• Biomolecules & Therapeutics
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• 제2권2호
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• pp.161-172
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• 1994

This study was conducted to examine DA-3002, a biosynthetic human growth hormone, for its acute and subacute toxicities in mice and rats. The drug was administered subcutaneously and orally at a dose level of 1.0, 3.0, 8.9, 26.7 or 80.0 lU/kg once for single dose toxicity and given subcutaneously at a dose level of 0.34, 1.7 or 8.4 lU/kg daily for 13 weeks to investigate repeated dose toxicity. In the acute toxicity study, doses up to 80 lU/kg had no adverse effect on the behavior or body weight gain. Pathological examinations revealed no abnormal changes which could be attributed to toxic effect of DA-3002. In the subacute toxicity study, the growth hormone was tolerated well in broth mice and rats. No drug related deaths occurred and all animals appeared to be normal throughout the dosing period. Increases in body weight gain, food utilisation and absolute organ weights were observed in the rats in the high dose group. Mild changes in the blood chemical parameters were also seen in the treated groups. Histopathologically, however, no abnormal changes were observed in any organ. The changes noted during the treatment periods presumably represent exaggerated pharmacological effects of the growth hormone, and no observed adverse effect level (NOAEL) was considered to be more than 8.4 lu/kg/day.

• 한국임상약학회지
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• 제11권1호
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• pp.7-12
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• 2001

Cilostazol has both antithrombotic and cerebral vasodilating effects, and one of the mechanism is the selective inhibition of platalet cyclic AMP phosphodiesterase. Bioequivalence of two cilostazol tablets, the $Pletaal^{TM}$ (Korea Otsuka Pharmaceutical Co.) and the LG $Cilostazol^{TM}$ (LG Chemical Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen normal male volunteers ($20\sim29$ years old) were randomly divided into two groups and a randomized $2\times2$ cross-over study was employed. After oral administration of $Pletaal^{TM}$ or LG $Cilostazol^{TM}$ tablet (100 mg cilostazol), blood samples were taken at predetermined time intervals and the serum cilostazol concentrations were determined using an HPLC method with UV/VIS detector. The pharmacokinetic parameters $(AUC_t,\;C_{max}\;and\;T_{max})$ were calculated and ANOVA was utilized for the statistical analysis. The results showed that the differences in AUCt, C_{max} and Tmax between two tablets based on the $Pletaal^{TM}$ tablet were $-5.39\%,\;2.32\%\;and\;4.26\%$, respectively. The powers (1-${\beta}$) for $AUC_t,\;C_{max}\;and\;T_{max}\;were\;83.81\%,\;96.02\%\;and\;91.04%$, respectively. Minimum detectable differences ($\Delta$) and $90\%$ confidence intervals were all less than $\pm20\%$. All these parameters met the criteria of KFDA for bioequivalence, indicating that LG $Cilostazol^{TM}$ tablet is bioequivalent to $Pletaal^{TM}$ tablet.

• 한국환경보건학회지
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• 제40권5호
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• pp.407-412
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• 2014

Objectives: The internal dose of ethyl parabens is important in order to evaluate the risk of this chemical. However, there are little PK model data for parabens to apply this. This experiment attempted PK modeling to ascertain PK values. Methods: Twenty mg/kg ethyl paraben was administered orally to Sprague-Dawley rats at the same point in time. The rats were sacrificed at times 0, 15, 30 and minutes, and 1, 2, 4, 8, 12, 24 hours after oral gavage. Blood and urine were collected and pretreated for analysis. Accuracy, precision and LOD (limit of detection) were calculated for this analysis. Ethyl paraben, detected by HPLC-MS, was applied to PK modeling using Berkeley Madonna. Results: This study showed 100.1-103.7% accuracy, 1.4-3.7% precision and a 1.0 ng/mL limit of detection. Orally administered ethyl paraben reached maximum concentration after 30 minutes of dosing in serum and urine of rats. The concentrations were 2,354 ng/mL in serum and 386,000 ng/mL in urine samples. These peak concentrations were excreted after one hour of intubation over 12 hours. For the pharmacokinetic parameters of ethyl paraben revealed using Berkeley Madonna, the absorption rate was 5.539/hour, the excretion rate was 0.048/hour, the half-life was 14.441 hours and AUC was 481,186 ng hour/mL. Conclusion: Orally administered ethyl paraben was absorbed rapidly in rats and excreted in urine. This chemical, ethyl paraben, accumulated in the body but was excreted over 12 hours after dosing.

