정상적인 한국인에서 아스트로마이신 1회 점적 주사후 약물동테학적 평가

복혜숙,최경업,김연화,백경란,송재훈 한국임상약학회 2003 한국임상약학회지 Vol.13 No.2

Astromicin is an aminoglycoside antibiotic that is structually different from conventional aminoglycosides. Astromicin has been shown to be active against aerobic Gram-negative bacilli. The pharmacokinetics of astromicin were determined in 12 healthy volunteers (65.5 ± 5.23 kg of body weight) following a 30-min continuous intravenous infusion at a dose of 200 mg. The plasma and urine samples were collected up to 24 h and drug concentrations were measured by a bioassay using Bacillus subtilis. Pharmacokinetic parameters were calculated by fitting individual concentration-time curve to a one-exponential decay model. The plasma levels were 16.9 ± 1.68 and 1.05 ± 0.346 g/ml at 0 h and 8 h after the infusion, respectively. The elimination half-life of astromicin was 1.86 ± 0.360 h. The volume of distribution was 0.182 ± 0.0164 L/kg, and the total body clearance was 5.25 ± 1.74 L/h. These pharmacokinetic parameters were similar to those of gentamicin, tobramycin, and amikacin. Therefore, it is recommended that therapeutic drug monitoring of astromicin could be conducted in a similar fashion as the other aminoglycosides.

로바스타틴 정제의 생물학적 동등성 평가

복혜숙,김명민,최경업 한국임상약학회 1998 한국임상약학회지 Vol.8 No.2

정상성인 한국인에서 아스트로마이신 1회 잠적 주사후 약물동태학적 평가

복혜숙,최경업,김연화,백경란,송재훈 한국임상약학회 2003 한국임상약학회지 Vol.13 No.2

Astromicin is an aminoglycoside antiviotic that is structually different from conventional aminoglycosides. Astromicin has been shown to be active against aerobic Gram-negative bacilli. The pharmacokinetics of astromicin were determined in 12 healthy volunteers ( of body weight) following a 30-min continuous intravenous infusion at a dose of 200 mg. The plasma and urine samples were collected up to 24 h and drug concentrations were measured by a bioassay using Bacillus subtilis. Pharmacokinetic parameters were calculated by fitting individual concentration-time curve to a one-exponential decay model. The plasma levels were at 0 h and 8 h after the infusion, respectively. The elimination half-life of astromicin was The volume of distribution was , and the total body clearance was . These pharmacokinetic parameters were similar to these of gentamicin, tobramycin, and amikacin. Therefore, it is recommended that therapeutic drug monitoring of astromicin could be conducted in a similar fashion as the other aminoglycosides.

세파클러 캅셀제에 대한 생물학적 동등성 평가

복혜숙,김명민,권이오,최경업 한국임상약학회 1997 한국임상약학회지 Vol.7 No.1

1세대 세파계 항생제인 Cefazedone의 MIC Test를 통한 비교 연구

복혜숙,김명민,최경업 한국임상약학회 1995 한국임상약학회지 Vol.5 No.2

제49차 추계학술대회 : 일반연제 ; 광생물학 : Candida Albicans를 이용한 Psoralen제제의 광독성 평가

김성환,여운철,복혜숙,김명민,이일수 대한피부과학회 1997 초록집 Vol.35 No.20

바이러스 감염세포계를 이용한 rHuIFN -aA의 항바이러스 효과

김현수,정재경,복혜숙,유관현,조남진 대한바이러스학회 1987 Journal of Bacteriology and Virology Vol.17 No.2

In vitro antiviral effects of human recombinant a-interferon(rHuIFN-aA) were compared with those of human leukocyte interferon (HuLeIFN-a ) using human and animal derived cell line infected with challenge viruses as a test system. rHuIFN-aA showed the highest antiviral effect on vesicular stomatitis virus, indiana strain. Also it gave high antiviral effects to herpes simplex virus type-1 (HSV-1), herpes simplex virus type-2 (HSV 2) and cytomegalo virus. However the interferon showed a lower effect on HSV-2 than HSV-1. There was no difference of antiviral effect between recombinant human a-interferon(rHu- IFN-aA)and human leukocyte interferon (HuLeIFN-a).

