• 제목/요약/키워드: Solvent effects.

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Permitted Daily Exposure for Diisopropyl Ether as a Residual Solvent in Pharmaceuticals

  • Romanelli, Luca;Evandri, Maria Grazia
    • Toxicological Research
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    • 제34권2호
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    • pp.111-125
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    • 2018
  • Solvents can be used in the manufacture of medicinal products provided their residual levels in the final product comply with the acceptable limits based on safety data. At worldwide level, these limits are set by the "Guideline Q3C (R6) on impurities: guideline for residual solvents" issued by the ICH. Diisopropyl ether (DIPE) is a widely used solvent but the possibility of using it in the pharmaceutical manufacture is uncertain because the ICH Q3C guideline includes it in the group of solvents for which "no adequate toxicological data on which to base a Permitted Daily Exposure (PDE) was found". We performed a risk assessment of DIPE based on available toxicological data, after carefully assessing their reliability using the Klimisch score approach. We found sufficiently reliable studies investigating subchronic, developmental, neurological toxicity and carcinogenicity in rats and genotoxicity in vitro. Recent studies also investigated a wide array of toxic effects of gasoline/DIPE mixtures as compared to gasoline alone, thus allowing identifying the effects of DIPE itself. These data allowed a comprehensive toxicological evaluation of DIPE. The main target organs of DIPE toxicity were liver and kidney. DIPE was not teratogen and had no genotoxic effects, either in vitro or in vivo. However, it appeared to increase the number of malignant tumors in rats. Therefore, DIPE could be considered as a non-genotoxic animal carcinogen and a PDE of 0.98 mg/day was calculated based on the lowest No Observed Effect Level (NOEL) value of $356mg/m^3$ (corresponding to 49 mg/kg/day) for maternal toxicity in developmental rat toxicity study. In a worst-case scenario, using an exceedingly high daily dose of 10 g/day, allowed DIPE concentration in pharmaceutical substances would be 98 ppm, which is in the range of concentration limits for ICH Q3C guideline class 2 solvents. This result might be considered for regulatory decisions.

Comparative Study of Extraction Solvents on the Anti-inflammatory Effects of Scutellaria baicalensis

  • Yoon, Tae-Sook;Cheon, Myeong-Sook;Kim, Seung-Ju;Lee, A-Yeong;Moon, Byeong-Cheol;Chun, Jin-Mi;Choo, Byung-Kil;Kim, Ho-Kyoung
    • 대한한의학회지
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    • 제30권6호
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    • pp.44-52
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    • 2009
  • Objectives: This study was performed to evaluate the influence of different extracting solvents (water, methanol, ethanol, or n-hexane) on the anti-inflammatory efficacy of Scutellaria baicalensis (Lamiaceae), which has been used widely as a traditional herbal medicine for its anti-inflammatory properties. Methods: The ability of each extract to inhibit the production of pro-inflammatory mediators such as NO, TNF-$\alpha$, and $PGE_2$ by lipopolysaccharide (LPS)-stimulated mouse macrophage RAW 264.7 cells was measured. Results: The results showed that extraction solvents (except n-hexane) for S. baicalensis showed significant inhibitory effects on NO, TNF-$\alpha$ and $PGE_2$ production. Especially, methanol was the solvent with the greatest activity against NO and $PGE_2$ production. However, there was no difference between the extracts for inhibitory activity of TNF-$\alpha$. Conclusion: The present study suggests that methanol is a superior extraction solvent than water, ethanol, or n-hexane for maintaining the anti-inflammatory effects of S. baicalensis.

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채소의 용매분획 추출물들이 Saccharomyces cerevisiae의 alcohol dehydrogenase 활성에 미치는 영향 (Effects of Vegetable Extracts by Solvent Separation on Alcohol Dehydrogenase Activity from Saccharomyces cerevisiae)

