Ciprofloxacin 제제의 생물학적 동등성에 관한 연구

최철희,신재국,신완균,유호진,이경훈,정원석,장인진,신상구 대한화학요법학회 1991 대한화학요법학회지 Vol.9 No.1

국내 시판중인 ciprofloxacin 제제인 Citopcin®(250㎎ tablet)의 동등성을 검토하기 위해 제조원인 Bayer사의 Citopcin®(250㎎ tablet)를 기준제제로 하여 18명의 건강한 남성 피험자를 대상으로 500㎎ 1회 교차 경구 투여후 약동학적 성상을 분석비교한 결과는 다음과 같다. 시험제제의 생체 이용율의 지표인 AUC, C_(mao), T_(max) 및 MRT들의 평균치는 백분율차이에 있어 모든 기준제제 지표의 ± 20% 이내였으며, 이들 생체 이용율 지표들은 분산분석 검정에서 차이를 인지할 수 없었다.생체 이용율 지표들의 기준제제에 대한 백분율 90% 대칭 신뢰구간 검토시 모든 경수들에서 ± 20% 이내의 조건을 만족하였으며 AUC의 경우에는 대칭형 신뢰구간으로 변환시 95% 신뢰구간에서도 동등성의 조건을 만족하였다, 이상의 시험결과로 시험제제인 Citopcin®은 기준제제인 Ciprobay®와 생물학적 동등한 제제로 판단되었다. The pharmacokinetics of ciprofloxacin was studied for the evaluation of the bioequivalence of the generic ciproflocacin products. Two single doses of 500㎎ each of ciprofloxacin(Ciprobay® 250㎎ tablet as a reference compound and Citopcin® 250㎎ tablet s a test compound) were administered orally to ighteen male volunteers in a balanced, randomized crossover design. Pek plasma levels of ciprofloxacin were observed about 1 hour after the doses and the peak concentrations of both products were similar(Ciprobay®, 3.18㎍/㎖; Citopcin®, 2.89㎍/㎖). The values of other pharmacokinetic parameter of ciprofloxacin computed for Ciprobay® are presented in that order: AUC=13.53:12.47㎍·h/㎖, T_(max)=1.28:1.14 hours; MRT=5.30:5.08 hours; t_(1/2)β=3.65:3.47 hours. No satistically significant, differences were detected when AUC and the other parameters were compared with the method of ANOVA. Using the criteria of 90% confidence interval for the assessment of bioequivalence al the parameters were acceptable. The products were found to be equivalent on the premise that no significant difference was detected when the relevant pharmacokinetic parameters were compared, and the confidence limit analysis showed acceptable results.

동하중을 받는 FRAME 구조물의 확률유한요소해석 및 신뢰성해석

신재철,김진홍,정인수,한성호 충남대학교 산업기술연구소 2003 산업기술연구논문집 Vol.18 No.1

Most dynamic systems have various random properties in excitation and system parameters. Therefore, in this paper, reliability analysis for structural response is proposed fro the linear dynamic system with random properties in both excitation and system parameters. The system parameters and responses with random properties are modeled by the perturbation technique. A displacement and bending moment of frame structure is acquired in Stochastic Finite Element Method Program(SFEMP) and Dynamic Stochastic Finite Element Method Program(DSFEMP) using perturbation method, and Direct Monte Carlo Simulation Program(DMCSP) is used to verify and compare previous results. Comparing outputs of SFEMP and DSFEMP with them of DMCSP, it show that they are similar to each other. Also DMCSP need much time to analyze a complicated structure, but SFEMP and DSFEMP can reduce quite time. In this study, it is assumed that excitations, system parameters and response are Gaussian. The results of response for the analysis are compared to those of numerical simulation. Also the probability of failure are calculated for using Advanced First Order Second Moment(AFOSM) of the general reliability analysis method.