Astromicin sulfate의 약동학 및 안전성 평가

정숙인,김연숙,오원섭,복혜숙,김명민,최경업,김연화,김성민,백경란,송재훈 대한화학요법학회 2001 대한화학요법학회지 Vol.19 No.3

목적 : Astromicin은 aminoglycoside계 항생제와 유사한 화학구조와 특성을 지니고, 기존의 aminoglycoside와 유사하거나 향상된 임상효과 및 부작용을 지닌 것으로 알려져 있다. 저자들은 astromicin의 약동학적 특성을 분석하고, astromicin 투여 환자를 대상으로 한국인에서 그 임상적 및 세균학적 효과와 안전성을 평가하고자 하였다. 대상 및 방법 : 약동학적 지표는 정상성인 남자를 대상으로 astromicin 200㎎을 30분간 정주한 후 24시간까지 혈장 및 뇨 검체를 수집하여 one-compartment open model에 따라 분석하였다. 중증으 세균감염이 있는 18세 이상의 환자를 대상으로 병용 또는 단독 투여한 후 임상적 효과와 세균학적 효과를 판정하였고, 치료전과 후의 순음청력검사와 혈청 크레아티닌으로 이독성과 신독성을 평가하였다. 결과 : 정상 성인 남자 12명을 대상으로 약동학적 지표를 평가하였고, 최고혈장농도는 투여 종료시점(C_(0))에서 16.87±1.68㎍/mL였으며, 반감기는 1.86±0.43 시간 이었고, AUC_(0-12h)은 38.12±10.57㎍ㆍhr/mL, Vd는 0.18±0.02L/㎏, CL은 5.25±2.07L/hr였다. 이러한 약동학적 지표는 다른 aminoglycoside와 유사한 결과를 보였다. 59명의 환자를 대상으로 시행한 임상적 효과 분석에서는 단독요법을 시행한 50명 중 임상적 치유율 94%, 세균학적 치유율 100%를 보였고, 순음청력검사를 시행한 48례의 환자중 의미있는 청력감소 소견은 관찰되지 않았으며, 신독성 또한 전혀 나타나지 않았다. 결론 : Astromicin의 약동학적 지표는 다른 aminoglycoside의 약동학적 지표와 비슷한 양상을 보이므로 향후 astromicin의 약물농도 감시에 있어서 다른 aminoglycoside의 치료적 약물 농도 감시 방법과 유사한 방법을 적용할 수 있으리라 기대된다. 또한 임상적 치유율이 우수하면서 신독성이나 이독성이 적어 세균 감염 환자의 치료에 있어서 단독 또는 병합 요법으로 비교적 안전하게 사용할 수 있으리라 생각된다. Astromicin(Fortimicin®) has some characteristics in common with other aminioglycoside antibiotics, although it has a unique chemical structure, which is different from them. This study was performed to elucidate the pharmacokinetic (PK) parameters of astromicin following single-dose intravenous infusion of 200 mg and to evaluate clinical efficacy and safety of astromicin in Korean populations. PK parameters of astromicin were determined in 12 healthy volunteers (65.5±5.2㎏). The plasma and urine samples were collected up to 24hrs. PK variables were calculated by fitting individual concentration-time curves to a one-compartment open model. Plasma level at the end of infusion was 16.87?1.68 ㎍/mL and declined to 1.05±0.35 (㎍/mL 8hr later. The half-life was 1.86±0.43 hr. Apparent volume of distribution was 0.18±0.02 L/㎏g, and total body clearance was 5.25±2.07 L/hr. These values were similar to those of other aminioglycosides. Clinical efficacy and safety were eviuated in 59 patients with moderate to severe bacterial infections who needed parenteral antibiotics. Among 50 patients who recieved astromicin monotherapy, 49 (98%) had favorable clinical reponse and 28 (100%) had favorable bacteriological response. Serial audiograms revealed no change in all of 48 patients. No nephrotoxicity was observed in all patients. Conclusively, our data suggest that therapeutic drug monitoring of astromicin can be conducted in a similar fashion as other aminioglycosides and astromicin is a useful and safe antibiotic in the treatment of severe bacterial infections.

