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란크릭 캅셀(플루옥세틴 20mg)에 대한 프로작 캅셀의 생물학적 동등성 시험
심상범,조요나,오한석,류재환,이경태,김남재,서성훈 경희대학교 동서의학연구소 2001 東西醫學硏究所 論文集 Vol.2000 No.-
Bioequivalence of two flouxetine capsule, ProzacR (Lilly kora Ltd.) and LanclicR (Samsung Pharm. IND. Co.), was evalated according to the guideline of KFDA. Twenty four healthy male volunteers (21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 60mg of fluoxetine was orally administered, blood was taken at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 32, 48 and 72 hours after administration and just before administration. Plasma was analyzed for fluoxetine and internal standard (clomipramine) by a sensitive and validated HPLC assay. The pharmaco kinetic parameters (AUCt, Cmax and Tmax) wre calculated and ANOVA test was used for the statistical analysis of parameters. Differences in (AUCt, Cmax and Tmax between two capsules were -0.90, 3.46 and -14.08% respectively. All powers (1-β) for AUGt, Cmax and Tmax were more than 0.9. Detectable differences (Δ) and confidence interval were all less than ±20%. All the parameters above met the criteria of KFDA for bioequivalence and indicated that LanclicR capsules are bioequivalent to ProzacR capsules.
인체 혈장에서 염산시프로플록사신(시프로플록사신으로서 250㎎) 정량을 위한 HPLC 분석법의 유효성검토
하용화,조성희,천성국,서성훈,류재환,최영욱,이경태 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.4
A simple HPLC method with ultraviolet detection of ciprofloxacin in human plasma was developed and validated. After protein precipitation with trichloroacetic acid, chromatographic separation of ciprofloxacin in plasma was achieved at 50℃ with a C_18 column and methanol-phosphate mixture (pH 2.5), as mobile phase. Quantitative determination was performed by ultraviolet detection at 278 nm. The method was specific and validated with a limit of quantification of 100 ng/ml. The infra- and inter-day coefficients of variation were between 1.67% and 10.55% and accuracy between 92.01% and 106.09%. The method has been successfully applied in a bioavailability study of 250 ㎎ ciprofloxacin hydrochloride tablet.
타리비드 정(오플록사신 100㎎)에 대한 파비드 정의 생물학적동등성
박완수,조성희,이헌우,임호택,홍성제,서성훈,류재환,이경태 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.1
The purpose of the present study was designed to evaluate the bioequivalence of two ofloxacin tablets, Tarivid (Jell Pharm. Co., Ltd.) and Favid (ILHWA Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four normal male volunteers, 23.67±3.12 year in age and 68.50±7.23 kg in body weight, were divided into two groups and a randomized 2x2 cross-over study was employed. After four tablets containing 100 mg of ofloxacin were orally administered, blood was taken at predetermined time intervals and concentrations of ofloxacin in plasma were deter mined using HPLC. Pharmacokinetic parameters such as AUC_(t) and T_(max) were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed AUC_(t), and C_(max) and untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transformed data were acceptance range of log 0.8 to log 1.25 (e.g., log 0.94-log 1.04 and log 0.90-log 1.07 for AUC_(t) and C_(max) respectively). The major parameters. AUC_(t) and C_(max) met the criteria of KDFA for bioequivalence indicating that Favid tablet is bioequivalent to Tarivid tablet.
레니텍^(�) 정(말레인산 에날라프릴, 10mg)에 대한 에나레이스 정의 생물학적 동등성
조성희,하용화,홍성제,서성훈,류재환,김동현,이경태 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.3
The purpose of present study was to evaluate the bioequivalence of two enalapril maleate tablets, Renitec^(™) (MSD Korea Ltd.) and Enalace ^(™) (Welfide Korea Ltd.), according to the guidelines of Korea Food Drug Administration (KFDA). Twenty-four normal male volunteers, 22.33±2.55 year in age and 66.54±8.30 ㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containint 10 ㎎ of enal-april maleate per tablet wre orally administered, blood was taken at predetermined time intervals and concentrations of enalapril in plasma were determined using LC-MS-MS. 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) and C_(max) untransformed T_(max). There were no sequence effects between two formulations in these parameters. The 90% confidence intervals for the log transfored data were acceptance range of log0.8 to log1.25(e.g., log1.02∼log1.14 and log1.03∼log1.19 for AUC_(t) and C_(max), respectively). The major parameters, AUC_(t) and C_(max), met the criteria of KDFA for bioequivalence indicating that Enalace^(™) tablet is bioequivalent to Renitec^(™) tablet.
