• Title/Summary/Keyword: Pharmacological effects

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Studies for the Guidance of Safety Pharmacology Studies in Compliance with Good Laboratory Practice (안전성약리시험의 Good Laboratory Practice 평가기술연구)

  • Choi Ki-Hwan;Park Ki-Sook;Lee Yun-Hee;Na Hang-Kwang;Yun Jae-Suk;Kim Dong-Sup;Kim Joo-Il
    • Toxicological Research
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    • v.22 no.2
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    • pp.109-116
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    • 2006
  • 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.

Food-Effect Bioavailability and Fed Bioequivalence Studies (생체이용률에 미치는 음식물의 영향 및 식후 생물학적동등성시험)

  • Choi, Sun-Ok;Kwon, Kwang-Il;Jung, Sung-Hee;Um, So-Young;Jung, Seo-Jeong;Kim, Joo-Il;Chung, Soo-Youn;Kim, Ok-Hee
    • Korean Journal of Clinical Pharmacy
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    • v.15 no.2
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    • pp.82-88
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    • 2005
  • A new medical system was started in Korea in 2000 and pharmaceutical affairs law was revised in 2001. According to the revised law, generic substitution is permitted only to therapeutically equivalent generic product. Bioequivalence studies are usually used to demonstrate therapeutic equivalence between reference listed drugs and generic drugs. The issues that are recently heating up in Korea are to increase bioequivalent drug products and at the same time to ensure the credibility of the therapeutic equivalence of generic drugs. Sometimes food can change the bioavailability (BA) of a drug and influence the bioequivalence (BE) between test and reference products as well. Food effects on BA can have clinically significant consequences. Food can alter BA by various means including delaying gastric emptying, stimulating bile flow and changing gastointestinal pH. This paper provides the recently published Korean guideline on food-effect BA and fed BE studies.

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General Pharmacology of (R)-JG-381, A New Antidiabetic Agent (항당뇨물질 (R)-JG-381의 일반약리작용)

  • 오우용;이상호;주상섭;박형근;함광수;조장섭;이선미
    • Biomolecules & Therapeutics
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    • v.9 no.1
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    • pp.63-68
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    • 2001
  • General pharmacological properties of (R)-JG-381 were examined in laboratory animals to investigate its safety profile. Administration of (R)-JG-381 (50 and 100 mg/kg) in mice and rats had no effects of general behaviors, central nervous system of the animals in test systems of pentobarbital-induced sleeping time, writhing syndromes induced by 0.7% acetic acid, chemo-shock produced by pentylenetetrazole, and, however, had mild effects on motor coordination. Heart rate and blood pressure were not changed by (R)-JG-381 treatment. (R)-JG-381 also showed mild effects on intestinal propulsion and gastric secretion. These results suggest that (R)-JG-381 dose not exert serious pharmacological effects.

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Pharmacological Effects of Extract of Bufonis Yenenum (섬수(Bufonis Yenenum) 추출물의 약리작용)

  • 김영훈;정성학;김종학;최재묵;지준환;강재구;박종구;김제학;조희재
    • Biomolecules & Therapeutics
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    • v.9 no.1
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    • pp.51-54
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    • 2001
  • Bufonis Venenum is a toad venom and its main components are bufadienolides, namely resibufogenin, bufalin and cinobufagin. The desensitizing effect of Bufonis Venenum is useful for the treatment of the premature ejaculation in Chinese medicine. But, minor components of Bufonis Venenum cause problems such as topical burring, pain, and erectile dysfunction. To clarify and eliminate the components responsible for these side effects, we prepared two extracts of Bufonis Venenum with either 70% ethanol or ethylacetate and tested their pharmacological effects. The extract of Bufonis Venenum with 70% ethanol produced pain response in rat hind paw, and exhibited contraction of rabbit corpus cavernosal muscle in vitro. On the other hand, the ethylacetate extract did not cause pain and smooth muscle contraction. The desensitizing effect of the ethylacetate extract was similar to that of the 70% ethanol extract. In conclusion, these results show that the extract of Bufonis Venenum with ethylacetate does not have the components causing side effects and deserve further study for therapeutic potential in premature ejaculation in men.

