• Title/Summary/Keyword: Korea GMP

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Mechanism for the Vascular Relaxation Induced by Butanol Extract of Agrimonia pilosa (선학초 부탄올 추출물의 혈관 이완 효과의 기전에 대한 연구)

  • Hua, Cao-Li;Lee, Jun-Kyung;Cho, Kuk-Hyun;Kwon, Tae-Oh;Kwon, Ji-Woong;Kim, Jin-Sook;Sohn, Eun-Jin;Lee, Ho-Sub;Kang, Dae-Gill
    • Korean Journal of Pharmacognosy
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    • v.37 no.2 s.145
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    • pp.67-73
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    • 2006
  • The butanol extracts of Agrimonia pilosa (BAP) induced dose-dependent vascular relaxation of phenylephrine-precontracted aorta, which was abolished by removal of functional endothelium. Pretreatment of the endothelium-intact aortic tissues with $N^G$-nitro-L-arginine methyl ester (L-NAME) and 1H-[1,2,4]-oxadiazole-[$4,3-{\alpha}$]-quinoxalin-1-one(ODQ) inhibited the relaxation induced by BAP. BAP-induced vascular relaxation was also markedly attenuated by addition of verapamiI, while the relaxant effect of BAP was not blocked by indomethacine, glibenclamide, tetraethylammonium (TEA), atropine, or propranolo. In addition, incubation of endothelium-intact aortic rings with BAP increased the vascular production of cGMP. These results suggest that BAP relaxes vascular smooth muscle via endothelium-dependent nitric oxide/cGMP signaling pathway, which may be causally related with L-type $Ca^{2+}$ channels.

Characterizing a Full Spectrum of Physico-Chemical Properties of Ginsenosides Rb1 and Rg1 to Be Proposed as Standard Reference Materials

  • Kim, Il-Woung;Hong, Hee-Do;Choi, Sang-Yoon;Hwang, Da-Hye;Her, Youl;Kim, Si-Kwan
    • Journal of Ginseng Research
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    • v.35 no.4
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    • pp.487-496
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    • 2011
  • Good manufacturing practice (GMP)-based quality control is an integral component of the common technical document, a formal documentation process for applying a marketing authorization holder to those countries where ginseng is classified as a medicine. In addition, authentication of the physico-chemical properties of ginsenoside reference materials, and qualitative and quantitative batch analytical data based on validated analytical procedures are prerequisites for certifying GMP. Therefore, the aim of this study was to propose an authentication process for isolated ginsenosides $Rb_1$ and $Rg_1$ as reference materials (RM) and for these compounds to be designated as RMs for ginseng preparations throughout the world. Ginsenoside $Rb_1$ and $Rg_1$ were isolated by Diaion HP-20 adsorption chromatography, silica gel flash chromatography, recrystallization, and preparative HPLC. HPLC fractions corresponding to those two ginsenosides were recrystallized in appropriate solvents for the analysis of physico-chemical properties. Documentation of the isolated ginsenosides was made according to the method proposed by Gaedcke and Steinhoff. The ginsenosides were subjected to analyses of their general characteristics, identification, purity, content quantitation, and mass balance tests. The isolated ginsenosides were proven to be a single compound when analyzed by three different HPLC systems. Also, the water content was found to be 0.940% for $Rb_1$ and 0.485% for $Rg_1$, meaning that the net mass balance for ginsenoside $Rb_1$ and $Rg_1$ were 99.060% and 99.515%, respectively. From these results, we could assess and propose a full spectrum of physicochemical properties for the ginsenosides $Rb_1$ and $Rg_1$ as standard reference materials for GMP-based quality control.

동물약계

  • Korea Animal Health Products Association
    • 동물약계
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    • no.107
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    • pp.3-4
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    • 2006
  • 해외전시회 주관단체 간담회 참석/검역원 동물의약품 분야별 협의체 참석/ILDEX 2006 축산박랍회 참관/동물의약연구회 추계 심포지움 개최/동물약품 GMP 실무과정 교육 실시/제4차 항생제 사용절감 연구모임 회의 참석/기업 신용정보 서비스 무료 이용/조합 알선품목 선정 안내/VIV CHINA 2006 전시회 단체 참가

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Inhibitory Effect of Mixture of Ethanol Extracts in Agastachis Herba and Pueraria Radix on the Proliferation and $PGE_2$ Production of HT-29 Human Colon Cancer Cell Line (곽향과 갈근 복합제제의 대장암 세포주 HT-29 증식 저해효과 및 $PGE_2$ 생성 억제효과)