  • 강배광;정순택;김선재
    • 한국식품과학회지
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    • 제34권2호
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    • pp.244-248
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    • 2002
  • 용매분획에 의한 콩나물, 미나리, 무의 추출물들이 Saccharomyces cerevisiae의 ADH의 활성에 미치는 영향을 in vitro에서 조사하였다. 이 추출물들은 알코올로 추출한 것을 용매분획에 의해 수용성 분획물과 유기성인 염기성, 산성, 중성, 페놀성 분획물들을 얻었다. 수용성 분획물들은 유기성 분획물들 보다 ADH 활성을 훨씬 높게 촉진시켰다. 수용성 분획물인 콩나물, 미나리, 무의 촉진율은 각각 125.75%, 104.94%, 87.63%를 나타냈다. 염기성, 산성, 중성의 분획물들에서 염기성 분획물이 약 40%로 가장 높았고 다른 분획물들은 25% 이하로 나타났으며 큰 차이를 보이지 않았다. 페놀성 분획물들 역시 ADH 활성에 큰 영향을 나타내지 못했다. 따라서, 이 분획물들을 ADH 활성 촉진에 이용할 때는 무기물, 아미노산 등의 상승효과를 얻을 수 있는 수용성 분획물들을 이용해야 할 것으로 사료된다.

사백산 물 추출물과 30% EtOH 추출물의 항염증 효과 비교연구 (The Comparison between Sabaek-san Water and 30% EtOH Extracts for Anti-inflammatory Effects)

  • 이동성;최현규;김경수;김동철;민홍기;리빈;김종수;박준형;오현철;김윤철
    • 약학회지
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    • 제56권4호
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    • pp.240-247
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    • 2012
  • Sabaek-san has been used for the treatment of inflammatory diseases derived from the cold with high fever, cough, and lung dysfunction in Korea and China. There is no study for the comparison between different solvent extracts of Sabaek-san. We made two samples, one is Sabaek-san water extract (SBSW) and the other is Sabaek-san 30% EtOH extract (SBSE). Both extracts inhibited inducible nitric oxide synthase(iNOS) protein, reduced iNOS-derived nitric oxide (NO) production in lipopolysaccharide (LPS)-stimulated RAW264.7 cells. Also, they reduced tumor necrosis factor-${\alpha}$ (TNF-${\alpha}$) and interleukin-$1{\beta}$ (IL-$1{\beta}$) production. These anti-inflammatory effects caused by induction of heme oxygenase (HO)-1. HO-1 enzyme plays an important role of cellular anti-oxidant and anti-inflammatory systems. The induction of HO-1 is primarily regulated at the transcriptional level, and its induction by various inducers is related to the nuclear transcription factor-E2-related factor 2 (Nrf2). However, it is worth taking note that SBSE has more powerful anti-inflammatory effects than SBSW. In this study we suggest that different solvent extraction makes different therapeutic actions.

Evaluation of Biological Activities of Invasive Alien Plants for Development of Functional Biomaterials

  • So Jin Kim;Su Hyeong Heo;Min Gun Kim;Kyung Hwan Boo;Chang Sook Kim
    • 한국자원식물학회:학술대회논문집
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    • 한국자원식물학회 2022년도 추계학술대회
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    • pp.112-112
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    • 2022
  • This study aims to confirm the possibility of using the invasive alien plants in Jeju as a functional biomaterial. To achieve this purpose, 70% ethanol extract and solvent fractions were prepared for five invasive alien plants (Hypochaeris radicata, Rumex acetosella, Humulus japonicus Siebold & Zucc., Solanum viarum, Lactuca scariolar) and their antioxidant, antibacterial anti-inflammatory and anti-obesity effects were investigated. The DPPH radical scavenging activity of ethanol extract from invasive alien plants was shown in the order of Rumex acetosella > Hypochaeris radicata > Humulus japonicus. Antimicrobial activity of ethanol extract against food poisoning bacteria (4 species) and oral cavity-induced microorganisms (6 species) was measured. As a result, the extract of Humulus japonicus showed high antibacterial effects against food poisoning bacteria (E. coli, V. parahaemolyticus) and oral microbes (L. casei, S. epidermidis, E. faecalis). In LPS-induced RAW 264.7 cells, the anti-inflammatory effect of ethanol extract from invasive alien plants was investigated. As a result, the NO production inhibition activity was highest in the Rumex acetosella and the Humulus japonicus Siebold & Zucc. ethanol extract, and the NO production inhibition activity was concentration-dependent. In addition, the Rumex acetosella and the Humulus japonicus Siebold & Zucc. ethanol extract showed a concentration-dependent inhibitory effect on cytokine (IL-6) production. These extracts also showed inhibitory activity of COX-2, an inflammatory protein. This suggests that NO production inhibition activity by the extract of invasive alien plants is the result of inhibition of iNOS and COX-2 expression. Currently, organic solvent fractions of crude extract are manufactured and the investigation of active ingredients is continuing along with evaluation of biological activity such as anti-inflammatory. These results are expected to be a major data for the study on the separation and utilization of active ingredients with antioxidant, antibacterial and anti-inflammatory effects using foreign plant crude extract and solvent fractions, and are highly likely to be applied to the development of functional food and cosmetics materials.

