• Journal of Pharmaceutical Investigation
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• 제34권2호
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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.

• Journal of Pharmaceutical Investigation
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• 제34권6호
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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.

• Restorative Dentistry and Endodontics
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• 제20권2호
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• pp.432-461
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• 1995

The basic principles in the design of Class II amalgam cavity preparations have been modified but not changed in essence over the last 90 years. The early essential principle was "extension for prevention". Most of the modifications have served to reduce the extent of preparation and, thus, increase the conservation of sound tooth structure. A more recent concept relating to conservative Class II cavity preparations involves elimination of occlusal preparation if no carious lesion exists in this area. To evaluate the ideal ClassII cavity preparation design, if carious lesion exists only in the interproximal area, three cavity design conditions were studied: Rodda's conventional cavity, simple proximal box cavity and proximal box cavity with retention grooves. In this study, MO amalgam cavity was prepared on maxillary first premolar. Three dimensional finite element models were made by serial photographic method. Linear, eight and six-nodal, isoparametric brick elements were used for the three dimensional finite element model. The periodontal ligament and alveolar bone surrounding the tooth were excluded in these models. Three types model(B option, Gap option and R option model) were developed. B option model was assumed perfect bonding between the restoration and cavty wall. Gap option model(Gap distance: $2{\mu}m$) was assumed the possibility of play at the interface simulated the lack of real bonding between the amalgam and cavity wall (enamel and dentin). R option model was assumed non-connection between the restoration and cavty wall. A load of 500N was applied vertically at the first node from the lingual slope of the buccal cusp tip. This study analysed the displacement, 1 and 2 direction normal stress and strain with FEM software ABAQUS Version 5.2 and hardware IRIS 4D/310 VGX Work-station. The results were as followed. 1. Rodda's cavity form model showed greater amount of displacement with other two models. 2. The stress and strain were increased on the distal marginal ridge and buccopulpal line angle in Rodda's cavity form model. 3. The stress and strain were increased on the central groove and a part of distal marginal ridge in simple proximal box model and proximal box model with retention grooves. 4. With Gap option, Rodda's cavity form model showed the greatest amount of the stress on distal marginal ridge followed by proximal box model with retention grooves and simple proximal box model in descending order. 5. With Gap option, simple proximal box model showed greater amount of stress on the central groove with proximal box model with retention grooves. 6. Retention grooves in the proximal box played the role of supporting the restorations opposing to loads.

• Journal of Chest Surgery
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• 제3권2호
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• pp.73-90
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• 1970

Clinical perfusion data on 16 cases of cardiopulmonary bypass using Sigmamotor pump and RyggKyvsgaard Oxygenator which performed at Seoul National University Hospital during the period of Aug. 1968 to Aug. 1970 was analized. AIl cases were hemodiluted and the perfusion was carried out under the normothermic condition. The age of the patients ranged between 6 and 43 years. The b:dy weight varied between 18.3 and 54.0 kg and the body surface area between 0.78 and 1. 59$M^2$. The priming solution was consiste:I with fresh ACD blood. Hartmann solution and Mannitol. The average amount of priming was approximately 2242 ml. The average hemodilution rate was 17%. The flow rate ranged from 1.7L to 3.5L/Min/$M^2$ and averaged 2.4L/Min/$M^2$ or 78mI/Min/kg. The duration of perfusion varied from 22 to 110 min with average of 56.9 minutes. Some hemodynamic responses were observed. The arterial pressure dropped immediately after the initiation of partial perfusion and was more marked after the total perfusion foIlowed by gradual increase to the safety level. The central venous pressure reflected the reduced blood volume especially in the cases of prolonged perfusion which lasted over 60 min. In most of the cases, red blood cell count decreased and white blood ceIl count increased after the perfusion. Hemoglobin level was decreased, averaging of 12.5mg%, Hct 3.3% and platelets count of 18% postoperatively. Plasma hemoglobin increased mildly, from pre-perfusion average value of 4. 06mg% to postperfusion value of 22.5mg%. Serum potassium was 4.4mEq/L pre-operatively and was decreased to 3.7mEq/L postoperatively. Five cases showed definite hypopotassemia immediately after the operation. Sodium and chloride decreased mildly. These electrolyte changes are thought to be related with hemodilution. diuretics and reduced blood volume during and after the perfusion. Arterial blood pH value revealed minimal to moderate elevation from preperfusion average value of 7.376 to 7.461 during perfusion and then 7.365 after perfusion. The pC02 and hicarbonate showed minimal to moderately lowered values. The total CO2 was decreased. Buffer base decreased during perfusion (Av. 42.6mEq/L) and further decreased after the perfusion (Av. 40.8mEq/L). These arterial blood acid base changes suggested that the metabolic acidosis was accompanied by respiratory alkalosis during and immediately after the perfusion. Authors belived that the acidosis could more effectively be corrected with the more additional dose of bicarbonate than we used by this study. The chest tune drainage during the first 24 hours following operation was 1158 ml in average. One case (Case No. 15) showd definite bleeding tendency and it was believed that the cause might be due to the defect of heparin and protamine titration. The average urinary out put during 24 hours post-perfusion was 1291ml. One case (Case No. ]) showed definite post perfusion oliguria. As conclusion hemodilution using fresh ACD blood. Hartmann and Mannitol solution added with Bivon and high flow rate unler normothermia. was thought to amelioratc the severity of mctabolic acidosis during and after perfusion with relatively satisfactory effect on the diuresis and bleeding tendency.

