• Title/Summary/Keyword: 생물학적 제제

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Bioequivalence Evaluation of the Tiropramide hydrochloride (염산티로프라미드제제의 생물학적 동등성 평가)

  • 명승운;김동현;김명수;강태경;민혜기;장윤정;손동렬;홍영훈;신창식
    • Biomolecules & Therapeutics
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    • v.8 no.3
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    • pp.262-268
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    • 2000
  • The bioequivalence of two tiropramide products was evaluated in 18 health male volunteers following oral administration. Test product was Tira $m^{R}$ tablet (Shin Poong SP-102) (Shin Poong Pharm. Co., Ltd.) and reference product was Tirop $a^{R}$ tablet (Dae Woong Pharm. Co., Ltd.) One capsule of the test and reference product containing 100 mg of tropramide.hydrochloride was administered to the volunteers by randomized two period cross-over study (2 $\times$ 2 Latin square method). The drug concentration in plasma was determined by GC/MS for over a period of 12hours after administration. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 3.85, 1.47 and -3.6%, respectively. Minimum detectable differences (%) at $\alpha$=0.1 were all less than 20% given as a guideline (18.07, 17.00 and 20.69% for AUC, Cmax and Tmax, respectively). From these results, the two products are bioequivalent.ent.

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Shipboard sewage treatment by SBR process with BM (BM 미생물제제를 이용한 크루즈선 오·폐수 처리)

  • Lee, Eon-Sung;Kim, In-Soo
    • Journal of Navigation and Port Research
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    • v.35 no.10
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    • pp.817-822
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    • 2011
  • Lab scale experiment study was carried out for biological treatment process development in cruise. SBR(Sequence Batch Reactor) process with BM(Beneficial Microorganisms) was investigated for practical application on shipboard sewage treatment. From the results it was suggested that SBR process with BM might be a suitable process for cruise sewage treatment in terms of decrease in odorous compounds, maintenance of useful microorganisms and creating special environmental conditions. By adding BM to SBR system, odor unit of sulfur compounds was about 20 times reduced.

Physico-chemical properties and biological activity of controlled-release granular formulations for the herbicide dicamba (방출조절형 dicamba 입제의 물리화학성 및 생물효과)

  • Oh, Kyeong-Seok;Oh, Byung-Youl;Park, Seung-Soon;Lee, Jae-Koo
    • The Korean Journal of Pesticide Science
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    • v.3 no.1
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    • pp.37-45
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    • 1999
  • Dicamba (3,6-dichloro-o-anisic acid) granular formulations for controlled release (DGFCRs) were prepared with biodegradable polymers, corn starch and pregelatinized starch, to minimize harmful side effects, extend weed control performance, and control the releasing rate of the active ingredient. Physico-chemical properties and biological activity of DGFCRs were studied. Six different granules were formulated by applying two processes, granulation and extrusion. Formulation efficiencies of active ingredient (A.I.) in the granules prepared by granulating and extruding were $90.0{\sim}96.3%$. Incorporation ratios of A.I. in the granules prepared by granulating and extruding showed $89.5{\sim}94.5%$ and $46.7{\sim}82.0%$, respectively. The highest swellability was DG-2 formulation prepared with corn starch. Whereas, the lowest floatability in water was DG-2 formulation, while the highest one was DG-1 formulation prepared with pregelatinized starch, Miragel 463. The degradation rates of dicamba in the granules under the elevated temperature of $50^{\circ}C$ were less than 5% for DG-1 and DG-2 formulations even after 90 days, meanwhile, those of DE-1 formulations prepared with pregelatinized starch, Mirasperse, were more than 5%. The release rates of A.I. from the granules into water under a static condition were about 100% after 2 weeks. Weeding effects of the granules on broad leaf weeds tested in greenhouse were more than 90% after 30 days.

