The bioequivalence of two nilvadipine products was evaluated in 16 normal male volunteers (age 22-32 yr, body weight 57-80 kg) following sidle oral dose. Test product was Overca $l_{R}$ tablet (Choong-Wae Pharm. Corp., Korea) and reference product was Nivadi $l_{R}$ tablet (Hyundai Pharm. Corp., Korea). Both products contain 4 mg of nilvadipine. One tablet of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study (2$\times$2 Latin square method). The determination of nilvadipine was accomplished using a validated capillary column GC with electron-capture detection. As a result of the assay validation, the quantiflcation of nilvadipine in human plasma by this technique was possible down to 0.5 ng/ml using 1 ml of plasma. Absolute overall recovery from five replicate analyses of nilvadipine-spiked sample were 88.4$\pm$ 10.24% (mean$\pm$ 5.D.) for human plasma of 10 ng/ml. The coefficients of variation (C.V.) were less than 20% and the actual concentration of nilvadipine measured by GC ranged from 80 to 99% in all plasma. 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 from time zero to 8 hr (AUCo-$_{8 hr}$) (22.8$\pm$5.90 vs 22.2$\pm$6.10 ng . hr/ml), maximum plasma concentration ( $C_{max}$) (10.0$\pm$2.85 vs 9.3$\pm$3.28 ng/ml) and time to reach maximum plasma concentration ( $T_{max}$) (1.2$\pm$0.31 vs 1.3 $\pm$0.47 hr). The differences of mean AU $Co_{8hr}$$C_{max}$, and $T_{max}$ between the two products (2.25, 7.65, and 10.30%, respectively) were less than 20%. The power (1-$\beta$) and treaeent difference (7) for AU $Co_{8hr}$, and $C_{max}$ were more than 0.8 and less than 0.2, respectively. Although the power for Tmax was under 0.8, Tm\ulcorner of the two products was not significantly different from each other (p>0. 05). These results suggest that the bioavailability of Overeat tablet is not significantly different from that of Nivadil tablet. Therefore, two products are bioequivalent based on the current results.sults.lts.lts.lts.
Hyperbaric oxygen (HBO) therapy for carbon monoxide (CO) poisoning eventually inducing the hypoxia-reoxygenation condition, may produce oxygen free radicals, which forms 8-hydroxydeoxyguanosine (8-OH-dG) by attacking C-8 position of deoxyguanosine (dG) in DNA. Effects of oxygen partial pressure or duration of HBO therapy with or without CO poisoning on the tissue 8-OH-dG formation were investigated. Male Sprague-Dawley rats were grouped and exposed to air (control group), 4000 ppm of CO for 10 to 30 minutes (CO only group), air for 30 minutes after 30 minute exposure to 4000 ppm of CO(CO-air exposure group), HBO after 30 minute exposure to 4000 ppm of CO(CO-HBO group), or HBO therapy fo. $10{\sim}120$ minutes(HBO only group). The 8-OH-4G concentrations in the brain and the lung tissues were measured with high performance liquid chromatography and electrochemical detector (ECD). Average concentrations of the 8-OH-dG of each group were statistically compared. In the brain tissues, 8-OH-dG concentrations of the CO only group, the CO-air exposure group, and the CO-HBO group did not significantly differ from those of the control group. Similar insignificance was also found between the CO-HBO group and the HBO only groups. No appreciable dose-response relationship was observed between the 8-OH-dG concentration and the oxygen partial pressure or the duration of HBO. However, the 8-OH-dG concentrations of the 30 minute CO only group were higher than those of the CO-air exposure group (p-value<0.05). In the lung tissues, there were no significant differences between the 8-OH-dG concentrations of the control group and those of the CO only group, the CO-air exposure group, and the CO-HBO group. However, mean 8-OH-dG concentration of the CO-air exposure group was significantly higher than that of the CO only group under the same CO exposure condition(p-value<0.05). With the duration of CO exposure, the 8-OH-dG concentrations of the lung tissues decreased significantly (p-value<0.05). The concentrations of 8-OH-dG in the lung tissues proportionally increased with the duration of HBO, but no such relation was observed with the oxygen partial pressure. These results suggest that the brain may be more resistant to oxygen free radicals as compared with the lungs, and that oxygen toxicity following HBO may be affected by factors other than oxygen free radicals.
