• 대한수의학회지
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• 제53권2호
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• pp.77-82
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• 2013

The present study was planned to evaluate the bioequivalence of two commercial formulations of enrofloxacin, which have been marketed as 10% injectable solution after intramuscular administration at a single dose of 2.5 mg/kg body weight to 12 clinically healthy goats The study was carried out on the basis of crossover design. The two formulations were: Baytril as a reference product and Spectrama Vet as a test product. The plasma concentrations of enrofloxacin were measured by high performance liquid chromatography (HPLC) with UV detector. The pharmacokinetics of that data was performed using non-compartmental analysis. The maximum plasma concentration ($C_{max}$), time to reach peak concentration ($T_{max}$), area under concentration-time curve (AUC), elimination half-life ($t_{0.5el}$) were 1.14 and $1.05{\mu}g/mL$, 0.79 and 0.83 h, 5.70 and $5.79{\mu}g.h/mL$, 5.19 and 5.39 h for Baytril and Spectrama Vet, respectively. The 90% confidence interval for the mean ratio of $T_{max}$, $C_{max}$ and AUC were 94.72-116.2, 87.88-97.16 and 86.44-118.72%, respectively. These values falls within the European Medicines Agency bioequivalence acceptance range of 80-125% for both $T_{max}$ and AUC and between 75-133% for $C_{max}$. In conclusion, Spectrama-Vet is bioequivalent to Baytril and both products can be used as interchangeable drug in veterinary medicine practice.

• 한국방사선학회논문지
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• 제18권3호
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• pp.257-265
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• 2024

본 연구는 자동노출제어 흉부 방사선 검사 시 신체 기능 일부를 대체 보조하거나 의약품 등을 주입하는 인체 이식형 의료기기가 흉부 영상의 선량과 화질에 영향을 미치는지 알아보고자 하였다. 제조회사와 모델이 다른 3대의 디지털 X선 발생장치와 인체모형 팬텀을 사용하여 흉부 검사와 동일한 방법으로 위치잡이를 선정 후 선행 연구에서 선량의 변화가 관찰된 인공심장박동기(Pacemaker), 심장 재동기화 치료기(CRT), 케모포트(Chemoport) 3개의 HIMD(Human Implantable Medical Device)를 상단 이온전리조센서에 부착한 후 Monte Carlo 방법론 기반의 프로그램 PCXMC 2.0을 사용하여 실험에서 도출된 DAP(Dose Area Product) 값을 입력하여 유효선량을 측정하였다. 또한 흉부 영상의 화질 평가를 하기 위해 가슴 부위에 관심 영역 3곳과 잡음영역 1곳을 설정하고 신호대잡음비(SNR; Signal to Noise Ratio), 대조도대잡음비(CNR; Contrast to Noise Ratio)를 측정하였다. 연구 결과는 유효선량의 유의미한 차이를 보여주었으며 AEC 적용과 미적용 그룹을 비교하였을 때 Pacemaker와 CRT는 유의한 차이가 있었다. (p<0.05) AEC 적용 시 Pacemaker에서 37%, CRT에서 52% 유효선량이 증가하였다. Chemoport는 유효선량의 10% 차이는 있었지만, 유의미한 차이를 보이지 않았다. (p>0.05) 영상 품질 평가에서는 모든 HIMD 삽입과 AEC 적용 유무에 따른 SNR, CNR의 유의미한 차이를 보이지 않았다. (p>0.05) 최종 결론은 AEC 적용 후 HIMD가 삽입된 환자의 흉부 X-ray 검사 시 유효선량이 증가하였으며 AEC 적용 유무에 따른 흉부 영상의 품질 차이는 없음을 알 수 있었다. 이는 HIMD가 삽입된 환자의 흉부 검사 시 AEC 미사용이 환자의 선량을 낮추는 타당성을 확인한 것이며 과피폭을 주의하고 피폭 저감화를 위한 다양한 방법을 모색하여야 한다.

