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한미 SMEDDS 실리마린 연질캅셀 제제의 임상약동학적 특성

Other Titles
 Clinical Pharmacokinetic Profiles of Hanmi SMEDDS Silymarin Soft Capsule Preparation 
 박민수  ;  유내춘  ;  김경환 
 Journal of Applied Pharmacology (응용약물학회지), Vol.8(3) : 269-275, 2000 
Journal Title
 Journal of Applied Pharmacology (응용약물학회지) 
Issue Date
Silymarin ; Self-Microemulsifying Drug Delivery System ; Pharmacokinetic ; HPLC
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).
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1. College of Medicine (의과대학) > Dept. of Pharmacology (약리학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Kim, Kyung Hwan(김경환)
Park, Min Soo(박민수) ORCID logo https://orcid.org/0000-0002-4395-9938
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