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이정표(Jeong Pyo Lee),김영옥(Young Ok Kim),손경훈(Kyung Hun Son),양성준(Seong Jun Yang),백옥진(Ock Jin Paek),양원준(Won Jun Yang),김종갑(Chong Kap Kim),최상숙(Sang Sook Choi) 大韓藥學會 2001 약학회지 Vol.45 No.5
The quasi-drugs including nonwoven fabric and gauze were sterilized using ethylene oxide (EO) gas. Residual EO in the quasi-drugs was extracted with water (20 Ml of water for 1 g of sample) for 24h at 37oC. Residual EO was determined using GC. The optimal analytical conditions were as follows : column, Carbowax 20M (1.D. 0.2 mm): mobile phase, helium with 30 mumin; oven temperature 50oC, injector temperature 180oC, detector temperature 200oC. The detection limit for EO was 0.10μg/Ml. When the residual EO extracted from nonwoven fabric and gauze was determined, it took more than 9h to get the lower level than 25 rpm which is the limit value of FDA guideline. When the EO residues, etcylene chlorohydrine (ECH) and ethylene glycol (EG) in the 7 commercially available quasi-drugs were determined, no residual EO, ECH, EG were found from the seven commercially available quasi-drugs analyzed by this method.
양성준(Seong Jun Yang),김영옥(Young Ok Kim),손경훈(Kyung Hun Son),이정표,정래석(Rae Sok Jung),양원준(Won Jun Yang),백옥진(Ock Jin Paek),이현경(Hyun Kyung Lee),최상숙(Sang Sook Choi) 대한약학회 2002 약학회지 Vol.46 No.4
A high-performance liquid chromatographic method for the simultaneous quantitative analysis of methylparaben (MP), ethylparaben (EP), propylparaben (PP), butylparaben (BP) and imidazolidinyl urea(IU) or diazolidinyl urea(DU) in cosmetics was studied by using a cyano-propyl column and 0.05M hexanesulfonic acid at 228 nm. Calibration curves were found to be linear in the 60-1000 μg/Ml range (parabens),100-1,250 μg/Ml range (IU) and the 120-2000μg/Ml range (DU). Linear regression analysis of the data demonstrates the efficacy of the method in terms of precision and accuracy. An extraction method is developed and validated in order to apply this chromatographic method to a commercial cosmetic cream. The precision of this method, calculated as the relative standard deviation (RSD) of the recoveries (0.46- 2.71%) was excellent for all compounds.
기능성화장품의 기능성평가에 관한 연구(I) -자위선차단화장품의 in vitro 시험법 연구
손경훈 ( Kyung Hun Son ),김영옥 ( Young Ok Kim ),이정표 ( Jeong Pyo Lee ),양성준 ( Seong Jun Yang ),백옥진 ( Ock Jin Paek ),김원희 ( Won Hee Kim ),김종갑 ( Chong Kap Kim ),허문영 ( Moon Young Heo ),최상숙 ( Sang Sook Choi ) 대한화장품학회 2002 대한화장품학회지 Vol.28 No.3
인체실험(in vivo) 방법과의 상관성이 우수한 in vitro 자외선차단지수(SPF) 측정방법을 개발하고자 본 연구를 수행하였다. 표준자외선차단제인 8% homomentyl salicyate(HMS) 제제와 P3 reference standard 제제 및 기능성화장품중 자외선차단화장품을 사용하여 자외선차단지수측정기(SPF 290 analyzer)를 가지고 in vitro 자외선차단지수를 측정하고, 인체실험과의 상관계수를 구하였다. 8% HMS 제제 및 P3 Reference standard 제제의 in vitro SPF 결과는 식약청고시 2001-64호의 규정과 유사한 결과를 나타내었고, 크림 및 로오숀 제형에서는 상관계수 0.9506 및 0.9769로서 인체실험과 높은 상관성을 나타내었다. 메이크업베이스 및 리퀴드파운데이션, 사용시 흔들어 쓰는 로오숀, 압축분말은 각각 상관계수 0.8812, 0.8632, 0.5984를 나타내었으며. 압축분말의 도포를 위해서는 크림베이스와 1:0.8의 비율로 섞는 것이 가장 좋은 결과를 나타내었다 본 실험결과를 통해 사람을 이용한 자외선차단지수 측정방법을 대체할 수 있을 것으로 기대되며, 이 후 자외선차단 화장품의 품질관리에 적용하고, 고시개정의 기초자료로 활용될 수 있을 것으로 기대된다. The present study was undertaken to develop the in vitro sunprotection factor(SPF) measurement method having good correlation with in vivo method. As in vitro method, 8% homomentyl salicylate, P3 reference standard and sunscreens on market were measured using SPF 290 analyzer and were compared the SPF with labed value. In vitro SPF of 8% HMS and P3 reference standard were 4.59 ± 0.12 and 14.94 ± 0.83. There are good correlation, correlation factor were 0.9506 and 0.9769 respectively, between the in vitro and in vivo SPF for the sunscreen creams and lotions examined. Correlation factors of makeup base & liquid goundation, lotion labled with “shake before use”, compact powder were 0.8812, 0.8632 and 0.5984. The best sample applied method of compact powder was 1:0.8 mixture with cream base. These results suggest that the in vitro test method could be used as an alternative method for SPF.
이정표,김영옥,손경훈,양성준,정정자,백옥진,양원준,김종갑,최상숙 식품의약품안전청 2000 식품의약품안전청 연보 Vol.4 No.-
산화에칠젠(EO) 가스로 멸균한 부직폰 거즈등 의약외품의 산화에칠렌가스 잔류량을 분석하기 위한 최적의 추출조건은 검체 1튜당-물 20n1의 비율로 37'c에서 24시간 추출한 것이었으며, 가스크로마토그 라프(GC) 분석조건은 Carl)owax 20M (t,D- 0.2mm) 칼럼을 써서 첼륨을 이동간스로 하여 유속 30mL/분, 항온조 온도 SOt, 주입구 온도 180t, 검출 온도 300'c인며, Headspace sampling 조건은 항온조 온도 70'C, 열굉형시간 20분, 주입시간 0.08분이었다. 이와같은 죠건에서 멸균후 방치시간에 따른 산화에칠렌가스 잔류량을 측정해 본 결과 부직포의 경우에는 약 9시간 이후에, 거즈의 경우에는 약 4시간이후에 FDA규제안의 혈액과 접촉하는 기군의 허용기준인 린ppm이하가 되었으며, 무균시험 결과는 적합하였다. 또한, 7종의 시판 의약외품중 산화에칠렌가스 잔류량을 븐석한 결과 산화에칠렌 가스f')검출되지 않았다. The euasi-drugs including nonwoven fabric and gauze was sterilized using ethyiene elude(EO) gas. Resldual EO in the qvasi-drugs was extracted with water (fOmL ofwater for Ig of sample) for 24hrs at 37'C. Residual EO was determined using GC. The optimalanalytical conditi㉠ns were as follows column, Carbowax 20M (1.D. 0.2mm); mobile phase,helium with 30mL/mirl, oven teirlperature 50'C , injector temperature 180'C, detector temperature200 "C. The anal!-tical (:onations o: Headspace sampler were as follows : oven temperature 70"ㄷ ,thermostat time 20ndn, injection time 0.08min. When the residual EO extracted from nonwoven fabric and gauze was determined, it tooltmore than ghrs to get the lower level than 25ppm which is the limit value of FDA guideline. And the EO residues in current 7 quasi-drugs were detenrned. It was found that residualEO are not detected in all of them.