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신민교,김석근,이상건,강영성,김성수,양은영,이현옥,백승화,Shin, Min-Kyo,Kim, Seok-Keun,Lee, Sang-kon,Gang, Yeong-Seong,Kim, Seong-Su,Yang, Eun-Yeong,Lee, Hyun-Ok,Baek, Seung-Hwa 한국생약학회 2001 생약학회지 Vol.32 No.1
The comparison of $IC_{50}$ values of Salvia plebeia R. Br. extracts on L1210, $P388D_1$ cancer and Vero normal cell lines showed that the n-hexane soluble extract of S. plebeia R. Br. retains the most growth-inhibitory activity against tumor cell lines. The minimum inhibitory concentration (MIC) of the extract against microorganisms were also examined. Antimicrobial activity of amocla and ketoconazole as references was compared to those of other solvent extracts such as $H_2O$, n-hexane, chloroform, ethyl acetate and methanol. The antimicrobial activity of extract had growth inhibition activity against gramnegative bacteria, gram-positive bacteria and fungi $(MIC\;>\;200\;{\mu}g/ml)$ except for n-hexane extract. Seven bacterial strains were tested for in vitro susceptibility to the extract of S. plebeia R. Br. However the n-hexane extract of S. plebeia R. Br. inhibited the growth of several bacterial strains (MIC values between 100 and $200\;{\mu}g/ml$ for gram positive bacteria, $25\;{\mu}g/ml$ for P. putida).
중등도 이상의 위험 수술을 받은 환자에서 수술 전후 항혈전제 약물 사용 평가
이현아,조윤희,조윤숙,한현주,이주연,정근화,이상건,Lee, Hyeon-Ah,Jo, Yun Hee,Cho, Yoonsook,Hahn, Hyeon Joo,Lee, Ju-Yeun,Jung, Keun-Hwa,Lee, Sang Kun 한국임상약학회 2017 한국임상약학회지 Vol.27 No.1
Objective: The perioperative management of antithrombotic therapy is often challenging and it requires a fine balance between the risk of hemorrhage and thrombosis. We aimed to evaluate the antithrombotic management for moderate to high risk patients in real world setting. Methods: Among the patients who were consulted to the neurologist for the evaluation of perioperative risk from 2010 to 2012, patients undergoing moderate to high risk surgery and taking antithrombotics within 30 days were identified. We analyzed the timing of discontinuation and reinitiation of antithrombotic drugs before or after surgery as well as the status of bridging therapy. In addition, the conformity with the guideline suggested by American College of Chest Physicians was assessed. The rate of thromboembolic event and major hemorrhage were also investigated. Results: A total of 329 patients were included. The concordance rate of warfarin stop and restart time with guideline was 23.4% and 10.3%, respectively. Continuing aspirin in patients undergoing coronary artery bypass surgery or non-cardiac surgery in patients with high risk for cardiovascular events were 59.2% and 2.6%, respectively. Bridging therapy was adopted in 92.9% and 81.2% in patients who had received anticoagulant before surgery and who were at high and low risk thromboembolism, respectively. In entire cohorts, 30-day incidence of major bleeding and thromboembolic event were 31.9% and 3.0%. Co-morbid renal disease were shown as independent predictor for major bleeding (adjusted OR 2.65. 95% CI 1.33-5.28). Conclusion: The concordance rate with guideline regarding perioperative antithrombotic use was low and bridging therapy was prevalent in patients undergoing moderate to high risk surgery.
백신위해성평가사업(Ⅱ) : 생물의약품의 안전성 평가를 위한 A형 간염 바이러스(HAV)의 오염지표 수립에 관한 연구
김병국,백선영,신진호,김재옥,민경일,류승렬,민복순,김도근,박미경,안미진,이상건,이석호,박순희 식품의약품안전청 2001 식품의약품안전청 연보 Vol.5 No.-
생물의약품의 안전성을 확보하기 위하여 제조공정 증 바이러스 등의 위해 물질 제거 및 불활즉 공정과정의 확립이 필수적이며 이에 대한 평가를 위하여 감도와 특이도가 높은 오염물질의 검출 방법 확립이 매우 중요하다. 본 연구에서는 모델 바이러스로 A형간염바이러스fhepautis A virus :HAV)를 대상으로 real-tile PCR을 이용하여 실시간으로 정확하고 민감하게 바이러스를 검색하고 정량할 수 있는 시험법을 개발하였고 이로부터 바이러스의 오염지표를 수릴할 수 있는 기반을 마련하였다. 먼저 LightC?cBerT.4i(Roche)를 이용하여 바이러스를 검색하기 위한 real-time PCR의 최적 조건을 확림하였다. HAV의 겅색과 정량을 위한 표준 RNA는 flasmid PHAV/7으로부터 in uitro transcription을 수행하여 만들었다. 정제된 RNA를 Ix10'copies/#』부터 Ix10"copies/낄까지 계단 희석하여 표준바이러스로 사용하였다. Real-time PCR로 표즌 RNA의 유효성과 재현성을 검사한 결과 각 희석 단계 모두 표준편차가 0.3을 넘지 않았고 변이계수는 0.02를 넘지 않아 표준 RNA는 우수한 유효성과 재현성을 보여 주었다. 세포배양으로부터 녈리한 HAV를 표준 RNA를 이용하여 정량하고 혈액제제에 spiking실험을 수행하였다. 이 패 제젠로 인한 PCR반응의 간섭이 나타났으며 이것은 표준 aHA를 오염되지 않은 같은 제제로_희석하여 끊색과 정량에 사용함으로서 오차를 줄일 수 있었다. 이 실험에서 개발된 Lightcycler를 이용한 real-time PCR법에 의해 HAV는 Ix102 copies/re이하까지 검색이 가능하였다. 또한 제제에 바이러스를 spiking 한 경우에도 같은 민감도를 보였다. Real-time 정량 PCR방법은 표준 RNA를 이용하여 생물학적제제에서 바이러스의 검색과 정량에 매우 유용하게 이응할 수 있다. The establishment of the highly specific and sensitive detection and clearance method of contaminants such as virus in the manufacturing process is essential and important for the safety of biological products. In this study, the sensitive real-time detection and quantification method of Hepatitis A virus as a model virus using LightCycerTM(Roche, Germany) was established for the viral clearance validation and contamination index. First, the optimization of real-time PCR condition such as annealing temperature and magnesium ion concentration was performed. The standard RNA(sRNA) used as quantification standard was prepared from plasmid pHAV/7 by in vitro transcription and was serially 10-fold diluted from 1×107 to 1×102copies/㎕. The standard deviation and coefficient variation of sRNA was not more than 0.3 and 0.02 respectively. It showed pretty good efficacy and reproducibility. The purified RNA from cell culture was quantified using sRNA and spiked into blood products. To reduce the interference of product itself in PCR reaction, sRNA was diluted with uncontaminated product. The sensitivity of the assay was 1×102 copies and the similar results was obtained in spiked blood products. From the study, real-time quantitative PCR method can be used to detect and quantify viral contaminants with a standard RNA in biological products.