• YAKHAK HOEJI
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• v.52 no.3
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• pp.195-200
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• 2008

Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug 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, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was 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, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% 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 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

• YAKHAK HOEJI
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• v.52 no.3
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• pp.188-194
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• 2008

Fexofenadine, ($\pm$)-4-1-hydroxy-4-{4-(hydroxydiphenylmethyl)-1-piperidinyl}-butyl-a,a-dimethyl benzeneacetic acid, is a selective histamine $H_1$ receptor antagonist, and is clinically effective in the treatment of seasonal allergic rhinitis and chronic idiopathic urticaria as a first-line therapeutic agent. The purpose of the present study was to evaluate the bioequivalence of two fexofenadine hydrochloride tablets, $Allegra^{(R)}$ (Handok Pharmaceuticals Co., Ltd.) and Alecort (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of fexofenadine from the two fexofenadine hydrochloride formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media. Twenty six healthy male subjects, 25.62$\pm$3.35 years in age and 70.05$\pm$11.71 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After a single tablet containing 120 mg as fexofenadine hydrochloride was orally administered, blood samples were taken at predetermined time intervals and the concentrations of fexofenadine in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in all tested dissolution media. The harmacokinetic 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, $Allegra^{(R)}$, were -1.37, 5.22 and 16.50% 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 0.83$\sim$log 1.08 and log 0.81$\sim$log 1.03 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Alecort tablet was bioequivalent to $Allegra^{(R)}$ tablet.

• The Journal of Korean Obstetrics and Gynecology
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• v.25 no.4
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• pp.1-11
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• 2012

Objectives: Osteoporosis, which occurs after menopause, is a kind of metabolic bone disorder. It develops when the bone mass begins to decrease radically, and its main symptoms are bone fracture and height-shortening. This thesis aims at what effects the Cuscutae Semen Extract(CSE) has on the prevention of osteoporosis in SD-rat that is caused by ovariectomy. Methods: The 24 female white rats, after removing their ovaries, were divided into the Normals, the Control group, and the CSE administrated group. For the next 8 weeks, distilled water to the normals and the control, and the CSE(45.9 mg/100 g) to the CSE administrated group were given in the mouths of them. After 8 weeks the rats were sacrificed. Weight, albumin, aspartate aminotransferase, alanine aminotransferase, total-cholesterol, triglyceride, phosphorus, calcium, tetraiodothyronine, estradiol, the weight of the femur, the amount of tibia ash, the area of trabecular bone, and the thickness of trabecular bone were measured. Results: The serum analysis shows that the calcium and phosphorous of the CSE administrated group significantly increased compared to that of the control group. Aspartate aminotransferase, alkalinephosphatase, total cholesterol, tetraiodothyronine of CSE group were decreased, but not so significant. Albumin, alanine aminotransferase, triglyceride and estradiol of the group showed the tendency to increase, but the significance wasn't admitted. Regarding the variation of bone, the femur weight and the ash content of tibia, CSE group was more increased than the control group but the significance wasn't admitted. The histological observation shows that the trabecular thickness was more increased than the control group, and trabecular area increased significantly compared to those of the control group. The number of osteoclast and osteoblast area of the CSE groups decreased significantly compared to those of the control group. Conclusions: From the result of the above study, CSE should be effective for the osteoporosis cure and precaution and deeper study through bedside and clinical demonstration is much needed from now on.

• Journal of The Korean Society of Clinical Toxicology
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• v.12 no.2
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• pp.77-84
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• 2014

Purpose: Carbamate insecticides are potent cholinesterase inhibitors capable of causing severe cholinergic toxicity. Use of carbamate rather than organophosphate insecticides has been increasing. Compared with organophosphate poisoning, relatively few studies have investigated carbamate-associated acute pancreatitis. We investigated general characteristics and pancreatitis of carbamate poisoning and the predictors, among those readily assessed in the emergency department. Methods: We performed a retrospective review of consecutive patients, aged over 18 years, who were admitted between January 2008 and April 2012 to an emergency department (ED) of an academic tertiary care center for treatment of carbamate poisoning. Patients who exhibited poisoning by any other material, except alcohol, were excluded. After application of exclusion criteria, patients were divided according to carbamate-induced pancreatitis and non-pancreatitis groups. Results: A total of 41 patients were included in this study. Among these 41 patients, the prevalence of acute pancreatitis was 36.6% (15 patients). Initial blood chemistry tests showed a statistically higher glucose level in the pancreatitis group, compared with the non-pancreatitis group (222, IQR 189-284 vs. 137, IQR 122-175 mg/dL, P<0.05). Regarding clinical courses and outcomes, a significantly higher proportion of patients developed pneumonia [10 (66.7%) vs. 6 (23.1%), P<0.05] and had a longer hospital stay (7 days, IQR 6-12 vs. 5 days, IQR 2-11, P<0.05), but no difference in mortality, in the pancreatitis group vs. the non-pancreatitis group. In multivariate analysis, the initial glucose was showing significant association with the presentation of carbamate-induced acute pancreatitis (odds ratio 1.018, 95% confidence interval 1.001-1.035, P<0.05). Conclusion: Carbamate-induced acute pancreatitis is common, but not fatal. Initial serum glucose level is associated with acute pancreatitis.

