Carvedilol is an antihypertensive and antianginal compound that combines nonselective beta-adrenoceptor blocking and vasodilation properties and is devoid of intrinsic sympathomimetic activity. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Carvelol^{TM}$ (Dae Won Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The carvedilol release from the two carvedilol tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB80 into water). Eighteen normal male volunteers, $24.22{\pm}1.86$ years in age and $64.81{\pm}4.56\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 25 mg of carvedilol was orally administered, blood was taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two carvedilol tablets were very similar at all dissolution media. Besides, 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 non-transformed and logarithmically transformed $AUC_t$ and $C_{max}$. The results showed that the differences in $AUC_t$, $C_{max}$ and $T_{max}$ between two tablets based on the $Dilatrend^{TM}$ were 2.23%, -2.00% and 0.00%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 13.55% and 17.61% for $AUC_t$ and $C_{max}$, respectively). The powers $(l-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t$ and $C_{max}$ were 98.08% and 88.81%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.69{\sim}10.16$ and $-12.30{\sim}8.30$ for $AUC_t$ and $C_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals using logarithmically transformed were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.95{\sim}1.11$ and $0.89{\sim}1.09$ for $AUC_t$ and $C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Carvelol^{TM}$ tablet is bioequivalent to $Dilatrend^{TM}$ tablet.
Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ 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 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. 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, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, 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 $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.
In order to study the effects of supplementary $Safmannan^(R)$(Beta-glucan & MOS complex) and $World-Labs^(R)$ (multiple probiotics) on the performance, nutrient availability, small intestinal microflora and immune response in broiler chicks, one thousand hatched broilers ($Ross^(R)$ were assigned to 4 treatments: control(basal diet), $BMD^(R),\;Safmannan^(R)\;and\;World-Labs^(R)$. There were no significant differences in the performance and in serum IgG, ND titre. However parameters of leukocytes and erythrocytes were significantly different among treatments (p<0.05). Leukocytes and RBC of $World-Labs^(R)\;and\;Safmannan^(R)$ were mostly lower than $BMD^(R)$ and control whereby MCH and MCHC of $World-Labs^(R)\;and\;Safmannan^(R)$ were higher than other treatments. The cfu of intestinal microflora had no significant differences among treatments. The $BMD^(R)$ treatment was higher than others in amino acid and crude fat availability and $World-Labs^(R)$ was higher than others in crude fiber availability. It was concluded that supplements used in the present experiment did not significantly affect the production parameters. However, significant impact on blood parameters, especially on leucocytes, may need further investigation.
Kim, Hyunsoo;Kim, Hee-Jin;Jeon, Jin-Joo;Son, Jiseon;You, Are-Sun;Kang, Bo-Seok;Hong, Eui-Chul;Kang, Hwan-Ku
Korean Journal of Poultry Science
/
v.48
no.4
/
pp.227-238
/
2021
This study investigates the effect of perch type and height on the growth performance, footpad dermatitis (FPD), blood parameters, behavioral characteristics, and meat quality of broilers. A total of 912 one-day-old male Ross 308 broilers (48.23±0.264 g) were subjected to a three x two factorial design of three types of perch (wood, steel, plastic) and two levels of perch height (10→30 cm change, 10 cm fixed) over a five-week experiment. Growth performance, perch availability, litter quality, FPD incidence, serum biochemical parameters, and meat quality of the broilers were evaluated. There were no significant differences in the body weight, feed conversion ratio, and biochemical parameters (except for aspartate aminotransferase), pH, color, and water holding capacity. The incidence of FPD was significantly higher in the plastic perch group than in the wood and steel perch groups (P<0.05) at five weeks of age. Perch use was high in the order of wood, steel, and plastic groups in the daytime and nighttime at one, three, and five weeks of age (P<0.05). Perch use was higher in the 10 cm fixed group than the 10→30 cm group (P<0.05). The shear force of the breast significantly increased in the order of wood, steel, and plastic groups (P<0.05). In conclusion, the group with a fixed perch height of 10 cm had high perch usage. Additionally, the use of wooden perches was higher than that of other materials, and it lowered the incidence of FPD in broilers.