• 한국식품과학회지
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• 제34권4호
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• pp.688-693
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• 2002

천연물을 이용하여 생리활성이 있는 성분을 추출 분리하여 그 유효 성분을 탐색함으로써 질병 예방 및 치료제로 이용하고자 하는 연구가 최근 활발히 진행되고 있다. 본 연구에서는 예부터 혈액 순환을 돕고, 지혈 작용에 효과가 있는 것으로 알려져 있는 식탁에 상용되는 야채인 부추를 이용하여 4종의 인체 암세포주인 HepG2, HeLa, MCF7 및 SK-N-MC를 이용하여 암세포 증식억제 및 암예방 QR 유도활성 효과를 측정하였다. MTT assay를 이용한 암세포 증식억제 실험 결과, 4종의 암세포주 모두 ethylether층인 ATMEE에서 아주 높은 농도 의존적이 암세포 증식억제 효과를 보였다. 즉 본 실험에 사용된 인체 암세포주 4종에서 시료의 농도가 $150\;{\mu}g/mL$일 때 각 세포주 모두 약 90% 이상의 높은 암세포 증식억제 효과가 나타났으며, 특히 신경아종세포주인 SK-N-MC 에서는 ethylether층의 시료 농도를 다른 층을 첨가시의 농도보다 적은 $100\;{\mu}g/mL$ 첨가에서도 이미 99.8%의 아주 높은 암세포 증식억제 효과를 나타내었다. 또 신경아종세포인 SK-N-MC에서는 ethylacetate층인 ATMEA의 경우에서도 최종 첨가 시료농도를 $200\;{\mu}g/mL$ 첨가했을 때 이미 91%의 높은 암세포 증식억제 효과가 나타났다. 암예방 quinone reductase(QR) 유도활성을 측정한 결과, 시료의 butanol 분획물 ATMB를 $50\;{\mu}g/mL$ 첨가했을 때 시료무처리구인 대조군을 1.0으로 한 경우 암예방 QR유도 효과가 아주 높은 3.92배의 활성이 나타났다. 본 연구 결과, 인체암세포 4종류에 대한 암세포 증식억제(cytotoxicity) 효과는 부추의 ethylether 분배층(ATMEE)에서 제일 뚜렷하였고, 암예방 QR 유도활성 효과는 butanol 분배층(ATMB)에서 가장 유도효과가 좋았다. 나아가 단계적인 생리활성 물질의 분리 동정이 계속 이루어져야 할 것으로 사료된다.

• 대한지역사회영양학회지
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• 제3권4호
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• pp.574-582
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• 1998