( Jae Hyun Yoon ),( Chung Hwan Jun ),( Sung Bum Cho ),( Wan Sik Lee ),( Sook In Jung ),( Chang Hwan Park ),( Young Eun Joo ),( Hyun Soo Kim ),( Sung Kyu Choi ),( Jong Sun Rew ) 대한내과학회 2014 대한내과학회 추계학술대회 Vol.2014 No.1
Background: To identify risk factors and clinical outcomes for spontaneous rupture of pyogenic liver abscess (SRLA). Methods: A total of 602 patients who were diagnosed with pyogenic liver abscess were analyzed retrospectively from January 2004 to July 2013. Among the 602 patients, 23 patients experienced SRLA. Results: The incidence rate of SRLA was 3. 8%. In multivariate analysis, underlying liver cirrhosis (OR: 4. 65, p=0. 009), gas forming abscess (OR: 3. 65, p=0. 026), abscess size (=6cm) (OR: 10. 99, p=0. 002), and other septic metastasis (OR: 1. 71, p=0. 047) were risk factors for SRLA in patients with pyogenic liver abscess. Regarding to the site of rupture, 20 patients (87%) had localized rupture; sub-phrenic abscess (13%), peri-hepatic abscess (43. 5%), localized peritoneal abscess (13%), empyema (17. 4%), and 3 patients (13%) had peritonitis. Ruptures resulting in peritonitis require urgent surgery, whereas localized rupture can be managed with percutaneous drainage in addition to appropriate antibiotics. The outcomes of SRLA (mortality rate; 4. 3%) were relatively good. Conclusions: Patients with cirrhosis, abscess size (=6cm), gas forming abscess, and other septic metastasis who have pyogenic liver abscess should need to be monitored closely and may need early intervention for spontaneous rupture of liver abscess.
Brunner선 선종 치료에 있어서 내시경 용종절제술의 안전성과 유용성에 대한 검토
박재홍 ( Jae Hong Park ),박창환 ( Chang Hwan Park ),박정호 ( Jeong Ho Park ),이수정 ( Soo Jung Lee ),이완식 ( Wan Sik Lee ),주영은 ( Young Eun Joo ),김현수 ( Hyun Soo Kim ),최성규 ( Sung Kyu Choi ),유종선 ( Jong Sun Rew ),김세종 ( 대한소화기학회 2004 대한소화기학회지 Vol.43 No.5
Background/Aims: Brunner`s gland adenoma is a rare benign tumor of the duodenum. Although several cases of successful endoscopic polypectomy have been reported, the studies on the safety and usefulness of endoscopic polypectomy are extremely rare. Therefore, we report the results of 10 cases of Brunner`s gland adenoma treated by endoscopic polypectomy. Methods: Between November 1998 and January 2003, 10 cases of Brunner`s gland adenoma were diagnosed. The mean age of the cases (6 male, 4 female) was 60.4 years. They were located in the bulb (9) and the second portion (1) of the duodenum. All cases were diagnosed and removed by endoscopic polypectomy. Results: The size of the tumor ranged from 1.0 to 3.5 cm in diameter. Pedunculated polyps were found in three cases. In other seven cases, semipedunculated polyps were observed and, three of them were presented as submucosal tumor. All cases had no malignant foci. There was no complication such as bleeding, perforation, and pancreatitis after endoscopic polypectomy. During follow-up period (range 1~39 months) after endoscopic polypectomy, there was no complication and recurrence of the lesions. Conclusions: Endoscopic polypectomy was a safe and useful method for the treatment of duodenal Brunner`s gland adenoma without complication and recurrence.(Korean J Gastroenterol 2004;43:299-303)
단보 : 건일로딘 캡슐(에토돌락 200 mg)에 대한 에토딘 캡슐의 생물학적동등성
이명재 ( Myung Jae Lee ),강종민 ( Jong Min Kang ),최상준 ( Sang Jun Choi ),이진성 ( Jin Sung Lee ),탁성권 ( Sung Kwon Tak ),서지형 ( Ji Hyung Seo ),류재환 ( Jae Hwan Rew ),임성빈 ( Sung Vin Yim ),이경태 ( Kyung Tae Lee ) 한국약제학회 2008 Journal of Pharmaceutical Investigation Vol.38 No.6
( Kyoung Won Yoon ),( Chang Hwan Park ),( Wan Sik Lee ),( Young Eun Joo ),( Hyeun Soo Kim ),( Sung Kyu Choi ),( Jong Sun Rew ),( Jae Hyug Lee ) The Editorial Office of Gut and Liver 2009 Gut and Liver Vol.3 No.3
Primary neuroendocrine carcinoma of the gallbladder is extremely rare because normal gallbladder mucosa does not contain neuroendocrine cells. Neuroendocrine cells can be detected at sites of intestinal metaplasia induced by chronic inflammation, which may be the initial step in the development of neuroendocrine tumor of the gallbladder. Anomalous union of the pancreaticobiliary duct (AUPBD) is an uncommon congenital anomaly that is frequently associated with choledocholithiasis, cholangitis, pancreatitis, and cancer of the gallbladder or bile duct. In AUPBD, cancers of the gallbladder and bile duct can be induced by chronic inflammation. We report herein a case of large-cell neuroendocrine tumor of the gallbladder associated with AUPBD. (Gut and Liver 2009;3:231-234)