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        • KCI등재

          수종 용제 중 퀘르세틴의 용해성 및 안정성

          곽혜선,김혜원,전인구 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.1

          The solubility and stability of quercetin in various vehicles were determined. The soubility of quercetin at 28℃ increased in the rank order of isopropyl myristate < oleyl alcohol < propylene glycol monocaprylate (PGMC) < polyethylene glycol-8 glyceryl linoleate < caprylocaproyl macrogol-6 glycerides < dietylene glycon mono ethy1 ether(DGME). The addition of DGME to non-aqueous vehicles such as PGL and PGMC markedly increased the solubility of quercetin. From the stability studies, it was found that quercetin was unstable due to rapid oxidation by dissoved oxygen. The addition of a combination of ascorbic acid and edetic acid (EDTA) at 0.1% markedly decreased the degrandation rates of quercetin in 40% polyethylene glycon 400 in saline. Quercetin was relatively unstable in non-aqueous vehicles such as PGL and PGMC alone, and PGL-PGMC co-solvent. The degradation of quercetin in such non-aqueous vehicles was fast, depending on temperature. The addition of butylated hydroxytoluene, butylated hydroxyanisole, citric acid and/or EDTA at 0.1% was effective in retarding the degradation of quercetin.

        • SCOPUSKCI등재

          테놀민 정(아테놀올 50 mg)에 대한 신일아테놀올 정의 생물학적 동등성

          곽혜선,강성하,전인구,Gwak, Hye-Sun,Kang, Sung-Ha,Chun, In-Koo 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.1

          This study was conducted to compare the bioavailability of a generic product of Sinil Atenolol Tablets (Sinil Pharmaceutical Co., Ltd., Korea) with the innovator product, $Tenormin^{\circledR}$ Tablets in 20 healthy Korean volunteers. The volunteers received a single 50 mg dose of each atenolol formulation according to a randomized, two-way crossover design. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs time curves, the following parameters were compared: area under the plasma concentration-time curve (AUC), peak plasma concentration $(C_{max})$, time to reach peak plasma concentration $(T_{max})$, and terminal first order elimination half-life $(t_{1/2})$. No statistically significant difference was obtained between the $T_{max}$ values, and the logarithmic transformed AUC and $C_{max}$ values of the two products. The 90% confidence for the ratio of the logarithmically transformed AUC and $C_{max}$ values of Sinil Atenolol Tablets over those of $Tenormin^{\circledR}$ Tablets were calculated to be between 0.99 and 1.07, and 1.04 and 1.16, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of $T_{max}$ in $Tenormin^{\circledR}$ Tablet group was 3.68 hour, and that in Sinil Atenolol Tablet group was 3.65 hour. The values of $t_{1/2}$ between the two products were found comparable, and the mean $t_{1/2}$ values of $Tenormin^{\circledR}$ Tablets and Sinil Atenolol Tablets were 5.9 and 6.0 hour, respectively. Based on these results, it was concluded that Sinil Atenolol Tablets were comparable to $Tenormin^{\circledR}$ Tablets in both the rate and extent of absorption, indicating that Sinil Atenolol Tablets were bioequivalent to the reference product, $Tenormin^{\circledR}$ Tablets

