: The accident at the Fukushima Daiichi nuclear power plant increased the level of anxiety related to the radioactive contamination of various foods sourced in Japan. Particularly, after the accident, the detection of artificial radionuclides in locally produced foods raised food safety concerns. In this study, the radioactivity concentrations and annual ingestions of 40K and 137Cs in food products commonly and frequently consumed by the general public were investigated, and the annual effective dose of each was evaluated. Materials and Methods: The 2016-2018 data from the Radiation Safety Management Report released by the Korea Nuclear Safety Technology Center was referenced for the evaluation of the amounts of 40K and 137Cs contained in food. Using the food-ingestion survey mentioned above as a reference, we selected 62 foods to include in our radioactivity concentration and dose assessment. We also developed a questionnaire and evaluated the responses from the subjects who answered the questionnaire. Results and Discussion: The radioactivity concentration of 137Cs was found to be close to or below the level of minimum detectable activity. Additionally, the annual ingestion of 62 foods was 294.77 kg/yr, the effective doses from 40K and 137Cs were 136.4 and 0.163 μSv/yr, respectively. Conclusion: Thus, the findings confirmed that the effective dose from 40K and 137Cs in food tends to be lower than the effective dose limit of 1 mSv/yr suggested by the International Commission on Radiological Protection (ICRP) Publication 60. The questionnaire developed in this study is expected to be useful for estimating the annual effective dose status of Korean adults who consume foods containing 40K and 137Cs.

사료내 타우린 첨가가 산란계의 지방대사에 미치는 영향 (Effects of Dietary Taurine on the Lipid Metabolism in Laying Hens)

  • 박강희
    • 한국가금학회지
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    • 제29권2호
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    • pp.95-100
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    • 2002
  • 타우린이 산란계의 지방대사에 미치는 영향을 구명하기 위하여 두 번의 시험을 수행하였다. 시험 1에 있어서 19주령 산란계를 사료에 타우린을 첨가하지 않은 대조구, 0.4%,0.8%그리고 1.2%를 첨가한 4가지 시험구에 균일하게 분포시켜 10주 동안 사양하였다. 1.2%타우린 첨가시 산란계의 복강지방 량은 대조구에 비하여 29.2% 낮았다. 혈청 중 중성지방과 HDL-콜레스테롤의 농도는 처리구간 타이가 없었으나 총 콜레스테롤의 농도는 1.2% 타우린 첨가구가 대조구에 비하여 22.4%높았다. 간의 중성지방과 총 콜레스테롤의 농도는 0.8%그리고 1.2%타우린 첨가구가 대조구에 비하여 각각 26.1%와 26.4% 그리고 28.2%와 26.4% 낮았고, HDL-콜레스테롤의 농도도 1.2% 첨가구가 대조구에 비하여 33.9%낮았다. 시험 2에서는 81주령 산란계를 사료에 타우린을 첨가하지 않은 대조구, 1%그리고2%첨가한3가지 시험구에 균일하게 분포시켜 6주 동안 사양시험을 실시하였다. 1% 타우린 첨가구는 대조구에 비하여 복강지방량이 25%감소하였으나, 혈청 중 중성지방, 총콜레스테롤 및 HDL-콜레스테롤의 농도는 대조구와 차이가 없었다. 그러나 2% 타우린 첨가구는 대조구에 비하여 혈청 중 중성지방과 콜레스테롤의 농도가 각각 44%와 19.8% 낮았으며, HDL-콜레스테롤 농도는 대조구에 비하여 75% 높았다. 그리고 간의 중성지방과 총 콜레스테롤의 농도의 경우, 1%첨가구가 대조구에 비하여 각각 36.8%와 23%낮았으나, 2%첨가구는 대조구에 비하여 각각 78.4%와 70% 높았다. 또한 간의 HDL-cholesterol 농도의 경우, 1% 첨가구는 대조구와 차이가 없었으나 2% 첨가구는 62.8% 높았다. 본 연구의 결과는 산란계에 타우린의 급여는 복강지방의 축적을 억제하며, 이는 중성지방과 콜레스테롤 대사의 변화를 수반한다는 것을 보여준다.는 역할을 한다. 소풍의 적절한 활용은 시각적 요소 및 비언어적 전달요소에 의한 정보전달을 중심으로 주목률을 높일 뿐만 아니라 그에 뒤따르는 소구과정의 단계를 증폭시키고 가속화시킨다. 또한 소품의 사용은 광고물의 분위기나 가치, 신념 등도 전달할 수 있다. 따라서 좀더 많은 새로운 모험과 실험이 많아질수록 광고의 미래전망이 밝아질 것으로 예측된다.t and t-test were utilized for the statistical analysis of each parameter. The results showed that the differences in AU $C_{0-}$30hr/, $C_{max}$ and $T_{max}$ between two were ~5.66, 1.74 and 0.00%, respectively. Minimum detectable differences ($\Delta$) at $\alpha$=0.05 were less than$\pm$ 20% except $T_{max}$ (8.44, 18.36, and 33.86%, respectively). The 90% confidence intervals of all parameters were within $\pm$20% (-10.60~ -0.72, -9.00~12.49 and -19.81~19.81%, respectively). Therefore, it is concluded that the two formulations are bioequivalent for both the extent and the rate of absorption after single dose administration.ation.ion.ion.ation.

Polynactin Complex (Tetranactin)와 BPMC 혼합제의 사과 및 토양 잔류성 (Residue of Combined Insecticide of Polynactin Complex(Tetranactin) and BPMC in Apple and Soil)

  • 윤재천;이석준;박종우;김장억
    • Current Research on Agriculture and Life Sciences
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    • 제11권
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    • pp.101-110
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    • 1993
  • Tetranactin과 BPMC 혼합유제의 사과 재배 중 살포횟수 및 처리시기에 따른 잔류정도와 토양에 처리한 후의 분해정도를 조사한 결과는 다음과 같다. Tetranactin과 BPMC의 잔류분석시의 회수율은 사과에서 0.5ppm과 1.0ppm의 농도 수준에서 tetranactin은 74.0-77.5% 이었으며 BPMC는 83.6-87.1% 이었다. 토양에서의 회수율은 tetranactin 82.3-84.4%, BPMC 83.6-87.1% 이었다. Tetranactin 및 BPMC의 잔류분석시의 검출한계는 두 약제 모두 사과의 과육 부분에서는 0.01ppm, 사과의 과피 및 토양에서는 0.3ppm 이었다. 사과의 과육 및 과피부분에서 tetranactin 및 BPMC의 잔류량은 수확 3일전 5회 처리에서 잔류량의 96% 정도가 사과의 과피 부분에 잔류되는 것으로 나타났다. 사과에 대한 tetranactin 및 BPMC의 잔류량은 수확 3일전 5회 처리에서 tetranactin은 0.39ppm, BPMC는 0.75ppm이 잔류되어 tetranactin 및 BPMC의 사과에 대한 안전사용기준은 수확 30일전, 2회 이내의 사용으로 추천할 수 있다. Tetranactin 및 BPMC의 토양 중 분해 반감기는 포장시험 조건에서 각각 6.9일과 6.3일 이었으며 실내시험 조건에서는 각각 24.4 및 23.2일로 나타났다.

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