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Real-Time PCR for Quantitative Detection of Bovine Herpesvirus Type 1 (Bovine Herpesvirus Type 1 정량 검출을 위한 Real-Time PCR)

  • Lee, Dong-Hyuck;Jeong, Hyo-Sun;Lee, Jung-Hee;Kim, Tae-Eun;Lee, Jung-Suk;Kim, In-Seop
    • Korean Journal of Microbiology
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    • v.44 no.1
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    • pp.14-21
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    • 2008
  • Bovine blood, cell, tissue, and organ are used as raw materials for manufacturing biopharmaceuticals, tissue engineered products, and cell therapy. Manufacturing processes for the biologicals using bovine materials have the risk of viral contamination. Therefore viral validation is, essential in ensuring the safety of the products. Bovine herpesvirus type 1 (BHV-1) is the most common bovine pathogen found in bovine blood, cell, tissue, and organ. In order to establish the validation system for the BHV-1 safety of the products, a real-time PCR method was developed for quantitative detection of BHV-1 in raw materials, manufacturing processes, and final products as well as BHV-1 clearance validation. Specific primers for amplification of BHV-1 DNA was selected, and BHV-1 DNA was quantified by use of SYBR Green I. The sensitivity of the assay was calculated to be $2\;TCID_{50}/ml$. The real-time PCR method was validated to be reproducible and very specific to BHV-1. The established real-time PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BHV-1. BHV-1 DNA could be quantified in CHO cell as well as culture supernatant. Also the real-time PCR assay could detect $10\;TCID_{50}/ml$ of BHV-1 artificially contaminated in bovine collagen. The overall results indicated that this rapid, specific, sensitive, and robust assay can be reliably used for quantitative detection of BHV-1 contamination during the manufacture of biologics.

Identification of Effective Microorganisms Isolated from Fermented Stevia Extract and Their Antimicrobial Activity (스테비아 추출물 발효액에서 분리된 유효 미생물들의 동정 및 항미생물 활성)

  • Lee, Tae-Hyeong;Park, Su-Sang;Lee, Yong-Eok
    • Journal of Life Science
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    • v.16 no.6
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    • pp.994-1000
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    • 2006
  • Stevia rebaudiana Bertoni is a sweet herb of the Asteraceae family originally derived from South America. Twenty three bacterial strains and ten yeast strains were isolated from fermented Stevia extract and identified by general taxonomic methods and molecular genetic method. Isolated strains from fermented Stevia extract include ten species of bacteria which belong to five genus and one species of yeast. Based on 16S and 18S rDNA sequence analysis, phylogenetic trees were constructed. Antimicrobial activity of the isolated strains was examined against various bacteria and plant-pathogenic fungi. Among them, Lactobacillus paracasei SB13 showed strong antibacterial activity towards a wide range of bacteria. These results may be useful to develop environmentally friendly microbial agent for soil improvement.

Selection and Antagonistic Mechanism of Bacillus thuringiensis BK4 against Fusarium Wilt Disease of Tomato (토마토시들음병의 생물학적 방제를 위한 토착길항세균 Bacillus thuringiensis BK4의 선발과 길항기작)

  • Jung Hee-Kyoung;Kim Jin-Rack;Kim Bo-Kum;Yu Tae-Shik;Kim Sang-Dal
    • Microbiology and Biotechnology Letters
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    • v.33 no.3
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    • pp.194-199
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    • 2005
  • In oder to select an antifungal substance-producing antagonistic bacterium against Fusarium oxysporum casuing fusarium wilt on tomato, strain BK4 was isolated from local soil of Gyeoungbuk and was identified as Bacillus thuringiensis by 16s rDNA analysis, biochemical test, and Mcirolog TM 3.0 System. The antibiotic of B. thuringiensis BK 4 was highly produced at $30^{\circ}C$ in nutrient broth (pH 9.0). The crude antibiotic was even stable at $121^{\circ}C$ and more stable at slight alkalic condition than acid condition. It was also remained $50{\%}$ activity at pH 3.0. B. thuringiensis BK4 showed the inhibition of spore germination and the biocontrol ability against F. oxysporum causing fusarium wilt of tomato in vivo test. According to these results, B. thuringiensis BK4 was enough to use with a microbial agent for biocontrol against fusarium wilt.

