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1
한미 SMEDDS 실리마린 연질캅셀 제제의 임상약동학적 특성

박민수(Min Soo Park),유내춘(Nae Choon Yu),김경환(Kyung Hwan Kim) 한국응용약물학회 2000 Biomolecules & Therapeutics(구 응용약물학회지) Vol.8 No.3
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  ScienceON
  
  KISS
Silibinin(silybin) is the active component of silymarin from Silybum marianum and has hepatoprotective effect. It is water-insoluble and has low bioavailability. To improve its bioavailability, self-microemulsifying drug delivery system (SMEDDS) has been developed by Hanmi Pharmaceutical Company (Silyman^R 140 soft capsule). In this study, the pharmacokinetic profiles of Silyman^R were examined and compared it with a reference preparation, L Caps 140 of B Pharmaceutical Company. This study was approved by Yonsei University Severance Hospital IRB(approval No. CR0004) and followed the bioequivalence test guideline of Korean FDA. Eighteen healthy adult volunteers were allocated based on 2 x 2 Latin square cross-over design. They were given 2 capsules (each contains silymarin 140 mg (60 mg as silibinin)) of either drug at each period and crossed over after a week of drug-free washout period. Blood concentration of silibinin was measured by HPLC. The C_(maX) and AUC of the Silyman^R were 1542.0±402.7 ng/ml and 3323.3 e±824.7 ng·h/ml, respectively, and were significantly higher than those of reference preparation. The T_(max) was 0.8±0.3 h and significantly shorter than reference preparation. The K_e and T_½ of both drugs were comparable. Percent differences in means against reference preparation were +88.3% for AUC, +222.6% for C_(max), and -61.1 % for T_(max).
2
Loxoprofen sodium 제제 ( 레녹스정 ) 의 생물학적 동등성시험

최주영(Joo Young Choi),유내춘(Nae Choon Yu),박민수(Min Soo Park),김경환(Kyung Hwan Kim) 한국응용약물학회 1998 Biomolecules & Therapeutics(구 응용약물학회지) Vol.6 No.4
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  ScienceON
  
  KISS
Loxoprofen sodium (sodium 2-[4-(2-oxocyclopentylmethyl)phenyl] propionate dehydrate) is a nonsteroidal antiinflammatory drug of α-phenyl propionic acid derivative. To test the bioequivalence of loxoprofen, the pharmacokinetic parameters of new preparation of loxoprofen, LENOX was compared with LOXONIN as a reference drug. Fourteen healthy volunteers were entered to the stydy (Yonsei University, College of Medicine, Severance Hospital IRB approval No. 9608). They were administered 60 mg of loxoprofen in 2 x 2 cross-over design. There was one week of drug-free interval between doses. The blood sample was taken on schedule up to 8 hours, and the plasma concentration loxoprofen was measured by reverse phase high-performance liquid chromatography (HPLC) with UV-detector. There were no significant difference between two preparations when AUC, Cmax, and Tmax were compared by ANOVA. The mean differences of AUC, Cmax, and Tmax were within 20% of the reference drug: the values were 2.22, 5.61, and 12.50%, respectively. The confidence limits of AUC and Cmax but not Tmax satisfied the bioequivalence criteria. These results suggest that the tested LENOX is bioequivalent to the reference drug.
3
The Effect of ZD 1839 (Iressa) in the Treatment of RefractoryNon Small Cell Lung Cancer

Yong Tai Kim,Chul Kim,Joo Hyuk Sohn,So Young Park,Soo Young Park,Nae Choon Yu,Young Sam Kim,Se Kyu Kim,Joon Chang,Kil Dong Kim,Kyung Young Chung,Joo Hang Kim 대한암학회 2003 Cancer Research and Treatment Vol.35 No.6
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Purpose: The aim of this study was to evaluate theefficacy and the safety of ZD 1839 (Iressa) as a 3rd or4th line chemotherapy regimen in NSCLC patients whoare refractory to a previous chemotherapy regimen.Materials and Methods: Twenty-five patients who wererefractory to previous chemotherapy were selected forthis study. The eligible patients had an ECOG performancestatus of 0 to 2, and an appropriate end organfunction. ZD 1839 (Iressa) 250 mg/d was orally administereduntil the patients experienced disease progressionor unacceptable toxicity.Results: Twenty-five patients were analyzed. The medianage of the patients was 57 years. The response ratewas 12.0% with partial responses in 3 patients. Fourteenpatients (56%) remained in the stable disease state and8 patients progressed. The median overall survival was9.0 months (95% CI 6.7~11.2). The median progressionfree survival was 3 months (95% CI 2.2~3.8). Hematologicaltoxicities of grade 3 or 4 neutropenia, anemia andthrombocytopenia were absent. Non-hematological toxicitieswere grade 2 or 3 skin rashes in 10 (40.0%) patientsand 1 (4.0%) patient and grade 3 nausea in 3 (12.0%) patients.No patient failed to continue chemotherapy due toany drug-related adverse events.Conclusion: The results suggest that ZD 1839 (Iressa)monotherapy is effective and tolerable as a 3rd or 4th linesalvage treatment for NSCLC patients refractory to previouschemotherapy regimens. (Cancer ResTreat. 2003;35:502-506)