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Bioequivalence of Glimed Tablet to Amaryl Tablet (Glimepiride 2 mg) (아마릴 정(글리메피리드 2mg)에 대한 글리메드 정의 생물학적 동등성)

  • Cho, Hea-Young;Park, Eun-Ja;Kang, Hyun-Ah;Baek, Seung-Hee;Lee, Suk;Kim, Se-Mi;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.34 no.2
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    • pp.147-153
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    • 2004
  • The purpose of the present study was to evaluate the bioequivalence of two glimepiride tablets, $Amaryl^{\circledR}$ (Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn II Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, $22.65{\pm}2.19$ years in age and $66.55{\pm}8.85$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 2 mg as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were 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 logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Amaryl were -3.70, -8.28 and 0.61% 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., $log(0.84){\sim}log(1.04)$ for $log(0.82){\sim}log(1.03)$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.

Bioequivalence of Tagamet Tablet to Sinil CIMETIDINE Tablet (cimetidine 400 mg) (타가메트정 400 mg에 대한 신일시메티딘정 400 mg의 생물학적동등성시험)

  • Yoon, Mi-Kyeong;Lee, Byoung-Moo;Lee, Sung-Jae;Kim, Sun-Kyu;Lee, Jae-Hwi;Choi, Young-Wook
    • Journal of Pharmaceutical Investigation
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    • v.34 no.6
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    • pp.521-527
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    • 2004
  • Cimetidine is a histamine $H_2-receptor$ antagonist, used for the treatment of endoscopically or radiographically comfirmed duodenal ulcer, pathologic GI hypersecretory conditions, and active, benign and gastric ulcer. Simple method for determining cimetidine in human plasma has been developed and validated. The analytical procedure for cimetidine showed a linear relationship in the concentration ranges from $0.05\;to\;5\;{\mu}g/ml$. Coefficient of variance (CV, %) for intraday and interday validation and relative error (RE, %) were less than ${\pm}15%$. Based on this analytical method, the bioequivalence of two cimetidine 400 mg tablets, reference (Tagamet 400 mg) and test drug (Sinil CIMETIDINE 400 mg) was evaluated according to the guidelines set by the Korea Food and Drug Administration (KFDA). Release of cimetidine from the tablets in vitro was tested using KP VIII Apparatus II with various dissolution media (pH 1.2, 4.0, 6.8 buffer solutions and water). Twenty-four healthy volunteers, $21.38{\pm}1.86$ years in age and $68.71{\pm}8.68\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was performed. After oral administration of a tablet containing 400 mg of cimetidine, blood samples were taken at predetermined time intervals and concentrations of cimetidine in plasma were determined using HPLC equipped with UV detector. The dissolution profiles of the two tablet formulations were very similar at all dissolution media. In addition, pharmacokinetic parameters such as $AUC_t$ and $C_{max}$ were calculated and ANOVA was employed for the statistical analysis of parameters. The results were revealed that the differences in $AUC_t$ and $C_{max}$ between the two tablets were 4.17 % and 0.97% respectively. At 90% confidence intervals, the differences in these parameters were also within ${\pm}20%$. All of the above mentioned parameters have met the criteria of KFDA guidelines for bioequivalence, indicating that the test drug tablet (Sinil CIMETIDINE tablet) is bioequivalent to Tagamet 400 mg tablet.

Effects of Green Tea Infusion on the Preneoplastic Lesions and Peroxidation in Rat Hepatocarcinogenesis

  • Kim, Hee-Seon;Kim, Hyung-Sook;Park, Haymie
    • Korean Journal of Community Nutrition
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    • v.2 no.5
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    • pp.735-744
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    • 1997
  • The effect of green tea drinking on the hepatocellular chemical cacinogenesis have been studied. Placental glutathione S-transferase(GST-P) positive foci area in a liver tissue, contents of thiobarbituric acid reactive substances(TBARS), total cytochrome P450 and glucose 6-phospphatase(G6P) activity in hepatic microsomes were investigated. Weaning Sprague-Dawley male rats were fed AIN-76A diet with deionized water or green tea infusion, Rats of CTR and CTR+ groups were provided deionized water while GTI and GTI+ groups were provided green tea instead of deionized water for the entire experimental period of 13weeks. Rats of GTP and GTP + groups had deionized water for the first 6 weeks and switched to green tea for the last 7weeks of the experimental period. CTR+, GTI +, and GTP + groups were carcinogen treated groups, Diethylnitrosamine(DEN) was injected as a single dose of 200mg/kg body weight intraperitoneally after 4 weeks of feeding. 2-Acetyla-minofluorene(AAF) was used as a carcinogen proliferater and suppled in the diets of carcinogen treated rats as 0.02% content for the last 6weeks starting from 2weeks after DEN injection. Rats were sacrificed after 13week weeks of feeding. The area and number of GST-P positive foci detected in carcinogen treated rats were decreased by green tea ingestion but when timing and duration of green tea ingestion was delayed after promotion period as in GTP + group, GST-P positive foci were not decreased as much as in GTI+ group. TBARS contents of carcinogen treated rats decreased by 13weeks of green tea ingestion but GTP groups did not show statiscally significant differences. G6P activities tended to decrease by carcinogen treatment but changes were not statiscally significant by green tea ingestion. Total cytochrome P450 contents were increased by carcinogen treatment. Thirteen weeks of green tea ingestion (GTI) also increased to total cytochrome P450 contents while 7weeks of green tea ingestion(GTP) did show any effects. These results suggest that green tea has suppressive effects on hepatocellular chemical carcinogenesis probably through the activities of antioxidant compounds. (Korean J Community utrition 2(5) : 735∼744, 1997)

