• 품질경영학회지
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• 제22권4호
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• pp.102-110
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• 1994

We investigate the small-sample behavior of the probability of rejection curves and its performance for a equivalence testing procedure based on confidence intervals which was developed with a motivation from bioequivalence studies. This type of equivalence studies are conducted frequently in pharmaceutical industries to compare the relative bioavailabilty of two formulations of a drug and can be applied various fields where assurance of quality equivalence is needed. From the Monte-Carlo simulation results we suggest proper sample sizes for the equivalence testing procedure.

• Biomolecules & Therapeutics
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• 제5권3호
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• pp.272-277
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• 1997

The effect of nonionic surfactant(polyoxyl 40 hydrogenated castor oil, PHCO), a common solubi-lizer, on the solubility of silymarin in the combined preparation containing ursoseoxycholic acid(UDCA) and silymarin was investigated in vivo using HPLC. The solubility of silybin, a major component of silymarin, was enhanced by increasing the amount of PHCO. The effect of PHCO on bioavailability was also evaluated in rats. The bioavailability was calculated by silybin content in bile juice that was excreted for 24 hr after oral administration. It was found that the bioavailability of silymarin containing PHCO was significantly increased compared to that of control. These results suggest that PHCO may improve the solubility and bioavailabilty of silymarin when it is combined with UDCA and silymarin.

• Journal of Nutrition and Health
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• 제39권3호
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• pp.252-263
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• 2006

Zinc is an antioxidant trace mineral, scavenging free radicals and known to be involved in inflammatory reactions. The prevalence of atherogenic diseases such as coronary heart disease (CHD) are increasing in Korean adults of middle age and elderly. The increased cell damage from free radicals and inflammation have been implicated in etiology of CHD, and the evidence is accumulating that low zinc status is involved in the prevalence of this inflammatory atherogenic disease. However, little is known about the zinc status of Korean CHD and its relationship with dietary zinc intake and zinc bioavailabilty. In this study the serum zinc levels of male patients with CHD over 40 yrs. were compared with that of healthy adult males and its associations with dietary zinc intake and zinc bioavailabilty affecting factors were examined. Serum zinc level was measured by HANARO research reactor using neutron activation analysis (NAA) method. The overall proportion of patients with zinc deficiency, serum zinc concentrations below $74.0{\mu}g/dL$ was 32.8% compared to the 10.3% in healthy group. The average serum zinc levels were $80.7{\mu}g/dL\;and\;88.3{\mu}g/dL$ in patients and healthy group, respectively, showing significantly low zinc status in CHD patients compared to healthy group. The intake of nutrients such as energy, carbohydrate, iron, and copper of CHD patients was significantly higher compared to that of the healthy group. In addition, the intake of calcium, iron, and protein from vegetable foods was significantly higher in CHD patients than that of healthy group. The dietary zinc intake was $12.7{\pm}4.5mg$ and $11.5{\pm}6.9mg$ in CHD patients and control group, respectively, which showed no difference. The phytate intake of patients group, which is 1389.0 mg, was significantly higher than the control group which showed 1104.8 mg. However, the ratio of phytate: zinc or phytate * calcium. zinc per 1000 kcal energy intake did not show any difference between two groups. The serum zinc levels did not show any correlation with zinc or factors that affect the bioavailability of zinc. The dietary factors influencing the zinc status were not found in CHD patients.

• Biomolecules & Therapeutics
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• 제16권2호
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• pp.168-172
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• 2008

