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딜티아젬서방정을 이용한 In vitro/In vivo 상관성
최명신,강찬순,최보경,홍정희,김길수 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.4
IVIVC (In vitro/in vivo correlation) is useful for predicting in vivo results from in vitro data. The aim of this study was to develop IvIVC of sustained release diltiazem. For this purpose, three types of diltiazem tablets with different in vitro dissolution rates were prepared. An in vitro dissolution testing method comprising of paddle apparatus, 50 rpm, water as dissolution medium was developed. Under these condition, we demonstrated that AUCinf could be predicted by evaluating d_70% (time dissolved 70%) in vitro since the in vivo AUCinf was correlated with the in vitro d_70% (r=-0.9981).
대한약전 시험법에 관한 연구(Ⅲ) : 연질캅셀의 붕해시험에 관한 연구 Evaluation of Disintegration test of Soft Capsules
최명신,장성재,강찬순,최보경,박상애,강명희,홍정희,김길수,박승희 식품의약품안전청 2000 식품의약품안전청 연보 Vol.4 No.-
연질캅셀에서 경환가 력해에 영향을 미치는 것으로 보고되고 있어 연질캅셀의 경차의 정도와 붕해와의 관계 및 붕해액의 차치에 따른 붕해시간을 비교 검토하고, 시판품에 적용하여 여러 붕해액에 대한 타당성을 연구하고자 '하였다. 또한 지름 20.Onhn 이상인 연질캅셀에 대하여 유리관의 지름o) 다른 대한약전 붕해시험기와 USP 붕해시함기 묘를 비교하여 타당한 시험기를 설정하고자 하였다. 연질캅셀을 0.05%, 0.3% 및 0.5% 포름알데히드를 사웅하여 가교결합시키고 가교결합이 일어난 연질 캅셀에 대하여 물, 약전 붕해 제1액 및 USP Simulated gastric fluid를 시험액으로 연질캅셀의 붕해시 험을 하였다. 포름알데히드의 농도가 높을수록 가교결합이 많이 일어나서 연질캅셀의 붕해는 느려졌다. 물을 시함액으로 하였을 때는 가교결합 정도의 차이에 따른 붕해시간의 차이가 컸으나 USP Sim띨ated gastric fluid를 시험액으로 하였을 때는 가교결합의 정도에 따른 붕해시간의 차이가 적었다. 시판품에 패하여 적용f'1였을 패 물, 약전 붕해 제1액 및 USP Simulated gastric fluid에 대한 붕해 시간은 차이가 적었칠 모두 약전 붕해기준에 적합하였다. 지름 20.Omm 이상인 변질캅셀의 시판품을 대상으로 약전 붕해시험기와 USP 붕해시험기 B에 대한 붕해시간은 차이가 적었고 모두 약전 붕해기준에 적합하였다. 그러므로, 연질캅셀의 렴해시험은 현 약전 붕해시험법과 같이 물을 시험액으로 하고 지름 20.Omm 이상인 연질캅셀은 약전 붕해시험기를 사용하여 시험하는 것이 타당한 것으로 사료된다. The crosslinking process in gelatin causes formation of a swollen, rubbery, water insoluble gelatin ?resulting in increasing disintegration time, The effect of crosslinking anddisintegration medium on disintegration time and the effect of disintegration apparatus on(iisintegration of soft capsules exceeding 20.Omm in diameter were studied.Soft capsules frfre filled with three solutions of aqueous formaldehyde in PEG(0.05, 0.3,0.5%), stored at ambient conditions for 96 hr, emptied, disinteEration tested scanned in hRspectrophotometer. The more increased concentration of formaldehyde, the more increaseddisintegration time in fFater, KP disintegration medium I and USP simulated gastric fluid. Butin USP simulated gastric fluid, the differences of disintegration time among crosslinkingamounts were less than in water.In the case of marketed samples, the differences of disintegration time in each test solutionwere not different and clisintegration thne met KP disintegration test criteria.We conducted disintrgration test with KP apparatus and USP apparatus B in the softcaps'lies of which diamcter was over 20.0 mm. The disintegration time between KP apparatusand USP apparatus B were not different and accepted by IfP disintegration test criteria.So, the disintegration test in soft capsules is applicable In present KP Osintegration test.