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Relation between Beverage Consumption Pattern and Metabolic Syndrome among Healthy Korean Adults (건강한 한국성인의 음료섭취패턴과 대사증후군의 연관성 연구 -2013~2015년 국민건강영양조사를 바탕으로-)

  • Dennis, Eun Ju;Kang, Minji;Han, Sung Nim
    • Korean Journal of Community Nutrition
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    • v.22 no.5
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    • pp.441-455
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    • 2017
  • Objectives: The purpose of this study is to describe beverage patterns among healthy Korean adults and investigate their association with prevalence and components of metabolic syndrome. Methods: Subjects consisted of 6,927 Korean adults, aged 19-64 years in the $6^{th}$ Korea National Health and Nutrition Examination Survey (KNHANES, 2013-2015). Beverages were regrouped into twelve groups based on food codes and beverage intake (g/day) was assessed by 24-hour recall. Factor analysis was used to obtain beverage patterns. Waist circumference and body mass index (BMI) were used as anthropometric data; fasting blood glucose, triglyceride, high density lipoprotein (HDL), and blood pressure were used as biochemical indicators. The odds ratio (OR) for prevalence of metabolic syndrome and components of metabolic syndrome was assessed using logistic regression analysis. Results: Three beverage patterns were identified using factor analysis: 1) carbonated soft drinks 2) coffee (without added sugar or powdered creamer), and 3) alcoholic beverages. Subjects with high scores for the carbonated soft drink and coffee without added sugar or powdered creamer patterns were younger and subjects with high scores for the alcoholic beverage pattern were older. There were significant differences in gender distribution in all three beverage patterns, with men more likely to have high scores for carbonated soft drink and alcoholic beverage patterns. On the other hand, women were more likely to have higher scores for coffee without added sugar or powdered creamer pattern. Within each pattern, there were significant differences in sociodemographic and lifestyle characteristics such as education, household income, frequency of eating out, and smoking status according to the quartile of pattern scores. Alcoholic beverages and carbonated soft drinks patterns were associated with an increased levels of metabolic syndrome components, but coffee without added sugar or powdered creamer was not associated with any of metabolic syndrome components in healthy Korean adults after adjusting for age, sex, education, BMI, weight management, household income, smoking status, frequency of eating out, and energy intake. Conclusions: Alcoholic beverages and carbonated soft drinks patterns are associated with increased levels of metabolic syndrome components while coffee without added sugar or powdered creamer pattern is not associated with any of metabolic syndrome components in healthy Korean adults.

Identification and inhibiting effect of Lactobacillus salivarius the formation of plaque and the production of volatile sulfur compounds by anaerobic bacteria (치태형성과 혐기성 세균의 황화합물 생성에 대한 Lactobacillus salivarius의 억제효과 및 동정)

