• 한국토양환경학회지
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• 제4권2호
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• pp.77-86
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• 1999

난분해성 유기물로 오염된 토양/지하수의 복원을 위하여 계면활성제를 이용 시 토양에 흡착된 계면활성제가 미치는 영향을 평가하기 위하여 소수성 유기물의 흡수현상을 시험하였다. 흡착된 계면활성제에 대한 유기오염물의 흡수계수($K_ss$)는 평형상태에서의 계면활성제 흡착곡선과 밀접한 관계를 이루었다. 즉, 낮은 농도의 흡착에 대한 $K_ss$는 가장 큰 값을 보였고 흡착량이 증가할수록 감소하는 경향을 보였다. SDS에 대한 $K_ss$값은 미셀분배계수($K_mic$) 보다 컸으며 Tween 80에 대해서는 가장 낮은 흡착농도에서의 $K_ss$값을 제외하고 모든 농도 범위에서 $K_{mic}$ 보다 큰 값을 보였다. 유기오염물의 분배계수 또한 계면활성제의 주입량에 따라 변하며 주입되는 계면활성제 농도가 증가할수록 증가하며 일정 농도 이상의 계면활성제 농도에서 감소하기 시작하였다. 이러한 결과는 미셀과 흡착된 상태의 계면활성제 사이에서 오염물 흡수를 위한 상호경쟁에 기인되는 것으로 판단된다. 결론적으로 토양에의 계면활성제 흡착은 유기오염물의 지체현상을 증가시키는 역할을 하여 계면활성제를 이용한 유기오염물 제거 시 저해영향을 미치므로 각 오염부지의 특성별로 유기오염물의 분포를 계면활성제 주입량의 함수로써 평가하는 단계가 선행되어야 한다.다.

• Biomolecules & Therapeutics
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• 제9권4호
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• pp.291-297
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• 2001

The bioequivalence of two triflusal products was evaluated with 20 healthy volunteers following single oral dose according to the guidelines of Korea Food and Drug Administration (KFDA). Trisa $l^{R}$ capsule (Whanin Pharm. Corp., Korea) and Disgre $n^{R}$ capsule (Myung-In Pharm. Corp., Korea) were used as test product and reference product, respectively. Both products contain 300 mg of trifusal. One capsule of test product or reference product was orally administered to the volunteers, respectively, by randomized two period crossover study (2$\times$2 Latin square method). Blood samples were taken at predetermined time intervals for 4 hours and the determination of trifusal was accomplished using semi-microbore HPLC equipped with automated column switching system. The analytical method with HPLC was validated according to the Bioanalytic Method Validation guideline by F7A prior to determining the plasma samples. The pharmacokinetic parameters (AU $C_{0-4h}$ $C_{max}$ and $T_{max}$) were calculated and ANOVA test was utilized for statistical analysis of parameters. As a result of the assay validation, the limit of quantification of trifusal in human plasma by current assay procedure was 50 ng/ml using 500 $\mu$l of plasma. The accuracy of the assay was from 97.76% to 116.51% while the intra-day and inter-day coefficient of variation of the same concentration range was less than 15%. Average drug concentration at the designated time intervals and pharmacokinetic parameters calculated were not significantly different between two products (p>0.05). The difference of mean AU $C_{olongrightarrow4hr}$, $C_{max}$, and $T_{max}$ between the two products (2.92, 4.39, and -2.44%, respectively) were less than 20%. The power (1-$\beta$) and treatment difference ($\Delta$) for AU $C_{olongrightarrow4hr}$ and $C_{max}$ were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different from each other (p>0.05). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating the two products of triflusal were bioequivalent.quivalent.ent.ent.

