국내 시판 항생제의 허가 용량 및 용법의 적정성에 대한 고찰 : 국내 약제사용설명서(package insert)와 미국 Physicians' Desk Reference의 비교 Comparison of Domestic Package Inserts with Physicians' Desk Reference

이재갑,이연주,황병연,정혜원,정성주,김성범,정희진,김우주,김민자,박승철 대한감염학회 2003 감염과 화학요법 Vol.35 No.5

목적 : 국내 시판중인 항생제의 1일 투여량과 투여간격의 적정성을 확인하고 적응증 및 중증도에 따른 항생제 용량 제시 여부를 확인하기 위하여 항생제 시판시 KFDA의 허가사항을 담은 약제사용설명서을 미국 FDA 공인 약제에 대한 사용지침으로 쓰이고 있는 PDR(Physicians' Desk Peference)과 비교하였다. 방법 : PDR에 등재되어 있는 항생제 중에서 시럽 및 도포용 항생제를 제외한 총 61종에서, 국내에 시판되어 있는 51종 항생제의 약제사용설명서를 대상으로 1일 투여량, 투약횟수, 적응증 및 중증도에 따른 설명 정도를 비교하였다. 결과 : 1) 1일 투여량 비교 : 비교 가능한 전체 항생제에서, 약제사용설명서가 PDR보다 적은 용량을 제시한 경우는 경구용 8종, 주사용 11종으로 총 19종(37%)였으며, 많은 용량을 제시한 경우는 경구용만 2(4%)종이었고, 동일하거나 비슷한 용량을 제시한 경우는 경구용 15종, 주사용 15종으로 총 30(59%)종이었다. 약제사용설명서에서 적은 용량이 제시된 항생제 중 경구용인 cefdnir, cefixime, cefpodoxime, ofloxacin, levofloxacin, norfloxacin(6종), 주사용인 cefazolin, cefotetan, ceftizoxime, meropenem (4종) 등 반수이상의 약제가 일본제약회사로부터 국내에 수입된 약들이었으며 일본의 약제 사용설명서와 동일한 용량을 제시한 것을 알 수 있다. 2) 투여간격 비교 : 비교가능한 항생제 51종 중에서 국내약제사용설명서가 PDR과 동일한 투약횟수, 투여간격을 제시한 항생제는 30종(59%)이었다. 국내 약제사용설명서가 PDR보다 적은 투약횟수, 긴 투여간격을 제시한 항생제는 9종(17%)이었다. 오히려 많은 투약횟수, 짧은 투여간격을 제시한 항생제가 12종(24%)이나 되었다. 경구용만 비교하였을 경우 국내 약제사용설명서가 PDR보다 적은 투약횟수를 제시한 항생제는 없었으며, 동일하세 제시한 경우는 15종, 빈번한 투약횟수를 제시한 경우는 10종이었다. 주사용 항생제에서 국내 약제사용설명서가 PDR보다 긴 투여간격을 제시한 항생제는 9종, 동일한 경우는 15종, 짧은 투여간격을 제시한 경우는 2종이었다. 3) 적응증 및 중증도에 따른 비교 : 약제사용설명서에서 적응증 또는 중증도에 따른 용량에 대한 설명이 부족한 경우는 경구용 13종, 주사용 7종으로 총 20종(39%)이었으며, PDR에서는 경구용 1종, 주사용 2종으로 총 3종(6%)이었다. 결론 : 항생제에 첨부되는 약제사용설명서 및 약제사용설명서를 바탕으로 편집되는 의약품집이 항생제를 처방하는 의사들이 용법과 용량을 결정함에 있어 참고 역할을 하고 있으나, 국내의 시판 허가사항을 담은 약제사용설명서가 많은 수에서 적응증 또는 중증도에 따른 1일 투여량과 투여간격에 대한 정확한 정보를 제공하고 있지 못하고 있다. Background : The appropriate usage of antibiotics needs informations such as its effectiveness for a given infection, administration route, the amount of effective dose, and the dose intervals. In this study, in order to find any significant discrepancy regarding to the details of explanation of the necessary information for appropriate antibiotic usages, we compares informations about 51 antibiotics, one from package inserts in Korea and the other from physician's desk reference (PDR) certified by FDA in the United States of America. Materials and Methods : Package inserts about antibiotics, only oral or parenteral agent, wereperused to collect three categories of data: the recommended dosage, dose interval, and adjustment of dose to indications or the severity of infection. These data available in Korea were compared with 61 antibiotics (32 oral and 29 parenteral agents) cited in PDR. Results : Package inserts for 51 antibiotics were gathered, because the remaining 10 antibiotics in PDR are not domestically commercialized. Among data on antibiotics comparable with those in PDR, 59% (30 cases: 15 oral and 15 parenteral agents) suggested the dose similar to that of PDR, 37% (19 cases: 8 oral and 11 parenteral agents) recommend less dose, and 4% in only 2 oral agents showed more dose. About half of the drugs recommending lower dosage were imported from Japanese pharmaceutical company, and the recommended doses of these antimicrobial agents were similar to those in Japan. About 59% (30 cases: 15 oral and 15 parenteral agents) directed dose interval or duration similar to those of PDR and 17% (9 parenteral agents) suggested less administration or longer duration. Surprisingly, in contrast to only 6% (3 cases) of PDR, 24% (12 cases : 10 oral and 2 parenteral agents) recommended more administration or shorter duration. About 39% (24 cases: 13 oral and 7 parenteral agents) revealed no information for dose adjustment commons to indications or the severity of infection. Conclusion : This study revealed that many guidelines in Korea recommend lower doses and/or unreasonable dose intervals. In future studies, improved antibiotic usage guidelines should be established based on pharmacokinetic and pharmacodynamic researches, on the aspect of optimal dosage, dose interval, and dose adjustment commensurate to the indications and the severity of the infection.

