• Journal of Pharmaceutical Investigation
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• 제32권3호
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• pp.215-221
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• 2002

Cephradine is a first generation cephalosporin and has broad spectrum antibacterial activity against gram-positive and gram-negative microorganisms, through inhibition of bacterial cell wall synthesis. Cephradine is useful for treatment of infections of the urinary and respiratory tract, skin and soft tissues. The purpose of the present study was to evaluate the bioequivalence of two cephradine capsules, Cefradine Yuhan (YuHan Corporation) and Broadcef (Ilsung Pharmaceuticals Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cephradine release from the two cephradine capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $23.10{\pm}2.90$ years in age and $67.69{\pm}8.04\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cephradine was orally administered, blood was taken at predetermined time intervals and the concentrations of cephradine in serum were determined using HPLC method with UV detector. The dissolution profiles of two cephradine capsules were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AVC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AVC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AVC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Cefradine Yuhan were -2.87%, -0.96% and -4.85%, respectively. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of 1og(0.8) to log(1.25) $(e.g.,\;log(0.93){\sim}log(1.02)\;and\;log(0.88){\sim}log(1.13)\;for \;AVC_t\;and\;C_{max},\;respectively)$. The 90% confidence interval using untransformed data was within ${\pm}20%$ $(e.g., \;-17.54{\sim}7.78\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Broadcef capsule is bioequivalent to Cefradine Yuhan capsule.

• Journal of Pharmaceutical Investigation
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• 제32권2호
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• pp.135-140
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• 2002

Cefadroxil is a semi-synthetic cephalosporin active against many Gram-positive and Gram-negative bacteria. The drug has been used for the treatment of the urinary and respiratory tract infections when caused by susceptible strains of the designated microorganism. The purpose of the present study was to evaluate the bioequivalence of two cefadroxil capsules, Duricef (Bo Ryung Pharmaceutical Co. Ltd.) and Hanacef (Korean Pharmaceutical Co. Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The cefadroxil release from the two cefadroxil capsules in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four normal male volunteers, $21.58{\pm}2.43$ years in age and $70.74{\pm}10.29$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one capsule containing 500 mg as cefadroxil was orally administered, blood was taken at predetermined time intervals and the concentrations of cefadroxil in serum were determined using HPLC with UV detector. The dissolution profiles of two cefadroxil capsules were very similar at all dissolution media. The pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t\;and\;C_{max}$ and untransformed $T_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two capsules based on the Duricef were 0.05%, -5.29% and 4.53%. There were no sequence effects between two capsules in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) $(e.g.,\;log(0.95){\sim}log(1.05)\;and\;log(0.87){\sim}log(1.02)$ for $AUC_t\;and\;C_{max}$, respectively). The 90% confidence interval using untransformed data was within ${pm}20%$ $(e.g.,\;-6.75{\sim}15.74\;for\;T_{max})$. All parameters met the criteria of KFDA guideline for bioequivalence, indicating that Hanacef capsule is bioequivalent to Duricef capsule.

• 한국임상약학회지
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• 제20권3호
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• pp.255-261
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• 2010

Cefprozil is a broad-spectrum oral beta-lactam cephalosporin consisting of cis- and trans-isomeric mixture whose ratio is approximately 90:10. Cefprozil is used to treat certain infections caused by bacteria such as bronchitis and ear, skin, and throat infections. The purpose of the present study was to evaluate the bioequivalence of two cefprozil tablets, $Cefzil^{(R)}$ tablet 250 mg (BMS Pharmaceutical Korea., Ltd.) and Procezil tablet 250 mg (Hanmi Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The in vitro release of cefprozil from the two cefprozil formulations were tested using KP VIII Apparatus I method with water dissolution media. Thirty five healthy male subjects, $24.00{\pm}1.53$ years in age and $69.77{\pm}9.99$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After four tablets containing 1000 mg as cefprozil were orally administered, blood samples were taken at predetermined time intervals and the concentrations of cefprozil in serum were determined using HPLC/UV detector. The dissolution profiles of two formulations were similar in water tested dissolution media. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ on the basis of total-cefprozil were calculated, and computer program (K-BE Test 2002) was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Cefzil^{(R)}$ tablets, were -0.81%, -3.00% and -6.83% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.9515~log 1.0454 and log 0.9613~log 1.0465 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Procezil tablet was bioequivalent to $Cefzil^{(R)}$ tablet.