The present study is to determine of sensitive nicorandil analysis method using HPLC and measure the pharmacokinetics parameters (bioavailability, $C_{max}$, $T_{max}$, Ke, $T_{1/2}$) of nicorandil (5 mg, Tab; Choongwae Pharma Corporation). Plasma (500 ul) was mixed with furosemide (internal standard, 500 ug/ml). Detection wavelength was 256 nm. The mixture of 0.01 M ammonium acetate and acetonitrile 80:20 (v/v) was used mobile phase. The HPLC separation was accomplished on ODC reverse HPLC column. The nicorandil was analyzed by a HPLC system, which consists of CAPCELL PAK C18 column (5 ${\mu}$m, 4.6 × 150 mm) and a chromatography data analysis S/W, using a isocratic mobile phase (mixture of 0.01 M ammonium acetate and acetonitrile 80:20 ) at 1.0 ml/min. Its sensitivity, selectivity, accuracy and precision must be adequate for the bioavailabilty study of nicorandil, and the linearity ($r^2$ ≥ 0.9994) of nicorandil was also proved in the range of 0.05 ug/ml . 3 ug/ml. The pharmacokinetic parameters of nicorandil (5 mg) tablets were measured as the follow. AUC: 0.19 ug/ml·hr, $C_{max}$: 0.14 ug/ml, $t_{max}$: 0.58 hr, Ke: 0.11 hr., $t_{1/2\beta}$: 6.76 hrs. This method is simple and sensitive HPLC method using UV detector for determination of nicorandil in human plasma.

• 한국임상약학회지
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• 제20권3호
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• pp.193-199
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• 2010

Tacrolimus, an immunosuppressant prescribed against graft-versus-host disease (GVHD) in patients with allogeneichematopoietic stem cell transplantation (HSCT), is affected to change its pharmacokinetic properties by various factors. For this reason, it is needed a close monitoring to adjust dosage amount in order to optimize the blood concentration of tacrolimus is located within the effective range. According to our in-house study, 62% of HSCT-patients were needed dosage-adjustment and it is necessary to optimize the current immunosuppressive regimen in clinical settings. A retrospective study was designed to evaluate the dosing regimen (converting ratio of IV:PO=1:4) of tacrolimus in HSCT patients (n=62). After collecting data from patient's profile and medical record, pharmacokinetic parameters were calculate and compared between the estimated and the actual values in the selected subjects (n=58). It was found that the bioavailabilty (BA) of oral tacrolimus was 40.5% very much different from that is known as 25%. It implies that the current protocol has a potent risk causes dose-related toxicities to the patients. Furthermore, analyses among factors demonstrated that there was no statistical significance between BA of tacrolimus and the variable factors. In the clinical perspectives, the current converting ratio of tacrolimus in patients with HSCT to be re-considered and an appropriate and optimal alternative regimen should be adopted to prevent GVHD and to increase the quality of life of patients.

• Journal of Pharmaceutical Investigation
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• 제34권4호
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• pp.283-288
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• 2004

The pharmacokinetics of nifedipine was studied after oral coadministration of nifedipine (5 mg/kg) with quercetin (1.5, 7.5, 15 and 30 mg/kg, respectively) and 0.5 h or 3days pretreatment with quercetin (1.5 and 7.5mg/kg) in rabbits. Pretreatment of quercetin significantly (p<0.05, at 0.5 h; p<0.01, at 3 days) increased the plasma concentration of nifedipine, but not significant in coadministraiton. The area under the plasma concentration-time curve (AUC) and the peak concentration $(C_{max})$ of nifedipine pretreated with quercetin were increased significantly (p<0.05, at 0.5 h; p<0.01, at 3 days) compared to the control. By coadministration of quercetin, only 7.5 mg/kg of quercetin increased plasma AUC and $C_{max}$ of nifedipine significantly (p<0.05) compared to the control. Plasma AUC of intravenous nifedipine (1 mg/kg) is $4235\;{\pm}\;1192\;ng/ml{\cdot}hr$. Pretreatment of quercetin significantly (p<0.05, at 0.5 h; p<0.01, at 3 days) increased the absolute bioavailability (AB%) of nifedipine to 23.9-29.2% compared to the control (17.8%). Coadministration of quercetin showed no significant effect on the AB% of nifedipine except for 7.5 mg/kg. It is suggested that quercetin alters disposition of nifedipine by inhibition of P-glycoprotein efflux pump and its first-pass metabolism. The dosage of nifedipine should be adjusted when it is administered chronically with quercetin in a clinical situation.