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수두생바이러스백신 국가표준품 (2차) 제조 및 확립에 관한 연구
김연희(Yeon Hee Kim),김도근(Dokeun Kim),손여원(Yeo Won Sohn),한의리(Euiri Han),김석환(Seok Hwan Kim),임종미(Jong-Mi Lim),원윤정(Yun Jung Won),윤희성(Heui Seong Yoon),조문희(Moon Hee Jo),김관수(Kwan Soo Kim),김재욱(Jaeok Kim) 한국생물공학회 2010 KSBB Journal Vol.25 No.6
수두 생바이러스 백신과 같은 생물의약품은 다양한 물질이 복합적으로 구성되어 있어 단순한 물리·화학적 분석방법만으로는 그 특성을 규명할 수 없다. 따라서 이러한 생물의약품의 품질을 평가하기 위해서는 표준품이 필수적이다. 2002년과 2003년에 제조 및 확립한 1차 국가표준품의 재고량 소진 및 역가 감소에 따라 식품의약품안전평가원에서는 수두 생바이러스 백신의 2차 국가표준품을 확립하기 위하여 2008년 용역연구사업을 통해 국내의 수두 생바이러스 백신 제조회사에서 표준품 후보물질을 제조하였으며, 국가표준품후보물질의 역가산정을 위하여 국내 제조사 및 식품의약품안전평가원에서 공동연구를 수행하였다. 국내제조사를 포함한 3개의 공동연구 시험소에서 7회 이상의 반복시험을 수행하여 얻은 공동연구 결과를 통계학적으로 분석한 결과 3곳의 공동연구 시험소의 통합역가에 대한 변이계수 (coefficient variation, CV)는 1.24%로 각 시험소간의 기하평균 (GMT) 변동 수준이 매우 낮음을 확인할 수 있었다. 또한, 수두 생바이러스 백신의 2차 국가표준품의 표시역가는 4.26 log10 PFU/0.5 mL로 산정하였다. Biological products, such as live varicella vaccine, are composed of biological substances derived from biological organisms. It is very difficult to identify these biologics’ characteristics by analysis of simple physical and chemical methods alone. So the reference material is essential in order to evaluate the quality of bilogics. The 1’st national standard for varicella live vaccine was manufactured, established in 2002 and 2003, and have been used for the manufacturer’s quality control and national lot release since then. As the lack of its availability and the decrease of its stability, this study was initiated by National Institute of Food and Drug Safety Evaluation (NiFDS) in 2008 to manufacture and establish the 2nd national standard for varicella live vaccine. The candidate material was manufactured from one of domestic manufacterers and the joint research of the NiFDS and manufacturers of varicella live vaccine was conducted to estimate of the reliable virus content. In the collaborative study, 3 laboratories including NiFDS performed the virus content test more than 7 times and all assay results were statistically analyzed. The mean coefficient of variation (CV) was 1.24%, and the geometric mean titre (GMT) variation range of each laboratory was low. On the basis of the results of this study, the candidate material of 2nd national standard for varicella live vaccine was assigned a potency of 4.26 log10 pfu/0.5 mL, when reconstituted in 0.7 mL.
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양파 껍질 추출물을 함유한 안면 마스크 팩의 주름 개선 효과
전수민(Soo-Min Jeon),최문희(Moon-Hee Choi),이용조(Yong-Jo Lee),신현재(Hyun Jae Shin) 한국생물공학회 2013 KSBB Journal Vol.28 No.6
In this study, the domestic onion skin has been used to investigate the anti-wrinkle effect of the ethanolic extract. The onion skin has been known to contain a large amount of antioxidant including quercetin. Solvent extraction by 80% ethanol was carried out of the onion skin. The high amount of quercetin have been identified using HPLC as a bioactive compound. The extraction yield of the quercetin increased according to temperature up to 80℃. Two different antioxidant assays (DPPH and ABTS) were performed to determine the free-radical scavenging activity of onion skin extracts. The antioxidant activities (EC50 of DPPH) of the vitamin C and the onion extracts were 2.2 and 5.09 μg/mL, respectively. The results of ABTS tests were 2.33 (of vitamin C) and 2.40 μg/mL (of the onion extracts), respectively. In a clinical study, a panel of 10 female volunteers between the ages of 30 and 40 (mean age: 42 years) was given a mask pack containing 1% of this extracts for 4 weeks. It was shown that a highly significant reduction in the deep and moderate wrinkled was obtained with those treated with this onion extracts as compared to the control group. The reduction in deep wrinkles increased with time. Eye wrinkle were reduced statistically significant (p<0.05). The application of the proper topical cream and mask pack containing onion skin extracts has therefore shown to be effective enhancing anti-wrinkle activities.
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조영례,조문희,김일선 대한마취과학회 1981 Korean Journal of Anesthesiology Vol.14 No.4
The most interesting change in anesthetic technic for pain relief during labor and delivery has been the sidespread acceptance of continuous lumbar epidural analgesia. Primary effect of epidural analgesia is to relieve pain and thereby to preserve the morale and to prevent exhaustion of the mother. For the past year in our hospital, continuous lumbar epidural analgesia was attempted on 38 pregnant women and its effect was assessed. In established labor, epidural analgesia was started for pain relief and was maintained with intermittent injections until delivery; in 45% the duration exceeded six hours. Labor was slightly retarded, probably due to inadvertent selection of patients with slow and painful progress. Vacuum extraction was used in 52.6%. Fetal condition was excellent(Apgar score of 7 or greater in 97.4%) Continuous epidural analgesia gives superior relief of pain but calls for experienced management and nursing care.
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소아환자 전투약제로서 Ketamine Hydrochloride 의 효과
조영례,정병연,조문희 대한마취과학회 1979 Korean Journal of Anesthesiology Vol.12 No.3
Preoyerative sedation of children is a difficult problem of great importance, for the psychic trauma comsequent to anticipation of surgery may be as great a hazard to the patient as his original diseaae. Until now, a number of sedatives have been used eommonly for adequate sedation of pediatric patients, but, no method has been universally accepted. At our hospital fifty pediatric patients receiving general anesthesia for minor elective surgery were studied to evaluate the effect of ketamine hydrochloride as a preanesthetic agent. The results were as follows: 1) The onset of drag action was about, about 5min. 2) The induction of anesthesia and maintenanee of operation was smooth, because a sedative effect was obtained without cardiovascular and respiratory depresaion. 3) With a small dosage of ketamine(2mg/kg), patients were free from apprehension. So, perioperative psychic trauma was preventible. 4) The two excitable patients were anesthetized by intravenous anesthetics with ease. 5) Mild cornplications, accured but they were not significant.
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