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직접 메탄올 연료전지용 산화극 제조 변수가 성능에 미치는 영향 (Effects of the Variables in the Fabrication of Anode on the Performance of DMFC)

  • 김준희;하흥용;오인환;홍성안;이호인
    • 전기화학회지
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    • 제6권1호
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    • pp.18-22
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    • 2003
  • 직접 메탄을 연료전지(DMFC)의 산화극 제조 변수들에 따른 단위전지의 성능변화 관찰 및 특성분석을 수행하였다. 촉매층에서의 이온 전도도에 영향을 주는 이오노머의 양과, 이오노머와 촉매의 결합구조를 결정하는 촉매 슬러리의 용매를 변수로 하였다 전체 이오노머의 비가 0.6일 때 최고 성능을 보였으며 분극 저항도 가장 작게 나타났다. 전기화학적 활성면적도 이오노머가 늘어날수록 증가하였다. 극성이 작은 용매일수록 이오노머가 잘 용해되지 않아 촉매 응집체의 크기가 커졌다 기존의 물이나 알코올 종류의 용매들에 비해 극성이 낮은 DPK $(\varepsilon=12.60)$를 사용하여 제조한 전극이 가장 높은 성능을 보였으며 낮은 분극 저항 값을 가졌다.

Comparative Antitumor Activity of Different Solvent Fractions from an Auricularia auricula-judae Ethanol Extract in P388D1 and Sarcoma 180 Cells

  • Reza, Ahsanur;Choi, Myung-Jin;Damte, Dereje;Jo, Woo-Sik;Lee, Seung-Jin;Lee, Joong-Su;Park, Seung-Chun
    • Toxicological Research
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    • 제27권2호
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    • pp.77-83
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    • 2011
  • The objective of this study was to evaluate and compare the antitumor activity of different solvent fractions (ethanol, dichloromethane, ethyl acetate, butanol and water) of the Auricularia auricula-judae 70% ethanol extract on the P388D1 macrophage and sarcoma 180 cells. A dose-dependent antitumor activity of each solvent fraction (from 0.01 mg/ml to 0.3 mg/ml) was shown against both cell types. These cytotoxic effects of all the tested fractions were confirmed on the MTT and SRB assays, without statistical differences each other. $IC_{50}$ value of dichloromethane fraction was 94.2 ${\mu}g/ml$ against sarcoma 180 cells lower than any other solvent fractions. The potent antitumor effect of the dichloromethane (DCM) fraction was also found against solid tumor in BALB/c mice. The splenomegaly and higher splenic index were found in tumor-bearing mice, with the DCM fraction returning to the negative control values. Thus, the results indicated the dichloromethane fraction may have potential ingredients as antitumor candidates.

Enhanced Performance Characteristics of Polymer Photovoltaics by Adding an Additive-incorporated Active Layer

