• 한국생물공학회:학술대회논문집
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• 2002.04a
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• pp.369-370
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• 2002

A fungus. Penicillium sp. PS-113, with high phosphate-solubilizing activities was isolated from soil and formulated to powder type in order to manufacture it as a solid powder fertilizer. First of all, in this research, we are trying to establish an optimal condition for a drying process based on the drying time, temperature and humidity by testing its viability on potato dextrose agar(PDA) media after storing at $4^{\circ}C$. As a result the number of Penicillium sp. PS-1l3 conidia, which was dried at $80^{\circ}C$ and 15% humidity, and then stored at $4^{\circ}C$, was maximally increased to 60 times more than the control. But the viability of the conidia at $100^{\circ}C$ or over was decreased suddenly in spite of the period of storage.

• Proceedings of the Korean Society of Applied Pharmacology
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• 1993.04a
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• pp.102-102
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• 1993

제1차년도 연구에서 Goto등의 방법을 응용하여 생체에 대하여 안전하고 transit 양상에 대해 재현성이 확보되는 경구용 방출조절성 마이크로캅셀을 개발 하였다. 즉 methacrylate polymer(Eudragit RS, RL, E, S 및 L)의 특성을 이용하여 B-락탑계 항생물질(amoxicillin 및 cephaiexin)을 함유하는 마이크로캅셀을 제조하는 방법을 개발하였다. 본 연구에 있어서는 제1차년도에 in vitro 실험결과 유용한 서방성 제제로 판단되는 cephalexin 함유 Eudragit RS/RL, S/L 및 RS/PEG 마이크로캅셀을 제조하여 가토에 경구투여 후 생체이용률을 평가하였다. 또한 소화관에서 약물의 방출속도 및 흡수속도등을 고려한 모델을 구축하여 약물속도론적으로 해석함으로써 실제 임상에 적용할 수 있는 유용한 경구투여용 마이크로캅셀을 개발하고자 하였다. 1. in vitro 실험 입도분포, 함량시험, 용출시험 2. in vivo 실험 1) AUC에 의한 평가 2) Vallver 등의 방법에 의한 평가 3) 약물속도론적 방법에 의한 평가 결론: 1. Eudragit 의 특성을 이용하여 유중건조법으로 40％ cephalexin 함유 Eudragit RL/RS, S/L 및 RS/PEG 마이크로캅셀을 제조할 수 있었고 각 조성비를 변화시킴으로써 약물방출을 조절할 수 있었다. 2. 약물속도론적 해석결과 마이크로캅셀제제의 Ka는 변화하지않고 Kr이 감소되는 즉, 약물흡수의 율속단계가 방출단계임을 보여주었다. 3. Eudragit RL/RS 마이크로캅셀은 제어방출 효율 및 흡수속도 효율이 우수한 서방성 제형으로 평가되었다.

• Communications for Statistical Applications and Methods
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• v.19 no.1
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• pp.47-55
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• 2012

The newly revised bioequivalence guideline of Korea allows the add-on test since July 1, 2008 when the initial bioequivalence trial fails to show the equivalence of two drugs. The statistical model of the add-on test and its two stage testing procedures are discussed. Some statistical points of consistency test in the add-on test are considered and the issue on the sample size of add-on test is discussed. Some reasonable alternative like Japan's guideline for bioequivalence studies is recommended to secure the proper use of an add-on study through some simulation studies.

• KSBB Journal
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• v.22 no.5
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• pp.328-335
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• 2007

In this work ursolic acid (UA), a poorly water-soluble compound, was inclusion complexed with 2-hydroxypropyl-$\beta$-cyclodextrin (HP-$\beta$-CD) by various methods such as kneading, solvent evaporation and two types of supercritical fluid processes. The solubility and characteristics of these UA/HP-$\beta$-CD complexes were investigated by scanning electron microscopy, x-ray diffraction and HPLC. The water solubilities of the two complexes obtained from solvent evaporation and ASES processes were observed to increase up to 6$\sim$240 folds and 12$\sim$56 folds, respectively, compared with that of unprocessed UA. The stability of UA/HP-$\beta$-CD complex samples in cosmetic formulations was examined at various temperatures for one month. The UA/HP-$\beta$-CD complex prepared by solvent evaporation was found to be most stable among all the cosmetic formulations tested in our experiments.

• Journal of the korean veterinary medical association
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• v.38 no.4
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• pp.305-316
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• 2002

동물용의약품은 가축질병의 예방 및 치료의 목적으로 이용되어 그동안 우리나라 가축의 질병방제와 사료효율의 증진으로 양축농가의 소득증대와 아울러 축산이 대규모로 발전할 수 있게 하는데 기여한 바가 크다. 그러나 특히 항생제나 합성 항균제의 오남용에 따른 가축의 장내 세균과 병원성 세균의 항생항균제에 대한 내성획득으로 질병치료 효과의 저하, 축산식품을 통하여 이들 제제의 잔류물질이 인체내로 들어가 부작용을 일으키거나 세균의 내성인자가 사람 병원체에 전달되어 사람의 질병치료에 장애요인이 될 수 있는 문제점이 제기되고 있다. 그리고 공중위생전인 측면에서 항생항균제, 호르몬제, 생물학적제제(백신 등), 마취제, 마약류, 등의 요주의동물용의약품을 체계적으로 관리할 필요성이 제기되고 있다. 본 주제에서는 동물용의약품 중 현재 가장 많은 량이 이용되고 있는 항생제를 중심으로 사용실태와 오남용 사례를 살펴보고자 한다.