Kim, Yong Hyun;Han, Kook-Il;Jeon, Miae;Hwang, Seon Gu;Jung, Eui-Gil;Kwon, Hyun-Jung;Han, Man-Deuk
Journal of Life Science
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v.24
no.11
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pp.1209-1216
/
2014
The aim of this study was to investigate the effect of water-soluble sulfated ${\beta}$-glucan (SBG) obtained from Ganoderma lucidum mycelia on the antihyperlipidemic and serum lipid levels in high-fat diet-induced obese rats. Five-week-old male Sprague-Dawley rats were fed a high-fat diet for two weeks to induce obesity. They were ten divided into five groups-normal control diet group (NC), high-fat control diet group (HC), high-fat diet and 200 mg/kg of SBG group (HC-HSBG), high-fat diet and 20 mg/kg of SBG group (HC-LSBG), and high-fat diet and 20 mg/kg of lovastatin group (HC-Lov)-and fed one of five diets for two more weeks. Although food intake and final body weight after four weeks of SBG consumption were similar in the five experimental groups, food efficiency ratio was higher in the high-fat diet groups(2, 3, 4, and 5) than in the NC group. In evaluating the hematological parameters of the rats, the neutrophil and monocyte ratios were higher in the HC-HSBG, HC-LSBG, and HC-Lov groups than in the HC group. Serum lipid profiles were analyzed after a 12 hr fast at the end of the study. Total cholesterol, triglyceride, and low-density lipoprotein cholesterol (LDL-C) levels were significantly lower in the HC-HSBG and HC-LSBG groups than in the HC group. These results suggest that chemically engineered sulfated mushroom ${\beta}$-glucan (SBG) might contribute to lower cholesterol and lipid levels in blood.
Park, Sung-Hye;Shin, Eon-Hwan;Park, Sung-Jin;Ran, Jong-Hyun
Journal of the Korean Society of Food Science and Nutrition
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v.34
no.4
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pp.476-483
/
2005
This experiment was planned to develop a functional supplement by food resources to prevent and lessen the deleterious effects caused by environmental pollutants such as polluted food, air, water and heavy metals. The goal of this study was to investigate the effects of peking-duck extracts supplemented with six kinds of medicinal herbs (DJ) on the intoxication of lead and mercury in rats. Sprague-Dawley rat weighing $150g\pm15g$ g, were randomly assigned to 5 groups, basal diet only (NCG), heavy metal without DJ injection (HCG), heavy metals and DJ (3 mg/mL) injection (HMLD), heavy metal and DJ (30 mg/mL) injection (HMMD), heavy metal and D] (300 mg/mL) injection (HMHD). Mecury (Hg) and lead (Pb) injected at the level of 50 ppm for 17 days. Also DJ oral feeding was continued for 31 days. The result of this study were as follows; Food intake and body weight gain in heavy metal administered groups were lower than those of control group (NCG). The activities of GOT, GPT and BUN level were significantly reduced in DJ-treated groups as compared to HCG. DJ was shown to suppress the accumulation of Hg and Pb in serum. The results suggest that DJ might have protective effect on Hg and Pb intoxication.
Han, Seon-Sook;Sung, Ji Hyun;Lee, Mi-Eun;Lee, Seung-Joon;Lee, Sung Joon;Kim, Woo Jin
Tuberculosis and Respiratory Diseases
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v.63
no.3
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pp.235-241
/
2007
Background: Airway mucus hypersecretion plays an important role in the pathogenesis of asthma, and is associated with the induction of MUC5AC expression in airway secretion. The MUC5AC gene is highly polymorphic; however, there are few studies about the association between the polymorphisms of the MUC5AC gene and asthma susceptibility or asthma phenotypes. We have investigated the association of MUC5AC promoter polymorphisms with the risk of asthma and asthma phenotypes. Methods: We determined the genotypes of the MUC5AC promoter (-1274G>A) in 78 asthma patients and in 78 age, sex-matched control individuals in the Korean population. Genomic DNAs from blood were analyzed by PCR and RFLP (restriction fragment length polymorphism) determination. We examined $FEV_1$, total eosinophil count, serum IgE level, $PC_{20}$ and the presence of atopy (by a skin test) in asthma patients. Results: The mean age of the patients was $47.7{\pm}16.1$ years and 38.5% were men, and the mean $FEV_1$ was $84.4{\pm}22.3%$ of predicted in the asthma patients. The -1274G>A polymorphism of the MUC5AC promoter in asthma patients was not significantly different as compared with normal individuals (GG 57.7%, AG 34.6% and AA 7.7% in asthma patients vs. GG 56.4%, AG 38.5% and AA 5.1% in control subject, p = 0.752, Cod). Several clinical parameters in asthma patients such as $FEV_1$, total eosinophil count, serum IgE level, $PC_{20}$ and the presence of atopy, were not associated with the -1274G>A polymorphism of the MUC5AC promoter. Conclusion: The -1274G>A single nucleotide polymorphism (SNP) frequency of the MUC5AC promoter was not associated with asthma in a Korean population.