• 대한의생명과학회지
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• 제26권2호
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• pp.66-74
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• 2020

This study was carried out to investigate the protective effect of crude saponin from Platycodon grandiflorum on Clinical chemical parameters in male rats acutely exposed to 2,3,7,8-tetrachlorodibenzo-ρ-dioxin (TCDD). Crude saponin was prepared from Korean Platycodon grandiflorum with Diaion HP-20 adsorption chromatography after extraction of 80% ethanol at 75℃. The crude saponin was confirmed by thin layer chrmatography. When compared with ginseng saponins, the crude saponin had both a few number of saponins and a broad distribution. Forty male rats (200±20 g) were divided into 4 groups. Normal control (NC) group received vehicle and saline; TCDD-treated (TT) group received TCDD (40 ㎍/kg, single dose) intraperitoneally; Platycodon grandiflorum saponin (PG5 and PG10) groups received crude saponin 5 mg/kg and 10 mg/kg (p.o), respectively, for 2 weeks before 1 week of TCDD-exposure. Increase of body weight was retarded greatly by TCDD-exposure. Body weight of animals in TT group was significantly decrease after 2 days of TCDD-exposure. However, body weights of animals in PG groups increased through the experimental perimental period, although the increasing rate was slower than that of NC group. Increases in contents of blood glucose, total cholesterol and triglyceride (TG) and activities of amylase, lipase, AST, ALT and LDH by toxic action of TCDD were significantly attenuated by crude saponin from Platycodon grandiflorum (P<0.05). In conclusion, these results suggest that crude saponin prepared from Korean Platycodon grandiflorum might be a member of useful protective agents against TCDD, which is one of the environmental hormones.

• 한국식생활문화학회지
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• 제27권4호
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• pp.407-413
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• 2012

In previous studies, we performed joint animal studies and clinical trials between Yonsei University and Oryza Oil & Fat Chemical Co. Ltd. We have shown that coffee bean extract has potent anti-obesity and hypotriglyceridemic activities as well as beneficial effects on body fat reduction.In this study, the effects of coffee bean extract (100 mg/capsule) on body fat reduction were evaluated in overweight/obese women (body mass index of 25~30 $kg/m^2$ or body fat > 30%) not diagnosed with any type of disease. Subjects were randomly assigned to a coffee bean extract group (n=10) or placebo group (n=10). We measured anthropometric parameters, abdominal fat distribution by computed tomography and blood components before and after the 8week intervention period. After supplementation, the coffee bean extract group showed body weight (p=0.08), body mass index (p=0.06), hip circumference (p<0.05), and upper waist circumference (p< 0.01). In addition, after 8 weeks, the coffee bean extract group showed a significant decrease in abdominal internal fat area compared to 0 weeks (0 weeks : $155.8cm^2$; 8 weeks : $145.9cm^2$, ${\Delta}$ change : $-9.9cm^2$, respectively). However, there were no significant differences in lipid profiles or serological measurements between the coffee bean extract group and placebo group. The results of our human study demonstrated that coffee bean extract supplementation for 8 weeks has beneficial effects on reducing abdominal internal fat area as well as hip and waist circumferences.

• Asian-Australasian Journal of Animal Sciences
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• 제25권9호
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• pp.1248-1254
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• 2012

The effect of silage additives on ensiling characteristics and nutritive value of Napier grass (Pennisetum purpureum) silages was studied. Napier grass silages were made with no additive, fermented juice of epiphytic lactic acid bacteria (FJLB), molasses or cassava meal. The ensiling characteristics were determined by ensiling Napier grass silages in airtight plastic pouches for 2, 4, 7, 14, 21 and 45 d. The effect of Napier grass silages treated with these additives on voluntary feed intake, digestibility, rumen fermentation and microbial rumen fermentation was determined in 4 fistulated cows using $4{\times}4$ Latin square design. The pH value of the treated silages rapidly decreased, and reached to the lowest value within 7 d of the start of fermentation, as compared to the control. Lactic acid content of silages treated with FJLB was stable at 14 d of fermentation and constant until 45 d of ensiling. At 45 d of ensiling, neutral detergent fiber (NDF) and acid detergent fiber (ADF) of silage treated with cassava meal were significantly lower (p<0.05) than the others. In the feeding trial, the intake of silage increased (p<0.05) in the cow fed with the treated silage. Among the treatments, dry matter intake was the lowest in the silage treated with cassava meal. The organic matter, crude protein and NDF digestibility of the silage treated with molasses was higher than the silage without additive and the silage treated with FJLB. The rumen parameters: ruminal pH, ammonia-nitrogen ($NH_3$-N), volatile fatty acid (VFA), blood urea nitrogen (BUN) and bacterial populations were not significantly different among the treatments. In conclusion, these studies confirmed that the applying of molasses improved fermentative quality, feed intake and digestibility of Napier grass.