  • Kim, Mi-Hyung;Sun, Gem-Ju;Ahn, Yeon-Jun
    • Journal of Korean society of Dental Hygiene
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    • v.5 no.2
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    • pp.131-145
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    • 2005
  • There are normal inhabitants doing medically useful functions in the body. There are many kinds of bacteria performing specific functions in the oral cavity. Two strains of lactic add bacteria were isolated from normal inhabitants of children's oral cavity, which inhibited the production of volatile sulfur compounds by anaerobic bacteria. The authors identified the isolates by 16S rDNA partial sequencing. 1. Two isolates were Gram-positive bacilli and produced hydrogen peroxide. 2. When Streptococcus mutans was cultured in the media, the mean weight of formed artificial plaque on the orthodontic wires was $124.4{\pm}30.4$ mg, whereas being reduced to $5.2{\pm}2.0$ mg and $10.6{\pm}6.6$ mg in the media cultured with Streptococcus mutans and each isolate, respectively(p<0.05). 3. The number of viable cells of Streptococcus mutans was $3.4{\times}10^9$ per ml in the cultured solution, whereas those of Streptococcus mutans in the combined culture with each of isolates were $4.6{\times}10^8$ and $2.4{\times}10^8$ per ml. 4. The optical density was 1.286 in the supernatant of Fusoacterium nucleatum after vortexing for 30 minutes, whereas in the supernatant of combined Fusoacterium nucleatum and each isolate, they were reduced to 0.628 and 00497, which the percentages of coaggregation between them were 2904% and 57.8%, respectively. 5. The optical density of Fusoacterium nucleatum precipitate was 1.794 in the culture media containing cysteine and $FeSO_4$ being reduced to 1.144 and 0.915 in the coaggregated precipitates of Fusoacterium nucleatum and each isolate. 6. The similarity values of 16S rDNA sequence between each of isolates and Lactobacillus salivarius subsp. salicinius were 99.60% and 99.73%, respectively, meaning that isolates were Lactobacillus salivarius subsp. salicinius. These results indicated that two strains isolated from children's saliva, which inhibited the formation of plaque and the production of volatile sulfur compounds, were identified as Lactobacillus salivarius subsp. salicinius.

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Acute Toxicity and the Effect of an Insecticide Monocrotophos on plasma Cholinesterase Acitivity in Albino Rat. (살충제(殺蟲劑) Monocrotophos가 흰쥐에 대한 독성(毒性) 및 혈액중(血液中) Cholinesterase 활성도(活性度)에 미치는 영향(影響))

  • Kim, Gwang-Po;Choi, In-Hu;Yang, Jae-Seol
    • Korean Journal of Environmental Agriculture
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    • v.7 no.1
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    • pp.58-64
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    • 1988
  • The acute oral, intraperitoneal and subacute toxicity of monocrotophos, an insecticide, was studied in albino rats. The acute oral $LD_{50}$ values for female and male rats were 5.0mg/kg and 8.7mg/kg, respectively. Conversely the intraperitoneal $LD_{50}$ values for female and male rats were 4.9mg/kg and 6.0mg/kg, respectively. Plasma cholinesterase (ChE) activity in rats treated with a single dose was the most depressed 4 hours after administration, but returned to normal within 72 hours of administration. Significant depression of body weight gain and food consumption was observed in rats receiving the 3.5mg/kg/day dose level for 28 days as compared with the controls. Additionally plasma ChE activity depression was also observed.

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Evaluation of Biological Effects of Low Concentrations of Mercury Chloride (II) and Ionizing Radiation in the Prepubertal Male Rats (미성숙 웅성 흰쥐를 이용한 이온화 방사선 조사 및 저농도 염화수은(II)의 음용에 따른 위해성 비교 평가)

  • Kim Ji Hyang;Kim Jin Kyu;Yoon Yong Dal
    • Korean Journal of Environmental Biology
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    • v.22 no.3
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    • pp.411-418
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    • 2004
  • Mercury, one of the most diffused and hazardous organ-specific environmental contaminants, exists in a wide variety of physical and chemical states. The murcury with the nature which evaporates easily can cause an acute or chronic mercury poisoning to workers at mercury-handling workplaces. Although many studies indicate that mercury induces a deleterious damage, little has been reported from the investigations of mercury effects at surrounding levels in living things. The purpose of this study was to evaluate the biological effects of mercury chloride and ionizing radiation. Prepubertal male F344 rats were administered mercury chloride in drinking water throughout the experimental period or were given wholebody irradiation with a dose of 6.5 Gy. The amount changed of body weight during the experimental period showed a 4.9% rise in the mercury-treated group and 14.4% decline in the irradiated group compared with the level of the control group. The results of hematological analysis (red blood cells, white blood cells, hemoglobin, and hematocrit) indicated the differential effects of mercury chloride and ionizing radiation. However the concentration of cortisol as assessed by radioimmunoassay increased in both of the groups. Relative expressions of mRNA related to mitochondrion-mediated apoptosis were investigated using semiquantitative reverse transcription polymerase chain reaction on gonad and urinary organs of the experimental groups. While the expression of Bcl-2 mRNA exhibited different patterns depending on the organs or the experimental groups, both of the experimental groups showed a conspicuous expressions of Bax mRNA. In conclusion, the target organ of mercury chloride seems to be a urinary organ and the pattern of damage induced by mercury chloride differs from that by ionizing radiation.