        • SCIESCOPUSKCI등재

          토끼의 비강, 직장 및 질 점막을 통한 로이신엔케팔린과 [D-알라^2]-로이신엔케팔린아미드의 투과 증진

          곽혜선,박인숙,전인구 한국응용약물학회 2002 Biomolecules & Therapeutics(구 응용약물학회지) Vol.10 No.2

          The effects of enzyme inhibitors and penetration enhancers on the permeation of leucine enkephalin (Leu-Enk) and its synthetic analog, [D-ala^2]-leucine enkephalinamide (YAGFL) across the nasal, rectal and vaginal mucosae were evaluated. Enzyme inhibitors and penetration enhancers employed for Leu-Enk permeation study were amastatin (AM), thimerosal (TM) and ethylenediaminetetraacetic acid disodium salt (EDTA), and sodium taurodihydrofusidate (STDHF). Those for YAGFL permeation study were TM, benzalkonium chloride (BC) and EDTA, and STDHF, sodium deoxycholate (SDC), sodium glycholate (SGC), glycyrrhizic acid ammonium salt (GAA), L-α-lysophosphatidylcholine (LPC) and mixed micelle (MM, STDHF : linoleic acid = 15 mM : 5 mM), The addition of TM alone on the donor and receptor solutions for Leu-Enk permeation study across all the three kinds of mucosae failed to inhibit the degradation; it completely degraded in 6 hrs, and no permeation occurred. However, with addition of three kinds of inhibitors together, the fluxes across nasal, rectal and vaginal mucosae were 20.7±2.5, 0.3±0.05 and 1.4±0.5 ㎍/㎠/hr, respectively. Moreover, the addition of STDHF in the presence of the above three inhibitors enhanced permeation across nasal, rectal and vaginal mucosae 1.3, 15 and 1.3 times, respectively. YAGFL also degraded in the donor and receptor solutions rapidly as time went. With mixed inhibitors of TM and EDTA, the percents of YAGFL remaining in the donor solutions facing nasal, rectal and vaginal mucosae were 69.7, 69.8 and 79.8%, respectively; the percent permeated increased to 10, 2.1 and 5.7%, respectively. The addition of STDHF in the presence of either BC/EDTA or TM/EDTA increased the permeation 2.2, 11.0 and 2.9 times, and 2.21, 14.0 and 2.7 times for nasal, rectal and vaginal mucosae, respectively. With SDC, SGC, GAA, LPC and MM in the presence of TM/EDTA increased permeation; especially, they increased permeation across vaginal mucosae effectively, and the enhancement factors were 12.5, 7.6, 8.7, 5.7 and 5.5, respectively. The degradation extent of YAGFL was correlated with protein concentrations in the epidermal and serosal extracts. The flux of YAGFL across nasal mucosa increased dose-dependently.

        • SCOPUSKCI등재

          테놀민 정(아테놀올 50㎎)에 대한 신일아테놀올 정의 생물학적 동등성

          곽혜선,강성하,전인구 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.1

          This study was conducted to compare the bioavailability of a generic product of Sinil Atenolol Tablets (Sinil Pharmaceutical Co., Ltd., Korea) with the innovator product, Tenormin^?? Tablets in 20 healthy Korean volunteers. The volunteers received a single 50㎎ dose of each atenolol formulation according to a randomized, two-way crossover design. Plasma samples were obtained over a 24-hour interval, and atenolol concentrations were determined by HPLC with a fluorescence detector. From the plasma atenolol concentration vs time curves, the following parameters were compared: area under the plasma concentration-time curve (AUC), peak plasma concentration (C_max), time to reach peak plasma concentration (T_max), and terminal first order elimination half-life (t_1/2). No statistically significant difference was obtained between the T_max values, and the logarithmic transformed AUC and C_max values of the two products. The 90% confidence for the ratio of the logarithmically transformed AUC and C_max values of Sinil Atenolol Tablets over those of Tenormin^?? Tablets were calculated to be between 0.99 and 1.07, and 1.04 and 1.16, respectively; both were within the bioequivalence limit of 0.80-1.25. The mean of T_max in Tenormin^?? Tablet group was 3.68 hour, and that in Sinil Atenolol Tablet group was 3.65 hour. The values of t_1/2 between the two products were found comparable, and the mean t_1/2 values of Tenormin^?? Tablets and Sinil Atenolol Tablets were 5.9 and 6.0 hour, respectively. Based on these results, it was concluded that Sinil Atenolol Tablets were comparable to Tenormin^?? Tablets in both the rate and extent of absorption, indicating that Sinil Atenolon Tablets were bioequivalent to the reference product, Tenormin^?? Tablets.

