• Title/Summary/Keyword: 생물제제

Search Result 244, Processing Time 0.028 seconds

Development of a rapid HPLC method for the determination of penciclovir in human plasma using a monolithic column and its application to a bioequivalence study (모노리틱 칼럼을 이용한 혈장 중 펜시를로버의 HPLC 신속분석법 개발 및 이를 이용한 생물학적동등성시험)

  • Kim, Jin Hee;Park, Ah Yeon;Jung, Eun Ha;Lee, Cheol Woo;Lee, Tae Ho;Youm, Jeong-Rok
    • Analytical Science and Technology
    • /
    • v.20 no.4
    • /
    • pp.323-330
    • /
    • 2007
  • A simple and rapid HPLC method with fluorescence detection(FLD) for quantitation of penciclovir in human plasma using a monolithic column was developed and validated. Penciclovir and ganciclovir(internal standard, I.S.) were separated on a Chromolith column RP-18e ($4.6{\times}100mm$) with a mobile phase consisting of a mixture of (A) methanol/50 mM sodium phosphate buffer containing 200 mg/L sodium dodecyl sulfate (3/97, pH 2.5) and (B) methanol/50 mM sodium phosphate buffer containing 200 mg/L sodium dodecyl sulfate (50/50, pH 2.5) at a flow gradient of $1.6{\sim}4.0mL/min$. The retention times of penciclovir and internal standard were less than 4.0 min. Calibration curve was linear ($R^2=0.9994$) over a concentration range of $0.1{\sim}5{\mu}g/mL$. Intra-day precision, accuracy and inter-day precision were 1.36~8.55 %, 92.8~100.0 % and 0.93~5.62 %, respectively with a limit of quantitation at $0.1{\mu}g/mL$. The present HPLC-FLD method is sensitive, precise and accurate. The method described herein has been successfully used for the bioequivalence study of a famciclovir formulation product after oral administration to healthy Korean volunteers.

The Effects of Negative- and Positive- Charged Surfactants on In vitro DM Digestibility and the Growth of Ruminal Mixed Microorganisms (양(+) 이온성 및 음(-) 이온성 계면활성제 첨가가 반추위 혼합 미생물에 의한 In vitro 건물소화율 및 미생물 성장에 미치는 영향)

  • Lee, S.J.;Shin, N.H.;Kim, W.Y.;Moon, Y.H.;Kim, H.S.;Ha, J.K.;Lee, S.S.
    • Journal of Animal Science and Technology
    • /
    • v.49 no.5
    • /
    • pp.647-656
    • /
    • 2007
  • In order to investigate the effects of supplemental ionic surfactants in in vitro ruminal fermentation, N-Lauroylsarcosine sodium salt(N-LSS) and sodium dodecyl sulfate(SDS) for negative(-) ionic surfactant, and hexadecylpyridinium chloride monohydrate(HPCM) and hexadecyltrimethyl ammonium bromide(HTAB) for positive (+) ionic surfactant were supplemented by 0.05% and 0.1% into the Dehority’s artificial medium containing rice straw(1mm) as a substrate. In vitro DM digestibility, the growth of rumen mixed microbes, pH, cumulative gas production and SEM(Scanning Electron Microscopy) observation of microbial attachment on rice straw particle were investigated through the experiment composing 9 treatments (two supplemental levels of two positive ionic(+) surfactant, two supplemental levels of two negative(-) ionic surfactant) including the control. The sample collection was at 6, 12, 24, 48 and 72 h post fermentation with 3 replications per treatments. DM digestibility in treatments supplemented (+) or (-) surfactants almost stopped afterward 12 h fermentation, in vitro DM digestibility at 72 h post fermentation in the ionic surfactants was at half level of that of the control(P<0.05). Accumulative gas production in in vitro was less(P<0.05) with addition of ionic surfactants compared to the control. The amount of rumen mixed microbes recovered from in vitro incubation fluid pleateaued at 12 h post fermentation for the positive (+) ionic surfactants, but steadily increased as fermentation time elapsed for the control. Rumen microbial growth rate was significantly(P<0.05) low in the negative(-) ionic surfactant compared to the control. pH of the incubation fluid was ranged from 6.02 to 7.20, and was the highest in the negative(-) ionic surfactants, and was the lowest in the control(P<0.05). In SEM observation, rumen microbial population attached on rice straw particle was less with addition of ionic surfactants than the control. In conclusion we could not found any positive effects of negative- and positive- charged surfactants on rumunal fermentation characteristics and rumen microbial growth rates.

