• Journal of Nutrition and Health
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• v.36 no.7
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• pp.736-742
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• 2003

Soybeans have been a major protein source for many centuries in Korea. Soybeans contain phytochemicals which are isoflavones, biochemically active component. Isoflavone is a kind of phytoestrogen, structurally and functionally similar to estrogen. It has been reported that the breast milk and blood of breast feeding mothers who consume soy products contain isoflavones. This study was conducted to investigate the effects of soy milk supplement on the isoflavones (daidzein, genistein) concentration of breast milk, plasma and urine from breast feeding woman. Seventeen healthy women who delivered at Kyung Hee Medical Center were recruited. For the first 2 weeks after delivery, seventeen women ingested 400 ml (isoflavone 43.2 mg) of soy milk on the given time starting from the day of giving birth. For the next 2 weeks, soy milk ingestion was withdrawn. Dietary intake and anthropometric data were checked and breast milk, blood, and 24 hr urine samples were collected on the day of giving birth, the 14th (the last day of the supplement phase) and 28th (the last day of the withdrawal phase) day, respectively. HPLC analysis was used to measure the concentration of isoflavones. Dietary intakes of the subjects were inadequate for the Korean RDA regardless of soy milk supplementation. Especially, intakes of vit A, calcium, and iron were very low. The Anthropometric data such as LBM, TBW, PIBW, BMI checked on the day of 14th decreased and maintained their levels by the 28th day. Daidzein concentration in breast milk was not affected by soy milk supplementation. However, genistein concentration decreased by the 28th day (14th day: 0.89 $\pm$ 0.10 $\mu$g/ml, 28th day : 0.48 $\pm$ 0.07 $\mu$g/ml) (p < 0.05). Plasma daidzein and genistein concentrations were not changed by the 14th day and decreased by the 28th day (14th day: 49.64 $\pm$ 3.30 ng/ml, 26.72 $\pm$ 2.90 ng/ml, 28th day: 38.30 $\pm$ 4.40 ng/ml, 6.51 $\pm$ 0.50 ng/ml, respectively) (p < 0.05). Twenty four hour urine concentrations of daidzein and genistein significantly increased by the 14th day and decreased by the 28th day (14th day: 5.80 :t 0.3 mg/d, 4.17 $\pm$ 0.2 mg/d, 28th day: 6.72 $\pm$ 0.4 mg/d, 5.09 $\pm$ 0.5 mg/d, respectively) (p < 0.001). The rate of urinary recovery of daidzein was greater than that of genistein. The results of this study indicate that the supplement of dietary soy milk to the lactating women elevates the contents of isoflavone in the breast milk.

• Analytical Science and Technology
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• v.28 no.6
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• pp.417-424
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• 2015

In this study, the relationship between selenoprotein concentrations in blood and stomach cancer have been searched for Korean. The concentration of each selenoprotein in blood serum was analyzed and the correlation between the concentration and stomach cancer was studied to find a potential for using Selenium as a biomarker. In concentration determination, a simple calibration curve method was used with the monitoring of m/z 78 without the use of solid phase extraction. This is a lot more simple than the method using SPE with post column isotope dilution. The result obtained from the analysis of CRM BCR-637, 72.20±3.35 ng·g⁻¹, showed similar value of reference value (81±7 ng·g⁻¹). The total concentration of Se for the controlled group, cardiovascular patients group, was 105.70±21.20 ng·g⁻¹. This value was the same as normal healthy person reported earlier. Each selenoprotein concentration of GPx, SelP and SeAlb was 26.12±7.84, 65.15±14.50, 14.43±6.99 ng·g⁻¹, respectively. The distribution of each selenoprotein was 24.7%, 61.6%, and 13.7%, which was similar to the normal person. The result of stomach cancer patients, the total concentration of Se was 76.11±28.12 ng·g⁻¹ and each concentration of GPx, SelP and SeAlb was 15.41±9.01, 50.83±17.91, and 9.87±5.21 ng·g⁻¹, respectively. The total and each selenoprotein concentration level showed significant decrease for the stomach cancer patients. The level of decrease was 41.0% for GPx, 22.0% for SelP, and 31.6% for SeAlb. However, the distribution of each selenoprotein was not much different. Either total Selenium or each selenoprotein could be used as a possible index for the diagnosis of cancer. However, in age group study, it is shown that young age group (30's-40's) did not show much difference.

