• Pediatric Infection and Vaccine
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• v.18 no.1
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• pp.91-96
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• 2011

Bacille Calmette-Gu$\acute{e}$rin (BCG) vaccine is a live attenuated vaccine derived from Mycobacterium bovis. Frequent complications after BCG vaccination are localized ulcer formation and regional lymphadenitis, but there could be rarely severe systemic reactions to BCG vaccine such as osteomyelitis and disseminated BCG infection. Although disseminated BCG infection can be complicated in infants with underlying immunodeficiency after BCG vaccination, it is very unlikely to develop in immunocompetent infants or children. We report a 13-month-old infant who presented with fever, skin nodules, and multiple enlarged lymph nodes 5 months following BCG vaccination. She was diagnosed with disseminated BCG infection by PCRconfirmed M. bovis BCG infection at ${\geq}$2 anatomical sites beyond the region of vaccination. The patient showed no obvious evidence of immunodeficiency as judged on the basis of previous disease history, plasma immunoglobulin levels, B and T lymphocytes counts in peripheral blood, DHR (dihydrorhodamine 123 fluorescence) test and HIV test. She started antituberculous treatment with isoniazid and rifampin, and now, apparently her symptoms have been improved.

• Asian-Australasian Journal of Animal Sciences
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• v.28 no.9
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• pp.1296-1302
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• 2015

This study was conducted to examine the effects of supplementing brown seaweed by-products (BSB) in the diet of ruminants on ruminal fermentation characteristics, growth performance, endocrine response, and milk production in Holstein cows. In Experiment 1, the effects of different levels (0%, 2%, and 4% of basal diet as Control, 2% BSB, 4% BSB, respectively) of BSB were evaluated at 3, 6, 9, 12, and 24 h in vitro batch culture rumen fermentation. The pH tended to be higher for the higher level of BSB supplementation, with the pH at 12 h being significantly higher (p<0.05) than that of the control. The concentration of ammonia nitrogen was lower at 3, 9, 12, and 24 h incubation (p<0.05) compared with the control, and tended to be low at other incubation times. Volatile fatty acid concentration appeared to be minimally changed while lower values were observed with 4% BSB treatment at 24 h (p<0.05). In Experiment 2, effects of levels (0%, 2%, and 4%) of BSB on growth performance, endocrine responses and milk production were studied with Holstein dairy cows during transition. Dry matter intake, daily gain and feed efficiency were not affected by BSB supplementation. The concentration of plasma estrogen for the control, 2% BSB and 4% BSB after three months of pregnancy were 55.7, 94.1, and 72.3 pg/mL, respectively (p = 0.08). Although the differences of progesterone levels between BSB treatments and the control were minimal, the concentration in 4% BSB treatment increased to 157.7% compared with the initial level of the study. Triiodothyronine and thyroxine levels were also higher after both three months and eight months of pregnancy than the initial level at the beginning of the study. In addition, BSB treatments during one month after delivery did not affect daily milk yield and composition. In conclusion, the present results indicate that supplementation of BSB did not compromise ruminal fermentation, and animal performance at lower levels and hence may have potential to be used as a safe feed ingredient in dairy cows.

• Journal of Microbiology and Biotechnology
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• v.23 no.5
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• pp.637-643
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• 2013

We have demonstrated that 1-deoxynojirimycin (DNJ) isolated from Bacillus subtilis MORI could enhance the levels of adiponectin and its receptors in differentiated 3T3-L1 adipocytes, which has been shown to be effective in lowering blood glucose levels and enhancing insulin sensitivity. DNJ was not toxic to differentiated 3T3-L1 adipocytes for up to a concentration of $5{\mu}M$. In terms of expression levels of adiponectin and its receptors (AdipoR1 and AdipoR2), DNJ in concentrations as low as $0.5{\mu}M$ elevated both mRNA and protein levels of adiponectin and transcript levels of AdipoR1 and AdipoR2. In addition, DNJ increased phosphorylation of 5' adenosine monophosphate-activated protein kinase (AMPK) in a statistically significant manner. Finally, treatment with DNJ resulted in increased mRNA expression of glucose transporter 4 (GLUT4), which encodes for a glucose transporter, along with a significant increase in glucose uptake into the adipocytes based on results of a 2-deoxy-D-[$^3H$] glucose uptake assay. Our findings indicate that DNJ may greatly facilitate glucose uptake into adipose tissues by increasing the action of adiponectin via its up-regulated expression as well as its receptor genes. In addition, the glucose-lowering effects of DNJ may be achieved by an increased abundance of GLUT4 protein in the plasma membrane, as a consequence of the increased transcript levels of the GLUT4 gene and the activation of AMPK.