• Asian-Australasian Journal of Animal Sciences
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• 제23권4호
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• pp.483-490
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• 2010

The objectives of this study were to measure particle size and evaluate the effect of increasing alfalfa hay particle size on production characteristics in lactating Holstein dairy cows. Ninety multiparous Holstein cows in early to mid-lactation were randomly assigned in a complete randomized design for a 30-day period. Animals were offered one of the three diets, which were identical in energy, protein, and chemical composition, but differed only in particle size of alfalfa hay. The treatments were A) total mixed ration (TMR) in which only fine chopped alfalfa hay was incorporated in the ration, B) the same diet in which half of the alfalfa hay was fine chopped and incorporated in the mixed ration and half was long hay and offered as a top dressing, and C) the same diet with long hay alfalfa offered as a top dressing. Distribution of particle size of rations was determined through 20,000, 8,000 and 1,000 ${\mu}m$ sieves. The new method of quantitative determination of manure index was examined for each cow on different treatments. The geometric mean length of particle size in the rations was 5,666, 9,900 and 11,549 ${\mu}m$ for treatments A, B and C, respectively. Fat corrected milk (4%), milk fat percentage and production were significantly different (p<0.05) in treatment A versus B and C (fat corrected milk (FCM, 4%)) 28.3 vs. 35.2 and 32.3 kg/d, fat percentage 2.89, 4.04 and 3.62; but the change of ration particle size had no significant effect on milk production (p>0.05). Blood concentration of cholesterol in treatment A was significantly higher (p<0.05) than treatment B and C (181.0 vs. 150.0 and 155.2 mg/dl). Manure index in treatment C was significantly different (p<0.05) from treatment B (15.86 vs. 17.67). Based on these experimental findings, it is concluded that an increase in the ration particle size can increase milk fat percentage due to providing more physically effective fiber, which in turn could effect changes in manure consistency.

• Environmental Analysis Health and Toxicology
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• 제30권sup호
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• pp.6.1-6.4
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• 2015

Objectives This study is conducted to estimate the cost paid by the public suffering from disease possibly caused by chemical and to examine the effect on public health. Methods Cost-benefit analysis is an important factor in analysis and decision-making and is an important policy decision tool in many countries. Cost-of-illness (COI), a kind of scale-based analysis method, estimates the potential value lost as a result of illness as a monetary unit and calculates the cost in terms of direct, indirect and psychological costs. This study estimates direct medical costs, transportation fees for hospitalization and outpatient treatment, and nursing fees through a number of patients suffering from disease caused by chemicals in order to analyze COI, taking into account the cost of productivity loss as an indirect cost. Results The total yearly cost of the diseases studied in 2012 is calculated as 77 million Korean won (KRW) per person. The direct and indirect costs being 52 million KRW and 23 million KRW, respectively. Within the total cost of illness, mental and behavioral disability costs amounted to 16 million KRW, relevant blood immunological parameters costs were 7.4 million KRW, and disease of the nervous system costs were 6.7 million KRW. Conclusions This study reports on a survey conducted by experts regarding diseases possibly caused by chemicals and estimates the cost for the general public. The results can be used to formulate a basic report for a social-economic evaluation of the permitted use of chemicals and limits of usage.

• Advances in Traditional Medicine
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• 제10권2호
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• pp.90-102
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• 2010

Effect of ethanol (ASE) and water (ASW) extracts of Argyreia speciosa on blood glucose and lipid profile was investigated in normoglycemic and Streptozotocin (STZ)-induced diabetic animals. In oral glucose and sucrose tolerance test, treatment with ASE and ASW (100 and 200 mg/kg) and Glidenclamide (10 mg/kg) significantly improved the glucose and sucrose tolerance in normal animals. In addition, respective treatment for fifteen-day resulted in significant percentage reduction in serum glucose (SG) ie., 30.39% (lower dose of ASE) and 33.21% (higher dose of ASW). In standardized STZ (50 mg/kg, iv)-induced diabetic rats, a single dose of ASE and ASW treatment exhibited reduction in SG levels at different time intervals compared to basal levels. Administration of both the doses of ASE and ASW for fifteen-day days exhibited greater percentage reduction in glycemia (24.6%, 24.7%, 23.9% and 21.9% respectively) and also ameliorated restored to near normal value of all tested lipid parameters. Further, treatment also exhibited significantly improved glucose tolerance over the period of 120 min compared to diabetic control group. Eventhough treatment failed to increase serum insulin levels significantly but peripheral utilization of insulin was increased as evident by insulin tolerance test. Taken together, present study supports the traditional usage of title plant in the treatment of diabetes mellitus.

• 한방재활의학과학회지
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• 제28권2호
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• pp.61-72
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• 2018

Objectives The purpose of this experiment is to evaluate 4 weeks DRF (Dose Rate Finding) and single oral dose toxicity of ChondroT in rats. Methods In 4-week DRF, male and female Sprague-Dawely rats were treated with ChondroT at oral dose of 0, 500, 1000, and 2000 mg/kg. clinical signs, body weight, food consumption, necropsy findings, organ weight, hematological and blood-chemical parameters, and histological findings were monitored for 4 weeks. Also, after single oral administration of ChondroT, mortality, clinical signs, body weight, and necropsy findings were minitored for 2 weeks. Results In 4-week DRF and single dose oral toxicity study of ChondroT in sprague-Dawley rats, ChondroT did not exhibit any toxicity under the study conditions employed. Conclusions The results suggested a no-observed adverse effects level (NOAEL) was over 2,000 mg/kg/day in SD rats after oral administration, this study could be used as basic study of the repeated dose 13-week oral toxicity study of ChondroT.