활성탄에 침착시킨 $TiO_2$와 ZnO가 자외선에 의하여 활성화되었을때 Escherichia coli의 살균효과에 미치는 영향에 관한 연구
최명신,정문호,김영규 대한환경위생공학회 1995 대한환경위생공학회지 Vol.10 No.3
There has been increasing awareness on the importance of not only removal of organic materials but also sterilization of microbial cell in the drinking water purification research, so there has been many researches on that area. This study has been designed to analyze the effects of $TiO_{2}$ and ZnO coated on activated carbon on Escherichia coli. In this study, the sterilization power was analyzed by (1) variation of $TiO_{2}$ and ZnO concentration coated on activated carbon (2) variation of UV intensity. In addition, the kinetics between exposure time and sterilization velocity was viewed by the method of Chick. The results are as follows. 1. Survival ratio of E. coli decreased as time goes on in application of $TiO_{2}$, ZnO and $TiO_{2}{\cdot}ZnO$. In $TiO_{2}$ and ZnO, the effect increased upto certain concentration, but decreased there-after. In $TiO_{2}{\cdot}ZnO$, the effect of sterilization was in similar way among 3 combinations. 2. Survival ratio of E. coli decreased proportionately to an increase of light intensity in ZnO and $TiO_{2}{\cdit}ZnO$. In $TiO_{2}$, the survival ratio differed over extent of irradiation but the difference over the light intensity was not significant. 3. When Chick's law of sterilization was applied, m values of three concentrations of $TiO_{2}$ were 1.57,0.98, 1.96 respectively. M values of three concentration of ZnO were 1.10, 1.18,0. 11 respectively and those of three combination of $TiO_{2}{\cdot}ZnO$ were 1.17, 1.24, 1.74 respectively.
딜티아젬서방정을 이용한 In vitro/In vivo 상관성
최명신,강찬순,최보경,홍정희,김길수 梨花女子大學校 藥學硏究所 2002 藥學硏究論文集 Vol.- No.11
IVIVC (In virolin vivo correlation) is useful for predicting in vive results from in vide data. The aim of thisstudy was to develop IVIVC of sustained release diltiazem. For this purpose, three types of diltiazem tablets with differentin vitro dissolution rates were prepared. An in vitro dissolution testing method comprising of paddle apparatus, 50 rpm.water as dissolution medium was developed. Under these condition, we demonstrated that AUCinf could be predicted byevaluating d_70% (time dissolved-70%) in vitro since the in vivo AUCinf was correlated with the in vitro d_70% (r=0.9981).
최명신,홍정회,장성재,강찬순 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.1
Drug excipients are material used in the formulation of pharmacologically active drugs. They have a variety of roles including dilutents/fillers/bulking agents, binders/adhesives, propellant, disintegrants, lubricants/dlidants, colors, flavors, coating agents, polising agents, fragrance, sweeteening agent, polymers and waxes. Excipient should be inert or inactive and does not interfere with the test. Nowadays within industry there has been a recent surge of interest in novel excipient for novel dosage forms. The purpose of the review is to introduce the administration systems of drug excipient about kinds, matters to be attended to change of excipeints.
최명신,최보경,한규원,김길수,장성재,강찬순 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.4
Nonproprietary name may be used without restriction by the public at large and can be called common name, generic name. Nomenclature agencies exist in US, Great Britain, Japan and so on. The agencies maintain liaison with one another in an effort to secure the wide adoption of the most appropriate and universally acceptable designation for each drug. To prevent the confusion which arises when several nonproprietary names are used for a single drug, either in the same country or in several different countries, the WHO has assumed the responsibility of coordination existing nomenclature at the international level. In this study, the nomenclature for new drugs and the terminology to harmonize specifications for revision of Korean Pharmacopoeia (KP) were established.