  • Lee, Seung-Youn;Kim, Hee-Seok;Kim, Jeoung-Ok;Hwang, Sung-Wan;Hwang, Sung-Yeoun
    • Korean Journal of Pharmacognosy
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    • v.37 no.4 s.147
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    • pp.283-289
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    • 2006
  • Ethanol extracts of the whole herb of Agastachis Herba (A) and of Pueraria Radix (P) alone and of their mixture (A+P) downregulated the cell growth, cyclooxygenase-2 (COX-2) expression, prostaglandin $E_2\;(PGE_2)$, and cGMP production. A, P, and A + P inhibited the cell growth of HT-29 colon cancer cells in a concentration- and time-dependent manner but not the growth of normal colon cell, CCD-112CoN. In addition, they markedly inhibited the productions of $PGE_2$ and cGMP as well as the mRNA expression of COX-2. These data suggest that non-toxic concentration of A, P, and A + P have a significant effect on the in vitro growth of HT-29 cells, specifically through the inhibition of the $PGE_2$ production via COX-2.

Cudrania Tricuspidata root extract (CTE) has an anti-platelet effect via cGMP-dependent VASP phosphorylation in human platelets (꾸지뽕나무 뿌리 추출물의 cGMP에 의한 VASP 인산화 기전을 통한 항혈소판 효과)

  • Ro, Ju-Ye;Cho, Hyun-Jeong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.20 no.12
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    • pp.298-305
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    • 2019
  • Cudrania tricuspidata has been reported to have many biological activities, including anti-inflammatory, anti-cancer, and antioxidant properties. However, the effects of C. tricuspidata root extract (CTE) on human platelet aggregation induced by collagen as well as the signaling pathways involved remain unknown. In the present study, we investigated the effect of CTE on human platelets. CTE inhibited platelet aggregation via down-regulation of thromboxane A2 (TXA2) by blocking cyclooxygenase-1 (COX-1) activity and intracellular Ca2+ mobilization in collagen-induced platelets. CTE also reduced the phosphorylation of phospholipase C (PLC) γ2 and syk. CTE regulated platelet aggregation via cyclic guanosine monophosphate (cGMP)-dependent phosphorylation of vasodilator-stimulated phosphoprotein (VASP) Ser239. In addition, administration of CTE (50 and 100 mg/kg) significantly reduced hyper-aggregated platelet aggregation by collagen (5 ㎍/mL) without hepatotoxicity in HFD (high fat diet)-fed rats. Taken together, these results suggest that CTE has anti-platelet effects both in vitro and in vivo. Therefore, CTE may be an effective therapeutic and preventive agent for cardiovascular disease, and is a safe and natural product.

Bacillus stearothermophilus 에서 부분 정제한 Cytosine Deaminase 의 특성

  • 장영채;이경형;김성영;조윤래;김종규
    • Korean Journal of Microbiology
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    • v.30 no.4
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    • pp.305-309
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    • 1992
  • Cytosine deaminase (EC 3.5.4.1) from BaciNus stc~urorhermophilus was partially purified 7.2-fold with an overall yield of 52.7%. The partially purified enzyme deiiminated cytosine only.but not 5-methylcytosine and 5-fluorocytosine. The apparent Michaclis constant. Km valuefor cytosine was 5.9 mM. The enzyme was relatively stable in the range of pH 4.0 to 7.0.furthermore extremely thermo-stable : more than 75'X) of the activity was remained afterheating at 80$^{\circ}$C for I0 min at pH 6.5. The enzyme had a pH optimum at around pH7.0 to 7.5. and temperature optimum at 35 to 31$^{\circ}$C. And the activation energ (En value)determined from an Arrhenius plot was 26 Kcal/mol. The enzyme activity was stronglyinhibited by heavy metal ions such as Cd", Hg". Cut' at 1 mM, anJ by o-phenanthroline,and p-chloromcrcuribcnzoate at I mM. But the enrymc activity was activatetl increased byGMP, and CMP at 1 mM.ased by GMP, and CMP at 1 mM.

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Effects of Ginsenosides on Acid Secretion in Gastric Cells Isolated from Human and Rabbit Gastric Mucosa (인체 및 토끼 위선세포에서 인삼사포닌의 위산분비 매개 신호전달체계에 미치는 영향)

