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백정희(Joung Hee Baek),유지혜(Ji hye Yoo),홍영기(Young Ki Hong),박태환(Tae Hwan Park),강소영(So yeong Kang),김민정(Min Jung Kim),김 호(Ho Kim),우정남(Jeong nam Woo),허지연(Ji yeon Heo),박기대(Ki Dae Park),엄준호(Joon Ho Eom),서수경(Soo 대한약학회 2018 약학회지 Vol.62 No.5
We have established a new National Reference Standard(NRS) of filgrastim to be used for the quality management of domestic genetic recombinant drugs. Filgrastim is a recombinant human granulocyte colony stimulating factor( G-CSF) and one of the first-generation biosimilars used as the hematopoietic agent. At first, the candidate substance for the NRS was manufactured on consignment in accordance with the manufacturing process of filgrastim. The identity, purity, potency and protein contents of the candidate substance were assessed using electrophoresis, HPLC systems and a biological assay, which showed it was comparable to filgrastim in quality. In addition the stability test showed it was stable for 12 months. We performed a collaborative study with other institutes to endow it with the labelled protein content and potency values. From the data, it has been assigned with the protein content of 0.240 mg/mL(95% confidence intervals: 0.238~0.242 mg/mL) and the potency value of 2.94 × 107 IU per vial. We had finally enrolled it as the first Korean NRS of filgrastim as approved by Working Committee on Development of Testing and Inspection in Korea Ministry of Food and Drug Safety.
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국내 허가된 유전자재조합의약품 품질시험에 사용되는 전하변이체 분석법 조사연구
엄준호(Joon Ho Eom),백정희(Jounghee Baek),홍영기(Young Ki Hong),손애라(Aera Son),강소영(Soyeong Kang),오호경(Hokyung Oh),김민정(Min-Jung Kim),우정남(Jeong-Nam Woo),안치영(Chiyoung Ahn) 대한약학회 2020 약학회지 Vol.64 No.1
Analysis on approval documents of recombinant DNA-derived biopharmaceuticals (172 items) marketed in Korea showed as followed. First of all, antibody drugs are about 37% among the biopharmaceuticals and most of antibodies as a major ingredient (about 92%) are humanized or human type. Second, charge variant assays using in quality (purity) test are distinctly different between antibody drugs and non-antibody drugs. The former prefer CEX and cIEF, the latter IEF and CZE. The preference difference may be related to size and complexity of target molecules. Third, the result of analysis on usage of 4 assays (CEX, CZE, IEF, and cIEF) in accordance with approval period indicated that cIEF usage got increased since 2010 and was about 50% after 2015. And finally, acceptance criteria of charge variant assays showed a few distinguished patterns independent of drug products. In the light of these facts, whether or not to establish a charge variant method and acceptance criteria as a quality test, and which method to use may depend on the characteristics of the product and analysis conditions of other manufacturers. In particular, in biopharmaceuticals that contain polymer proteins as the main component, such as antibodies, charge variant analysis is important, and the use of modern analytical methods such as the icIEF method is expected to increase.
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급성 하벽 심근경색증의 임상양상을 보인 복부 대동맥류 파열 1예
이준엽,남지형,김승민,김준섭,김강,성낙일,박정배,천우정,배준호,나득영 동국대학교 의학연구소 2006 東國醫學 Vol.13 No.2
대부분의 복부 대동맥류 파열은 저혈압, 복통을 동반하거나, 복부의 박동성 종괴가 촉지된다. 하지만 급성 심근경색의 임상양상을 나타낸 증례는 세계적으로 1예만이 보고되어 드문 것으로 알려져 있다. 그러나 수술적 치료가 요구되는 복부 대동맥류 파열과 혈전 용해제, 관상동맥성형술 등의 내과적 치료가 우선시 되는 급성 심근경색은 질환의 특성상 증상발현과 동시에 치명적인 결과를 초래할 수 있어, 신속하고 정확한 진단과 동시에 적절한 치료가 요구된다. 특히 복부 대동맥류를 가진 환자 중 22%에서 심혈관질환을 동반한 경우가 있고, 복부 대동맥류 파열로 인한 저혈압은 관상동맥의 혈류량을 감소시켜 급성 심근경색의 임상양상을 나타낼 수 있다. 따라서 급성 심근경색의 전형적인 흉통을 호소하는 환자도 이전의 병력이 없더라도 급성 대동맥 증후군의 위험인자를 가지고 있을 경우 급성 대동맥 증후군을 염두에 두어, 좀 더 세심한 이학적 검사, 전산화단층촬영 등의 대동맥에 대한 검사를 고려 해야 한다. 이에 저자들은 전형적인 급성 하벽 경색의 증상과 심전도 소견을 나타내었으나, 대동맥 조영술과 복부전산화단층촬영을 통해 복부 대동맥류 파열을 진단하였던 예를 문헌고찰과 함께 보고하는 바이다. The majority of acute aortic aneurysmal rupture presents the symptoms of hypotension, abdominal pain, and/or palpable pulsating abdominal mass. Acute aortic aneurysmal rupture with symptoms of acute myocardial infarction was rarely reported. The treatment of ruptured abdominal aortic aneurysm needs surgery, but acute myocardial infarction needs thrombolytc agents and/or coronary interventions. Hence these diseases need prompt and accurate differential diagnosis. Especially, the 22% of patients with aortic aneurysm have coronary heart disease, and the hypotension due to aortic aneurysmal rupture decreases the flow of coronary artery and causes mimic symptoms of acute myocardial infarction. Therefore, the patients with typical symptoms of acute myocardial infarction without pervious history of aortic aneurysm need more careful examination such as chest/abdominal CT for differential diagnosis of aortic aneurysmal rupture. We reported a 74-year-old female developed typical symptoms of acute myocardial infarction, but was diagnosed as ruptured abdominal aortic aneurysm by aortogram and computed tomography.
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혈역학적 불안정성을 보인 골반골절 손상환자의 급성기 치료
김대성,강성준,김익용,남우정 대한외상학회 1998 大韓外傷學會誌 Vol.11 No.2
The management of hemodynamically unstable patients with pelvic bone fractures and associated abdominal,thoracic,or head injuries is controversial. We studied 307 consecutive injury patients with pelvic fractures admited from Januaryl, 1992 through December 31,l996; seventy of these patients were in shock(SBP $lt;_ 90mmHg) and were treated by a protocol i.ncluding resuscitation, and treatment of the associated injuries. Evaluation of the pelvic fractures revealed 45.79b to be APC(Anterior-posterior compression), 22.9% were LC(Lateral compression) and 25.7% were VS(Vertical shearing) in Young's classification. The mean Injury Severity Score was 29. Twenty one patients(30%) required tho- racotamy, laparotomy, or both. The mean of total blood requirement in the initial 72 hours posttrauma was about 4964mI. Death of eleven patients(15.7%) were a function of associated injuries and comorbid factors. The data suggest that aggressive resuscitation of these patients and treatment of extrapelvic injuries in conjuction. The mean ISS and initial hemodynamic instablity were significantly greater in nonsurvivors. Only a small percentage of patients with pelvic fracture reqiure embolization but when it is used, embolization can be successful for all patients.
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