넘취 정유의 Murine Macrophage Raw 264.7세포에서 in vitro항염효과

김륭규(Ryung Gyu Kim),신경민(Kyung Min Shin),천성국(Sung Kuk Chun),지사영(Sa Young Ji),서성훈(Seong Hoon Seo),박희준(Hee Juhn Park),최종원(Jong Won Choi),이경태(Kyung Tae Lee) 대한약학회 2002 약학회지 Vol.46 No.5

In the present study, effects of essential oils isolated from various plants have been evaluated on lipopolysaccharide (LPS)-induced release of nitric oxide (NO), prostaglandin E2(PGE2) and tumor necrosis factor-α(TNF-α) by the macrophage RAW 264.7 cells. Among the tested essential oils, essential oil of Lingularia fischeri var. spiciformis (LF-oil) signifcantly inhibited the LPS-induced generation of NO, PGE2 and TNF-αIn Raw 264.7 cells. Consistent with these observations, the expression of inducible NO synthase (Inos) and cyclooxygenase (COX)-2 enzyme was inhibited by LF-oil in a concentration- dependent manner Thus, this study suggests that inhibition of release of Inos, COX-2 expression, and TNF-α By the essential oil of Lingularia fischer may be one of the mechanisms responsible for the anti-inflammatory effects of this medicinal plant.

대원제약 원클러® 캅셀(Cefaclor 250㎎)제의 생물학적 동등성 평가

천성국,남기원,류재환,김남재,송보완,서성훈,이경태 한국병원약사회 2002 病院藥師會誌 Vol.19 No.2

The bioequivalence of two cefaclor product was evaluated according to the guideline of KFDA. Test product was Dae Won Wonclor® capsules (Dae Won Korea Ltd.) and reference product was Ceclor® capsules(Lily Korea). 16 healthy male volunteers(20~27 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 500㎎ of cefaclor was orally administered, blood was taken at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours after administration and just before administration. Plasma was analyzed for cefaclor and internal standard(cefadroxil) by a sensitive and validated HPLC assay. The pharmacokinetic parameters(AUC_(t), C_(max) and T_(max)) were calculated and ANOVA test was used for the statistical analysis of parameters. Difference in AUC_(t), C_(max) and T_(max) between two products were 11.88, -6.652 and 15.097% respectively. the powers(1-β) and detectable differences(Δ) and confidence interval for AUC_(t), and C_(max) were more than 0.9 and less than 20%, respectively. Although the power of T_(max) was under 0.8 T_(max)s of the two products were not significantly different each other. These results suggest that the bioavailability of Dae Won Wonclor® capsules is not significantly different from that of Ceclor® capules. Therefore, two products are bioequivalent based on the current result.

대원제약 원클러^� 캅셀(Cefaclor 250mg)제의 생물학적 동등성 평가

천성국,남기원,류재환,김남재,송보완,서성훈,이경태 WHO COLLABORATING CENTRE FOR TRADITIONAL MEDICINE 2002 東西醫學硏究所 論文集 Vol.2002 No.-

Abstract : The bioequivalence of two cefaclor product was evaluated according to the guideline of KFD-A. Test product was Dae Won Wonclor^R capsules(Dae Won Korea Ltd.) and reference product was Ceclo r^R capsules(Lily Korea). 16 healthy male volunteers(20~27 years old ) were dicided into two groups and a randomized 2 × 2 cross-over study was employed. After 500mg of cefaclor was orally administered, blood was taken at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 8, 12 hours after administration and just before administration. Plasma was analyzed for cefaclor and internal standard(cefadroxil) by a sensitive and validated H-PLC assay. The pharmacokinetic parameters(AUC_1, C_max and T_max) were calculated and ANOVA test was used for the statistical analysis of parameters. Didderences in AUC_t, C_MAX and T_MAX between two products were 11.88, -6.652 and 15.097% respectively. The powers(1-β) and detectable differences(Δ) and confidence interval for AUC_t, and C_MAX were more than 0.9 and less Ihan 20%, respectively. Although the power of T_MAX was undee 0.8, T_MAX of the two products were not significantly different each other. These results suggest that the bioavailability of Dae Won Wonclor capsules is not significantly different from that of Ceclor capules. Therefore, two products are bioequivalent based on the current result.