Effects of varying nursery phase-feeding programs on growth performance of pigs during the nursery and subsequent grow-finish phases

  • Lee, Chai Hyun;Jung, Dae-Yun;Park, Man Jong;Lee, C. Young
    • Journal of Animal Science and Technology
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    • v.56 no.7
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    • pp.24.1-24.6
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    • 2014
  • The present study investigated the effects of varying durations of nursery diets differing in percentages of milk products on growth performance of pigs during the nursery phase (NP) and subsequent grow-finish phase (GFP) to find the feasibility of reducing the use of nursery diets containing costly milk products. A total of 204 21-d-old weanling female and castrated male pigs were subjected to one of three nursery phase feeding programs differing in durations on the NP 1 and 2 and GFP diets containing 20%, 7%, and 0% lacrosse and 35%, 8%, and 0% dried whey, respectively, in 6 pens (experimental units) for 33 d: HIGH (NP 1, 2 and 3 diets for 7, 14, and 12 d), MEDIUM (NP 2 and 3 for 14 and 19 d), and LOW (NP 2 and 3 and GFP 1 for 7, 14, and 12 d). Subsequently, 84 randomly selected pigs [14 pigs (replicates)/pen] were fed the GFP 1, 2 and 3 diets during d 54-96, 96-135, and 135-182 of age, respectively. The final body weight (BW) and average daily gain (ADG) of nursery pigs did not differ among the HIGH, MEDIUM, and LOW groups (14.8, 13.3, and 13.7 kg in BW and 273, 225, and 237 g in ADG, respectively). The average daily feed intake during the nursery phase was greater (p < 0.01) in the HIGH group than in the MEDIUM and LOW groups, whereas the gain:feed ratio did not differ across the treatments. The BW on d 182 and ADG during d 54-182 were greater in the HIGH and MEDIUM groups vs. the LOW group (110.0, 107.6, and 99.6 kg in BW, respectively; p < 0.01). The backfat thickness and carcass grade at slaughter on d 183 did not differ across the treatments. In conclusion, the MEDIUM program may be inferior to the commonly used HIGH program in supporting nursery pig growth. Nevertheless, the former appears to be more efficient than the latter in production cost per market pig whereas the LOW program is thought to be inefficient because of its negative effect on post-nursery pig growth.

Effect of the Water Soluble Extracts from Velvet Antler on Lipid Metabolism and Blood Components in Rats (수용성 녹용 추출물이 랫드의 지방대사 및 혈액성분에 미치는 영향)

  • Cui, Xang Soon;Kim, Hye In;Cho, Seong Koo
    • Journal of Animal Science and Technology
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    • v.50 no.3
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    • pp.417-428
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    • 2008
  • An experiment was conducted with 80 male rats for 4 weeks to investigate the effect of water soluble extracts(WSE) from different sections of farmed Elk(Cervus elaphus) antler on lipid metabolism and hematology. Antlers were divided into four sections of tip, upper, middle and base. Water soluble extract(35g/60ml) was prepared from each section of antler, and was administered orally to male Sprague- Dawley rats(10ml/kg body weight) once a day. Administration of WSE from upper, middle and base sections of antler decreased(P<0.0027) AST values at 3 weeks of feeding, however AST value was decreased(P< 0.0136) in the WSE of base section compared to that of control at 4 weeks of feeding. Administration of antler WSE for 4 weeks decreased total cholesterol in visceral fat(P<0.0035) and liver(P<0.0003) at 4 weeks of feeding compared to those of control. Feeding antler WSE for 4 weeks increased the compositions of C14:0(P<0.0037), C16:1(P<0.0061), C18:1(P<0.0066), C18:2(P< 0.0069) and C18:3(P<0.0035) in the visceral fat compared with that of control.

Effects of Total Mixed Rations on Growth Performance and Carcass Charcteristics of Hanwoo Steers (섬유질배합사료 급여가 거세한우의 발육 및 도체특성에 미치는 영향 미치는 영향)

  • Cho, Young Moo;Kwon, Eung Gi;Chang, Sun Sik;Kim, Tae Il;Park, Byung Ki;Kang, Su Won;Paek, Bong Hyun
    • Journal of Animal Science and Technology
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    • v.50 no.3
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    • pp.363-372
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    • 2008
  • To investigate the effects of total mixed ration(TMR) on growth performance and carcass characteristics of Hanwoo steers, sixty steers were randomly assigned to one of four treatment groups; separate feeding of concentrate and rice straw(control), wet TMR(TMRⅠ), dry TMR with 20%(TMRⅡ) and 40%(TMRⅢ) barley bran from 6 to 28 month of age. In growth performance, average daily gains of TMRⅡ group was the highest(0.70kg/day) but significant differences between treatments were not found(p>0.05). Average feed required for kg body weight gain of control group was 11.63kg. Those of TMRⅠ through TMRⅢ were 9.29, 10.46 and 10.71kg, respectively. Dressing percentage and retailed cut percentage were 59% and 63%, without any significant differences between treatments(p>0.05). There were no significant differences in rib-eye area, back fat thickness, meat color and fat color (p>0.05). Average marbling score was higher(p<0.05) in TMRⅠ than in control group.