  • Kim, Hye-Yeong;Kim, Sin-Il;Kim, Gyeong-Hwan
    • Journal of Ginseng Research
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    • v.22 no.1
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    • pp.22-31
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    • 1998
  • Antiulcer effects of ginseng saponin, acidic polysaccharide and methanol extract of Panax ginseng in the patients and experimental animals were reported. Postulated action mechanisms of ginseng were histamine-Ht receptor blocking and increasing gastric blood flow In the present study, the effect of ginsenosides, the biologically active glycosides of ginseng, on gastric acid secretion was examined using gastric cells isolated from human and rabbit gastric mucosa. Ginseng saponin, ginsenoside $Rb_1$, $Rb_2$, $Rg_1$ and $Rh_2$ were tested in unstimulated as well as stimulated gastric cells. Histamine ($10^4$M) and 3-isobutyl-1-methylxanthine ($10^4$M) were used as secretagogues. To investigate the mechanism of ginsenosides on acid secretion, the levels of cAMP and cGMP were monitored in gastric cells. As a result, high concerltration(1mg/ml) of ginseng saponin showed 73-75% of stimulated acid secretion in control gastric cells. However, ginseng saponin had no effect on unstimulated acid secretion and the levels of cGMP and cAMP in gastric cells. Ginsenoside $Rb_1$, $Rb_2$ and $Rh_2$ significantly inhibited stimulated acid secretion. Gastric cGMP levels were increased by all ginsenosides tested while cAMP levels were increased by all ginsenosides in unstimulated state of gastric cells, but increased by ginsenosides ginsenoside $Rg_1$ and $Rh_2$in stimulated state of gastric cells. The results suggest that inhibition of ginseng saponin on gastric acid secretion represents a complex effect of individual ginsenosides, which produce a range of effect on acid secretion. The inhibition site of ginseng saponin on stimulated acid secretion is postulated as post cAMP levels in acid secretary pathway such as protein phosphorylation or proton pump. Nitric oxide may not be involved in the inhibitory effect of ginseng saponin on stimulated acid secretion.

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Effects of Heme Oxygenase System on the Cyclooxygenase in the Primary Cultured Hypothalamic Cells

  • Lee, Hae-Uk;Lee, Hee-Jee;Park, Ha-Young;Lee, Sang-Ho;Jang, Choon-Gon;Lee, Seok-Yong
    • Archives of Pharmacal Research
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    • v.24 no.6
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    • pp.607-612
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    • 2001
  • Endogenous carbon monoxide (CO) shares with nitric oxide (NO) a role as a putative neural messenger in the brain. Both gases are believed to modulate CNS function via an increase in cytoplasmic cGMP concentrations secondary to the activation of soluble guanylate cyclase (sGC). Recently CO and NO were proposed as a possible mediator of febrile response in hypothalamus. NO has been reported to activate both the constitutive and inducible isoform of the cyclooxygenase (COX). Thus, we investigated whether CO arising from heme catabolism by heme oxygenate (HO) is involved in the febrile response via the activation of COX in the hypothalamus. $PGE_2$ which is a final mediator of febrile response released from primary cultured hypothalamic cells was taken as a marker of COX activity. $PGE_2$ concentration was measured with EIA kits. Exogenous CO (CO-saturated medium) and hemin (a substrate and potent inducer of HO) evoked an increase in $PGE_2$ release from hypothalamic cells, and these effects were blocked by methylene blue (an inhibitor of sGC). And membrane permeable cGMP analogue, dibutyryl-cGMP elicited significant increases in $PGE_2$release. These results suggest that there may be a functional link between HO and COX enzymatic activities. The gaseous product of hemin through the HO pathway, CO, might play a role through the modulation of the COX activity in the hypothalamus.

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Structural Studies on PDE and Inhibitor Complexes

  • Lee, Jie-Oh
    • Proceedings of the Korean Biophysical Society Conference
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    • 2002.06b
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    • pp.15-15
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    • 2002
  • Cyclic nucleotide phosphodiesterases (PDEs) regulate physiological processes by degrading ubiquitous intracellular second messengers, cAMP or cGMP. The first crystal structure of PDE4D catalytic domain and a bound inhibitor, zardaverine, was determined. Zardaverine binds to a highly conserved pocket that includes the catalytic metal binding site.(omitted)

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Validation of Sterilization Process (멸균제제공정의 Validation)

  • 김길수
    • YAKHAK HOEJI
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    • v.29 no.5
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    • pp.305-315
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    • 1985
  • Validation이란 용어는 1970년대에 우리나라에 GMP개념이 도입되면서 처음 사용되기 시작하여 지금은 흔히들 사용하면서도 그 개념은 아직도 정확히 이해되고 있지 않은것 같다. 제약공업에서의 validation의 적용범위는 아주 광범위하며 제조기기, 제조공정, 조직, 인원 등에 그 개념을 도입하여 관리하고 있다. 따라서 본 란에서는 validation의 일반적인 개념을 서술한 후 액상제제 특히 무균제제에 대한 calidation중 멸균공정에 대하여 상술하고자 한다.

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