• Korean Journal of Plant Resources
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• v.28 no.2
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• pp.168-177
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• 2015

Here we study the anti-obesity effects of by-product from soybean on mouse fed high fat diet. The body weight gain, visceral and subcutaneous adipose tissue weight, liver and epididymal adipose tissue weight in freeze-dried soybean-soaking-water (SSW) powder fed group showed lower level than those in high fat diet (HFD) group by determining with weight measuring and histological methods. Also, histological analyses of the liver and fat tissues of SSW grouped mice revealed significantly less number of lipid droplets formation and smaller size of adipocytes compared to the HFD group. Moreover, the levels of total serum cholesterol, LDL-cholesterol and the atherogenic index were decreased in the SSW groups. Especially, in SSW group, the levels of phosphorylation of two lipid oxidation enzymes, adenosine monophosphate-activated protein kinase (AMPK) and acetyl-CoA carboxylasse (ACC) were elevated hence that may activate fatty acid oxidation. But AST and ALT levels were not changed in blood. By micro-CT analysis of abdomen, SSW groups significantly showed a tendency to decrease visceral and subcutaneous fats as well as fat-deposited areas compared to HFD group. Taken together, we suggest that soybean soaking water has a function in ameliorating obesity through inhibiting lipid synthesis as well as stimulating fatty acid oxidation.

• Herbal Formula Science
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• v.29 no.4
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• pp.239-252
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• 2021

Objectives : This study is to effect of improving muscle atrophy through water extract on the solid-phase fermentation extraction with Phellinus linteus of discarded Schisandra chinensis in an atorvastatin-induced atrophy C2C12 cell. Methods : C2C12 myoblast were differentiated into myotube by 2% horse serum medium for 6 days, and then treated solid-phase fermentation(S-P) extract at different concentrations for 24h. To investigate the effect of S-P extract on the induction of muscle atrophy and expression of atrophy-related genes and apoptosis in differentiated C2C12 myotubes using a GSH, ROS, real-time PCR, western blots analysis. Results : As a result of treatment with atorvastatin at concentrations of 5, 10, and 20 uM on the 6th day of differentiation in C2C12 myotube cells, it was confirmed that the cell morphology was damaged in a concentration-dependent manner, and the length and thickness of the myotube also decreased in a concentration-dependent manner. Treatment with S-P extract (50, 100 and 200 ㎍/㎖) increased of GSH and inhibited ROS in the atorvastatin-induced muscle atrophy cell model at a concentration that did not induce toxicity. In addition, it was confirmed that it has an effect on muscle reduction by inhibiting apoptosis of muscle cells as well as being involved in protein production and degradation of muscle cells. Conclusions : Atorvastatin-induced atrophy C2C12 cell, S-P extract activates related to differentiation/generation and proteolysis, and inhibits cell death of atrophy in C2C12 cell. Based on this, it is necessary to prove its effectiveness through animal models and human application test, but it is considered to be discarded Schisandra chinensis can present the potential for development as a recycling industrial material.

• Journal of Animal Science and Technology
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• v.63 no.6
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• pp.1314-1327
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• 2021

Bacillus is characterized by the formation of spores in harsh environments, which makes it suitable for use as a probiotic for feed because of thermostability and high survival rate, even under long-term storage. This study was conducted to investigate the effects of Bacillus-based probiotics on growth performance, nutrient digestibility, intestinal morphology, immune response, and intestinal microbiota of weaned pigs. A total of 40 weaned pigs (7.01 ± 0.86 kg body weight [BW]; 28 d old) were randomly assigned to two treatments (4 pigs/pen; 5 replicates/treatment) in a randomized complete block design (block = BW and sex). The dietary treatment was either a typical nursery diet based on corn and soybean meal (CON) or CON supplemented with 0.01% probiotics containing a mixture of Bacillus subtilis and Bacillus licheniformis (PRO). Fecal samples were collected daily by rectal palpation for the last 3 days after a 4-day adaptation. Blood, ileal digesta, and intestinal tissue samples were collected from one pig in each pen at the respective time points. The PRO group did not affect the feed efficiency, but the average daily gain was significantly improved (p < 0.05). The PRO group showed a trend of improved crude protein digestibility (p < 0.10). The serum transforming growth factor-β1 level tended to be higher (p < 0.10) in the PRO group on days 7 and 14. There was no difference in phylum level of the intestinal microbiota, but there were differences in genus composition and proportions. However, β-diversity analysis showed no statistical differences between the CON and the PRO groups. Taken together, Bacillus-based probiotics had beneficial effects on the growth performance, immune system, and intestinal microbiota of weaned pigs, suggesting that Bacillus can be utilized as a functional probiotic for weaned pigs.