비디오시스템과의 일체형 지면반력 Windows 프로그램 개발

신인식,문영진,정철수,이기청 서울대학교 체육연구소 2000 서울大學校 體育硏究所論集 Vol.21 No.2

The study was designed to develop the window version force platform from the former program operated in DOS version. The window version program was developed utilizing a visual-basic program of Microsoft Inc. The characteristics of the program are as follows: 1.The compatibility among the board was enhanced so that all AD board of Data Translation Inc. can be utilized. 2.The program can be operated with the connection to the image analysis system which consists of force platform and D-5100 Panasonic Video Camera. 3.The automation of analysis was achieved so that the variable can be analyzed immediately after the button on the force platform was pressed. 4.Multi-file processing was adopted so that several files can be performed simultaneously for the analysis. 5.The program was designed in user-friendly mode. The program can be operated by even novice because the main menu was composed in flowchart format. There were not significant differences between the values obtained utilizing the program developed in the present study and the former program. The present results suggest that the program developed in this study may have advantage with regard to conveniency and economical efficiency over the expensive programs imported from the foreign countries.

VHDL을 이용한 실시간 JPEG 인코더 설계

신인철,어진우,강호준 단국대학교 1997 論文集 Vol.31 No.-

Image compression techniques have been necessary to transfer and save a great amount of image data in an efficient way. Because the compression and decompression of image signal require the real time processing, various hardware implementation methods have been studied. In this paper we propose the algorithm which is parallel form of processing 2 dimensional 8*8 blocks simultaneously, so increase speeds. It outputs compressed bit sequences 8 clocks later for the input data synchronized to clocks. Proposed algorithm is designed using VHDL. Simulation and circuit synthesis has been performed by the Powerview CAD Tool on the SUN Sparc-10 workstation. Results shows that maximum operating frequency is up to 15㎒. The final schematic circuit and comparison of processing speed are shown.

우수방사성의약품 생산시설 개발

신병철,정원명,박상현,이규일,박경배,박진호 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.2

Manufacturing facilities of the pharmaceuticals must meet certain level of the cleanness required so that foreign substances such as dust, moisture, heat, microorganism, or virus do not contaminate the product. In case of radiopharmaceuticals for medical treatment and diagnosis, not only should the operators and environment be protected from radiation but also need to be isolated from the foreign contaminant. Therefore, manufacturing facilities for radiopharmaceuticals must satisfy the design standards of both hot cell and clean room which are specified by GNP. However, standards of maintaining negative pressure for preventing spread of radioactive contaminant in isolated facilities conflict with the standards of maintaining positive pressure for keeping cleanness. To solve this problem, are pressure of hot cell was designed lower than in the adjacent area to meet standards of the radiation safety. To keep higher cleanness in certain part of the hot cell for filling, minimal relative positive pressure allows. In order to effectively maintain the cleanness that is required for production of Tc-99m generator, which takes 70% of whole demand of radiopharmaceuticals, the rooms placed in each side of production room are used as a buffer area and three lead hot cells are installed in production room. In this research, we established the appropriate engineered design concept for Tc-99m generator manufacturing facility, which satisfies both GMP cleanness standard for preventing particles, bacteria, other contaminants and the regulations of radiation safety for supervising and controlling the amount of radiation exposure and exhausted radioactivity. And the concept of multi-buffer zones is introduced to apply negative air pressure for hot cell with first priority and to continue relative positive air pressure for clean room.

정신분열병 환자의 뇌파를 대상으로 한 혼도의 정량화

신철진 용인정신의학연구소 1995 용인정신의학보 Vol.2 No.2

성인 남자의 식습관과 혈중 지질 농도에 관한 연구

신승렬,황보진향,박동철 慶山大學校 1997 論文集 Vol.15 No.1

This paper was carried out to study on the food & daily habit score and lipid contents in serum of adult man as basal research for research on the effects of food & daily habits on the lipid contents in serum of adult man. The number of normal, dangerous leval and hypercholesterolemia was each 133(60.5%), 62(28.2%) and 25(11.3%) of adult man. respectively. The mean age. weight. Broca's index(RBW) and Quetelet index(BMI) was 48.4 9.5. 67.7 10.2. 109.1 14.3, 23.6 3.0. respectively. The numbers of good food habits was 5.4 percentage, but those of bad food habits was 35.5 percentage, It was appeared to bad the mode of dietary and hormony of food. The contents of trigryceride and cholesterol in serum was 115.8 and 192.4mg/dℓ, respectively. The numbers of triglyceride contents(90∼120mg/dℓ in serum was 53(24.1%) of the subjects of research, and those of triglyceride contents (150-210mg/dℓ) in serum was 133(60.5%) of the adult man.