• Korean Journal of Clinical Pharmacy
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• v.7 no.2
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• pp.73-80
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• 1997

The bioequivalence of two loxoprofen tablets between the $Loxonin^{TM}$ (Dong Hwa Pharmaceutical Co., Ltd.) and the $Lokpen^{TM}$ (Dong Il Pharmaceutical Co., Ltd.) was evaluated. 12 normal male volunteers (age $21\sim27$ years old) were divided into two groups and a randomized cross-over study was employed. After one tablet containing 60 mg of loxoprofen sodium anhydrous was orally administered, blood was taken at predetermined time intervals and the concentration of loxoprofen in serum was determined with an HPLC method using UV/VIS detector. The pharmacokinetic parameters ($C_{max},\;T_{max}$, and $AUC_t$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max},\;T_{max}$, and $AUC_t$ between two tablets were $1.13\%,\;0\%,\;and\;0.69\%$, respectively The powers (1-${\beta}$) for $C_{max},\;T_{max}$, and $AUC_t$ were $84.88\%,\;88.61\%,\;and\;84.81\%$, respectively Detectable differences ($\delta$) and confidence intervals were all less than $20\%$. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Lokpen^{TM}$ tablet is bioequivalent to $Loxonin^{TM}$ tablet.

• Korean Journal of Food Science and Technology
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• v.29 no.2
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• pp.369-375
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• 1997

We have isolated an anticoagulant polysaccharide from the alkali extracts of Coriolus versicolor. The anticoagulant polysaccharide was purified through a gradual ethanol precipitation and three concecutive chromatography of DEAE-Toyopearl 650C, Sephadex G-100, and Sepharose CL-6B by measuring activated partial thromboplastin time (aPTT). The anticoagulant polysaccharide showed the homogenecity on HPLC using a gel permeation column and had about $7.2{\times}10^{5}$ molecular weight. The polysaccharide consisted of fucose, glucose, and galactose in a molar ratio of 1.0:0.2:0.2:0.1, and also compromised 19.32% of sulfate at its constituent sugars. The polysaccharide showed the two typical bands of C-O-S $(823\;cm^{-1})$ and S=O $(1257\;cm^{-1})$ in the IR spectroscopy. The sulfated polysaccharide (CV-40-Va-1) inhibited the blood coagulation via the intrinsic pathway like heparin whose activity produced a concentration dependent effect in aPTT and thrombin time (TT).

• Korean Journal of Clinical Pharmacy
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• v.14 no.2
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• pp.85-90
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• 2004

Bisoprolol, one of the $\beta_1-adrenorecepter$ antagonist, has been used for the treatment of mild to moderate essential hypertension anti stable angina pectoris. The oral bloavailability of bisoprolo1 is high $(90\%)$ and the drug has a long elimination half-life, $9{\sim}12\;hr$, which allows once-daily administration. The bioequivalence of two bisoprolol preparations was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Concor $tablet^{(R)}$ made by Newgenpharm and the reference product was Monocor $tablet^{(R)}$ made by Wyeth Korea. Twenty healthy male subjects, 23.8 (21-30) years old and 03.8(52-92) kg, were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After two tablets containing 10 mg bisoprolol hemifumarate were orally administered, blood was taken at predetermined time intervals and the concentration of bisoprolol in plasma was determined using an HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t\;and\;C_{max}$ were calculated and analyzed statistical]y for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The $90\%$ confidence intervals of $AUC_t\;and\;C_{max}$ were log $0.95{\sim}1og\;1.04\;and\;1og\;0.96{\sim}1og\;1.07,\;respectively.$ These values were within the acceptable bioequivalence intervals of log $0.8{\sim}log\;1.23$. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Concor tablet is bioequivalent to Monocor tablet.

• Journal of Pharmaceutical Investigation
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• v.29 no.1
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• pp.61-66
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• 1999

Bioequivalence of two terazosin tablets, the $Hytrine^{TM}$ (Il-Yang Pharmaceutical Co., Ltd.) and the $Hytrine^{TM}$ (Daewon Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Sixteen normal male volunteers $(21{\sim}30\;years\;old)$ 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 serum was determined with a HPLC method using spectrofluorometric detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and 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 two tablets were 6.02%,3.44% and -3.67%, respectively. The powers $(1-{\beta})$ for $AUC_t$, $C_{max}$ and $T_{max}$ were 98.05%, 98.34% and 29.81 %, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than ${\pm}20%$ except $T_{max}$. $AUC_t$ and $C_{max}$ met the criteria of KFDA for bioequivalence, indicating that $Terasin^{TM}$ tablet is bioequivalent to $Hytrine^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.28 no.3
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• pp.193-198
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• 1998

Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co., Ltd.) and the $Losazol^{TM}$ (Kyoung Dong Pharmaceutical Co., Ltd.), was evaluated according to the guideline of KFDA. Fourteen normal male volunteers (age $20{\sim}28$ years old) were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two tablets containing 50 mg of cilostazol were orally administered, blood was taken at predetermined time intervals and the concentration of cilostazol in plasma was determined with an HPLC method using UV detector. The pharmacokinetic parameters $(C_{max},\;T_{max}\;and\;AUC_t)$ were calculated and ANOVA was utilized for the statistical analysis of parameters. The results showed that the differences in $C_{max},\;T_{max}\;and\;AUC_t$ between two tablets were 3.14%, 10.0% and 7.35%, respectively. The powers $(1-{\beta})$ for $C_{max},\;T_{max}\;and\;AUC_t$ were 89.67%, 80.97% and 83.87%, respectively. Detectable differences $({\Delta})$ and confidence intervals were all less than 20% except $T-{max}$, but confidence interval of $T_{max}$ was also less than 20% at the significance $level({\alpha})$ of 0.1. All of these parameters met the criteria of KFDA for bioequivalence, indicating that $Losazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM} tablet$.

• Korean Journal of Clinical Pharmacy
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• v.16 no.1
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• pp.34-39
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• 2006

Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 120 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration(KFDA). The test product was Hanmi Fexofenadine Hydrochloride Tablet $120mg^{(R)}$ made by Hanmi Pharm. Co. and the reference product was Allegra Tablet $120mg^{(R)}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2{\times}2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t\;and\;C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t\;and\;C_{max}$ were log $0.844{\sim}log$ 1.149 and log $0.833{\sim}log$ 1.109, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet 120 mg is bioequivalent to Allegra Tablet 120 mg.

• Journal of Pharmaceutical Investigation
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• v.36 no.1
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• pp.53-58
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• 2006

Fexofenadine, one of selective histamine $H_1$ receptor antagonists, has been used for the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria. The bioequivalence of two fexofenadine hydrochloride preparations, containing 180 mg fexofenadine hydrochloride, was evaluated according to the guidelines of Korea Food & Drug Administration (KFDA). The test product was Hanmi Fexofenadine Hydrochloride $Tablet^{\circledR}$ made by Hanmi Pharm. Co. and the reference product was Allegra $Tablet^{\circledR}$ made by Handok Parmaceuticals Co.. Twenty healthy male subjects were randomly divided into two groups and a $2\;{\time}\;2$ cross-over study was employed. After one tablet was orally administered, blood was taken at predetermined time intervals and the concentration of fexofenadine in plasma was determined using a validated HPLC method with fluorescence detector. Two pharmacokinetic parameters, $AUC_t$ and $C_{max}$, were calculated and analyzed statistically for the evaluation of bioequivalence of the two products. Analysis of variance was carried out using logarithmically transformed parameter values. The 90% confidence intervals of $AUC_t$ and $C_{max}$ were $log\;0.822{\sim}log \;1.142$ and $log\;0.848{\sim}log\;1.172$, respectively. These values were within the acceptable bioequivalence intervals of log 0.8 to log 1.25. Thus, the criteria of the KFDA guidelines for the bioequivalence was satisfied, indicating that Hanmi Fexofenadine Hydrochloride Tablet is bioequivalent to Allegra Tablet.

• Biomolecules & Therapeutics
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• v.9 no.4
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• pp.285-290
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• 2001

Bioequivalence of two acetyl-1-carnitine tablets, test product (Carnitile tablet: Hanmi Pharm. Co., Ltd.) and reference product (Nicetil $e^{R}$ tablet: Dong-A Pharm. Co., Ltd.), was evaluated according to the guide- lines of Korea Food and Drug Administration (KFDA). Twenty-six healthy volunteers were divided randomly into two groups and administered the drug orally at the dose of 500 mg as acetyl-1-carnitine in a 2$\times$2 crossover study. Blood samples were taken at predetermined time intervals for 12 hours and the plasma concentration of acetyl-1-carnitine was determined using HPLC by derivatization with p-bromophenacyl bromide. The pearmacokinetic parameters (AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$) were calculated and ANOVA was utilized for the statistical analysis of parameters. The apparent differences of these parameters between two drugs were less than 20% (i.e., 1.26,-5.08 and 8.59% for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). The powers (1-$\beta$) for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, and Tmax were over 0.9. Minimal detectable difference ($\Delta$) at $\alpha$=0.05, 1-$\beta$=0.8 were less than 20% (i.e.,7.31, 14.88 and 11.77% for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). The confidence intervals ($\delta$) for these parameters were also within $\pm$ 20% (i.e.,-3.03$\leq$$\delta$$\leq$5.54, -13.80$\leq$$\delta$$\leq$3.64 and 1.69$\leq$$\delta$$\leq$15.48 for AU $C_{0-}$12h/ $C_{max}$ and $T_{max}$, respectively). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating Carnitile bioequivalent to Nicetil $e^{R}$ .TEX>$^{R}$ .> R/ . R/ .