The bioequivalence study of two tiropramide products was evaluated in 16 health male volunteers following intra-muscular injection. Test product was Tiram$^{(R)}$ injection (S Pharm. Co, Ltd.) and reference product was Tiropa$^{(R)}$ injection(D Pharm. Co., Ltd.). The drug concentration in plasma was determined by GC/MS for over a period of 8 hours after injection. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 0.73, -1.385 and -12.994%, respectively. Minimum detectable differences (%) at ${\alpha}=0.05$ were all less than 20% given as a guideline (10.05, 17.90 and 19.01% for AUC, Cmax and Tmax, respectively). From these results, the two formulations of tiropramide are bioequivalent and thus, may be prescribed interchangeably.
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 $0.1{\mu}g/L$.
The structure of the actual detector was computed using the code of the PENELOPE. Using the standard mixed sources (450, 1,000 ml), compare the effectiveness of each energy according to various densities and height of the PENELOPE computer simulation, and calculate the effectiveness of the various environmental specimens and apply them to various environmental specimens to determine the lower limit. The values obtained by the obtained value were obtained by applying the obtained efficiency to the actual environmental specimens and obtaining the lower limit values. The density correction factor is 1.155 g of the density correction factor of $0.4g/cm^3$ (59.54keV), 1.153 (661 keV), $1.06g/cm^3$ 1.064 (1,836.04keV), 1.03, and 1.033. It was confirmed that the radioactivity concentration of environmental samples decreased as the amount of specimen was measured increases, and the MDA value decreased as time measured increases.
Kim, Seung Hwan;Lee, Sang-Han;Oh, Jung Suk;Choi, Jong Ki;Kang, Tae Gu
Journal of Radiation Protection and Research
/
v.40
no.4
/
pp.223-230
/
2015
The objective of this study is to identify the radionuclide distribution in public water by carrying out the analysis of artificial radionuclides($^{134}Cs$, $^{137}Cs$, $^{239+240}Pu$), natural radionuclide($^{210}Pb$) and TOC in the lake Euiam sediment in Chuncheon, South Korea. The $^{134}Cs$ concentration in all lake sediments showed below MDA values, and the $^{137}Cs$ concentration in lake sediment were ranged from MDA to $8.79Bq{\cdot}kg^{-1}-dry$. The $^{137}Cs$ concentrations in surface sediment were reported to be 2.4 to $4.2Bq{\cdot}kg^{-1}-dry$. The lowest concentration of $^{137}Cs$ was reported at St. 4 and the highest concentration was reported at St. 3, respectively. The $^{239+240}Pu$ concentration in lake sediment were ranged from 0.049 to $0.47Bq{\cdot}kg^{-1}-dry$. The lowest concentration was reported at St. 2 and the highest concentration was reported at St. 3. The correlation(r) between the $^{239+240}Pu$ concentration and $^{137}Cs$ concentration in lake sediment presented higher values (0.54 to 0.97) and this suggests the behavior and origin of $^{137}Cs$ is identical to the $^{239+240}Pu$ in the sediment. The $^{134}Cs$ concentration below MDA value and the $^{239+240}Pu/^{137}Cs$ ratio(mean value of 0.041) indicated that the artificial radionuclides in the sediment were originated from global fallout by the atmospheric testing of nuclear weapons conducted by former USSR and U.S.A, but not from the Fukushima Daiichi NPP accident. The sedimentation rate derived from $^{210}Pb$ age-dating method at St. 2 is calculated to be $0.31{\pm}0.06cm{\cdot}y^{-1}$. This value is similar to the value ($0.41{\pm}0.05cm{\cdot}y^{-1}$) estimated from the $^{137}Cs$ maximum peak produced from early 1960's. The content of TOC in lake Euiam sediments varied from 0.20 to 13.01%. While the highest correlation between TOC and $^{137}Cs$ concentration in the sediment were found at St. 1, the others presented the low correlation.
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.
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.
Journal of Korean Society of Occupational and Environmental Hygiene
/
v.27
no.1
/
pp.38-45
/
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.
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
/
v.47
no.4
/
pp.204-213
/
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.
Two experiments were conducted to investigate the effect of taurine supplementation on lipid metabolism in laying hens. In experiment 1, 19-wk-old laying hens were given one of four taurine supplemented diets (0 (control), 0.4, 0.8, and 1.2% taurine) fur 10 weeks. Abdominal fat weight was lower in the 1.2% diet by 29.2% compared to the control. Serum concentrations of triacylglycerol and HDL-cholesterol were not different among the treatments. However, seam concentration of total cholesterol was higher by 22.4% in the 1.2% diet compared to the control. Concentration of triacylglycerol or total cholesterol in the liver were decreased by 26.1% or 26.4% and 28.2% or 26.4%, respectively in the 0.8% and 1.2% diets compared to the control. The concentration of HDL-cholesterol in liver was also lower by 33.9% in the 1.2% diet compared to the control. In experiment 2, 81-wk-old laying hens were allocated to one of three taurine supplemented diets (0 (control), 1 and 2% taurine) fur 6 weeks. Abdominal fat weight was lower by 25% in 1% taurine supplementation compared to the control. Serum concentrations of triacylglycerol, total cholesterol and HDL-cholesterol of hens fed with 1% diet were not different from those of control group. However, sew concentrations of triacylglycerol and total cholesterol were lower by 44.0% and 19.8%, respectively in the 2% diet compared to the control. Furthermore, serum concentration of HDL -cholesterol in the 2% diet was higher by 75% compared to the control. Concentrations of triacylglycerol and total cholesterol in the liver in the 2% diet were decreased in the 1% diet by 36.8 and 23%, respectively, but increased by 78.4% and 70%, respectively, compared to the control. The concentration of HDL-cholesterol in the liver was not different between the 1% diet and the control, but higher by 62.8% in the 2% diet compared to the control. These results indicated that taurine supplementation decreased the fat storage in abdominal cavity, which was accompanied by the changes in triacylglycerol and cholesterol metabolisms of laying hens.
Yoon, Jae Cheon;Lee, Seok Joon;Park, Jong Woo;Kim, Jang Eok
Current Research on Agriculture and Life Sciences
/
v.11
/
pp.101-110
/
1993
The residues of combined insecticide of polynactin complex(tetranactin) and BPMC were determined to establish an index for the safety use to apple. Evaluation was made on residual concentration of tetranactin and BPMC in apple as a function of application frequency and date when the combined insecticide of tetranactin and BPMC was sprayed into apple. Their persistence in soil were also studied under the field and laboratory conditions. Recovery percentage from apple was ranged from 74.0 to 77.5 in tetranactin, 87.1 to 83.6 in BPMC, those from soil was 82.3 to 88.4 in tetranactin, 83.6 to 887.1 in BPMC. The minimum detectable limits of tetranactin and BPMC were 0.01ppm in apple pulp and 0.03ppm in apple peel and soil. The residue percentage of tetranactin and BPMC in the peel and pulp part of apple was about 96 in peel part by five sprays up to 3th day before harvest. The residues of tetranactin and BPMC in apple are proved to 0.39ppm and 0.75ppm by five sprays up to 30days before harvest. Maximum residue limit(MRL) of BPMC for fruits was established of 0.3ppm in Environment Protection Agency of Korea, and thus it is suggested that the preharvest intervals of combined insecticide for apple could be 30 days with twice spray. The half life of tetranactin in soil under field and laboratory conditions was 6.9 and 24.4 days, and in case of BPMC was 6.3 and 23.2 days, respectively.
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