C형 간염 바이러스 core 단백의 대장균내 발현

신현진,김철중,신광순 충남대학교 수의과대학 동물의과학연구소 1995 動物醫科學硏究誌 Vol.3 No.-

C형 간염 바이러스(HCV)의 구조 유존자중 core 유전자를 fusion protein vector인 pGEX-2T vector에 cloning하여 core단백질을 발현시켜서 항원성을 증가시키고자 하였다. HCV의 core gene을 PCR (polymerase chain reaction) 기법을 이용하여 증폭한 후, 약 0.57kb 정도의 증폭된 core gene을 TA cloning vector에 cloning 한 후, restriction exzyme BamH I으로 잘라, gel elution method로 elution하여 pGEX-2T vector의 BamH I site에 cloning 시켰다. Cloning된 plasmid를 E coli cell인 JM105에 transformation시킨 후, IPTG에의해 protein induction 하였다. pGEX-2T에서 발현된 HCV core 단백질은 SDSPAGE및 Western-blotting 분석 결과, 양성 C형 간염 환자의 serum및 monoclonal antibody와 특이적으로 반응하였다.

정신분열병에 대한 Risperidone의 효과 및 안전성에 관하여

신석철,왕성근,지익성,이선우,이규광,이봉희,이진영,황선희,신용재,배경도,김정란 충남대학교 의과대학 지역사회의학연구소 1997 충남의대잡지 Vol.24 No.1

In order to evaluate the efficacy and safety of risperidone, 10 patients with chronic schizophrenia were examined for 8 weeks in a silgle-open study. After the wash-out period of 1 week, risperidone was administered. Efficacy was evaluated by means of Positive and Negative syndrome Scale for Schizophernia(PANSS) and Clinical Global Impression(CGI). Safety assessment included the Extrapyramidal Symptom Rating Scale(ESRS), vital signs, body weight, ECG, and laboratory tests. The results were as follows 1) On the PANSS total score, there was significant improvement of total score after 1 week (P<.05) of administratiom. 2) On the PANSS positive and negative subscal, there were significant improvement of posotive and negative scores after 2 weeks (P<.05) of administration. 3) On the PANSS general psychopatholgy subscals, there were significant improvement of general psychopathologyscores after 1 week (P<.05) of administratiom. 4) On the CGI, there was significant decreasement of clinical impression of severity of schizophrenia score after 2 week (P<.05) of administration. 5) A statistically significant increase in body weight (P<.05) was observed after 8 weeks of administration. 6) EPS reached the peak at the end of the 1st week of administration of risperidone (11.8± 24.25) but they were easily relieved by addition of benztropine and clonazepam. There was not significant change in laboratory tests, vital sign, ECG after 8 weeks of administration. These results suggest that Risperidone is an effective antipsychotics and clinically safe except for increased body weight in chronic schizophrenia.

L-라이신 발효에 있어서 당밀전처리의 영향

신현철,김성준,성진석,전영중,이재흥 한국미생물생명공학회 ( 구 한국산업미생물학회 ) 1996 한국미생물·생명공학회지 Vol.24 No.3

Can molasses, the most widely used carbon source for the industrial fermentation of L-lysine, usually contains a high concentration of calcium ions which tend to cause scaling problem in the recovery process. To remove the calcium ions, cane molasses was pretreated with sulfuric acid by adjusting the pH to 2.5~3.5. When the pretreated solution was directly heat-sterilized and used in the fermentation, a significant reduction in L-lysine production was observed. In this paper, we proved that sucrose is a superior substrate for L-lysine fermentation of that of glucose or fructose and that the above-mentioned decrease of L-lysine production was caused by the hydrolysis of sucrose in the molasses when the molasses was heat-sterilized at a low pH. The problem was overcome by adjusting the pH of molasses to neutral before sterilization.