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KMID : 0664720000260010141
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Drug Information
2000 Volume.26 No. 1 p.141 ~ p.144
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이동석/Lee, Dong Suck
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Abstract
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Background: We evaluated the pharmacokinetic characteristics of a new silymarin containing formulation i
Legalon cap. 1401 in healthy volunteers and compared the pharmacokinetic characteristics of with those of i Silymarin.
Methods: The trial was a single-blind, randomized, 2-way crossover Latin square design study in 18 healthy f
subjects. Subjects were separated into two groups, A and B. Subjects in group A were administered Legalon cap. 140´ via oral route and 1 week later they were administered Silymarin´. Dosage was 120 mg as silibinin (two capsules of Legalon 1401 and four tablets of Silymarin). Subjects in group B were administered the drugs with opposite sequence in the same manner. Blood samples were collected till 24 hours after the drug ad-ministration. Plasma concentrations of silibinin diastereomers were assayed by HPLC and total silibinin concentrations were obtained. Pharmacokinetic parameters were estimated by non-compartmental analysis.
Results: Mean of AUC and Cmax of the Legalon cap. 1401 were 2.5 and 29 times higher than those of
´ Silymarin respectively(AUC: 4045227 vs 1602114 ng hr/ml, Cmax: 981-x-54.9 vs 339-1_-31.5 ng/ml, Legalon vs Silymarin mean-1-SEM). The difference of AUC and Cmax of those drugs were statistically significant (p < 0.001). Tmax, MRT and terminal half-life of those drugs were not statistically different (Tmax: 1.70.15 vs 2.20.26 hr, MRT: 5.380.29 vs 5.570.36 hr, terminal half-life: 4.33-x--0.28 vs 3.960.36 hr, Legalon vs Silymarin´ meanSEM). The confidence interval(95%) of the relative bioavailability(Legalon
` 140/SilymarinO) was 228307% and that of individual ratio of Cmax was 2.673.85_
Conclusion: Relative bioavailability of Legalon cap 1400 was at least 2 times higher than that of Silymarin without any significant adverse events. It is expected that twice daily regimen of Legalon cap. 140 is equivalent to or better than thrice daily regimen of Silymarin in terms of AUC or pharmacokinetics.
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KEYWORD
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