• Childhood Kidney Diseases
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• 제21권2호
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• pp.128-135
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• 2017

Purpose: Extended-spectrum ${\beta}$-lactamase-producing bacteria-induced urinary tract infections are increasing and require more potent antibiotics such as carbapenems. We evaluated the clinical significance of extended-spectrum ${\beta}$-lactamase -urinary tract infection in children younger than 5 years to select proper antibiotics and determine prognostic factors. Differences were compared between age groups. Methods: We retrospectively studied 288 patients with their first febrile urinary tract infection when they were younger than 5 years. Patients were divided into extended-spectrum ${\beta}$-lactamase-positive and extended-spectrum ${\beta}$-lactamasenegative urinary tract infection groups. Clinical characteristics and outcomes were compared between the groups; an infant group was separately analyzed (onset age younger than 3 months). Results: Extended-spectrum ${\beta}$-lactamase urinary tract infection occurred in 11 % patients who had more frequent previous hospitalization (P=0.02) and higher recurrence rate (P=0.045). During the antimicrobial susceptibility test, the extended-spectrum ${\beta}$-lactamase-positive urinary tract infection group showed resistance to third-generation cephalosporins; however, 98% patients responded clinically. In the infant group, extended-spectrum ${\beta}$-lactamase-positive urinary tract infection occurred in 13% patients and was associated with a longer pre-onset hospitalization history (P=0.002), higher C-reactive protein level (P=0.04), and higher recurrence rate (P=0.02) than that in the older group. Conclusion: Extended-spectrum ${\beta}$-lactamase urinary tract infection requires more attention because of its higher recurrence rate. The antimicrobial susceptibility test demonstrated resistance to third-generation cephalosporins, but they can be used as first-line empirical antibiotics because of their high clinical response rate. Aminoglycosides can be second-line antibiotics before starting carbapenems when third-generation cephalosporins do not show bactericidal effects for extended-spectrum ${\beta}$-lactamase urinary tract infection.

• Journal of Microbiology and Biotechnology
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• 제20권6호
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• pp.1042-1052
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• 2010

Forty-seven Salmonella Typhimurium (33 zoonotic, 14 clinical) strains were tested for antimicrobial resistance using the standard disk diffusion method. The presence of relevant resistance genes and class 1 integrons were investigated by using PCR. Pulsed-field gel electrophoresis (PFGE) and plasmid profiling were carried out to determine the genomic diversity of Salmonella Typhimurium. Approximately 57.4% of the S. Typhimurium strains were multidrug resistant (MDR) and showed high resistance rates to tetracycline (70.2%), sulfonamides (57.4%), streptomycin (53.1%), ampicillin (29.7%), nalidixic acid (27.6%), kanamycin (23.4%), chloramphenicol (21.2%), and trimethoprim (19.1%). Resistance towards cephalosporins was noted for cephalothin (27.6%), cephradine (21.2%), amoxicillin clavulanic acid (17.0%), and cephalexin (17.0%). Resistance genes, $bla_{TEM}$, strA, aadA, sul1, sul2, tetA, tetB, and tetC, were detected among the drug-resistant strains. Thirtythree strains (70.2%) carried class 1 integrons, which were grouped in 9 different profiles. DNA sequencing identified sat, aadA, pse-1, and dfrA genes in variable regions on class 1 integrons. Thirty-five strains (74.4%) were subtyped to 22 different plasmid profiles, each with 1-6 plasmids (2.0 to 95 kb). PFGE subtyped the 47 strains into 39 profiles. In conclusion, high rates of multidrug resistance were found among the Malaysian Salmonella Typhimurium strains. The emergence of multidrug-resistant Salmonella Typhimurium to cephalosporin antibiotics was also observed. The strains were very diverse and no persistent clone was observed. The emergence of MDR Salmonella Typhimurium is a worldwide problem, and this report provides information for the better understanding of the prevalence and epidemiology of MDR S. Typhimurium in Malaysia.