        • KCI등재

          용제 중 염산온단세트론의 용해성 및 안정성

          곽혜선,오익상,전인구 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.1

          The solubility and stability of ondansetron hydrochloride (OS) in various vehicles were determined. The effect of cyclodextrins (CD) on the solubility of OS in water was determined by equilibrium solubility method. The solubility of OS at 32℃ increase in the rank order of isopropyl myristate (IPM)<propylene glycol laurate (PGL)《 propylene glycol monolaurate<propylene glycol monocaprylate (PGMC)<poly(ethylene glycol) 400<diethylene glycol mono ethyl ether (DGME)<ethanol<poly(ethylene glycol) 300<water(36.1㎎/ml)《 propylene glycol (PG) (283㎎/ml). The addition of PG or DGME to non-aqueous vehicles such as IPM, PGL and PGMC markedly increased the solubility of OS. The addition of CDs in water increased the solubility. Apparent stability constant for the CD complexation with OS was calculated to be 25.5M^-1 for 2-hydroxypropyl-β-CD(2HPβCD0. Twenty mM β-CD, 69.4mM sulfobutyl ether β-CD and 115.4mM 2HPβCD increased the aqueous solubility of OS 1.27, 2.18 and 1.85 times, respectively. OS was stable in buffered aqueous solution (pH 5.0). However, OS was relatively unstable in non-aqueous vehicles in the order of PG<DGME<PGMC-DGME(60:40) co-solvent<PGMC. The degradation of OS in these vehicles was accelerated, depending on temperature.

        • KCI등재

          멜라토닌 플라스터의 제제설계 및 평가

          곽혜선,김승웅,전인구 한국약제학회 2002 Journal of Pharmaceutical Investigation Vol.32 No.2

          To investigate the feasibility of developing a novel melatonin plaster, the effects of vehicles and drug loading dose on the in vitro permeation of melatonin across dorsal hairless mouse skin from pressure-sensitive adhesive (PSA) matrices were examined. Vehicles employed were propylene glycol laurate (PGL), propylene glycol monocaprylate (PGMC) and diethylene glycol monoethyl ether (DGME). Among PSAs used, only Duro-Tak^?? 87-2196 showed a good peeling property. The release from Duro-Take^?? 87-2196 was proportional to the square root of time, and dose-dependent. The fluxes increased as the loading dose increased over the doses under solubility. The relatively high permeation flux (3.03±1.37 ㎍/㎠/hr) was obtained when using PGMC at the melatonin loading dose of 45 mg/140㎠. Lag time was not affected by the vehicles used but by the thickness spread. The melatonin plasters prepared using PGMC showed a good adhesive property onto skin, and showed no crystal formation.

        • KCI등재
        • KCI등재

          인체혈장 중 에탐부톨의 HPLC 분석법의 검증 및 단일용량 투여에 의한 약물동태 연구

          곽혜선,박경호,최준식,송진아,성민경,장정옥,이화정 한국약제학회 2005 Journal of Pharmaceutical Investigation Vol.35 No.2

          An HPLC method was employed for the determination of ethambutol in human plasma. After addition of internal standard (IS, octylamine, 2 μg/mL) and alkalinization of the plasma with 5 M sodium hydroxide, the drug and IS were extracted into the mixture of chloroform and diethyl ether (40:60, v/v). Following a 15-min vortex-mixing and a 10-min centrifugation, the organic phase was spiked with 100 pL of phenylethylisocyanate (2000 μg/mL) for chemical derivatization, mixed for 5 min and evaporated to dryness under a stream of nitrogen. The residue was reconstituted with 100 μL of mobile phase and 20 pL was injected into Cl8 column with a mobile phase consisting of methanol:water (70:30, v/v). The samples were detected utilizing an ultraviolet detector at 200 nm. The method was specific and validated with a limit of 0.15 μg/mL. Infra- and inter-day precision and accuracy were acceptable for all quality control samples including the lower limit of quantification. The applicability of this method was demonstrated by analysis of human plasma after oral administration of a single 1200-mg dose to 20 healthy subjects. From the plasma ethambutol concentration vs. time curves, the mean AUC was 9.61 ± 1.64 μg hr/mL. and Cmax of 2.68 μg/mL reached 2.73 hr after administration. The mean biological half-life of ethambutol was 3.46 ± 1.21 hr. Based on the results, this simple and validated assay could readily be used in any pharmacokinetic studies using humans.

        • KCI등재

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