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안서연,이근우,권태근,김동연,An, Seoyeon,Lee, Keunwoo,Kwon, Taekeun,Kim, Dongyeon 한국군사과학기술학회 2017 한국군사과학기술학회지 Vol.20 No.2
An autoinjector allows a single use medical device serving for automatic intramuscular injection to deliver a dose of a particular emergency drug through an intuitive activation mechanism. By design and structure, autoinjectors are easy to use and are intended for self-administration by patients or untrained personnel. Depending on the number of drugs filled in the cartridge, autoinjectors are divided by one-chamber type and multi-chamber type. Most autoinjectors may have a special structure including spring-loading syringes and needle which is specially designed to ensure strength due to the necessity of penetration through layers of clothing. The purpose of this study was to introduce the design technology of autoinjector of multi-chamber type that could be released into the two drugs sequentially. Additionally, we verified performance of the prototype developed by applying the design.
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아트로핀 및 팜 함유 다중챔버 단일주사기 및 KMARK-1: 비글개를 이용한 단회 근육투여 비교 생체이용률 연구
이근우,안서연,권태근,정인홍,김동연,Lee, Keunwoo,An, Seoyeon,Kwon, Taekeun,Jung, Inhong,Kim, Dongyeon 한국군사과학기술학회 2017 한국군사과학기술학회지 Vol.20 No.4
In this study, multi-chambered single autoinjector(2in1) and KMARK-1 containing atropine and 2-PAM(pyridine-2-aldoxime methylchloride) were administered to the beagle's muscle, and blood samples were taken for a certain period of time to compare and evaluate the pharmacokinetic profiles of the two drugs. Male beagles were used and classified into two test groups(G1, G2), and crossover pharmacokinetic studies were performed in two test groups. Blood samples were collected from the jugular vein for analysis after administration. The 90 % confidence interval(CI) for log transformed data indicated that the Cmax for both atropine(log 0.9683 ~ log 1.113) and 2-PAM(log 0.9453 ~ log 1.214) was within the limits of bioequivalence criteria, but the AUC for atropine(log 1.1786 ~ log 1.3238) failed to meet this criteria. This is expected as the amount of atropine dose is 25 % higher for the test as compared to the reference formulation. In summary, in view of the ATNAA(antidote for nerve agent of US) authorization, the Cmax equivalence was more important than AUC equivalence, so in this study, we also focused on verifying the equality of Cmax between the two autoinjectors.
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이근우,안서연,허병일,Lee, Keunwoo,An, Seoyeon,Hur, Byungil 한국군사과학기술학회 2016 한국군사과학기술학회지 Vol.19 No.1
The US Army used MARK-1 composed of atropine autoinjector and 2-PAM autoinjector as a medical countermeasure against nerve agent poisoning. Recently, it has been being replaced by the ATNAA(Antidote Treatment Nerve Agent AutoInjector) for improvement the convenience in use and rapid detoxification effect. ATNAA(FDA approval, NDA 21-175, 2002. 1. 17) is a multi-chambered autoinjector that sequentially delivers atropine and 2-PAM through a single needle to allow Warfighters to survive against lethal exposure to nerve agents. In this paper, our group investigated the case of FDA approval of ATNAA in a point of the various data required by FDA guideline, thereby making it easy to meet the KFDA guideline for the approval of the prototype our group has been developed. The purpose of this study is to provide a reference for efficient research activities to minimize time and cost. Additionally, the purpose of this study is to provide a reference for the planning for the development of similar drug.
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정승은 대한의사협회 2020 대한의사협회지 Vol.63 No.3
Until now, automatic contrast agent injector syringes licensed for consecutive one-time use have been employed with a number of patients. In 2016, regulation of automatic injector syringes ensured their single use, and reuse was strictly limited by law. However, this regulation creates the social problems of rising medical costs and resource waste. Many doctors are not significantly concerned about infection from contrast agent injection because the needle and connection lines on the patient side are set up for single use, the connections between syringes and contrast agents are reusable, and there are no reports of excessive infection. However, infection can nevertheless occur with injection of contrast agents. We should therefore implement the correct and safe use of contrast agents and take precautions against infection. To prevent infection due to contrast agents, syringes and connection lines for injection of such agents should be used once per patient, or multi-use licensed products should be used. In the latter case, reverse flow prevention filters must be used on the patient’s side.
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