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The Anti-inflammatory Mechanism of Xanthoangelol E is Through the Suppression of NF-${\kappa}B$/Caspase-1 Activation in LPS-stimulated Mouse Peritoneal Macrophage

  • Seoa, Jung-Ho;Kim, Su-Jin
    • Biomedical Science Letters
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    • v.18 no.4
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    • pp.345-354
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    • 2012
  • Angelica keiskei has exhibited numerous pharmacological effects including antitumor, antimetastatic, and antidiabetic effects. However, the anti-inflammatory effects and mechanisms employed by xanthoangelol E isolated from Angelica keiskei are incompletely understood. In this study, we attempted to determine the effects of Xanthoangelol E on the lipopolysaccharide (LPS)-stimulated mouse peritoneal macrophage. The findings of this study demonstrated that xanthoangelol E inhibited the production of tumor necrosis factor (TNF)-${\alpha}$, interleukin (IL)-6, and prostaglandin $E_2$ ($PGE_2$). Xanthoangelol E inhibited the enhanced levels of cyclooxygenase (COX)-2 and inducible nitric oxide synthase (iNOS) caused by LPS. Additionally, we showed that the anti-inflammatory effect of xanthoangelol E is through the regulation of the activation of nuclear factor (NF)-${\kappa}B$ and caspase-1. These results provide novel insights into the pharmacological actions of xanthoangelol E as a potential candidate for the development of new drugs to treat inflammatory diseases.

The Inhibitory Effect of Gooseberry on DNCB-induced Atopic Dermatitis in vivo and in vitro

  • Kim, Su-Jin
    • Biomedical Science Letters
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    • v.24 no.4
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    • pp.349-356
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    • 2018
  • Generally, berry fruits have various pharmacological activities such as anti-inflammation, anti-oxidation and anti-cancer effects. The effects of gooseberry, a berry fruits, on atopic dermatitis (AD) have not been widely examined. The aim of this present study is to investigate whether gooseberry modulates AD. We examined the pharmacological effects of gooseberry on 2, 4-dinitrochlorobenzene (DNCB)-induced AD symptoms in mice. To determine the anti-atopic mechanism of gooseberry, we investigated its effects on the production of inflammatory cytokines and activation of nuclear factor-${\kappa}B$ in PMA + ionophore -stimulated human mast cells (HMC-1). The results demonstrated that gooseberry attenuated AD clinical symptoms such as erythema, edema and dryness as well as histamine and IgE serum levels in DNCB-induced AD model mice. Additionally, gooseberry suppressed the expression of inflammatory cytokines and activation of nuclear factor-${\kappa}B$ in stimulated HMC-1. These findings demonstrate that gooseberry is potential agent for treating AD and allergic inflammation.

General Pharmacology of Artesunate, a Commonly used Antimalarial Drug: Effects on Central Nervous, Cardiovascular, and Respiratory System

  • Lee, Hyang-Ae;Kim, Ki-Suk;Kim, Eun-Joo
    • Toxicological Research
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    • v.26 no.3
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    • pp.223-232
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    • 2010
  • Artesunate, a semi-synthetic derivative of artemisinin, is used primarily as a treatment for malaria. Its effects on the central nervous system, general behavior, and cardiovascular, respiratory, and other organ systems were studied using mice, rats, guinea pigs, and dogs. Artesunate was administered orally to mice at doses of 125, 250, and 500 mg/kg and to rats and guinea pigs at 100, 200, and 400 mg/kg. In dogs, test drugs were administered orally in gelatin capsules at doses of 50, 100, and 150 mg/kg. Artesunate induced insignificant changes in general pharmacological studies, including general behavior, motor coordination, body temperature, analgesia, convulsion modulation, blood pressure, heart rate (HR), and electrocardiogram (ECG) in dogs in vivo; respiration in guinea pigs; and gut motility or direct effects on isolated guinea pig ileum, contractile responses, and renal function. On the other hand, artesunate decreased the HR and coronary flow rate (CFR) in the rat in vitro; however, the extent of the changes was small and they were not confirmed in in vivo studies in the dog. Artesunate increased hexobarbital-induced sleeping time in a dose-related manner. Artesunate induced dose-related decreases in the volume of gastric secretions and the total acidity of gastric contents, and induced increases in pH at a dose of 400 mg/kg. However, all of these changes were observed at doses much greater than clinical therapeutic doses (2.4 mg/kg in humans, when used as an anti-malarial). Thus, it can be concluded that artesunate is safe at clinical therapeutic doses.