• 대한기관식도과학회지
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• 제15권2호
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• pp.57-63
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• 2009

Background and Objectives : Peritonsillar abscess is one of the most common illnesses m the ENT field, though its prevalence has been drastically reduced with the development of antibiotics and appropriate early treatment. We analyzed recent clinical characteristics of peritonsillar abscess and compared them with ones of 7 and 14 years ago respectively. Materials and Methods : Sixty-six cases of peritonsillar abscess from 2006 through 2008 were investigated retrospectively and compared with results of 7 and 14 years ago on various clinical factors. Results : Peritonsillar abscess was prevalent in men in their 20s and 30s. Mean period from symptom onset to visit to hospital tended to decrease(5.2 days) but admission days has increased(7.4 days). Body temperature on admission was lower than that of previous studies($36.4^{\circ}C$). Bacteria were isolated in 26 cases(74.2%) out of 35 cases in which culture had been performed. The most common cultured organism was a-hemolytic streptococcus and $\beta$-hemolytic streptococcus that had been most frequently cultured 14 years ago wasn't detected in this study. Conclusion : We found some changes of clinical features in peritonsillar abscess when compared with previous researches. Although there were some differences in cultured organism, antibiotics used commonly-cephalosporin, aminoglycoside, quinolone - were still effective for their eradication.

• 대한미생물학회지
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• 제9권1호
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• pp.7-11
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• 1974

저자(著者)들은 1967년(年), 1971년(年길) 및 1972년(年)에 각기(各其) 41주(株), 45주(株) 및 88주(株)의 전형적(典型的)인 이질균주(痢疾菌株)를 동정시험(同定試驗)하고 그들의 미생물학적(微生物學的) 및 생화학적(生化學的) 성상(性狀)과 혈청형적(血淸型的) 분류결과(分類結果)를 보고(報告)한 바 있었다. 1973년(年)에 전국(全國) 11개시도(個市道) 위생시험소(衛生試驗所)와 각급(各級) 종합병원(綜合病院)에서 동정의뢰(同定依賴)된 1644건(件)의 균주중(菌株中) 58주(株)의 이질균(痢疾菌)이 최종적(最終的)으로 동정(同定)되었으므로 그들의 성상(性狀)과 시험결과(試驗結果)를 요약(要約)하여 이에 보고(報告)하는 바이다. 비록 검체(檢體)는 전국각지(全國各地)에서 수집(蒐集)되었으나 최종적(最終的)으로 이질균(痢疾菌)이 동정검출(同定檢出)된 지역(地域)은 서울지방(地方)과 전라북도(全羅北道), 강원도(江原道) 및 제주도(濟州道)이었으며 총균주(總菌株) 58주중(株中)에서 51주(株)가 S. flexneri이었고 나머지 7주(株)는 S. sunnei이었다. S. flexneri 51주중(株中) 26주(株)가 $B_{2a}$이었으며 서울지방(地方) 및 강원도(江原道)에서 분리(分離)되었다. $B_{3a}$가 25주(株) 있었던바 전라북도(全羅北道)와 강원도(江原道)에서 검출(檢出)되었다. 제주도(濟州道)에서는 전년(前年)에 $B_{3a}$ 1주(株)가 분리(分離)된데 이어 금번(今番)에는 S. sonnei 1주(株)가 검출(檢出)되어 과거(過去)에 장내(腸內) 병원성세균(病原性細菌)이 검출(檢出)되지 않던 내력(來歷)이 근년(近年)에 와서 달라졌다고 하겠다. 생화학적성상(生化學的性狀)에 있어서는 arginine decarboxylase양성균(陽性菌)이 S. flexneri $B_{2a}$에서 2주(株) 곤찰(觀察)된 것 외(外)에는 전년도(前年度)와 같이 전형적(典型的)인 양상(樣相)을 나타내었다. 한국(韓國)에서 상용(常用)되는 몇가지 항균제(抗菌劑)에 대(對)한 감수성검사(感受性檢査)를 Ericsson씨법(氏法)에 의(依)하여 실시(實施)한 결과(結果) ampiciltin, cephalosporin 및 nitrofurantoin에 대(對)하여서는 전균주(全菌株)가 감수성균(感受性菌)으로 나타난 반면(反面) neomycin, bacitracin 및 colistin에 대(對)하여서는 내성균(耐性菌)으로 나타났다. chloramphenicol에 대(對)하여서는 S. flexneri $B_{2a}$는 대부분(大部分) 내성균(耐性菌)이었으나 $B_{3a}$는 대부분(大部分) 감수성(感受性)이 있었으며 S. sonnei는 약(約) 반반(半半)이었다. gentamycin에 대(對)하여서도 비교적(比較的) 감수성(感受性)이 있었던 것으로 시험관내시험(試驗管內試驗)에서 관찰(觀察)되었다.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제5권2호
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• pp.150-157
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• 2002