This study was carried out to discover the effects of eating habits and health-related life style on blood pressure, $\gamma$-Glutamic acid Peptide Transferase($\gamma$-GPT), blood glucose and High Density Lipoprotein-Cholesterol(HDL-C). 185 subjects(85 male, 100 female) were selected, who were living in the Cheonju area aged 40#s to 60#s. The mean systollic blood pressure(SBP), diastollic blood pressure (DBP), $\gamma$-GPT, fasting blood sugar(FBS) and HDL-C for all the subjects were 118mmHg, 77mmHg, 281U/l, 90mg/dl and 45mg/dl, respectively. The SBP and DBP for subuects over 60 years old were 126mmHg and 81mmHg and were significantly higher than subjects in their 40#s and 50#s(p<0.001, p<0.005). The HDL-C of the group that rarely ate breakfast was 57mg/dl and that was significantly higher than the 44mg/dl scored by those who ate breakfast everyday(p<0.05). The SBP for subjects having a snack 2-3 times/week was 125mmHg and that was significantly higher than the 114mmHg of those having a snack everyday(p<0.05). The $\gamma$-GPT for subjects consuming alcohol everyday was 44IU/L and that was significantly higher than 18IU/I of the non-drinking group(p<0.001). The $\gamma$-GPT of light smokers was 53IU/I and that was significantly higher than the 22IU/I for non-smoking participants(p<0.001). The DBP, SBP, $\gamma$-GPT, FBS and HDL-C related to exercise not significantly different. The SBP(p<0.001) and DBP(p-0.01) between age group was positively correlated. The $\gamma$-GPT between drinking frequency(p<0.001), drinking quantity(p<0.05), and smoking(p<0.05) was also positively correlated. The FBS between exercises had a negative correlation(p<0.05), and the HDL-C between breakfast had a negative correlation(p<0.05). These results indicate that decreasing drinking and smoking, when combined with appropriate exercise, will decrease the $\gamma$-GPT and fasting blood sugar level, and help preventing adult diseases.

• 임상간호연구
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• 제26권1호
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• pp.47-58
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• 2020

Purpose: The aim of this study was to develop a simulation-based High Flow Nasal Cannula Oxygen Therapy training program based on NLN/ISF to identify the effect on knowledge, clinical performance, and educational satisfaction compared to a group who had traditional High Flow Nasal Cannula Oxygen Therapy training after applying it to clinical nurses. Methods: 31 experimental groups and 33 control groups were conducted from August 2019 to September 2019 for inexperienced nurses over 4 months to 5 years with no experience using high-flow oxygen therapy. Educational programs were developed in scenarios according to Airvo2 and Optiflow, such as facilitator, participant, educational condition, design, characteristics, and educational outcomes. The education application was conducted in advanced for knowledge and clinical performance ability after watching therapy video. Since then, a total of 90 minutes have been conducted for respiratory failure theory training, airvo2 and optiflow simulation training, and debriefing. After applying the education, the medical institution measured nurses' knowledge, clinical performance, and education satisfaction. Data were analyzed using descriptive statistics, with the SPSS/WIN 22.0 program. Results: Both knowledge and educational satisfaction were higher in the experimental group than in the control group (t=-14.09, p<.001), (t=-12.99, p<.001). The clinical performance for both use of Optiflow and Airvo2 were higher in the experimental group than in the control group (t=-11.39, p<.001), (t=-11.38, p<.001). Conclusion: Results showed that the simulation-based High Flow Nasal Cannula Oxygen Therapy training was effective with the experimental group having increased scores for every area of this study.

• 한국산림과학회지
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• 제90권6호
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• pp.717-724
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• 2001

본 연구는 1979년에 조성된 해송 채종원에서 6년간(1995~2000년) 개화량를 조사하여 얻은 자료를 토대로 생식과정에 관계된 몇 가지 특성들을 계량화 하고자 하였다. 전체 60개 클론 중 18개 클론(30%)이 차지하는 자화의 상대적인 기여도는 0.37(1999)~0.46(1995), 웅화는 0.44(1999)~0.57(1995)로 자화보다 다소 높게 나타났으며 소수 클론에 의해 편중되는 현상이 다른 수종에 비하여 작게 나타났다. 배우체(v♀, v♂) 수준에서 상대적인 유효집단수는 각각 0.59(1995)~0.91(1999)과 0.56(1995)~0.83(1998), 접합체($v_b$) 수준에서는 0.72(1995)~0.93(1999)으로 추정되어 자성배우체가 웅성배우체보다 많게 나타났다. 웅화 개화량에 대한 평균지수는 전체 클론의 73% 이상이 0.4~0.6($0.5{\pm}0.1$)의 값을 나타내었으며, 연도간에는 73%(1996)~100%(2000)로 다양하게 나타났다. 성적 불균형도($A_s$)는 0.09~0.26으로 추정되어 다른 수종에 비해 상대적으로 낮아 높은 유전적 균일성을 나타내었다. 모든 유효집단수 간에는 정의 상관을 보였으며, 성적 불균형도는 모든 유효집단수와 부의 상관을 나타내었다.

• 약학회지
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• 제52권3호
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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.

• 약학회지
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• 제52권3호
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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.