Effect of Phosphorous Acid on Control of Phytophthora Blight of Red Pepper (고추 역병에 대한 아인산 (phosphorous acid)의 방제 효과)

  • Lee, Yong-Se;Ryu, Yeon-Ju;Cho, Jeong-Sang;Lim, Tae-Heon;Chang, Tae-Hyun
    • Korean Journal of Environmental Agriculture
    • /
    • v.20 no.3
    • /
    • pp.180-185
    • /
    • 2001
  • Control effects of phosphorous acid were investigated on Phytophthora blight of red pepper plants in greenhouse and field. In vitro test, the mycelial growth of Phytophthora capsici was inhibited by the phosphorous acid more than 97% at 1,000 ${\mu}g$ and 10,000 ${\mu}g$ a.i./mL in the liquid and solid culture, respectively. At concentration of 10 ${\mu}g$ a.i./mL of phosphorous acid, in the liquid culture the mycelial growth of P. capsici was inhibited 46.2%, however inhibited only 4.9% on the soild culture. Zoosporangial formation was also inhibited 89.1% by phosphorous acid at 100 ${\mu}g$ a.i./mL. Phosphorous acid affected more zoosporangial formation of P. capsici than its mycelial growth. At the concentrations of 10,000, 1,000 and 100 ${\mu}g$ a.i./mL of phosphorous acid, germination of zoosporangia was inhibited 100, 84.3 and 44.2%, respectively. Mycelial growth and zoosporangial formation of P. capsici were little affected at the concentration of 10 ${\mu}g$ a.i./mL of phosphorous acid. Cermination of zoosporangia was also little affected at this concentration, however growth of the germ tubes was inhibited and the abnormal mycelial growth was observed. Phosphorous acid suppressed the incidence of Phytophthora blight of red pepper plants up to $77.0{\sim}62.0%$, in greenhouse. Phosphorous acid suppressed the incidence of Phytophthora blight of red pepper plants up to 54.0% at the conventional culture in field. Treatments of phosphorous acid increased up to 113% in height, 135% in number of fruit, and 129% in weight of fruit.

  • PDF

Shipboard sewage treatment by Sequence Batch Reactor utilizing Beneficial Microorganisms (유용미생물을 적용한 선박오수용 SBR공정에 관한 연구)

  • Kim, In-Soo;Lee, Eon-Sung;Ha, Shin-Young;Oh, Yeom-Jae;Ekpeghere, Kelvin I.;Koh, Sung-Cheol
    • Proceedings of the Korean Institute of Navigation and Port Research Conference
    • /
    • 2010.10a
    • /
    • pp.36-37
    • /
    • 2010
  • Lab scale experiment was carried out to study applicability of BM (Beneficial Microorganisms) to the conventional SBR system for the shipboard sewage treatment. BM has been successfully applied to the wastewater treatment by the SBR process and hence this system maintained a stable effluent quality together with an increased treatment efficiency, meeting the requirements of IMO regulations. The SBR system facilitated by BM would be a suitable process for cruise ships in terms of the malodor control, treatment efficiency and operation conveniences.

  • PDF

Status and Prospect of Natural Products Industry Infra in Jecheon, Chungbuk (충북 제천의 천연물산업 기반구축 현황과 전망)

  • Yoon, Seung-Won
    • Proceedings of the Plant Resources Society of Korea Conference
    • /
    • 2018.10a
    • /
    • pp.34-34
    • /
    • 2018
  • 천연물 산업은 과학적 기술력이 요구되는 고부가가치 산업으로 건강기능식품 등의 원료 산업으로 각광받고 있다. 최근 친환경, 지속가능성에 대한 관심 증가로 천연물 제품에 대한 수요가 증가되고 있으며 고령화 사회 진입과 건강에 대한 의식 수준 상승으로 전세계 건강기능 식품 시장 확대 추세에 있다. 생물자원의 70%이상을 수입에 의존하고 있는 우리나라는 천연물 산업의 경쟁력 확보와 고부가가치화 실현을 위해 천연물 산업 육성 촉진이 필요하다. 또한 지역 균형발전 측면에서 신성장동력 마련 및 국가 차원의 형평성을 고려한 전략적 투자가 필요한 시점에서 천연물 관련 산업의 신성장동력화를 통해 지역의 한계점 등을 개선하고, 새로운 먹거리 발굴과 함께 지역 전략산업으로 육성이 필요하다. 제천의 특화산업업인 한방천연물산업의 고도화와 활성화를 위해 영세한 스타트업 및 중소기업의 연구 및 제품개발을 지원하기 위한 인프라와 산업 클러스터 조성이 요구되고 있다. 제천은 풍부한 한약재 생산지를 보유하고 있어 전체 면적의 50% 이상이 석회암 지대로 알칼리성 토양이 넓게 분포되어 있고, 토양의 양분이 풍부하며 해발고도 250m 이상의 준산간 지역에서 주로 재배가 이루어지고 있어, 배수가 양호하고 병충해가 적어 한약재의 친환경 재배 및 다년생 한약재 재배가 가능한 지역이다. 이러한 천연물 산업을 육성하기 위하여 산업통상자원부, 충청북도, 제천시, (재)충북테크노파크는 180억원의 사업비로 '글로벌 천연물 원료제조거점시설'을 구축하여 규격화된 천연물 원료공급 시스템을 갖추었으며 150억원을 투자하여 '천연물 조직배양 상용화 시설'을 건립 중에 있다. 또한 향후에는 천연물 클러스터 가치 사슬의 완성형으로 160억 상당의 '천연물 제제개발 생산시설' 사업을 기획하고 있어 장차 대한민국의 천연물 산업을 앞장서 견인할 것으로 예상 된다.