서울의 Penicillinase Producing Neisseria gonorrhoeae 발생빈도(1998)

김재홍,김준호,반재용,이정우,황성주,정준규,정성태,강진문,조흔정,홍창의,정혜신,이한승,김이선,이봉길,이종호,선영우,한기덕,윤성필,이성훈,안종성,박석범,문승현,조항래,김형섭,류지호,황재영,박준홍,손상욱 한양대학교 의과대학 2001 한양의대 학술지 Vol.21 No.1

In recent years, gonorrhea has been pandemic and remains one of the most common STDs in the world, especially in developing countries. For the detection of a more effective therapeutic regimen and assessing the prevalence of Penicillinase Producing Neisseria gonorrhoeae(PPNG), we have been trying to study the patients who have visited the Venereal Disease Clinic of Choong-Ku Public Health Center in Seoul since 1980 by menas of the chromogenic cephalosporin method. In 1998, 93 strians of N. genorrhoeae were isolated, among which 60(64.5%) were PPNG. The prevalence of PPNG in Seoul, which had been decreased to 39% in 1996 after a peak of 74.3% in 1993, is increased to 64.5% in 1998.

다제내성 그람양성균에 대한 Linezolid(Zyvox^(�))의 시험관내 항균력 비교

박대원,정희진,엄중식,황병연,김성범,이재갑,이연주,정혜원,정성주,박재형,이진수,손장욱,김우주,김민자,박승철 대한감염학회 2003 감염과 화학요법 Vol.35 No.5