인체 혈장에서 염산시프로플록사신(시프로플록사신으로서 250㎎) 정량을 위한 HPLC 분석법의 유효성검토

하용화,조성희,천성국,서성훈,류재환,최영욱,이경태 한국약제학회 2004 Journal of Pharmaceutical Investigation Vol.34 No.4

A simple HPLC method with ultraviolet detection of ciprofloxacin in human plasma was developed and validated. After protein precipitation with trichloroacetic acid, chromatographic separation of ciprofloxacin in plasma was achieved at 50℃ with a C_18 column and methanol-phosphate mixture (pH 2.5), as mobile phase. Quantitative determination was performed by ultraviolet detection at 278 nm. The method was specific and validated with a limit of quantification of 100 ng/ml. The infra- and inter-day coefficients of variation were between 1.67% and 10.55% and accuracy between 92.01% and 106.09%. The method has been successfully applied in a bioavailability study of 250 ㎎ ciprofloxacin hydrochloride tablet.

프로작® 캅셀(플루옥세틴 60㎎)에 대한 플루틴® 캅셀의 생물학적 동등성 시험

남기원,천성국,오한석,조요나,류재환,김남재,서성훈,이경태 한국병원약사회 2001 병원약사회지 Vol.18 No.4

Bioequivalence of two fluoxetine, Prozac®(Lilly Korea Ltd.) and Flutin®(Daewon Pharm. Co. LTD.), was evaluated according to the guideline of KFDA. Twenty four healthy male volunteers(21-26 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 60 ㎎ of fluoxetine was orally administered, blood was taken at 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 32, 48 and 72 hours after administration and just before administration. Plasma was analyzed for fluoxetine and internal standard(clomipramine) by a sensitive and validated HPLC assay. The pharmacokinetic parameters (AUC_(t), C_(max) and T_(max,) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUC_(t), C_(max) and T_(max) between two capsules were 3.24, 0.86 and -3.86 % respectively. All powers(1-β) for AUC_(t), C_(max) and T_(max) were more than 0.9. Detectable differences(Δ) and confidence interval were all less than ±20 %. All the parameters above met the criteria of KFDA for bioequivalence and indicated that Flutin® capsules are bioequivalent to Prozac® capsules.

클래리시드®(Clarithromycin 250㎎)정제의 생물학적 동등성 평가

남기원,천성국,류재환,김남재,송보완,서성훈,이경태 한국병원약사회 2002 病院藥師會誌 Vol.19 No.1

The bioequivalence of two clarithromycin products was evaluated according to the guideline of KFDA. Test product was Dae Won Clarithromycin tablets(Dae Won Korea Ltd.) and reference product was Klaricid® tablets(Abott Korea). 18 healthy male volunteers(20~28 years old) were divided into two groups and a randomized 2×2 cross-over study was employed. After 500㎎ of clarithromycin was orally administered, blood was taken at 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12hours after administration and just before administration. Plasma was analyzed for clarithromycin and internal standard(erythromycin) by a sensitive and validated HPLC assay. The pharmacokinetic parameters(AUC_(t), C_(max) and T_(max)) were calculated and ANOVA test was used for the statistical analysis of parameters. Differences in AUC_(t), C_(max) and T_(max) between two products were -6.55, 3.78 and 1.44 %, respectively. The powers(1-β) and detectable differences(Δ) and confidence interval for AUC_(t), and C_(max) were more than 0.8 and less than 20%, respectively. Although the power of T_(max) was under 0.8, T_(max) of the two products were not significantly different each other. These results suggest that the bioavailability of Dae Won Clarithromycin tablets is not significantly different from that of Klaricid® tablets. Therefore, two products are bioequivalent based on the current result.

클래리시드^�(Clarithromycin 250mg)정제의 생물학적 동등성 평가

남기원,천성국,류재환,김남재,송보완,서성훈,이경태 WHO COLLABORATING CENTRE FOR TRADITIONAL MEDICINE 2002 東西醫學硏究所 論文集 Vol.2002 No.-

Abstract : The bioequivalence of two clarithromycin product was evaluated according to the guideline of KFDA. Test product was dae Won clarithromycin tablets(Dae Won Korea Lts.) and just before administration. Plasma was assay. The pharamcokinetic parameters. differences in AUC, C and T, between two products were -6.55, 3.78 and 1.44 %, respectively.