  • PDF

Stability Improvement of Esomeprazole Magnesium Dihydrate Enteric-Coated Tablet by Adding Alkalizing Agents (에스오메프라졸 마그네슘 이수화물을 함유하는 장용성 제제의 안정성 개선)

  • Cho, Young Ho;Jeon, Hyo Bin;Lee, Jong-Hwa;Lee, Gye Won
    • KSBB Journal
    • /
    • v.32 no.2
    • /
    • pp.108-116
    • /
    • 2017
  • Omeprazole, a benzimidazole derivative, suppresses gastric acid secretion by inhibiting $H^+/K^+$ ATPase in gastric parietals cells, and by reducing $H^+$ concentration. To improve stability of esomeprazole magnesium dihydrate (ESMD), enteric-coated preperation was composed of core tablet, subcoating and enteric coating layer. We were evaluated in vitro dissolution characteristics between test and reference ESMD preparation and stability. We could prepare enteric-coated formulation of ESMD by controlling disintegrating agent and coating ratio which could rapidly dissolved in neutral or alkali medium. The formulation D5 with crospovidone of 1.25% and coating ratio of 16.25% had a similar dissolution behavior compare to reference preparation. Difference factor ($f_1$) and similarity factor ($f_2$) were 0~15 and 50~100 and there was no significant difference in bioequivalence between formulations. The content and dissolution rate of formulation D5 were $96.54{\pm}0.21$ and $78.56{\pm}0.87%$ without change of color in accelerated condition ($40^{\circ}C$, RH 75%, high density polyethylene (HDPE) container) for 6 months. This study concluded that our enteric coated preparation of ESMD could be an useful method to improve stability of unstable drug without direct contact with coating material.

Bioequivalence Evaluation of Senafen Tablet and Airtal Tablet Containing Aceclofenac 100 mg (아세클로페낙(100mg) 제제인 세나펜 정과 에어할 정의 생물학적동등성 평가)

  • 박은우;송우헌;차영주;최영욱
    • Biomolecules & Therapeutics
    • /
    • v.6 no.4
    • /
    • pp.423-428
    • /
    • 1998
  • Aceclofenac is an orally effective non-steroidal anti-inflammatory agent of the phenylacetic acid derivative. Bioequivalence study of two aceclofenac preparations, the test drug (Senafe $n_{R}$: Daewon Phar-maceutical Company) and the reference drug (Airta $l_{R}$: Daewoong Pharmaceutical Company), was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Sixteen healthy male volunteers, 24$\pm$4 years old and 63.9$\pm$6.9 kg of body weight in average, were divided randomly into two groups and administered the drug orally at the dose of 100 mg as aceclofenac in a 2$\times$2 crossover study. Plasma concentrations of aceclofenac were monitored by HPLC method for 12 hr after administration. AU $Co_{-12h}$ (area under the plasma concentration-time curve from initial to 12 hr) was calculated by the linear trapezoidal method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{msx}$) were compiled directly from the plasma drug concentration-time data. Student's t-test indicated no significant differences between the formulations in these parameters. Analysis of variance (ANOVA) revealed that there are no differences in AU $Co_{12h}$, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations were far less than 20% (e.g., 0.25, 0.01 and 7.32 for AU $Co_{-12h}$, $C_{max}$. and $T_{max}$, respectively). Minimum detectable differences (%) between the formulations at $\alpha$=0.05 and 1-$\beta$=0.8 were less than 20% (e.g., 14.65, 12.47 and 15.46 for AU $Co_{-l2h}$, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within $\pm$ 20% (e.g.,-10.19~10.68, -8.87~8.89 and -3.69~ 18.33 for AU $Co_{-12h}$, $C_{msx}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of KFDA guidelines, indicating that two formulations of aceclofenac are bioequivalent.quivalent.ivalent.ent.t.ent.

