Furbenicillin is a broad-spectrum semisynthetic penicillin with strong antibacterial activity against Gram-negative bacteria. Furbenicillin sodium is determined by volumetric method in current criteria. However, the criteria does not contain an assay of related substances of furbenicillin sodium. In this study, we established a method for detection and analysis of furbenicillin sodium and its related substances by HPLC. The analysis was performed with a C18 column under a gradient elution, the detection wavelength was 225 nm, and the column temperature was 35 degrees C. The reliability and accuracy of established method was validated in this study. Pure samples of furbenicillin sodium and its related substances were prepared. The structures, biological activities, and chromatographic retention behaviors of furbenicillin sodium and its related substances were identified using NMR, CLSI agar dilution method, and HPLC. All results in the current study provide ample evidence that this method is able to determine the reasonable limits in the quality-control protocol for furbenicillin sodium.

01 Feb 2015·The Journal of AntibioticsQ4 · MEDICINE

Isolation, identification and characterization of related substances in furbenicillin

Q4 · MEDICINE

Article

Author: Tian, Ye ; Zhang, Dou-Sheng ; Feng, Yan-Chun ; Hu, Changqin ; Chang, Yan

Furbenicillin is a broad-spectrum semisynthetic penicillin with strong antibacterial activity against Gram-negative bacteria. In this study, three impurities in furbenicillin, including an unknown epimer, were determined. On the basis of a complete analysis of the spectrum (MS, (1)H,(13)C, 2D NMR and CD) and the results of chemical methods, the unknown epimer impurity was identified as 10-epi-furbenicillin (impurity 1). Isolation and structure elucidation of impurity 1 was also reported here for the first time.

01 Jul 1999·Chinese medical journalQ3 · MEDICINE

A surveillance study on penicillin-resistant streptococcus pneumoniae in China.

Q3 · MEDICINE

ArticleOA

Author: Chen, Y ; Zhang, Y ; Liu, J ; Hao, F ; Xue, F ; Lu, Y ; Li, J

OBJECTIVESTo find out whether there are also penicillin-resistant streptococcus pneumoniae and the resistant rate in China.METHODSA surveillance study which is a part of the international surveillance on pneumococci resistance to penicillin and other antimicrobial agents was conducted in Beijing, China. More than 900 pediatric patients with respiratory tract infections aged from six months to three years selected from two pediatric units were enrolled in the study. Perthroat swabs were immediately streaked onto blood agar plates. Isolates were identified as pneumococci by their typical appearance, gram stain, confirmation tests. Antibiotic susceptibility was assessed by the disk diffusion method and minimal inhibition concentration (MIC) determination according to Protocol and National Committee for Clinical Laboratory Standards (NCCLS).RESULTSOf the 51 streptococcus pneumoniae isolates, 5 strains had zones of inhibition indicative of penicillin resistance, of which two had penicillin MICs > or = 0.1 mg/L and were considered to be relatively or fully resistant to penicillin. The MICs of two penicillin resistant strains were 2 mg/L and 4 mg/L. Resistant rates to ceftriaxone and cefotaxime were 0% and 10% respectively. For the other ten antimicrobial agents, the resistant rates were as follows: ampicillin 12%, piperacillin 26%, furbenicillin 14%, cefuroxime 6%, erythromycin 54%, clarithromycin 52%, meleumycin 64%, roxithromycin 52%, chloramphenicol 35%, tetracycline 100%.CONCLUSIONSThe study suggested that penicillin resistant streptococcus pneumoniae strains existed in China and were also resistant to ampicillin, piperacillin, furbenicillin and cefuroxime. Moreover, the resistant rates of penicillin resistant streptococcus pneumoniae to macrolides and tetracycline were high.

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