배경 : MRSA, VRE, VRSA같은 다제 내성 그람 양성균의 등장에 따라 glycopeptide를 대체할 새로운 항생제의 개발이 필요하게 되었고 결과적으로 새로운 항생제인 linezolid라는 항생제가 개발되었다. Linezolid는 이전의 항생제와는 다른 새로운 계열의 oxazolidinone으로 경구 이용률이 우수하다. 원내 및 원외감염의 중요한 원인균이 되고 있는 MRSA, VRE에 대한 적절한 경구용 항균제가 없는 국내에서 폐렴 및 피부 연조직 감염에서 경구용으로 사용해 볼 수 있는 약제이다. 본 연구에서는 고대 구로 병원에서 분리된 MRSA, VRE 등을 대상으로 다른 여러 항균제와 비교한 linezolid의 시험관내 항균력을 조사하고자 하였다. 재료 및 방법 : 연구대상은 1998년 1월부터 2000년 12월까지 본원에서 입원 및 외래를 통하여 피부 연조직 감염증 및 호흡기 감염증, 요로감염증으로 진단된 환자들의 가검물로부터 분리된 MRSA 60균주, VRE 43균주, PRSP 25균주를 액체배지 또는 한천배지 희석법을 통하여 linezolid 및 기타 항균제에 대한 최소발육억제농도를 구하였다. 결과 : 실험에 사용한 S. aureus는 모두 MRSA였고 이들은 linezolid에 대해 MIC_(90) 2㎍/㎖(MIC 범위 1-2㎍/㎖), Enterococcus spp는 모두 VRE로 linezolid의 MIC_(90)은 2㎍/㎖로 MIC 범위는 1-4㎍/㎖였다. 한 개의 균주에서 MIC 4㎍/㎖로 중등도 감수성을 보였으나 MIC breakpoint가 (8㎍/㎖인 내성균주는 없고 모두 감수성을 보였다. S. pneumoniae의 경우 penicillin 내성이었고, linezolid MIC_(90) 1㎍/㎖ (MIC 범위 0.5-1㎍/㎖)로 전부 감수성을 보였다. 결론 : Linezolid는 MRSA를 위시한 VRE, PRSP 등의 다제 내성 그람 양성균에 대하여 우수한 시험관내 항균력을 보임을 알 수 있었다. Background : The emergence of multi-drug resistant Gram-positive cocci, such as MRSA, VRE, and VRSA, necessitated to develop new antibiotics, which could replace the glycopeptide. As a result, a new antibiotics named linezolid was developed. Linezolid is different line of oxazolidinones with a good oral bioavailability, compared to other antibiotics. Since appropriate oral antibiotics are not presently available for MRSA, which is a major cause of nosocomial and community acquired infections, the introduction of linezolid will have favorable effect on treatment of infections such as pneumonia or skin infections. In this study, we investigated the antibiotic effect of linezolid on MRSA and VRE isolated from patients who were treated in Korea University Guro Hospital. Material and Methods : By using broth microdilution and agar dilution method we measured minimum inhibitory concentration (MIC) with sixty S. aureus, forty three Enterococcus spp., and twenty five S. pneumoniae isolates from patients who were diagnosed as skin, soft tissue, respiratory, and urinary infections in Korea University Guro Hospital from January, 1998 to December, 2002. Results : All of S. aureus used in this study were MRSA, and MIG_(90) of linezolid was below 2 ㎍/㎖ (MIC ranged between 1-2 ㎍/㎖). All of Enterococcus spp. were VRE, and had MIG_(90) of 2 ㎍/㎖ (MIC ranged between 1 to 4 ㎍/㎖). One of the VRE showed intermediate susceptibility with MIC of 4 ㎍/㎖. However, none was resistant with MIC breakpoint above 8 ㎍/㎖. All of S. pneumoniae were resistant to penicillin, but they were susceptible to linezolid with MICao of 1 ㎍/㎖(MIC range 0.5-1㎍/㎖). Conclusion : In conclusions, linezolid has an excellent in vitro antibiotic effect on multi-drug resistant Gram-positive cocci, such as MRSA, PRSP, and VRE.

Alginate Bead를 이용한 고분자 약물의 제어방출형 약물수송체

황성주,이계주,조항범,이기명,김종국 충남대학교 약학대학 의약품개발연구소 1993 藥學論文集 Vol.9 No.-

The purpose of this paper is to explore the possible applicability of alginate beads as an oral controlled release system of polymeric drugs. Cellulases was used as a model polymeric drug. The release of cellulase from alginate beads was moderately affected by the ratio of cellulase to sodium alginate and strongly affected by CaCl_2 concentration. However, the release was not particularly affected by the other factors such as sodium alginate concentration and curing time. The drug was not released from alginate beads at pH 1.2 but was released continuously up to 8 hr at pH 6.8. At pH 6.8, the beads were swollen highly up to 3 hr, thereafter, were eroded into the bulk solution up to 6 hr, completely. Drug release from the beads can be caused due to diffusion and erosion of the matrix. Activity of cellulase was reduced when alginate beads containing cellulase were stored in simulated gastric juice. Further investigation would be necessary to improve the acid resistance of beads. Since the release of cellulase as a model polymeric drug could be controlled by tthe regulation of the preparation conditions of alginate beads, the alginate beads may be used for a potential oral controlled release system of such polymeric drugs as polypeptide drugs.