M. aeruginosa isolated from Lake Paldang was cultured in CB medium, and then each wet plants put into the cultured medium at a rate of 0.5 g and 2.5 g wet wt/l. There was slight inhibition by the input of cattail and iris of each 0.5 g wet wt/l cultured medium, but showed no reduction in algal growth in other flasks. Among the applied plants, ginkgo, pine needles, big cone pine, waterreed and water chestnut had an effect on inhibition of algal growth at the input of 2.5 g wet wt/l. Plants which were dried for 3 days at $50^{\circ}C$ introduced into the testing flask for 10days cultured at dose rates of 2.5 g/l. When chlorophyll a concentration was remarkably high as $802.6\;{\mu}g/l$ after five days, there was noticeably less chlorophyll compared with control at a rate of 98% by big cone pine, 96% by ginkgo, 95% by pine needles and 86% by rice straw, respectively. To examine the effect of plant extracts on algal growth, big cone pine and water chestnut were put to the amount of 1.25 g liquid extracts/l. Chlorophyll a concentration and cell density decreased to the extent of average 43% as compared with the beginning of experiment, but when concentration of chlorophyll a increased a most high, the inhibition of algal growth by liquid extracts did not affect at all. When a quantity of plant equivalent to 2.5 g liquid extracts/l inhibited the growth of algae by 95% after nine days.
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.
The Tamjin River which flows from Jangheung-gun via Gangjin-gun to the South Sea was reported to be a highly endemic area of Metagonimus yokogawai infection in 1977 and 1985. However, there were no recent studies demonstrating how much change occurred in the endemicity, in terms of prevalence and worm burden, of metagonimiasis in this river basin. Thus, a small-scale epidemiological survey was carried out on some residents along the Tamjin River basin in order to determine the current status of M. yokogawai infection. A total of 48 fecal samples were collected and examined by the Kato-Katz thick smear and formalin-ether sedimentation techniques. The egg positive rate of all helminths was 50.0%, and that of M. yokogawai was 37.5%, followed by C. sinensis 22.9% and G. seoi 4.2%. To obtain the adult flukes of M. yokogawai, 6 egg positive cases were treated with praziquantel 10 mg/kg in a single dose and purged with magnesium sulfate. A total of 5,225 adult flukes (average 871 specimens per person) of M. yokogawai were collected from their diarrheic stools. Compared with the data reported in 1977 and 1985, the individual worm burdens appeared to have decreased remarkably, although the prevalence did not decrease at all. It is suggested that the endemicity of M. yokogawai infection along the Tamjin River has been reduced. To confirm this suggestion, the status of infection in snail and fish intermediate hosts should be investigated.
Pulmonary embolism demands rapid and accurate diagnosis. And ventilation imaging has greatly improved the diagnostic accuracy of pulmonary embolism in addition to perfusion imaging. Agents currently used include xenon-133, krypton-81m and technetium-99m radioaerosols. However radioactive gases are compromised by availability and cost for krypton-81m, radiation dose, gamma energy and non?physiologic behaviour for xenon-133. Radioaerosols of technetium-99m componds are rapidly cleared from the lung after inhalation, and their relative low effeciency (specific radioactivity) and wide distribution of particle sizes make them also suboptimum. A new ventilation agent, Technegas is a suspension of structured graphite ellipsoids with diameter below 20nm, labelled with $^{99m}Tc$ in a carrier gas of Argon. This report describes the authors' clinical experience with Technegas. This is the first reported clinical study of this agent in Korea. A comparison of Technegas and $^{99m}Tc-DTPA$ aerosol was performed in 12 patients with various pulmonary diseases such as COPD, pulmonary tuberculosis and pleural effusion. All patients were studied with $^{99m}Tc-DTPA$ aerosol inhalation and Technegas ventilation. In both studies image quality was assessed (1) semiquantitatively by scoring bronchial and gastric activity, (2) subjectively by direct visual comparison of peripheral lung images and (3) quantitatively by computing the peripheral penetration index(PI) for each lungs. The bronchial activites were seen in 7 out of 12 cases with $^{99m}Tc-DTPA$ aerosol and in 5/12 with Technegas. The gastric activities were seen in 5/12 and 1/12 cases respectively. The average values of PI were 61.26% with $^{99m}Tc-DTPA$ aerosol and 69.20% with Technegas (p>0.05). Using $^{99m}Tc-DTPA$ aerosol, COPD patients showed deposition in the central airways with poor visualization of the peripheral areas of the lungs. In Technegas studies these phenomena were less prominent, and the examination is well tolerated by pateients and requires only a minimum of patient cooperation. With superiority of easy availability and handling, better physical characteristics and favorable Image quality, Technegas is a Promising agent for lung ventilation scanning.