• Archives of Pharmacal Research
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• 제28권1호
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• pp.106-110
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• 2005

The preventive effects of Sophorae Fructus extracts (I: hot water extract and II: combination product using I) on bone loss in ovariectomized (OVX) rats were investigated. Sophorae Fructus extracts were orally administrated to OVX rats for 9 weeks. Ovariectomy caused the increase of body weight and deoxypyridinoline (Dpd: bone resorption marker) and decrease of calcium (Ca: bone formation marker) level in serum. Dpd level were significantly decreased and Ca levels were elevated at 9 weeks in Sophorae Fructus extracts administered groups after ovariectomy at a dose of 0.556 g/kg/day compared with control group. In administered groups, trabecular bone area (TBA) in the tibia and lumbar were also increased compared with control group in histomorphological analysis. The preventive or treatment effects of Sophorae Fructus extracts on bone loss in OVX rats appears to be due to suppression of bone turnover.

• Nuclear Engineering and Technology
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• 제54권8호
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• pp.3176-3180
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• 2022

A gamma irradiator is a well-developed installation for gamma radiation sterilization. A "shuffle-dwell" mode is preferable for high dose applications. A novel configuration of a shuffle-dwell gamma irradiator is proposed to increase energy utilization and throughput, which would result in higher profitability. While the minimum distance between any irradiation position and each source pencil, the minimum distance between the neighboring irradiation positions and the size of source pencils are kept the same as the current configuration, the irradiation positions and source pencils are rearranged based on the fact that radiation is emitted in an isotropic fashion. The computational results suggest that the proposed configuration requires an 8.7% smaller area and exposes the product to 11.8% more gamma radiation in a 10.7% shorter irradiation time. In other words, the proposed configuration needs a smaller area and shorter irradiation time to have a better performance compared to the current shuffle-dwell gamma irradiator. Note that the claim is based primarily on an analytical calculation. Experimental and manufacturing among other practical considerations will be taken into account in the future work to exhaustively evaluate the performance of the proposed configuration and to compare it with that of the traditional configuration.

• Journal of Pharmaceutical Investigation
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• 제31권4호
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• pp.209-216
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• 2001

The purpose of the present study was to investigate the hepatic uptake and biliary excretion of l-anilino-8-naphthalene sulfonate (ANS) in vivo. The plasma concentration and liver concentration of ANS were determined after its i.v. bolus administration at a dose of $30\;{\mu}mol/kg$ in rats. The hepatic uptake clearance $(CL_{uptake})$ of ANS was 0.1 ml/min/g liver. On the basis of the unbound concentration of ANS, the permeability-surface area product $(PS_{influx})$ was calculated to be l0.4 ml/min/g liver, being comparable of in vitro data. On the other hand, we determined the plasma concentration, liver concentration and biliary excretion rate of ANS at steady-state after its i. v. infusion $(0.2-1.6\;{\mu}mol/min/kg)$ in rats. The excretion clearance $(CL_{excretion})$ of ANS showed Michaelis-Menten kinetics with increasing the infusion rate. The permeability-surface area product $(PS_{excretion})$ based on the unbound concentration in the liver was calculated to be 0.0165 ml/min/g liver, which is negligible compared with the intrinsic clearance $(CL_{int}=3.3\;ml/min/g\;liver)$ by rat liver microsomes. The sequestration process of ANS, therefore, was considered to be mainly due to the metabolic process in the liver $(PS_{seq}{\risingdotseq}CL_{int})$. Furthermore, $PS_{efflux}$ value calculated from $PS_{influx}$ and $PS_{seq}$ was 4.4 ml/min/g liver, which was comparable of in vitro data. In conclusion, in vivo parameters such as $PS_{influx}$, $PS_{efflux}$ and $PS_{seq}$ in the present study showed good in vivo-in vitro relationship. Thus, the kinetic analysis method proposed in the present study would be useful to analyze the hepatic transport of drugs in vivo.