• Journal of Pharmaceutical Investigation
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• v.35 no.4
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• pp.309-315
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• 2005

The purpose of the present study was to evaluate the bioequivalence of tamsulosin HCl capsule, $Harnal^{\circledR}$(Jeil Korea Ltd.) and $Yutanal^{\circledR}$(Kukje Korea Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, $23.29{\pm}2.14$ year in age and $72.08{\pm}7.83$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 0.2 mg of tamsulosin HCl were orally administered, blood was taken at predetermined time intervals and concentrations of tamsulosin in plasma were determined using LC-MS/MS. Pharmacokinetic parameters such as $AUC_t$, $T_{max}$ and $C_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log0.8 to log1.25 (e.g., $log0.93{\sim}log1.11$ and $log0.80{\sim}log0.94$ for $AUC_t$, and $C_{max}$, respectively). The major parameters, $AUC_t$, and $C_{max}$, met the criteria of KFDA for bioequivalence indicating that $Yutanal^{\circledR}$ capsule is bioequivalent to $Harnal^{\circledR}$ capsule.

• Journal of Pharmaceutical Investigation
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• v.36 no.6
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• pp.413-419
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• 2006

In this study, the main purpose was to evaluate the bioequivalence of two thioctic acid tablests, Thioctacid HR tablet(Bukwang Pharm. Co., Ltd.) and Daewon thioctic acid HR tablet 600 mg(Daewon Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration(KFDA). Twenty-four, healthy Korean volunteers were divided into two groups, randomized and treated by $2{\times}2$ crossover study. After the administration of one thioctic acid tablet containing 600 mg thioctic acid, blood samples were taken until 8 hr after the oral administration. LC-MS/MS was applied to determination of thioctic acid, and we calculated the $AUC_t,\;C_{max},\;T_{max}$ from the plasma concentration-time data. Analysis of variance(ANOVA) 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 Daewon thioctic acid tablet 600 mg/Thioctacid HR were log 0.9877$\sim$log 1.1938 and log 0.8169$\sim$log 1.2237, respectively. These values were within the acceptable bioequivalence intervals of log 0.80$\sim$log 1.25, recommended by KFDA. In all of these results we concluded that Daewon thioctic acid tablet 600 mg was bioequivalent to Thioctacid HR tablet, in terms of rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.193-199
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• 2005

Gabapentin is an antiepileptic drug that is structurally similar to ${\gamma}-aminobutyric$ acid (GABA), but does not interact with the GABA receptor. It does not bind significantly to plasma proteins, and is excreted to unchanged form in the urine. The purpose of the present study was to evaluate the bioequivalence of two gabapentin capsules, $Neurontin^{TM}$ capsule 300 mg (Pfizer Pharm. Co., Ltd.) and Kuhnil $Gabapentin^{TM}$ capsule 300 mg (Kuhnil Pharm. Co., Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty six healthy male subjects, $22.46{\pm}1.86$ years in age and $67.64{\pm}7.24$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single capsule containing 300 mg as gabapentin was orally administered, blood samples were taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar at all dissolution media. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Neurontin^{TM}$ capsule 300 mg, were -2.03, -0.43 and 4.29% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 $(e.g.,\;log\;0.89{\sim}log\;1.09\;and\;log\;0.91{\sim}log\;1.09$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Kuhnil $Gabapentin^{TM}$ capsule 300 mg was bioequivalent to $Neurontin^{TM}$ capsule 300 mg.

• Journal of Pharmaceutical Investigation
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• v.35 no.4
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• pp.295-301
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• 2005

Famciclovir is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, $Famvir^{TM}$ tablet 250 mg (Novartis Korea Ltd.) and Famcivir (Hanmi Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $24.19{\pm}2.08$ years in age and $71.55{\pm}6.89$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 250 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar at water. In addition, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Famvir^{TM}$ tablet 250 mg, were -2.93, -8.02 and 10.47% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log0.8 to log1.25 (e.g., $log0.92{\sim}log1.01$ and $log0.85{\sim}log1.00$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir was bioequivalent to $Famvir^{TM}$ tablet 250 mg.