HPLC를 이용한 혈중 히드로클로로티아지드의 분석 및 이를 이용한 한국인 성인남성에 대한 생체이용률 평가

박아연,김진희,김성용,지상철,복혜숙,김호중,염정록,한상범,Park, Ah-Yeon,Kim, Jin-Hee,Kim, Sung-Yong,Chi, Sang-Cheol,Bok, Hae-Sook,Kim, Ho-Jung,Youm, Jeong-Rok,Han, Sang-Beom 대한약학회 2006 약학회지 Vol.50 No.5

A simple and sensitive high-performance liquid chromatographic method for quantitation of hydrochlorothiazide in human plasma was developed and bioavailability parameters of hydrochlorothiazide were assessed in Korean healthy male volunteers. Caffeine was used as an internal standard. Hydrochlorothiazide and internal standard in plasma sample were extracted using tert-butylmethylether (TBME). A centrifuged upper layer was then evaporated and reconstituted with mobile phase of acetonitrile-25 mM phosphate buffer (20/80, pH 2.5). The reconstituted samples were injected into a Luna C18 column $(250{\times}4.6\;mm,\;5{\mu}m)$ at a flow-rate of 1.0 ml/min. The wavelength was set at 230 nm and no endogenous substances were found to interfere, A linear relationship for hydrochlorothiazide was found in the range of $10{\sim}300\;ng/ml$. The lower limit of quantitation (LLOQ) was 10 ng/ml with acceptable precision and accuracy. Assayed in plasma, the intra- and inter-day validation for all coefficients of variation (R.S.D.%) were found less than 15%. Main pharmacokinetic parameters of 50mg of hydrochlorothiazide were revealed as follows: $AUC_t\;1761{\pm}509.0\;ng{\cdot} hr\;ml,\;C_{max}\;296.5{\pm}95.5\;ng/ml,\;T_{max}\;1.94{\pm}0.85hr,\;K_{el}\;0.12{\pm}0.04\;hr^{-1}\;and T_{12}\;6.81{\pm}2.92\;hr.\;C_{max}\;and\;T_{max}$ were in accordance with the values $(270{\sim}350\;ng/ml\;and\;1.9{\sim}2.7\;hr)$ of Caucasian.

Innovative Distribution Priorities for the Medical Devices Industry in the Fourth Industrial Revolution

이문재,윤엽,류규하,복혜숙,윤기찬,박세원,이규성 대한배뇨장애요실금학회 2018 International Neurourology Journal Vol.22 No.S2

Purpose: This study aimed to set priorities for improving the medical device distribution structure and to suggest an innovative improvement plan for the distribution structure using the analytic hierarchy process (AHP) method, focusing on stakeholders in the medical device industry. Methods: This study conducted a survey with 35 specialists using the AHP method, which is a multiple-criteria decisionmaking methodology, in order to set priorities for improvement plans to address the problems faced by the medical device distribution structure. Results: The AHP analysis showed that supply stability was the most important factor, followed by greater transparency, efficiency, smart supply, and cost reduction. Conclusions: It is necessary to establish a stable supply system and manage crises through supply stability, as well as to provide opportunities for fair trade through greater transparency. As steps towards those goals, we propose establishing a unique device identification system, an information disclosure system, online distribution, and a group purchasing organization system in Korea.