This study was designed to investigate the effect of iron supplementation on the iron nutritional status and anemia of high school girls in Korea. One hundred thirty-five female students residing in Ulian metropolitan city in Korea diagnosed as having anemia or iron deficiency participated in this study. One or two tablets of iron medicine(80-160 mg Fe as ferrous sulfate/day) were administered to all participants for 3 months. Subjects were evaluated with a questionaire, measurement of hematological indices before and after iron supplementation. The average height and weight of respondents were 161.62 $\pm$ 4.68 cm and 53.87 $\pm$ 6.10 kg, respectively. Daily intakes of energy were 1597.8 $\pm$ 302.35 kcal(76.0% RDA). Iron intakes were 13.72 $\pm$ 4.17 mg (76.3% of RDA) and calcium intakes were 580.74 $\pm$ 177.21(72.5% of RDA) before iron supp]ementation. At baseline, 63% of all participants had depleted store(serum ferritin 12 ug/ml and/or transferrin saturation(TS) < 14%). After iron supplementation, this proportion declined to 19.3%. 55.6% of subjects had 12 ug/m1 of basal ferritin concentration before iron supplementation, and this proportion declined to 16.3% after iron supplementation. The basal hemoglobin(Hb) concentrations were 12.13 $\pm$ 1.01 g/dl and they increased to 12.79 $\pm$ 0.81 g/dl, which showed significant difference artier iron supplementation(p < 0.001). The basal ferritin and TS(%) were 13.24 $\pm$ 11.66 ng/ml, 18.42 $\pm$ 10.12% and they significantly increased to 32.95 $\pm$ 21.14 ng/ml, 33.53 $\pm$ 16.64%, respectively(p < 0.001). The basal total iron binding protein(TIBC) were 467.81 $\pm$ 97.24 ug/dl and they significantly decreased to 325.05 $\pm$ 48.89 ug/dl(p < 0.001) after iron supplementation. The number of tablets administered was positively correlated with serum iron(t = 0.553, p < 0.01), serum ferritin(t = 0.557, p < 0.01), TS(%)(t = 0.588, p < 0.01) and negatively correlated with TIBC(t= -0.409, p <0.01). The anemia symptoms such as ‘Shortening of breath when going upstairs(p < 0.01)’, ‘Tired out easily(p < 0.01)’, ‘Feeling blue(p < 0.001)’, ‘Decreased ability to concentrate(p < 0.01)’, and ‘Poor memory(p < 0.001)’improved significantly after iron supplementation. In this study, daily iron supplementations were efficacious in improving the iron status and anemic symptoms of female high school students. Regular check-ups and nutrition education for adolescents are necessary because of their vulnerability to iron deficiency. Further studies are needed to determine the minimum effective dose of iron and to examine the adverse effect of long-term iron supplementation.
Humans are exposed by a range of pollutants in soil via exposure routes such as ingestion, inhalation, and dermal contact. Risk assessment is a process of evaluating the adverse health effects of chemicals as a result of exposure to stressors, and it is a very useful tool to establish the cleanup goals in contaminated lands. In the exposure assessment that is one of main process in risk assessment, exposure factor plays a significant role to quantify the intake of soil pollutants. However there is a very limited study about the exposure factor applicable to Korea. In this study, we compared the exposure factors applied by the developed countries including the United States and representative European countries, and suggested the exposure factor that might be suitable in our situation. The exposure factors considered in this study include average lifetime, body weight, (exposed) skin surface area, life time, skin absorption, soil-skin adherence factor, and soil ingestion rate. This information is needed to quantitatively estimate the intake of soil pollutants in contaminated lands.
The human adipose and milk samples analyzed in this study were collected at hospitals in Seoul, Masan and Jinju. The mean values of International Dioxin Toxic Equivalents (I-TEQ) of PCDDs and PCDFs in human adipose samples from the three regions were calculated as 9 pg I-TEQ/g(0.2 ~ 30 pg TEQ/g, lipid weight basis) and 8 pg I-TEQ/g (0.8 ~ 25 pg TEQ/g), respectively. The residue levels of PCDDs-TEQ and PCDFs-TEQ in human milk collected from Masan were 13 pg I-TEQ/g (lipid wt.) and 4.8 pg I-TEQ/g, respectively. On the whole, the contamination levels of these compounds in the Korean population were lower than those in the other countries. Based on the analytical data and assuming a daily intake consumption of 800 mL milk with 3% fat, the average daily intake of PCDDs/DFs via human milk for a baby weighing 5 Kg could be calculated. The daily intake of PCDDs/DFs via breast-feeding was estimated to be 39 pg/kg body weight/day for 2,3,7,8-TeCDD and 86 pg/kg/day for TEQ. These levels are far above all virtually safe dose(VSD) or tolerable daily intake(TDI) values proposed by health authorities in various countries, ranging from 0.001(US EPA) to 4 pg/kag/day (WHO).
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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