Meta-Analysis of the Effects of Nonpharmacological Interventions for Anxiety Disorder (불안장애 대상자에게 적용한 비약물적 중재효과 메타분석)

  • Kim, Hyeun sil;Kim, Eun Joo
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.16 no.11
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    • pp.7273-7284
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    • 2015
  • The purpose of this study was to investigate the effect size of non-pharmacological intervention applied to patients with anxiety disorder and to provide information about evidence-based intervention. Twenty three studies were selected for meta-analysis through a systematic review of domestic studies. We searched journal articles published in Korea up to May, 2015 using the key words "Anxiety Disorders (MeSH)" and "Treatment or Intervention". Meta-analysis was performed using a random effects model, and the effect sizes on each of anxiety and depression were calculated. The effect size for anxiety of non-pharmacological intervention in this study was Hedges' g=1.693 (95% CI; 1.267-2.120), indicating a large effect size. The effect size for depression was Hedges's g=1.571 (95% CI; 0.481-2.661), indicating a large effect size. It is significant that this study systematically synthesized the study results for non-pharmacological intervention effects applied to patients with anxiety disorders in Korea. It also established a basis that can be applied to nursing intervention.

Abuse Potential of Synthetic Cannabinoids: AM-1248, CB-13, and PB-22

  • Hur, Kwang-Hyun;Ma, Shi-Xun;Lee, Bo-Ram;Ko, Yong-Hyun;Seo, Jee-Yeon;Ryu, Hye Won;Kim, Hye Jin;Yoon, Seolmin;Lee, Yong-Sup;Lee, Seok-Yong;Jang, Choon-Gon
    • Biomolecules & Therapeutics
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    • v.29 no.4
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    • pp.384-391
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    • 2021
  • Currently, the expanding recreational use of synthetic cannabinoids (SCBs) threatens public health. SCBs produce psychoactive effects similar to those of tetrahydrocannabinol, the main component of cannabis, and additionally induce unexpected pharmacological side effects. SCBs are falsely advertised as legal and safe, but in reality, SCB abuse has been reported to cause acute intoxication and addictive disorders. However, because of the lack of scientific evidence to elucidate their dangerous pharmacological effects, SCBs are weakly regulated and continue to circulate in illegal drug markets. In the present study, the intravenous self-administration (IVSA) paradigm was used to evaluate the abuse potential of three SCBs (AM-1248, CB-13, and PB-22) in rats. All three SCBs maintained IVSA with a large number of infusions and active lever presses, demonstrating their reinforcing effects. The increase of active lever presses was particularly significant during the early IVSA sessions, indicating the reinforcement-enhancing effects of the SCBs (AM-1248 and CB-13). The number of inactive lever presses was significantly higher in the SCB groups (AM-1248 and CB-13) than that in the vehicle group, indicating their impulsive effects. In summary, these results demonstrated that SCBs have distinct pharmacological properties and abuse potential.

Pharmacological Effects of Lycium chinensis (구기자나무의 약물활성)

  • Kim, Nam-Jae;Youn, Whang-Geum;Hong, Nam-Doo
    • Korean Journal of Pharmacognosy
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    • v.25 no.3
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    • pp.264-271
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    • 1994
  • Pharmacological effects of water extracts of Lycii Fructus, Lycii Folium and Lycii Cortex Radicis from Lycium chinensis were investigated. Lycii Folium significantly protected the hepatic function from damages orally caused by $CCl_4 $administration in mice and had a strong hypoglycemic effect in hyperglycemic mice induced by streptozotocin. Lycii Fructus decreased the blood pressure rise associated with the growth of normal rats. Lycii Cortex Radicis had a strong hypoglycemic effect in hyrerglycemic mice induced by streptozotocin. Also, hypolipidemic effects in hyperlipidemic rats induced by 1% cholesterol fed-diet and 75% fructose were significantly observed by oral administration of water extracts of Lycii Fructus, Lycii Folium and Lycii Cortex Radicis.

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