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원격무선측정장치를 이용한 항히스타민제의 심혈관계영향평가
이윤희(Yun Hee Lee),나한광(Han Kwang Na),윤재석(Jae Suk Yun),정수연(Soo Youn Chung),김주일(Joo-Il Kim),최기환(Ki Hwan Choi) 대한약학회 2006 약학회지 Vol.50 No.2
Two Antihistamines, terfenadine and astemizole have been withdrawn from major markets for the reason that these durgs have been reported to induce QT interval prolongation associaed with the onset of Torsades de Pointes (TdP), resulting in a life-theatening ventricular arrhythmia. In this study, we investigated effects of diphenhydramine on electrocardigrans and hemodynamic parameters in conscious telemetered dogs. We validated and defined the sensitivity of the test system by monitoring basal parameters and using positive control substancem terfenadine. Single administration effects were tested during 24 hours for each test drug at dose 1㎎/㎏, 10㎎/㎏, 30㎎/㎏, 100㎎/㎏. We monitored QT, QTc, heart rate, blood pressure and body temperature after administering test drugs. In conscious telemetered dogs, diphenhydramine significantly prolonged QT (6.8% of basal) and (7.8% of basal) at 100㎎/㎏. Other parameters were not affected significantly. These findings suggest that antihistamines could induce inportant clinical relevance for patients taking excessive dosages of conventional antihistamines and those at risk of developing cardiac arrhythmias. Future studies that include other antihistamines and other classes will be necessary to predict the torsadogenic risk of drug in humans.
전용준(Yong Joon Jeon),윤재석(Jae Suk Yun),임화경(Hwa Kyung Lim),박기숙(Ki Suk Park),나한광(Han Kang Na),김동섭(Dong Sup Kim),김주일(Joo Il Kim),윤여창(Yea Chang Yoon),최기환(Ki Hwan Choi) 대한약학회 2005 약학회지 Vol.49 No.5
Lactoferrin is a multifunctional protein that is found in milk, neutrophils, and other biological fluids, and its receptors have also been identified in the central nervous system. Recently, it was reported that bovine milk-derived lactoferrin (BLF) produced analgesia via a μ-opioid receptor-mediated response in the spinal cord. However the precise mechanism of this analgesic effect is remains unclear. In Randall-Selitto paw pressure study, each single administration of morphine (10 mg/kg) and BLF (50, 100 and 200 mg/kg) induced analgesia, however, NMDA receptor antagonist MK-801 (0.1, 0.2 and 0.3 mg/kg), inhibited analgesia induced by BLF(100mg/kg). Intracerebroventricular infusion (I.C.V) of N-methyl-D-aspartic acid (NMDA) (0.3 μg/8.0 μl/hr/day), as a NMDA receptor agonist, reversed inhibition of MK-801 (0.3mg/kg) on analgesia induced by BLF (100mg/kg). These results suggest that BLF have analgesic effect, through NMDA receptor activation.
안전성약리시험의 Good Laboratory Practice 평가기술연구
최기환(Ki Hwan Choi),박기숙(Ki Sook Park),이윤희(Yun Hee Lee),나한광(Hang-Kwang Na),윤재석(Jae Suk Yun),김동섭(Dong-Sup Kim),김주일(Joo-Il Kim) 한국독성학회 2006 Toxicological Research Vol.22 No.2
Safety pharmacology studies are conducted to investigated the potential undesirable pharmacodynamic effects of a substance on physiological functions in relation to exposure in the therapeutic range and above. In the International Conference on Harmonisation (ICH), the guideline “S7A : Safety Pharmacology Studies for Human Pharmaceuticals” has been developed and reached Step 5 of the ICH process in 2001. Now the Korea Food and Drug Administration (KFDA) are going to transfer “The Guideline for General Pharmacology” into “The Guideline for Safety Pharmacology”. Safety pharmacology studies should be performed in compliance with Good Laboratory Practice (GLP). Thus, the present paper reviews the Japanese GLP guidelines for pharmaceuticals to help the conduct and inspection of safety pharmacology studies in compliance with GLP. We also reviewed the ICH guidelines “S7B revised : The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals” and “E14 : The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-antiarrhythmic Drugs” to apply our drug approval systems.