• Journal of Pharmaceutical Investigation
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• 제37권5호
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• pp.315-321
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• 2007

The purpose of the present study was to evaluate the bioequivalence of two lercanidipine hydrochloride tablets, Zanidip tablet (LG Life Sciences Ltd., Korea, reference drug) and Samchundang Lercanidipine tablet 10 mg (Sam Chun Dang Pharm. Co. Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). After adding an internal standard (amlodipine maleate) to human serum, serum samples were extracted using hexan-isoamyl alcohol (100:1, v/v). Compounds were analyzed by liquid chromatography/tandem mass spectrometry. This method showed linear response over the concentration range of 0.05-20 ng/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 0.5 mL of serum was 0.05 ng/mL which was sensitive enough for pharmacokinetic studies. Thirty healthy male Korean volunteers received each medicine at the lercanidipine hydrochloride dose of 20 mg in a $2\;{\times}\;2$ crossover study. There was a one-week washout period between the doses. Serum concentrations of lercanidipine were monitored by an LC/MS/MS fer over a period of 24 hr after the administration. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 24 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters, indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Samchundang Lercanidipine/Zanidip were log 0.9505-log 1.2258 and log 0.9987-log 1.2013, respectively. These values were within the acceptable bioequivalence intervals of log 0.80-log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Samchundang Lercanidipine tablet 10 mg and Zanidip tablet are bioequivalent.

• Journal of Pharmaceutical Investigation
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• 제40권2호
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• pp.109-115
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• 2010

The purpose of the present study was to evaluate the bioequivalence of two choline alphoscerate soft capsules, Gliatilin soft capsule (Daewoong Pharmaceuticals Co., Ltd.) and Cholicerin soft capsule (Sam Chun Dang Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Serum concentrations of choline after oral administration of choline alphoscerate were determined using a validated LC/MS/MS method. This method showed linear response over the concentration range of 0.5-20 ${\mu}g$/mL with correlation coefficient of 0.9999. The lower limit of quantitation using 100 ${\mu}L$ of serum was 0.5 ${\mu}g$/mL which was sensitive enough for pharmacokinetic studies. Thirty six healthy male Korean volunteers received each medicine at the choline alphoscerate dose of 1200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Blood samples were taken at predetermined time intervals up to 8 hr. $AUC_t$ (the area under the serum concentration-time curve from time 0 to 8 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (the maximum serum drug concentration) and $T_{max}$ (the time to reach $C_{max}$) were compiled from the serum concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters, indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for Cholicerin/Gliatilin were log0.9998-log1.1172 and log0.9938-1.0944, respectively. These values were within the acceptable bioequivalence intervals of log0.80-log1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating Cholicerin soft capsule and Gliatilin soft capsule are bioequivalent.

• 한국식품영양과학회지
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• 제29권6호
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• pp.1050-1056
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• 2000

방사선 조사된 닭고기에서 방사선 조사선량에 대해 양의 상관성을 가지는 휘발성 조사물질을 구명함으로서 방사선 조사판별을 위한 표지 물질을 선정하기 위해 각 선량별(0, 1, 3, 5, 10 kGy)로 조사된 닭고기를 시료로 하여 LLCE법으로 휘발성 향기성분을 추출한 후 GC/MS 법으로 분석하였다. 그 결과 총 129종의 휘발성성 분이 방사선조사된 닭고기에서 검출되었으며 이는 주로 탄화수소류 (62종), 방향족화합물류(44종), 알데히드류(9종), 케톤류(5종) 및 기타화합물류(10종)로 구성되어 있었다. 이중 비조사된 시료에서는 검출되지 않으면서 방사선 조사선량의 증가에 대해 그 함량의 변화가 양의 상관성을 가지는 휘발성 조사물질로서 2-methylpentanal, 4-methylcy clohexne 및 cyclotetradecene 등 3종의 화합물이 선정되었으나 방사선 조사선량 증가와의 상관성을 고려한 결과 cyclotetradecene만이 닭고기의 방사선 조사판별을 위한 표지 물질로 선정되었다.

• 한국식품영양과학회지
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• 제29권6호
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• pp.1042-1049
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• 2000