菩提達摩 傳記에 對한 硏究

黃尙周 동국대학교 불교대학 1974 東國思想 Vol.7 No.-

優先順位를 附與한 ATM 멀티캐스트 스위치의 呼處理 構造에 關한 硏究

황성호,오주현,임해진 三陟大學校 1999 論文集 Vol.32 No.1

An ATM multicast switch which can effectively accommodate diverse classes of traffic, is the core component of broadband ISDN. In this paper, we proposed a new call scheduling algorithm assigning priority according to the quality of service under the diverse traffic environment in multicast switch. The algorithm presented in this paper is using unfairness of switch structure, and delay-sensitive traffic may be given the high priority such that it can be transmitted as soon as possible. Also, we proposed a new hardware structure for the algorithm which can be constructed with combinational logic gates and it is beneficial for high-speed operation and VLSI implementation. The results of simulation for performance evaluation show that mean waiting time of delay-sensitive call is considerably reduced.

Effect of Al and Mg Contents on Wettability and Reactivity of Molten Zn–Al–Mg Alloys on Steel Sheets Covered with MnO and SiO2 Layers

Joo‑Youl Huh,Min‑Je Hwang,Seung‑Woo Shim,Tae‑Chul Kim,Jong‑Sang Kim 대한금속·재료학회 2018 METALS AND MATERIALS International Vol.24 No.6

The reactive wetting behaviors of molten Zn–Al–Mg alloys on MnO- and amorphous (a-) SiO2-covered steel sheets wereinvestigated by the sessile drop method, as a function of the Al and Mg contents in the alloys. The sessile drop tests werecarried out at 460 °C and the variation in the contact angles (θc) of alloys containing 0.2–2.5 wt% Al and 0–3.0 wt% Mg wasmonitored for 20 s. For all the alloys, the MnO-covered steel substrate exhibited reactive wetting whereas the a-SiO2-coveredsteel exhibited nonreactive, nonwetting (θc > 90°) behavior. The MnO layer was rapidly removed by Al and Mg contained inthe alloys. The wetting of the MnO-covered steel sheet significantly improved upon increasing the Mg content but decreasedupon increasing the Al content, indicating that the surface tension of the alloy droplet is the main factor controlling its wettability. Although the reactions of Al and Mg in molten alloys with the a-SiO2 layer were found to be sluggish, the wettabilityof Zn–Al–Mg alloys on the a-SiO2 layer improved upon increasing the Al and Mg contents. These results suggest that thewetting of advanced high-strength steel sheets, the surface oxide layer of which consists of a mixture of MnO and SiO2,withZn–Al–Mg alloys could be most effectively improved by increasing the Mg content of the alloys.

老·莊의 道와 繪畵精神

黃尙周 동국대학교 경주대학 1996 東國論集 Vol.15 No.-

From ancient times up to the present time, all of Eastern people, including Koreans, tries to find out the fundamental characteristics of nature in the transmigration and change. They called the origion of continous order in such mutation To (the way of truth and justiceon the nature and human being: the principles of order.) This To the order of nature and the universe at the same time it was the order of morality. As the order of nature or morality is rulled by To, only those who fallowed Tao in completing themselves or any King who did so in managing a state, could really complete themselves and could really rule his state in peace. In an artist who is painting also, only who follow To can be respected as a great artist, as a completed artist. To is the basis of Lo_thought and JaM thinks To to be the most important beauty in the objective things. For a true artist (as in the case of other philosophers, painting work itself must be the very thing to cultivate To joining the universal order of To) he must live togther with To and express it as art. The effects of beauty in the Eastern Painting does not lie in a richness of flesh or something like a geometrical molding but beauty of nature and cleanliness. That is created by the dynamic rhythm and moving brush, the changing illution in many different kind made by the ink and colors. In a painting the relation to the object can be accomplished in a balanced harmonization of reality and emptiness. As a result, the world of painting is very close to the minds of human being and the Eastern aesthetics is based on the Eastern Philosophy. Therefore To becomes the basis and not only of the morals and ethics but also of eastern To aesthetics.