• 한국콘텐츠학회논문지
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• 제12권3호
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• pp.244-250
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• 2012

본 연구는 현재 법령 개인선량계인 PLD와 TLD의 선량 분석을 통해 성능 차이를 알아보고자 하였다. 자동판독장치를 이용해 PLD와 TLD의 적산선량을 판독 후 선량 교정 과정을 거친 두 소자의 값은 70kVp, 200mA, 0.012sec와 42kVp, 100mA, 0.012sec의 각각의 촬영조건에서 TLD는 PLD 측정 시와 통계적 차이를 나타냈다(각각 p<0.001, p<0.001). DAP와 두 소자의 측정값 차이는 70kVp, 200mA, 0.012sec 촬영조건에서 TLD는 DAP 평균값보다 $44.2mGy{\cdot}cm^2$이 낮은 값이 나타났고, PLD는 DAP 평균값에 $15.5mGy{\cdot}cm^2$이 낮은 $246.8mGy{\cdot}cm^2$으로 나타났다. 42kVp, 100mA, 0.012sec 촬영조건에서는 TLD는 DAP 평균 값의 $17.9mGy{\cdot}cm^2$이 낮은 값을 보였으며, PLD는 DAP 평균값에 $7.6mGy{\cdot}cm^2$이 낮은 $82.6mGy{\cdot}cm^2$으로 나타나 PLD가 DAP에 더 근접한 값을 보였다. 또한 PLD에 비해 TLD는 10개의 각 소자마다 측정된 선량 값에서 소자 상호간의 편차가 크게 나타났고, 1개의 소자를 반복 측정한 재현성 실험에서 PLD는 ${\pm}1%$ 이내로 TLD ${\pm}2%$ 보다 낮게 나타났다. 따라서 PLD가 TLD에 비해 선량 측정 능력면에서 더 우수한 결과가 나타났고, 진단용 방사선영역에서 방사선작업종사자의 개인피폭 관리에 PLD가 더욱 적합하고 유리함을 확인할 수 있었다.

• 대한방사선기술학회지:방사선기술과학
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• 제39권3호
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• pp.407-414
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• 2016

본 연구의 목적은 엑스선 선원과 검출기사이의 거리(SID)변화와 부가필터 사용 유무에 따른 피폭선량을 측정하여 환자선량을 최소화 하는 것이다. 연구를 위해 사용한 기기 및 팬텀은 DR시스템, 복부 조직 등가팬텀 그리고 알루미늄 필터를 사용하였다. 촬영 조건으로는 관전압을 80 kVp로 고정하고, 선량은 자동노출제어 장치를 통해 설정 하였다. 또한, 조사야는 $16{\times}16inch$를 사용하였다. 실험방법으로는 SID를 100 cm, 110 cm, 120 cm, 130 cm로 변화를 주어 각각 10회 측정하였고, 조사야 중심에 Piranha657 선량계를 위치시켰다. 촬영된 영상은 이미지J 통해 분석하였다. 실험 결과는 관전류량은 SID가 증가함에 따라 증가한 반면, 입사표면선량(ESD)은 SID가 증가함에 따라 급격히 감소하였다. 이는 낮은 에너지를 갖는 X선 광자들이 여과판사용으로 인해 제거되어 ESD의 감소로 기인한 것으로 사료되며, 이미지 J를 통한영상의 히스토그램 분석결과 SID 변화에 따라 ESD와 조사조건의 차이가 나타나지만 영상의 히스토그램상의 분포는 큰 차이는 없었다. 따라서, SID를 크게 할수록 환자의 선량을 줄일 수 있으며, 아울러 소아 등을 촬영할 때, 부가필터를 사용하면 환자선량을 더욱 줄일 수 있을 것이라 사료된다.

