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아젭틴 정(염산아젤라스틴 1 mg)에 대한 아젤라 정의 생물학적 동등성
조혜영,윤지훈,서유리,오인준,이성관,문재동,이용복 전남대학교 약품개발연구소 2001 약품개발연구지 Vol.10 No.-
Azelastine, a phthalazinone derivative, is an antiallergic agent which demonstrates histamine H_1-receptor antagonist activity and also inhibits histamine release from mast cells following antigen and non-antigen stimuli. Thus, azelastine may be useful in the management of both asthma and allergic disorders. The purpose of the present study was to evaluate the bioequivalence of two azelastine hydrochloride tablets, Azeptin^TM (Bu Kwang Pharmaceutical Co., Ltd.) and Azela^TM (Kyung Dong Pharmaceutical Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). Eighteen normal male volunteers, 22.44±2.01 years in age and 61.99±6.18㎏ in body weight, were divided into two groups and a randomized 2×2 cross-over study was employed. After two tablets containing 1㎎ of azelastine hydrochloride per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of azelastine in serum were determined using HPLC with fluorescence detector. 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. The results showed that the differences in AUC_t, C_max and T_max between two tablets were -6.45%, -2.60% and -7.14%, respectively, when calculated against the Azeptin^TM tablet. The powers (1-β) for AUC_t and C_max were 96.65% and 88.47%, respectively. Minimum detectable differences (Δ) at α=0.05 and 1-β=0.8 were less than 20% (e.g., 14.40% and 17.65% for AUC_t and C_max, respectively). The 90% confidence intervals were within ±20% (e.g., -14.87∼1.97 and -12.92∼7.72 for AUC_t and C_max respectively). Two parameters met the criteria of KFDA for bioequivalence, indicating that Azela^TM tablet is bioequivalent to Azeptin^TM tablet.
환경ㆍ에너지 시스템에 관한 수치해석적 연구 : SNCR, 보텍스튜브
장동순,신나일,서재동,신미수,엄태인,김동찬 한국전산유체공학회 1999 한국전산유체공학회 학술대회논문집 Vol.1999 No.-
Numerical study has been performed to develop a computer code for the design & optimal operating condition of SNCR(Selective Noncatalytic Reactor) for NOx reduction together with the analysis of the performance of vortex tube.<br/> Especially for the SNCR of the scale of industrial boiler, the required mixing and residence time of NH₃ solution was successfully tested numerically by the implementation of some baffle setups in a combustor.<br/> The introduction of interesting phenomena of vortex tube and similar system is made together with a theoretical hypothesis and simple cold flow simulation for the flow field analysis.