  • 이혜현;황종원;조영란;강용수;박성희;최영선
    • 한국진공학회:학술대회논문집
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    • 한국진공학회 2010년도 제39회 하계학술대회 초록집
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    • pp.316-316
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    • 2010
  • Thin films spin-coated from solvent solutions are characterized by solution parameters and spin-coating process. In this study, performance characteristics of polymer solar cells were investigated with changing solution parameters such as solvent and additives. The phase-separation between polymer and fullerene is needed to make the percolation pathway for better transportation of hole and electron in polymer solar cells. For this reason, cooperative effects of solvent mixtures adding additives with distinct solubility have been studied recently. In this study, chlorobezene, 1, 2-dichlorbenzene, and chloroform were used as solvent. 1, 8-diiodoctaned and 1, 8-octanedithiol were used as additives and were added into poly(3-hexylthiophene-2, 5-diyl)/[6, 6]-phenyl C61 butyric acid methyl ester (P3HT/PCBM) blends. Pre-patterned ITO glass was cleaned using ultrasonication in mixed solvent with ethyl alcohol, isopropyl alcohol and acetone. PEDOT:PSS was spin-coated on to the ITO substrate at 3000rpm and was baked at $120^{\circ}C$ for 10min on the hotplate. The prepared solution was spin-coated at 1000rpm and the spin-coated thin film was dried in the Petri dishes. Al electrode was deposited on the thin film by thermal evaporation. The devices were annealed at $120^{\circ}C$ for 30min. By adding 2.5 volume percent of additives into the chlorobenzene from that bulk heterojunction films consisting of P3HT/PCBM, the power efficiency (AM 1.5G conditions) was increased from 2.16% to 2.69% and 3.12% respectively. We have investigated the effect of additives in P3HT/PCBM blends and the film characteristics and the film characteristics including J-V characteristics, absorption, photoluminescence, X-ray diffraction, and atomic force microscopy to mainly depict the morphology control by doping additives.

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감초폴리페놀 추출효율에 있어 열처리, 에탄올 농도, 추출시간 및 용매비율이 미치는 영향 탐색 (Effect of Heat Treatment, Ethanol Content, Extraction Time and Ratio of Solvent on the Efficiency of Polyphenol Extraction from Licorice Root (Glycyrrhizauralensis))

  • 채정일;류경선;서강석;김경훈;오영균;장선식;최창원;최낙진
    • 한국유기농업학회지
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    • 제20권3호
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    • pp.399-409
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    • 2012
  • Effects of pretreatment and extraction conditions on total polyphenol yield from licorice root were investigated using statistical method. For pretreatment, heat treatment at $121^{\circ}C$ for 10 min was applied. Licorice root content in solvent (10, 20, and 30%) ethanol concentration (20, 40, and 60%) and reaction time (1, 2, and 3 h) were used as variables for extraction conditions. Two experiments, with heat treated and no treated licorice, were prepared with same experimental design. Box behnken design was employed and produced a total of 15 trials. Total polyphenol yield from licorice root was not affected by heat treatment. Among variables, licorice content in solvent showed most significant effect regardless of other variables (p<0.05). Finally, optimum conditions for the extraction of total polyphenol from licorice root was detected as following: 10% of licorice in solvent, 52% ethanol as solvent, 2 h of reaction time and non-heat treatment and the extraction yield from optimized condition was 17.6 mg/g licorice root.

용매 추출법에 의한 분해경유중의 방향족 분리 -추출상중의 방향족의 역수출- (Separation of Aromatics in Light Cycle Oil by Solvent Extraction - Re-extraction of Aromatics in Extract Phase -)

  • 김수진;김덕현
    • 공업화학
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    • 제8권6호
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    • pp.967-972
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    • 1997
  • 접촉분해경유(LCO)와 dimethylsulfoxide(DMSO)수용액의 평형추출로부터 얻어진 추출상을 원료로 사용한 역추출에 의해 추출상중의 방향족의 회수를 검토했다. 역추출 용매의 선정을 위해, Benzene, Toluene, m-Xylene(mX), n-Hexane(Hx)과 n-Octane(Ot)을 용매로 사용하여 추출상-용매간의 분배평형을 측정한 결과, 추출상중의 방향족의 회수면에서 Hx이 가장 적절한 용매이었다. 또, Hx을 용매로 사용하여 평형 역추출을 행해 방향족의 회수에 대한 조작인자의 영향을 검토했다. 방향족에 대한 분배계수는 용매/원료(추출상) 질량비(S/F)(S/F를 변화시켜 얻어진 추잔상 혹은 추출상중의 질량분율)에 관계없이 일정했으나 수율은 S/F가 증가함에 따라 증가했다. 조작온도는 방향족의 분배계수와 수율에 영향을 미치지 못했다. 나프탈렌류 성분(탄소수:10~12)간에는 탄소수가 많을수록 분배계수 및 수율이 컸다. 또한, 회분 교반조를 사용하여 역추출을 행해 방향족 성분의 물질이동 속도를 측정했다.

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