Purification of Diphtheia Toxin and the Production of Detoxificated Toxoid Vaccine (디프테리아 toxin 정제와 무독화 toxoid 백신 생산)

  • Cho, Min;Ryu, Yeon-Woo
    • KSBB Journal
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    • v.14 no.2
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    • pp.248-254
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    • 1999
  • Adverse reactions after injection of diphtheria vaccine are induced by impurities present in crude toxoids that cannot be removed completely by purification of toxoids after formalization. To increase toxoid purity, toxin purification was tried before formalization. Crude toxin was purified with ultrafiltration and ion-exchange chromatography. Purified toxin purity was improved 2.9 times higher than crude toxin, and purity was 2,560 Lf/mg PN. Purified toxin was detoxified with formalin and lysine, and potency test were performed. Toxoid, prepared from toxin treated with formalin and lysine, did not show reversion to toxin and purity was higher than the toxoid purified after formalization. Therefore, we concluded that the use of toxoid vaccine prepared from toxin purified is a useful method of minimize adverse reaction after injection of diphtheria vaccine.

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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
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    • v.20 no.4
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    • pp.323-330
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    • 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.

PCR-DGGE Analysis of the Fungal Community of Red-pepper Fields Utilizing Eco-friendly Farming Methods (PCR-DGGE를 이용한 친환경 농법 적용 고추경작지 내 진균의 군집 다양성 분석)

  • Jung, Byung-Kwon;Kim, Gwang-Seop;Song, Jin-Ha;Kim, Sang-Dal
    • Microbiology and Biotechnology Letters
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    • v.41 no.3
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    • pp.292-299
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    • 2013
  • In this study, we analyzed the changes in fungal populations of red-pepper fields employing eco-friendly farming methods, such as microbial agents and crop rotation, by using polymerase chain reactions coupled with denaturing gradient gel electrophoresis (PCR-DGGE). Primer specific for fungi were used to determine the contribution of domains to the microbial community. Analysis of planted and non-planted soil samples applying PCR-DGGE technology offered evaluation of long-term patterns in fungal species richness. To evaluate the stability of DGGE patterns from different soils, comparison of planted and non-planted soil samples were compared using PCR-DGGE. The number of DNA fragments obtained from all planted soil samples by DGGE separation was far greater (14 to 15 bands) than that of the non-planted soil samples (3 to 4 bands). In addition, 14 bands were observed from crop continuation soil treated with agrochemicals and 18 bands from crop rotation soil treated with microbial agents. The PCR-DGGE analysis suggests that the use of crop rotation and microbial agents benefits the fungal community more than crop continuation using agrochemicals. These results indicate that crop rotation with microbial agents was better able to support beneficial organisms, enable more effective biological control and maintain a healthier balance of nutrients, organic matter and microorganisms.

Bioequivalence Evaluation of the Tiropramide Formulation by GC/MS (티로프라미드 주사제의 생물학적 동등성 평가를 위한 GC/MS 방법)

  • Myung, Seung-Woon;Kim, Myungsoo;Kim, Hye-Young;Kwak, Hyun-Tae;Min, Hye-Ki;Sohn, Dong-Ryul;Hong, Young-Hun
    • Analytical Science and Technology
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    • v.14 no.3
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    • pp.221-229
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    • 2001
  • The bioequivalence study of two tiropramide products was evaluated in 16 health male volunteers following intra-muscular injection. Test product was Tiram$^{(R)}$ injection (S Pharm. Co, Ltd.) and reference product was Tiropa$^{(R)}$ injection(D Pharm. Co., Ltd.). The drug concentration in plasma was determined by GC/MS for over a period of 8 hours after injection. Analysis of variance reveal that there are no differences in AUC (area under the plasma concentration-time curve from time zero to infinity), Cmax (maximum plasma concentration) and Tmax (time to reach Cmax). The differences of mean AUC, Cmax and Tmax between two products were 0.73, -1.385 and -12.994%, respectively. Minimum detectable differences (%) at ${\alpha}=0.05$ were all less than 20% given as a guideline (10.05, 17.90 and 19.01% for AUC, Cmax and Tmax, respectively). From these results, the two formulations of tiropramide are bioequivalent and thus, may be prescribed interchangeably.

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