• Journal of Pharmaceutical Investigation
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• 제33권1호
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• pp.51-53
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• 2003

This study was conducted to compare the bioavailability of a generic product of Sinil Atenolol Tablets (Sinil Pharmaceutical Co., Ltd., Korea) with the innovator product, $Tenormin^{\circledR}$ Tablets in 20 healthy Korean volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way crossover design. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs time curves, the following parameters were compared: area under the plasma concentration-time curve (AUC), peak plasma concentration $(C_{max})$, time to reach peak plasma concentration $(T_{max})$, and terminal first order elimination half-life $(t_{1/2})$. No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed AUC and $C_{max}$ values of the two products. The 90% confidence for the ratio of the logarithmically transformed AUC and $C_{max}$ values of Sinil Atenolol Tablets over those of $Tenormin^{\circledR}$ Tablets were calculated to be between 0.99 and 1.07, and 1.04 and 1.16, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ Tablet group was 3.68 hour, and that in Sinil Atenolol Tablet group was 3.65 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean $t_{1/2}$ values of $Tenormin^{\circledR}$ Tablets and Sinil Atenolol Tablets were 5.9 and 6.0 hour, respectively. Based on these results, it was concluded that Sinil Atenolol Tablets were comparable to $Tenormin^{\circledR}$ Tablets in both the rate and extent of absorption, indicating that Sinil Atenolol Tablets were bioequivalent to the reference product, $Tenormin^{\circledR}$ Tablets

• Biomolecules & Therapeutics
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• 제15권3호
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• pp.187-191
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• 2007

This study was conducted to compare the bioavailability of two brands of atenolol (50 mg) tablets, which are a generic product of $Ditent^{\circledR}$ (Daewon Pharmaceutical Co., Ltd., Korea) and an innovator product $Tenormin^{\circledR}$ (Hyundai Pharm. Ind. Co., Ltd., Korea), in 20 healthy Korean male volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way cross-over design. The washout period between treatments was 1 week. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs. time curves, the following parameters were compared: area under the plasma concentration-time curve ($AUC_{0-24}$), peak plasma concentration ($C_{max}$), time to reach peak plasma concentration ($T_{max}$), and terminal first order elimination half-life ($t_{1/2}$). No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed $AUC_{0-24}$ and $C_{max}$ values of the two products. The 90% confidence interval for the ratio of the logarithmically transformed AUC and $C_{max}$ values of $Ditent^{\circledR}$ over those of $Tenormin^{\circledR}$ were calculated to be between 0.85 and 1.04, and 0.89 and 1.07, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ group was 3.1 hour, and that in Ditent$^{\circledR}$ group was 3.2 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean values were 5.2 hour in the both products. Based on these results, it was concluded that $Ditent^{\circledR}$ was comparable to $Tenormin^{\circledR}$ in both the rate and extent of absorption, indicating that $Ditent^{\circledR}$ was bioequivalent to the reference product, $Tenormin^{\circledR}$.

• Mass Spectrometry Letters
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• 제12권1호
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• pp.16-20
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• 2021

We aimed to compare the content of ginsenosides and the pharmacokinetics after the oral administration of four different ginseng products at a dose of 1 g/kg in rats. The four different ginseng products were fresh ginseng extract, red ginseng extract, white ginseng extract, and saponin enriched white ginseng extract prepared from the radix of Panax ginseng C.A. Meyer. The ginsenoside concentrations in the ginseng product and the rat plasma samples were determined using a liquid chromatography-tandem mass spectrometry (LC-MS/MS). Eight or nine ginsenosides of the 15 tested ginsenosides were detected; however, the content and total ginsenosides varied depending on the preparation method. Moreover, the content of triglycosylated ginsenosides was higher than that of diglycosylated ginsenosides, and deglycosylated ginsenosides were not present in any preparation. After the single oral administrations of four different ginseng products in rats, only four ginsenosides, such as 20(S)-ginsenosides Rb1 (GRb1), GRb2, GRc, and GRd, were detected in the rat plasma samples among the 15 ginsenosides tested. The plasma concentrations of GRb1, GRb2, GRc, and GRd were different depends on the preparation method but pharmacokinetic features of the four ginseng products were similar. In conclusion, a good correlation between the area under the concentration curve and the content of GRb1, GRb2, and GRc, but not GRd, in the ginseng products was identified and it might be the result of their higher content and intestinal biotransformation of the ginseng product.