  • PDF

Cost-Minimization Analysis of Biologic Disease-Modifying Antirheumatic Drugs Administered by Subcutaneous Injections in Patients with Rheumatoid Arthritis (피하주사로 투여하는 생물학적 항류마티스 제제의 비용 최소화 연구)

  • Park, Seung-Hoo;Lee, Min-Young;Lee, Eui-Kyung
    • Korean Journal of Clinical Pharmacy
    • /
    • v.26 no.1
    • /
    • pp.59-69
    • /
    • 2016
  • Background: The subcutaneous formulation of biologic disease-modifying antirheumatic drugs (DMARDs) was preferred due to favored self-administration and would be an economical treatment option for patients with rheumatoid arthritis. This study was to compare the economic impact of biologic DMARDs administered by subcutaneous injection in patients with rheumatoid arthritis who had inadequate response to conventional DMARDs. Methods: The cost-minimization analysis was conducted to estimate the lifetime health care costs of treatment sequences with subcutaneous biologic DMARDs as first-line therapy from a health care system perspective. The Markov model was developed to represent the transitions through treatment sequences based on American College of Rheumatology response rate and discontinuation rate. The health care costs comprised the cost of medications, administration, dispensing, outpatient visits, test/diagnostic examination, palliative therapy and treatment of serious infection. All costs were expressed in 2016 Korean Won (KRW) and discounted at 5%. Results: The mean lifetime health care cost per patient was lowest in the etanercept sequence, which was estimated at KRW 63,441,679. The incremental costs of the treatment sequence started with adalimumab, golimumab, abatacept, and tocilizumab were KRW 7,985,730, KRW 4,064,669, KRW 2,869,947, and KRW 4,282,833, respectively, relative to etanercept sequence. These differences in costs mainly were attributable to medication costs. One-way and probabilistic sensitivity analyses confirmed that etanercept represented the option with the lowest cost compared with comparators. Conclusion: This study found that etanercept is likely a cost-saving treatment option among subcutaneous biologic DMARDs in patients with rheumatoid arthritis.

Concentration of Heavy Metals in Granule, Globular and Liquid types of Herbal Medicines (과립제와 환제 및 현탁액으로 만들어진 생약제제의 중금속 농도)

  • Bae, Jong-Sup;Park, Jong-Pil;Kim, Yong-Ung;Park, Moon-Ki
    • KSBB Journal
    • /
    • v.25 no.1
    • /
    • pp.91-96
    • /
    • 2010
  • This study is an endeavor to evaluate the safety of medicines from heavy metals, prescribed on the basis of herbal medicinal system and oriental medical prescription which are circulated much recently. For that, six globular types, six granular types and seven liquid types of herbal medicines were bought to compare and analyze the content of heavy metals, such as As, Pb, Cd and Hg, which are harmful to human body. The concentration of As was 0.219 mg/kg to 1.243 mg/kg, Cd was 0.0282 mg/kg to 0.8481 mg/kg, Pb was 0.9582 mg/kg to 5.233 mg/kg and Hg was 0.001 mg/kg to 0.01 mg/kg in globular and granular types. Otherwise, in the liquid types, As was 0.0123 mg/kg to 0.5024 mg/kg, Cd was 0.0128 mg/kg to 0.0568 mg/kg, Pb was 0.1755 mg/kg to 0.712 mg/kg, and Hg was 0.001 mg/kg to 0.002 mg/kg. It was found that the concentration of heavy metals in liquid types herbal medicines was relatively lower than globular and granular types. It is required to treat, manufacture and manage herbal medicines for safety.

Enhanced Insecticidal Activity of Bacillus thuringiensis against the Diamondback Moth, Plutella xylostella, Using an Immunosuppressive Effect of Juvenile Hormone Analogue, Pyriproxyfen, Formulation (유약호르몬 유사체인 피리프록시펜 제제의 배추좀나방(Plutella xylostella) 면역 억제 효과와 이를 이용한 Bacillus thuringiensis 살충력 제고 기술)

  • Kim, Geun-Seob;Kim, Yong-Gyun
    • The Korean Journal of Pesticide Science
    • /
    • v.13 no.2
    • /
    • pp.111-116
    • /
    • 2009
  • Juvenile hormone (JH) is an insect hormone mediating immature metamorphosis and adult reproduction. It also mediates immune responses to suppress hemocyte behavior, which is, however, activated by ecdysteroid. This study investigated an effect of a commercial pyriproxyfen (a JH agonist) formulation on a cellular immune response of the diamondback moth, Plutella xylostella, and analysed its mixture with Bacillus thuringiensis (Bt) in insecticidal potency. The commercial pyriproxyfen formulation significantly suppressed hemocyte-spreading behavior at low doses as did in pyriproxyfen technical grade. When the commercial pyriproxyfen formulation was mixed with Bt, Bt toxicity was significantly increased against P. xylostella larvae in laboratory. The mixture effect was then confirmed in field cultivating cabbage infested with P. xylostella larvae. The mixture showed a significantly enhanced mortality and reduced effective lethal time, compared to only Bt treatment.