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아세틸 - 엘 - 카르니틴 정제의 생물학적 동등성 평가
박경미(Kyung Mi Park),이미경(Mi Kyung Lee),신지영(Jee Young Shin),우종수(Jong Soo Woo),임수정(Soo Jeong Lim),임윤영(Yoon Young Lim),김종국(Chong Kook Kim) 한국응용약물학회 2001 Biomolecules & Therapeutics(구 응용약물학회지) Vol.9 No.4
N/A Bioequivalence of two acetyl-l-carnitine tablets, test product (Carnitile tablet: Hanmi Pharm. Co., Ltd.) and reference product (Nicetile^? tablet: Dong-A Pharm. Co., Ltd.), was evaluated according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-six healthy volunteers were divided randomly into two groups and administered the drug orally at the dose of 500㎎ as acetyl-l-carnitine in a 2×2 crossover study. Blood samples were taken at predetermined time intervals for 12 hours and the plasma concentration of acetyl-l-carnitine was determined using HPLC by derivatization with p-bromophenacyl bromide. The pharmacokinetic parameters (AUC_(0-12h), C_max, and T_max.) were calculated and ANOVA was utilized for the statistical analysis of parameters. The apparent differences of these parameters between two drugs were less than 20% (i.e., 1.26, -5.08 and 8.59% for AUC_(0-12h), C_max, and T_max, respectively). The powers (1-β) for AUC_(0-12h), C_max and Tmax were over 0.9. Minimal detectable difference (Δ) at α=0.05, I-β=0.8 were less than 20% (i.e., 7.31, 14.88 and 11.77% for AUC_(0-12h), C_max, and T_max, respectively). The confidence intervals (δ) for these parameters were also within ± 20% (i.e., -3.03≤δ≤5.54, -13.80≤δ≤3.64 and 1.69≤δ≤15.48 for AUC_(0-12h), C_max, and T_max, respectively). These results satisfied the criteria of KFDA guideline for bioequivalence, indicating Carnitile bioequivalent to Nicetile^?
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조완익 ( Wan Ik Cho ),김현규 ( Hyun Kyu Kim ),박주희 ( Juhee Park ),박귀영 ( Kui Young Park ),임윤영 ( Yoon Young Lim ),김영희 ( Young Heui Kim ),김기호 ( Ki Ho Kim ),김형미 ( Hyung Mi Kim ),이갑석 ( Kapsok Li ),김범준 ( Beom Joon 대한천식알레르기학회 2012 천식 및 알레르기 Vol.32 No.1
Background: Houttuynia cordata has long been used in traditional oriental medicine for the treatment of inflammatory disease. In the present study, we investigated the anti-inflammatory effect of Houttuynia cordata extracts on Raw 264.7 cells, which is activated with lipopolysaccharide (LPS) and interferon-γ (IFN-γ). Methods: We treated LPS-and IFN-γ-activated murine macrophage Raw 264.7 cells with extracts of Houttuynia cordata and measured the production of nitric oxide (NO) and prostaglandin E2 (PGE2), and the expression of inducible nitric oxide synthase (iNOS), cyclooxygenase (COX)-2, and pro-inflammatory cytokines (Interleukin [IL]-1α, IL-1β, IL-4, IL-6, IL-10, IL-12, tumor necrosis factor-α, regulated on activation normal T-cell expressed and secreted) in activated Raw 264.7 cells after treatment with Houttuynia cordata extracts. Results: NO formation by activated Raw 264.7 cells was reduced in response to Houttuynia Cordata in a dose-dependent manner. Formation of PGE2, a final product of the COX pathway was reduced by Houttuynia cordata extracts and reduction in COX-2 expression was proportional to the reduction in PGE2. The expression of proteins, iNOS and COX-2 decreased with increasing concentration of Houttuynia cordata extracts. The related pro-inflammatory cytokines did not decrease in the cells treated with Houttuynia cordata extracts. Conclusion: Houttuynia Cordata extracts suppressed the production of NO and PGE2 and decreased the expression of iNOS and COX-2. It has potential for the treatment of inflammatory diseases. Further studies are needed to elucidate the effects of Houttuynia Cordata extracts on the production of inflammatory cytokines. (Korean J Asthma Allergy Clin Immunol 2012;32:43-50)
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