각 선량별(0, 1, 3, 5, 10 kGy)로 조사된 쇠고기를 시료로 하여 LLCE법으로 휘 발성 향기성 분을 추출한 후 GC/MS법으로 분석 동정함으로써 방사선 조사선량과 양의 상관성을 가지는 휘발성 조사물질을 구명하여 방사선 조사판별을 위한 표지물질로 제시하고자 하였다. 그 결과 총 150종의 휘발성 성분이 방사선 조사된 쇠고기에서 검출되었으며 이는 주로 탄화수소류, 방향족화합물류, 알데히드류, 케톤류, acid류, 에스테르화합물류 및 기타화합물류로 구성 되어 있었다. 이중 탄화수소류(71종)와 방향족화합물류(35종)가 가장 많이 검출되었으며, 휘발성 조사물질로서는 (E)-2-hexenal, nonene, 2-nonenal, cyclodecene, dodecene 및 cyclododecene등 총 6종의 화합물이 선정되었다. 하지만 검출 조사선량 범위와 상관계수값을 고려하였을 때 dodecene과 cyclododecene은 표지 물질로서는 부적당하였으며 (E)-2-hexenal, nonene, 2-nonenal 및 cyclodecene 등 4종의 화합물이 쇠고기의 방사선 조사판별을 위한 표지 물질로 선정하였다. 이중 방사선 조사선량 증가에 대해 가장 높은 양의 상관성을 나타낸 화합물은 cyclodecene(r=0.88)이었으며, 다음으로 (E)-2-hexenal, nonene 및 2-nonenal 순이었다.

• 대한임상검사과학회지
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• 제41권4호
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• pp.167-172
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• 2009

Methotrexate (MTX) in one of the antineoplastic drug and it is known to effective to management of acute lymphoblastic leukemia in children, management of choriocarcinoma and related trophoblastic tumors in women, management of carcinomas of the breast, tongue, pharynx, and tests, maintenance of remission in leukemia and treatment of serve, debilitating psoriasis. Intermediate to high-dose methotrexate administration followed by leucovorin rescue is effective in treatment of carcinoma of the lung and osteogenic sarcoma. Intrathecal administration is effective in treating meningeal leukemia or lymphoma. There are FPIA (Fluorescence polarization immunoassay) and EMIT (Enzyme multiplied immunotechique) methods that measure for MTX. We evaluated the FPIA and EMIT methods. MTX were measured by Hitachi-7600 P-module using EMIT and FPIA using TDX in the sera 60 patients. The performance characteristics evaluated were, light influence, linearity, comparison with FPIA. Also, precision evaluated were three level controls through put following CLSI evaluation protocols (EP10-A). When the MTX value of $4.16{\pm}5.78{\mu}{\mu}mol/L$ (mean, SD) by the Hitachi-7600 P-module was compared with that of $4.05{\pm}5.47{\mu}{\mu}mol/L$ by FPIA, coefficients of correlation of 0.988 was obtained. The regression equation was Y (Hitachi-7600 P-module) = 0.9408 x (FPIA) + 0.1316 (r=0.9885, n=60). CVs of MTX measured by Hitachi 7600 P-module was 6.78% at $0.33{\mu}{\mu}mol/L$, 0.96% at $1.16{\mu}{\mu}mol/L$, and 0.96% at $8.04{\mu}{\mu}mol/L$. The precision was excellent in each group. The linearity was acceptable. We evaluated that MTX is light-sensitive on prolonged exposure to direct sunlight. Comparing with the FPIA using TDX, the Hitachi-7600 P-module using EMIT showed good coefficient of correlation and precision. Therefore the Hitachi-7600 P-module can replace the FPIA for quantitative analysis of MTX.

• Biomolecules & Therapeutics
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• 제6권2호
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• pp.219-224
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• 1998

The bioequivalence of two clarithromvcin products was evaluated with 16 normal male volunteers (age 23-28 yr, body weight 57.5-75.517g) following single oral dose. Test product was ReYon Clarithromycin tablets (ReYon Pharm. Corp., Korea) and reference product was Klarici $d_{R}$ tablets (Abbott Korea). Both products contain 250 mg of clarithromucin. One tablet of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2$\times$2 Latin square method). The determination of clarithromycin was accomplished using a modified agar well diffusion bioassay. As a result of the assay validation, the quantification of clarithromycin in human serum by this technique was possible down to 0.03$\mu$g/ml using 100$\mu$l of serum. The coefficient of variation (C.V.) was less than 10%. Average drug concentrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products P>0.05); the area under the curve to last sampling time (24 hr) (AU $Co_{24hr}$ (8.10$\pm$ 1.26 vs 8.22$\pm$ 1.627g . hr/ml), AUC from time zero to infinite (AU $Co_{\infty}$) (8.61 $\pm$ 1.28 vs 8.84$\pm$ 1.71 $\mu$g . hr/ml), maximum plasma concentration ( $C_{msx}$) (0.87$\pm$0.22 vs 0.88$\pm$0.19 $\mu$g/ml) and time to maximum plasma concentration ( $T_{max}$) (2.69 $\pm$0.48 vs 2.56$\pm$ 0.51 hr). The differences of mean AU $Co_{24h}$, $C_{msx}$ and $T_{msx}$ between the two products (1.44, 1.39, and 4.65%, respectively) were less than 20%. The power (1-$\beta$) and treatment difference ($\Delta$) for AU $Co_{24hr}$, and $C_{max}$ were more than 0.8 and less than 0.2, respectivly. Although the power for $T_{max}$ was under 0.8, $T_{max}$. of the two products was not significantly different each other (p>0.05). These results suggest that the bioavailability of ReYon Clarithromycin tablets is not significantly different from that of Klarici $d_{R}$ tablets. Therefore, two products are bioequivalent based on the current results. results.sults.sults.s.s.s.s.s.s.s.

