원보 : 국내 의약품 첨가제 정보체계 연구

박인숙 ( In Sook Park ),박상애 ( Sang Aeh Park ),김은정 ( Eun Jung Kim ),박효민 ( Hyo Min Park ),홍정희 ( Chong Hui Hong ),정주연 ( Joo Yeon Jung ),김호정 ( Ho Jung Kim ),이지현 ( Ji Hyun Lee ),한의식 ( Eui Sik Han ),강신정 ( Shin 한국약제학회 2006 Journal of Pharmaceutical Investigation Vol.36 No.4

의약품중 잔류유기용매 시험법 확립에 관한 연구

고용석,강찬순,최보경,김혜수,홍정희,최명신,김상현,장성재,김길수 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-

Headspace-GC(딘5-GC)를 이용하여 ICH 잔류웅매 가이드라인 class 1, 2에 속하는 28종의 잔류유기웅매 분석방법을 연군한 결과 SPB-5, BB-WAX column을 동시 이용하여 각각을 확인, 정량할 수 있었다.또한 염의 참가효과, 평형시간,평형온도가 headspace분석에 미치는 영향을 검토한 결과 평형 시간 30분,평형온도 85℃,Na₂SO₄Ig을 첨가하여 시험할 때 최적 부넉조건을 나타내었다. 회수율은 1,1-achloroethene(68.3%)를 제외하고 90.9 ~ 114.5%로 패체적으로 양호하였다. 따로 HS-GCJECD, DB-524 column을 이용하여 9종의 잔류유기용매에 대하여 각각의 검랸선을 작성하고 검출한계를 구하였다. 실제 의약품 원료 10종및 제제 5종에 적용시킨 결과 모두 불검출되었으며 본 시험법은 의약품중의 잔류유기용매 분석에 적용할 수 있는 방법이라고 판단된다. The headspace-fC/FID(HS -GC/FID) method was performed for test method developnlent of residu;31 organic solvents in pfrarmaceuticals. Using SPB-S and BB-WAXcolumn, 28 kinds of solvents iri ICH residual sof)·ents guidetine class 1, 2 couBd be individuallt-identified and quantitated. The foIBowing residoal soIYents were not detected by the headspaceinjection condition : N,N-Cmethylacetamide, N,N-dimeth)rlformamide, ethyfeneglycol, formamide,2-methoryethanot, N-rnethylpyrrolidone, suBforane. The effects of the addition of salts,equilibration time, and equilibration temperature on headspace analt·sis were invesugated. Theoptimum conditions weiFe obtained with addtion of Ifa2s04 19 as a salt, simultaneously. thetime and temperature of equitibration were 30min and 8i'f, respectivety. The recovery havefound between 90.9 and 114.5% except 1,1-dichloroethene(fi8.3%). Using DB-624 column &HS-GC/:ECD method, 9 kinds of residual solvents could be individually identified andfuantitated. This HS-GC method can be applied to test the residua3 organic solvent in thepharmaceuticals.

남·북한 약전에 대한 비교조사연구

최명신,강찬순,김혜수,김은정,홍정희,고용석,김상현,장성재 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.5

With the Sunshine policy, exchange of materials and cultures inter Koreas has been broadened and expectancy of reunification is getting higher. Especially, medical supplies and medicines are one of the biggest parts in the exchange goods. So, preparing an unified official drug standard preparing new medical administration system is required. We compared the Korean pharmacopoeia with North Korean Pharmacopoeia. Two pharmacopoeias have been developed in different direction and have many differences in the nomenclature and format. In this study, we compared general notices, general rules for preparations and crude drugs, monographs, general tests, processes and apparatus.

키랄 HPLC를 이용한 원료 및 제제로부터 클로르페니라민 광학이성질체의 분석

조종운,김경태,이은주,홍정희,채규한,이은실,강종성 충남대학교 약학대학 의약품개발연구소 2014 藥學論文集 Vol.29 No.-

Chlorpheniramine(CPM) is an antiallergic drug with H1 antihistamine properties. The molecule has an asymmetric carbon, hence, two stereoisomers, d- and l-CPM, are available. It was reported that d-CPM showed higher antihistaminic effect than l-CPM, which was eliminated slower than d-CPM in CYP2D6 metabolism. The method of chiral separation for CPM enantimers was developed and the validated method was then applied to the quality control of raw materials and pharmaceutical formulations of CPM. The chiral analysis was carried out on a chiral stationary phase, Chiralcel OJ-H (0.46 × 15 cm, 5 μm), with the mobile phase of hexane : ethanol : diethylamine (98 : 2 : 0.1, v/v/v) in 0.3 ml/min. The eluent was monitored at UV 262 nm. The validation studies were carried out according to ICH requirements. The mean concentration of l-CPM in racemic raw materials and formulations were 42.8~53.5%, while those of d-CPM were 44.2~56.0%, and total mean concentration of dl-CPM was 91.4~108.5%. All commercially available samples showed good results within KP range, except some pharmaceutical formulations containing dextromethorphan due to the incomplete separation of d-CPM, dextromethorphan and l-CPM.

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).

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.