목 적: 비장티푸스성 살모넬라균은 세균성 위장관염 및 장열 등을 일으키는 중요한 원인균으로 전 세계적으로 발생률이 증가할 뿐 아니라 항생제에 대한 다제내성률도 증가하는 추세이다. 그러나 이에 대한 소아에서의 연구 보고는 많지 않아 저자들은 비장티푸스성 살모넬라 위장관염의 임상양상과 항생제 내성률 등에 대하여 알아보고자 하였다. 방 법: 2000년 1월부터 2002년 6월까지 서울대학교 어린이병원에 내원하여 비장티푸스성 살모넬라 위장관염으로 진단받은 환아를 대상으로 임상양상, 항생제 내성률 및 변역 상태에 따른 내성률과 다제내성률 등을 조사하였다. 결 과: 대변 검사상 비장티푸스성 살모넬라균이 분리된 99례 중, 남아가 66례 여아가 33례였다. 2세 이상 3세 미만이 23례로 가장 많았으며 5세 미만에서 발생한 경우가 전체의 71%에 해당하였고 평균 연령은 4.0세였다. 25례는 항암 화학요법이나 스테로이드 및 면역 억제제 치료 등으로 면역 기능이 저하된 환자였다. 혈청군 중 D군이 65례로 가장 많았고 B군이 16례, C군과 E군이 각각 8례였다. 3례에서 균혈증이 동반되었다. 항생제에 대한 내성률을 보면 ampicillin에 31%, chloramphenicol에 12%, TMP-SMX에 20%, cefotaxime에 11%, cefixime에 8%의 내성률을 보였으며 ciprofloxacin은 모든균주에서 감수성을 보였다. Cefotaxime과 cefixime에 대한 내성률은 변역가능이 저하된 환아군에서 각각 24%, 14.3%로 정상군에서의 6.8%, 5.6%보다 유의하게 높았다 (p<0.05). 연령별(5세 미만 vs 5세 이상), 혈청군별(D군 vs 비D군) 내성률의 차이는 없었다. 한편 3가지 이상의 항생제에 내성을 보이는 다제내성균은 11례에서 동정되었고, 변역가능이 저하된 환아군에서의 동정률이 24%로 정상군에서의 동정률인 6.8%보다 유의하게 높았다(p<0.05). 결 론: 비장티푸스성 살모넬라 위장관염인 소아환자에서 항생제 치료를 해야 하는 경우에, 소아에서 안정성이 확립되지 않은 quinolone을 제외한다면 3세대 cephalosporin을 1차 선택제로 고려할 수 있다. 그러나 본 연구에서처럼 변역 가능이 저하된 환자에서는 cefotaxime과 cefixime에 대한 내성률과 다제내성률이 유의하게 높으므로 적절한 항생제 선택에 주의해야 할 것이며 향후 이에 대한 연구가 더 필요하리라 생각된다.