오메프라졸복합체 함유 직장좌제의 특성비교

황성주,박성배,이계주 충남대학교 약학대학 의약품개발연구소 1995 藥學論文集 Vol.11 No.-

Omeprazole(OMP) complexes such as inclusion complexes of OMP with hydroxypropyl-β-cyclodextrin(HPCD) and β-cyclodextrin(β-CD). OMP-cholestyramine(CHL) and OMP-ethylenediamine(OMP-ED) were prepared, respectively. The partition coefficients in Witepsol H-15/pH 7.4 phosphate buffer solution of OMP complexes(OMP-HPCD; 3.69±0.26, OMP-β-CD; 4.08±0.21, OMP-CHL; 4.36±0.25 and omeprazole sodium(OMP-Na); 3.64±0.37) were higher than that of OMP (2.66±0.47). OMP was not completely dissolved until even 3 hrs, but all the OMP complexes studied were released about 100% in 20 min. The rectal suppositories containing OMP or each above OMP complex were prepared using Witepsol H-15 base, and their dissolution and stability were examined, and pharmacokinetic study were investigated after their rectal administrations to the rabbits. While the suppository containing OMP was released only less than 60 in 150 min, OMP-β-CD, OMP-CHL, OMP-Na and OMP-ED suppositories were all released about 65% in 20 min. Especially, OMP-HPCD suppository released OMP about 70% in 10 min. All the additives such as sodium laurylsulfate, eglumine, arginine and PVP increased drug release from OMP-HPCD suppository to some extent. The decomposition rate constants of OMP in the suppositories were 9.117×10^-3 day^-1 for OMP suppository, 2.121×10^-2 for OMP-HPCD, 1.607×10^-2 for OMP-β-CD, 9.26×10^-3 for OMP-Na, 6.769×10^-3 for OMP-CHL and 5.58×10^-3 day^01 for OMP-ED suppository, respectively. Additives such as arginine, eglumine and ED had some stabilizing effect for OMP-HPCD, OMP-CHL and OMP-Na suppositories, respectively. Afrer 6 month-storage at 30℃, 75% RH, OMP-CHL suppository was most stable. The values of Tmax for OMP-HPCD and OMP-Na suppositories were 11.7±2.36 and 11.4±2.56 min, respectively. The values of Cmax for OMP-HPCD and OMP-CHL suppository were 2.31 ㎍/㎖ (p<0.01) and 1.89 ㎍/㎖ (p<0.01), respectively. The values of AUC for OMP and OMP-β-CD suppository were 61.9±25.79 and 68.6±29.48 ㎍ ·min/㎖, and the corresponding values for OMP-HPCD and OMP-CHL were 106.1±43.16 (p<0.05) and 127.3±42.52 ㎍ ·min/㎖(p<0.01), respectively. The above results indicate the OMP-HPCD and OMP-CHL suppositories have the excellent bioavailabilties in vivo study.

수종의 붕해제가 살리실아미드정제의 제제특성에 미치는 영향

황성주,이계주,지웅길,곽효성,김종국 충남대학교 약학대학 의약품개발연구소 1992 藥學論文集 Vol.8 No.-

Six common tablet disintegrants (corn starch, Avicel PH102, calcium carboxymethylcellulose, Primojel, Kollidon CL and Ac-Di-Sol) were used at the concentration of 0, 2, 4 and 6% (w/w) in salicylamide tablets made with wet granulation method. Certain physical parameters of the disintegrants (moisture sorption, hydration capacity and bulk density) were determined to evaluate their relative efficiency. The disintegration time and dissolution rate of the tablets were correlated well with the ranks of initial rate of moisture sorption for each disintegrant as follows; Ac-Di-Sol, Kollidon CL, primojel, calcium CMC, corn starch and Avicel PH102. The initial rate of moisture sorption was important for the disintegration capacity as well as hydration capacity. The effect of storage at different temperatures and relative humidity upon the tablets containing various disintegrants was evaluated in terms of tablet hardness and disintegration time. Storage at high temperature reduced the hardness substantially and retarded the disintegration of the all tablets studied. Especially, the hardness of tablets containing Kollidon CL was significantly reduced. Although the tablet hardness was decreased and the disintegration time was increased under a moderate humid condition, both of them were decreased under the severely high humid condition of 80 or 90% RH, which was due to the breakrupture of tablet matrix bonds by the excessive uptake of moisture. Therefore, the stability caused by moisture sorption should be considered, when disintegrants having high moisture sorption such as Kollidon CL, Ac-Di-Sol and Primojel were employed in the tablets containing water-labile or hygroscopic drugs.