• Journal of Applied Biological Chemistry
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• 제64권2호
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• pp.177-184
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• 2021

축산용 항생제는 투여된 양의 일부만이 체내에서 사용되며 나머지는 분뇨로 배출되며 이를 활용한 퇴비를 농경지에 살포함으로써 농업환경에 유입되어 2차 오염 등을 초래하고 있다. 따라서, 농업환경 중 항생제 관리기준 설정 등 사후 관리 기술이 필요하다. 본 연구는 국내 사용빈도가 높은 것으로 알려진 tetracycline 및 sulfonamide 계열 등의 항생제를 대상으로 매체별 잔류량을 비교하고 퇴비 시용 전·후 농경지 토양 중 잔류항생제의 위해성을 평가하기 위하여 수행되었다. Buffer 및 SPE를 사용한 전처리 방법은 ppb 수준에서 70% 이상의 회수율을 나타냈으며, 검출한계(LOD)의 범위는 퇴비와 토양에서 각각 0.13-0.46 ㎍/kg과 0.05-0.25 ㎍/kg이었다. 잔류 항생제 분석결과 퇴비 중 tetracycline 계열 항생제의 잔류 농도는 5.38-196.0 ㎍/kg, sulfonamide 계열은 below the detection of limit (BDL)-259.0 ㎍/kg 수준으로 검출되었다. 농경지 토양의 경우 각각 0.30-53.3 ㎍/kg, BDL-4.16 ㎍/kg의 잔류 수준을 나타냈으며 토양분배계수(Kd) 값이 높은 tetracycline 계열 항생제의 잔류 농도가 sulfonamide 계열보다 높았다. 퇴비 시용 전후의 농경지 토양의 항생제에 대한 인체위해도는 항생제 종류에 따른 차이가 있었으나, 전체 HQ가 1 이하에서 안전하다는 기준에 의하면 조사된 항생제 5종 모두 인체 위해성이 매우 낮았으며 시용 전·후의 영향이 전체 위해도에 미치는 비율을 고려하면, 퇴비시용이 토양의 항생제에 대한 인체위해성에 미치는 영향은 미비한 것으로 판단되었다.

• 한국방사선학회논문지
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• 제15권4호
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• pp.429-435
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• 2021

방사선 근접치료에서 잘못된 선원의 위치는 정상조직에 과도한 선량을 유발할 수 있기 때문에 선원의 위치 정확성 평가는 필수적이다. 이에 본 연구에서는 기존 아날로그 검증방식을 개선시키기 위해 lead (II) oxide (PbO) 기반의 디지털 선량계에 대한 기초연구를 수행하였다. 이에 다결정 PbO 선량계를 제작하였고 Ir-192 선원에 대한 계측 성능을 평가하였다. 그 결과 재현성은 상대표준편차가 0.82%로 평가 기준 1.5% 이내를 만족하였다. 선형성은 선형함수 R²이 0.9998로 우수한 결과를 보였다. 거리 의존성 평가의 경우, 거듭제곱함수 R²은 PbO에서 0.9855, diode에서 0.9974를 보였고, 전체 평균차이는 PbO에서 1.66%, diode에서 2.18% 차이를 보였다. 본 연구는 다결정 PbO 선량계의 Ir-192 선원에 대한 기초 검출성능을 제시하며, 방사선 계측분야에서 기초자료를 제공할 수 있다.