• Journal of the Korea Convergence Society
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• v.9 no.11
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• pp.203-208
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• 2018

The purpose of this study was to investigate whether there is a relationship between pulmonary function, serum lipid and pulse pressure, which is a risk factor of cardiovascular disease, in subjects with 109 office workers(51 males and 58 females) be at Seoul, Korea. The mean age of the subjects was $43.44{\pm}7.23$ years old (male $43.44{\pm}7.27$, fenale $49.1{\pm}11.5$). The subjects' height, weight, BMI, systolic and diastolic blood pressures were measured and there was statistical difference between men and women.The mean pulse pressure of the subjects was $47.82{\pm}9.02mmHg$, and the mean of FVC was $84.26{\pm}9.91%$. There was no difference between men and women in both. There was a positive correlation between pulse pressure and systolic blood pressure in males (p<0.01) and females (p<0.01), and FVC and HDL in males were positively correlated (p<0.05). Pulse pressure and %FVC were negatively correlated (r =-0.267, P<0.01). Pulse pressure and %FVC were negatively correlated (r =-0.267, P<0.01). Regression analysis showed that PP was the independent affected %FVC. Therefore, pulse pressure and %FVC may be useful as a predictor of cardiovascular disease in middle-aged subjects with normal, suggest a long-term convergence follow-up is warranted to elucidate the incidence of cardiovascular disease.

• Laboraroty Animal Research
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• v.33 no.2
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• pp.57-67
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• 2017

The inhibitory effects of Asparagus cochinchinensis against inflammatory response induced by lipopolysaccharide (LPS), substance P and phthalic anhydride (PA) treatment were recently reported for some cell lines and animal models. To evaluate the hepatotoxicity and nephrotoxicity of A. cochinchinensis toward the livers and kidneys of ICR mice, alterations in related markers including body weight, organ weight, urine composition, liver pathology and kidney pathology were analyzed in male and female ICR mice after oral administration of 150, 300 and 600 mg/kg body weight/day saponin-enriched extract of A. cochinchinensis (SEAC) for 14 days. The saponin, total flavonoid and total phenol levels were found to be 57.2, 88.5 and 102.1 mg/g in SEAC, respectively, and the scavenging activity of SEAC gradually increased in a dose-dependent manner. Moreover, body and organ weight, clinical phenotypes, urine parameters and mice mortality did not differ between the vehicle and SEAC treated group. Furthermore, no significant alterations were measured in alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), blood urea nitrogen (BUN) and the serum creatinine (Cr) in the SEAC treated group relative to the vehicle treated group. Moreover, the specific pathological features induced by most toxic compounds were not observed upon liver and kidney histological analysis. Overall, the results of the present study suggest that SEAC does not induce any specific toxicity in the livers and kidneys of male and female ICR mice at doses of 600 mg/kg body weight/day.

• Pediatric Infection and Vaccine
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• v.26 no.1
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• pp.51-59
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• 2019

Purpose: The aim of this study was to evaluate the relationships between cytokine and chemokine levels and the clinical severity of Mycoplasma pneumoniae pneumonia. Methods: A retrospective analysis of clinical and laboratory parameters were performed. Serum levels of interleukin (IL)-6, IL-8, IL-10, IL-18, interferon-${\gamma}$-inducible protein-10 (IP-10), macrophage inflammatory $protein-1{\beta}$, and tumor necrosis $factor-{\alpha}$ were measured. The severity of patients' clinical course and radiologic findings were also assessed. Results: Seventy-two patients (35 males and 37 females) with a median age of 3.9 years (range, 1-16 years) were enrolled. Patients with lobar pneumonia (n=29) had significantly higher C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and IL-18 values than those with broncho-interstitial pneumonia (n=43). However, the cytokine and chemokine values did not differ between the group that was treated with corticosteroids (n=31) and the one that was not (n=41). The CRP, ESR, lactate dehydrogenase (LDH), IL-18, and IP-10 values showed positive correlations with fever duration prior to admission. The CRP and ESR values were positively correlated with IL-18, and LDH, with IP-10 levels. Conclusions: CRP, ESR, LDH, IL-18, and IP-10 values were associated with the severity of the disease, manifesting lobar pneumonia or prolonged fever duration prior to admission.