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모세관 전기영동법을 이용한 베타차단제 광학이성질체의 분석
임환미,린팜두안,강종성 충남대학교 약학대학 의약품개발연구소 2000 藥學論文集 Vol.16 No.-
The effects of type of chiral selectors, pH and concentration of electrolyte on the resolution of the enantiomers of β-blockers by capillary electrophoresis were examined and the analysis of β-blocker enantiomer was attempted using various chiral selectors, such as carboxymethyl-, methyl-, succinyl, hydroxypropyl and dimethyl-β-cyclodextrin. Among the used chiral selectors, carboxymethyl-β-cyclodextrin (CM-β-CD) was the best for the separation of β-blockers. The optimum separation of the enantiomers of β-blocker was achieved on fused silica capillary (75 um i.d.×47 cm, 40 cm to detector) with phosphate buffer (pH 6, 70 mM) containing 10 mM of CM-β-CD as electrolyte at 10 KV running voltage. Injection was hydrodynamically for 3 psi×s and detection was carried out at UV 210nm.
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이온쌍 크로마토그래피를 이용한 혈액 중 Pravastatin의 분석
이순희,임환미,린팜두안,강종성 충남대학교 약학대학 의약품개발연구소 藥學論文集 Vol.16 No.-
A new HPLC method for the determination of pravastatin, a HMG-CoA reductase inhibitor, in human plasma is described. Sample preparation and separation on a reversed-phase column were carried out by the principle of ion-pair formation of pravastatin with alkyl amines as ion-pair reagent. Pravastatin and triamcinolone acetonide (internal standard) were extracted from human plasma with chloroform in the presence of 0.2 mM tetrabutyl ammonium ion and separated on a C_18 column with 30% acetonitrile in phosphate buffer (pH 6, 10 mM) containing 2 mM tetraoctyl ammonium ion. The limit of determination in plasma was 5 ng/ml.
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티로파 정(염산티로프라미드 100 mg) 에 대한 안티모딕정의 생물학적 동등성
곽손혁,구선회,린팜두안,강종성,황성주 충남대학교 약학대학 의약품개발연구소 2000 藥學論文集 Vol.16 No.-
Bioequivalence of two tiropramide tablets, test drug (Antimodic® tablet: Chong Kun Dang Pharm. Co.) and reference drug (Tiropa® tablet: Dae Woong Pharm. Co.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty healthy male volunteers were divided randomly into two groups and administered the drug orally at the dose of 100 mg as tiropramide hydrochloride in a 2×2 crossover study. There was a week washout period between administrations. Blood samples were taken at predetermined time intervals for 10 hr and the plasma concentration of tiropramide HCl was determined by a GC/MS method. AUC_0-10hr (area under the plasma concentration-time curve from time zero to 10 hr), C_max (maximum plasma drug concentration) and T_max (time to reach C_max) were estimated from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed no difference in AUC_(0-10hr), C_max and T_max between two products. The apparent differences of these parameters between two products were less than 20% (i.e., 0.043, 6.430 and 8.929% for AUC_(0-10hr), C_max and T_max, respectively). The powers (1-β) for AUC_(0-10hr) and C_max were over 0.9. Minimal detectable differences (Δ) at α=0.05, 1-β=0.8 were less than 20% (i.e. 15.71 and 12.53% for AUC_(0-10hr) and C_max, respectively). The 90% confidence intervals (δ) for these parameters were also within ±20% (i.e. -9.15≤δ≤9.24 and -0.90≤δ≤13.77 for AUC_(0-10hr) and C_max, respectively). These results satisfied the criteria of KFDA guidelines for bioequivalence, indicating the two tablets of tiropramide were bioequivalent.
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