• 동물약계
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• no.28
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• pp.3-5
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• 1996

1. 동물용의약품 제조업 신규허가 2. 제조(수입)업체 대표자 변경 3. 가축질병 병성감정 실시기관 지정 4. 96년 유당 업체별배정 5. 유당 200mesh 오파 알선 6. 국가검정기준 추가안내 7. 생물학적제제 밀봉용 알루미늄 비표캡 변경 8. 국가검정 불합격품 폐기방법 변경 9. 가축질병 예찰 협의회 개최 10. `사료내 잔류농약 및 동물용의약품의 허용기준`에 대한 의견수렴 11. 배합사료 제조용 동물약품천가 사용기준 잠정 조치 12. 동물용의료용구 적정수입을 위한 협조요청 13. 96상반기 알찬거래선 14. 유방염연고제 색소첨가 15. 협회 임시이사회 개최 16. 조합총회 개최결과 안내 17. 국가검정 항생물질제제 유효기간 적용 18. 국가검정품중 산제 검정비 변경안내 19. 제 4 차 정기총회 개최 20. 대한수의사회 공로패 수상

• Microbiology and Biotechnology Letters
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• v.36 no.3
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• pp.173-181
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• 2008

Bovine blood, cell, tissue, and organ are used as raw materials for manufacturing biologics such as biopharmaceuticals, tissue-engineered products, and cell therapy. Manufacturing processes for the biologics have the risk of viral contamination. Therefore viral validation is essential in ensuring the safety of the products. Bovine parvovirus (BPV) is one of the common bovine pathogens and has widely been known as a possible contaminant of biologics. In order to establish the validation system for the BPV safety of biologics, a real-time PCR method was developed for quantitative detection of BPV contamination in raw materials, manufacturing processes, and final products. Specific primers for amplification of BPV DNA were selected, and BPV DNA was quantified by use of SYBR Green 1. The sensitivity of the assay was calculated to be $1.3{\times}10^{-1}\;TCID_{50}/mL$. The real-time PCR method was validated to be reproducible and very specific to BPV. The established real-time PCR assay was successfully applied to the validation of Chinese hamster ovary (CHO) cell artificially infected with BPV. BPV DNA could be quantified in CHO cell as well as culture supernatant. Also the real-time PCR assay could detect $1.3{\times}10^0\;TCID_{50}/mL$ of BPV 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 BPV contamination during manufacture of biologics.

• Journal of the Korean Data and Information Science Society
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• v.28 no.4
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• pp.743-754
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• 2017

Assessing bioequivalence between original drug and generic drug is traditionally based on $2{\times}2$ crossover design. As bioequivalence trials for highly variable drugs are getting popular, the required sample size based on $2{\times}2$ crossover design would be very large, which might cause the ethical concerns. Regulatory agencies like EMA and MFDS recommended higher order crossover designs such as $2{\times}4$, $4{\times}2$ and $4{\times}4$ crossover designs. Alternatively, a $2{\times}3$ dual design may be recommended in terms of economical and ethical points of view in comparison with the $2{\times}4$ crossover design for highly variable drug. In this study, we consider some statistical characteristics of $2{\times}3$ dual design and propose statistical procedures for calculating sample size and assessing bioequivalence based on $2{\times}3$ dual design. We also discuss the proposed procedures from the perspective of newly revised bioequivalence guidance issued by MFDS.

• KSBB Journal
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• v.22 no.4
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• pp.213-217
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• 2007

It has been reported that hydrophobic additives generally decrease the release rate of protein drugs from drug delivery systems (DDS) and hydrophilic additives increase the release rate. In many cases, however, the addition of hydrophilic molecule is necessary for improving the stability of protein drugs. In the present work, the effects of hydrophilic additives on the release profiles, and micelle formation of protein drug formulations were investigated to develop a novel method for protein drug delivery. For model protein drug, bovine serum albumin (BSA) was employed and several hydrophilic additives were used in the release experiments. Hydrophilic additive D-sorbitol showed the lower release rates of BSA than other hydrophobic additives due to the gel strengthening ability of the additive and the optimum concentration of D-sorbitol was 3 w/v % for the retarded release rate. In addition, it was found that the addition of D-sorbitol was very effective for obtaining homogeneous and stable DDS. The results were discussed in terms of the micelle formation and the micelle structure, i.e., the differences in gel structure and the distribution of drugs in micelles.

• Microbiology and Biotechnology Letters
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• v.32 no.2
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• pp.172-178
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• 2004

This research is performed for a biological control of Chinese cabbage clubroot, we isolated an antagonistic bacterium AC-3 against Plasmodiophora sp., causal pathogens of cabbage clubroot. The isolated strain was identified as Streptomyces sp. by culture morphology, biochemical reactions, and homology research based on l6S rDNA sequences. Streptomyces sp. AC-3 produced chitinase (9.3 units/$m\ell$) in culture broth. So Plasmodiophora sp. mycelia changed abnonnal swelling, curling and branching mycelia by Streptomyces sp. AC-3 culture. In a field infected by Plasmodiophora sp., the treatment of a organic fertilizer added 2% Streptomyces sp. AC-3 microbial inoculant, it resulted in about 50% reducing the severity of cabbage clubroot significantly on cabbage plants compared with treated organic fertilizer plants. Additional disease such as sclerotinia rot, fusarium wilt and pythium rot were also significantly reduced by the treatment of the organic fertilizer added Streptomyces sp. AC-3 microbial inoculant.