• Journal of Pharmaceutical Investigation
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• v.38 no.3
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• pp.199-205
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• 2008

Famciclovir, 9-(4-hydroxy-3-hydroxymethylbut-1-yl) guanine, is an oral prodrug of the antiherpesvirus nucleoside analogue, penciclovir. In human, famciclovir is orally well absorbed and then undergoes extensive first pass metabolism to penciclovir and essentially no parent compound is recovered from plasma or urine. The purpose of the present study was to evaluate the bioequivalence of two famciclovir tablets, Famvir tablet 750 mg (Novartis Korea Ltd.) and Famcivir tablet 750 mg (Hanmi Pharmaceutical. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of famciclovir from the two famciclovir formulations in vitro was tested using KP VIII Apparatus II method with water. Twenty six healthy male subjects, $23.38{\pm}1.72$ years in age and $68.59{\pm}7.84\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 750 mg as famciclovir was orally administered, blood samples were taken at predetermined time intervals and the concentrations of penciclovir in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations ere similar at water. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Famvir^{(R)}$ tablet 750 mg, were -0.53%, 1.12% and -24.82% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., $log\;0.9569{\sim}log\;1.0423$ and $log\;0.8763{\sim}log\;1.2136$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Famcivir tablet 750 mg was bioequivalent to Famvir tablet 750 mg.

• Journal of Animal Science and Technology
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• v.44 no.4
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• pp.483-490
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• 2002

The aim of this study was to determine if a low-molecular weight casein hydrolysate has an anti- hypertensive effect in spontaneously hypertensive rats (SHR). Prior to the in vivo experiment, the casein hydrolysate was confirmed to be resistant to gastrointestinal digestion by confirming the retention of its potency as an inhibitor of angiotensin I-concerting enzyme after incubation with pepsin, trypsin, or chymotrypsin. The in vivo anti-hypertensive effect of the hydrolysate was determined by the tail cuff method. Following an oral administration of the hydrolysate solution, the systolic blood pressure (SBP) decreased by 12.9% (－28.9mmHg; P<0.05) at 3 h after the administration at a dose of 500mg/kg body weight. When the hydrolysate was administered as an emulsion with 30% egg yolk, its anti-hypertensive effect was even more greater at the same dose(－30.8mmHg or －15.9%; P<0.01). In a 50-day long-term trial where the casein hydrolysate was administered once a day, the SBP-lowering effect of the hydrolysate was apparent (P<0.05) from day 35 through the end. Moreover, organ weights and plasma glutamate oxaloacetate transaminase and glutamate pyruvate transaminase activities of the administered SHR were not significantly different from those of controls at the end of the long-term trial.

• Journal of Nutrition and Health
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• v.25 no.6
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• pp.429-449
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• 1992

The consumption of foods rich in TDF should not be associated with impaired mineral absorp-tion and long-term mineral status. In surveys of populations consuming high amounts of TDF e.g Third World populations and vegetarinas gross deficiencies in mineral nutrition have not been noted. If mineral status is low among these groups it is most likely caused by the inadequacy or imbalance of the diet and not by the TDF. The key word is interaction which should be inte-rpreted in dietary imbalances that produce nut-rient deficiencies. There are no strong data to support the concept that TDF inhibits mineral absorption through a binding chelation mechanism. Limited data sug-gest that positively charged groups on polymers such as chitosan and cholestyramine will decrease iron absorption in humans and animals. Because TDF does not contain positively charged groups future research should be directed at the possible role of protein consumed along with TDF and the combination of effects on mineral nutrition Phytic acid is acknowledged as a potent chela-tor of zinc. However its association with zinc and its propensity to lower Zn bioavaiability may enhance the absorption of other elements notably copper and iron. The importance of interactions among nutrients including TDF will gain addi-tional attention in the scientific community. Soluble and insoluble dietary fiber function di-fferently in the intestine. Insoluble fibers accele-rate movement through the intestine. Soluble die-tary fibers appear to regulated blood concentra-tions of glucose and cholesterol albeit by some unknown mechanism. In creased viscosity produ-ced by the SDF in the intestine may provide an explanation of how this class of polymers affects plasma glucose cholesterol and other nutrients. Employing a double-perfusion technique in the rat we demonstrated that viscosity produced by SDF will delay transfer of zinc into the circulatory system. This delayed absorption should not be interpreted as decreased utilization. A great deal of additional research is required to prove the importance of luminaly viscosity produced by SDF on slowing nutrient absorption or regulating bllod nutrient homeostasis. Increased intake of TDF in the total human diet appears desirable. A dietary intake of 35g/day should not be considered to have a negative effect on mineral absorption. It is important to educate people that an intake of more than 35g TDF/day may cause an imbalance in the diet that can adve-rsely affect mineral utilization. Acknowledgments. Appreciation is given to Dr. George V. Vahouny(deceased) who was intense a great competitor in and out of science and who gave the author inspiration Portions of this work were supported by the University of Missouri Ag-ricultural Station and by a grant from the Univer-rch Support Grant RR 07053 from the National Institutes of Health. Contribution of the Missouri Agriculatural Experiments Station Journal Series No. 10747.