Oh, Seo Young;Jeong, Yong Dae;Kim, Doo Wan;Min, Ye Jin;Yu, Dong Jo;Kim, Ki Hyun;Kim, Young Hwa
Journal of the Korea Academia-Industrial cooperation Society
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v.18
no.7
/
pp.130-139
/
2017
This study investigated the effect of heat stress on the performance and blood characteristics in commercial pig farms. A total of 180 growing pigs and 180 finishing pigs were assigned to two treatments consisting of thermal-neutral period(TNP) and high-temperature period(HTP) with three replications in floor pen, respectively. Feeding trials in the TNP and HTP were individually performed in autumn and summer seasons, respectively. Temperature-humidity index(THI) was calculated by temperature and humidity. Performance and physiological responses were identified per growth stages and feeding trial. Average temperature and THI were $16.8^{\circ}C$ and 61.4 at the TNP, and $25^{\circ}C$ and 74.3 at the HTP, respectively. Growing pigs in HTP exhibited lower BW, ADG and ADFI than in TNP(p<0.01). Similarly, finishing pigs showed lower growth parameters in HTP than in TNP(p<0.01). Lymphocytes and neutrophils of growing pigs were lower in HTP than in TNP(p<0.05). The serum T-PRO and NEFA in finishing pigs were higher in HTP than in TNP(p<0.05). In HTP, finishing pigs had higher cortisol levels than in TNP. Therefore, HTP can negatively influence growth performance and nutritional metabolism in pigs. Our results may provide useful information for developing feeding programs and diets to control heat stress for swine farms.
Kim, Joong-Hark;Hong, Sung-Gil;Kim, Wha-Young;Jung, Ji-Sang;Hwang, Sung-Ju;Mok, Chul-Kyoon;Park, Mi-Hyoun;Lee, Ju-Yeon
Journal of the Korean Society of Food Science and Nutrition
/
v.36
no.4
/
pp.439-446
/
2007
This study was performed to investigate the effect of long-term administration of Saengshik on growth parameters of growing rats. Male Sprague-Dawley rats were fed on AIN-93G basal diets for 12 weeks and assigned to the following groups: rats administrated orally with Saengshik at the dose of 1g/kg/day (1xJS ), 2g/kg/day (2xJS), 4g/kg/day (4xJS) and distilled water (Control). Rats were sacrificed at 4, 8, 12 weeks after oral administration. Bone mineral density (BMD) and bone mineral contents (BMC) were measured by PIXImus densitometry and serum insulin-like growth factor-1 (IGF-1) concentration were determined by using EIA method. Body weight and food intake did not show significant changes within groups for 12 weeks. Physical longitudinal growth indexes, body length and femur length were significantly increased in Saengshik-administered groups at 12 weeks, in which BMD and BMC also significantly increased. Also, in blood IGF-1 level, Saengshik-administered groups were remarkedly higher than control group at 4 week (p<0.001), in which significantly higher at 8 week and 12 week. These results suggest a close relation between administration of Saengshik and increment of longitudingal bone growth. Therefore, as the result of this study, it could be expected that the administration of Saengshik for 12 weeks is helpful to the increase of longitudinal growth and growth factors in rats. Furthermore, we propose that the consumption of Saengshik as dietary supplementation may promote to increase in longitudinal bone growth in growing children.
Kim, Chi-Hong;Kim, Young-Kyoon;Kwon, Soon-Seog;Kim, Kwan-Hyoung;Han, Ki-Don;Moon, Hwa-Sik;Song, Jeong-Sup;Park, Sung-Hak
Tuberculosis and Respiratory Diseases
/
v.39
no.5
/
pp.386-391
/
1992
Background: Recently, bronchial provocation of the airway of atopic asthmatic subjects with inhaled allergen has been shown to produce an initial peripheral blood eosinopenia followed by an eosinophilia occurring approximately 12 to 18 hrs after the challenge. However there are few studies about the change of peripheral eosinophil count (PEC) after bronchial provocation with nonspecific stimuli such as histamine or methacholine. Interestingly our preliminary study demonstrated a notable change of PEC during bronhial provocation with inhaled histamine in some asthmatic subjects. This study was designed to reevaluate our preliminary data and to further investigate the change of PEC during as well as after bronchial provocation with inhaled histamine in bronchial asthma tics. Methods: Sixteen asthmatic subjects participated in this study. Bronchial provocation with inhaled histamine was done between 9 AM and 12 MD. Blood samplings for PEC were done with 5 minutes intervals during the procedure, and repeated at 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, and 48 hours after the procedure. Results: The results were as follows; 1) The patients were divided into two groups characterized by each pattern in the change of PEC during the procedure. A group (11 of sixten, group I) showed an increasing pattern of PEC and another group (5 of sixteen, group II) showed a decreasing pattern of PEC during the procedure. 2) Group I demonstrated a tendency to maintain continuously higher level of PEC than the baseline value until 48 hours after the procedure. 3) Group II demonstrated a tendency to maintain continuously lower level of PEC than the baseline value until 48 hours after the procedure. 4) There were no significant differences in their clinical parameters including baseline eosinophil count, baseline $FEV_1$, $PC_{20}$ of histamine, and serum IgE level between group I and group II. Conclusion: Our results suggest that the change of PEC produced by inhaled histamine in asthmatic subjects is much different from that produced by inhaled allergen, and that each patient may have their individual characteristics in the change of PEC in response to bronchial provocation with inhaled histamine. Alternatively these findings suggest that eosinophils may be partially involved in the early asthmatic reaction.
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