• Childhood Kidney Diseases
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• 제10권1호
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• pp.18-26
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• 2006

목적 : 요로감염은 조기 진단 및 치료를 적절히 하지 않으면 비가역적 신손상, 패혈증 등을 유발하므로 원인 균주를 알기 전에 경험적 항생제 요법을 시행하는 것이 중요하다. 따라서 경험적 항생제의 적절한 선택을 위하여 원인 균주의 분포와 임상특징을 알아보고, 원인 균주의 대부분을 차지하는 E. coli의 항생제 감수성 정도에 대해 알아보고자 하였다. 방법 : 2004년 2월부터 2005년 2월까지 발열을 주소로 분당차병원 응급실과 소아과 외래를 방문하여 요로감염으로 진단된 환아 103명을 대상으로 요 배양검사 결과, 성별, 연령, DMSA 신스캔상 결손 유무, 방광 요관 역류 유무, 6개월이내 재발 여부 등을 후향적으로 조사하고 원인 균주 중 가장 흔한 균인 E. coli에 대해 항생제 감수성 정도를 분석하였다. 결과 : 103명의 환아 중 92명(89.3%)이 E.coil에 의한 요로감염이었으며 ESBL 생성 E.coli는 3명(3.3%)에서 동정되었다. E. coli의 항생제 감수성 조사 결과 AMP, AMS, SXT는 각각 27.2%, 34.8%, 65.2%로 낮은 감수성을 보였으며 cephalosporin계 항생제는 1세대 cephalosporin인 cefazoline이 91.3%, 2세대인 cefoxitin이 100%, 3세대인 ceftriaxone 97.8%를 보여 대부분 매우 높은 감수성을 나타내었다. 또한 AMP와 SXT의 경우 연령이 1세 이상일 경우 1세 미만인 경우에 비해 내성의 위험이 증가하였다. 결론 : 1세 이상의 환아에서는 소아과 외래에서 흔히 사용하는 AMP, SXT에 대한 내성발생의 위험이 증가하므로 3세대 cephalosporin계 항생제를 초기 경험적 치료에 사용하는 것이 권장되나, ESBL 생성 E. coli에 대한 지속적인 조사와 발생 위험 요인에 대한 연구가 더욱 필요하다.

• 미생물학회지
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• 제46권1호
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• pp.9-14
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• 2010

본 연구는 우리나라 전통 발효식품인 장류, 김치류 및 젓갈류로부터 angiotensin converting enzyme 저해활성이 우수한 젖산균을 분리하고자 하였다. 젖산균을 분리하기 위한 선택배지로서 bromocresol purple (BCP) 한천배지를 사용하여 1차적으로 젖산균을 분리하였으며, 그 중 angiotensin converting enzyme 저해활성이 우수한 균주를 최종 선발하였다. 분리된 젖산균을 16S rRNA 유전자 염기서열 분석으로 동정한 결과 Lactobacillus brevis ATCC $14869^T$와 99.7%의 유사도를 나타냄에 따라 L. brevis HLJ59로 명명하였다. L. brevis HLJ59는 내산성의 경우 pH가 2.0, 3.0으로 보정된 DeMan Rogosa Sharpe 액체배지에서 접종 후 각각 90분, 30분이 경과하였을 때 배양초기와 비교 시 약 99% 감소하는 결과를 보였으나, 담즙산(Bile extract)의 경우 1% 첨가 시에도 생육에 저해를 받지 않는 것으로 조사되어 L. brevis HLJ59 균주는 담즙산에 대한 내성이 우수한 균주임을 확인하였다. 항생제 내성의 경우 20종의 항생제를 paper disc법으로 조사한 결과 본 균주는 cephalosporin계의 cefoxatin (30 ${\mu}g$), ceftnaxone (30 ${\mu}g$), penicillin계의 penicillin (10 units), quinolones계 cprofloxacin (5 ${\mu}g$), nalidixic acid (30 ${\mu}g$), lincosamid계의 lincomycin (2 ${\mu}g$) 및 기타 chloramphenicol (30 ${\mu}g$)에 대해서는 내성을 가지고 있음을 확인하였다.