预约演示
更新于：2025-12-04
Biapenem
比阿培南
更新于：2025-12-04
概要
基本信息
原研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C15H18N4O4S |
InChIKeyMRMBZHPJVKCOMA-YJFSRANCSA-N |
CAS号120410-24-4 |
关联
15
项与 比阿培南 相关的临床试验NCT04799626
Population Pharmacokinetics and Dosage Individualization of Biapenem,Meropenem,Piperacillin and Tazobactam,Tigecycline,Levofloxacin .Etc in Elderly Patients Who Was Hospitalized in Intensive Care Unit
ChiCTR1900024945
Pharmacokinetics/ Pharmacodynamics study and dosing regimen optimization of evaluating biapenem in high-risk patients with febrile neutropenia
NCT04552444
Clinical Efficacy of Combination Therapy Based on High-dose Biapenem in CRKP Infections
100 项与 比阿培南 相关的临床结果
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100 项与 比阿培南 相关的转化医学
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100 项与 比阿培南 相关的专利（医药）
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494
项与 比阿培南 相关的文献（医药）2026-01-01JOURNAL OF CHROMATOGRAPHY A
From reaction energetics to automated analysis tool auxiliary identification: A self-validating multidimensional liquid chromatography- mass spectrometry framework for characterizing polymerized impurities in carbapenem antibiotics
Article
作者: Guo, Kexin ; Zhai, Haochen ; Song, Yiren ; Yu, Peilin ; Zhou, Fangyu ; Zhu, Bingqi ; Zhang, Bingxing ; Fan, Tonglin ; Chen, Xin ; Chen, Zhangyi ; Wang, Fan ; Mu, Rongkang ; Yin, Xiaoying ; Xu, Zhihao ; Mao, Xuan ; Hong, Liya ; Wang, Jian
The presence of polymerized impurities in carbapenem antibiotics poses a public health risk due to their potential to induce passive cutaneous allergic reactions. Previous literature has shown that isomeric impurities can exhibit different biological properties and toxicological profiles. Therefore, studying the polymerized and isomeric impurities of carbapenem antibiotics is highly significant. However, these impurities have received relatively little attention in previous studies. Conversely, current studies on the structural elucidation of pharmaceutical impurities often neglect to investigate formation mechanisms. They also neglect the in-depth analysis of MS/MS fragment ion disparities, which can result in incorrect structural attribution. In order to characterize impurities and elucidate polymerization mechanisms, this study has developed an integrated analytical strategy incorporating multidimensional chromatographic separation, high-resolution mass spectrometry, theoretical calculations, and an automated analytical tool assisted in the auxiliary identification. HPSEC and RP-HPLC methods with novel separation principles and two-dimensional chromatographic methods (UHPLC-Q-TOF MS and 2D HPSEC × LC-Q-Exactive MS) were established to resolve polymerized species in biapenem and meropenem. This enabled the systematic separation and identification of 15 impurities (including 11 polymerized variants) through multistage MSⁿ fragment analysis in dual ionization modes. On this basis, the possible dimerization mechanism of the dimeric isomers was elucidated via theoretical calculations. This allowed both the dominant polymerization sites and the dimerization reaction to be recognized. Additionally, our self-developed automated analytical tool assisted in the auxiliary identification of dimeric isomer configurations in actual samples. The dimer configurations identified from the LC-MS/MS results were consistent with the dominant dimer configurations revealed by theoretical calculations. This work establishes a self-validating methodology that integrates "multidimensional separation-high-resolution MSn characterization -mechanistic validation- automated analysis tool auxiliary identification analysis," for the precise characterization of polymerized impurities.
2025-10-03JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY
Phenotypic and genotypic profiles of clinical isolates of various Nocardia species to carbapenems and fluoroquinolones
Article
作者: Xue, Jiaoyu ; Jiang, Tingfei ; Zhang, Mingrui ; Shi, Dongyan ; Yang, Jing
Abstract:
Objectives:
To establish patterns of the antimicrobial susceptibility of Nocardia species to carbapenems and fluoroquinolones and analysis of phenotypic–genotypic correlations.
Methods:
Isolates were identified to the species using 16S rRNA, secA1, or rpoB gene sequencing analysis. The antimicrobial susceptibility testing was performed using the broth microdilution method, and WGS was employed to analyse the presence of resistance genes and/or mutations of Nocardia species against carbapenems and fluoroquinolones.
Results:
Among 143 Nocardia isolates, N. farcinica (27.27%, 39/143) and N. cyriacigeorgica (25.17%, 36/143) were the most common species, followed by N. abscessus Complex (18.88%, 27/143). The MIC90s of the seven carbapenems were 8 mg/L for doripenem, 8 mg/L for meropenem, 16 mg/L for ertapenem, 16 mg/L for biapenem, 64 mg/L for imipenem, 64 mg/L for faropenem and 128 mg/L for tebipenem, respectively. The susceptibility rates to imipenem were 76.9% and 88.9% for N. farcinica and N. cyriacigeorgica, respectively, but only 14.3% and 0% for N. otitidiscavarium and N. brasiliensis, respectively. Further, 90% of N. brasiliensis and 50% of N. otitidiscaviarum isolates were susceptible and intermediate to meropenem. WGS identified blaFAR-1 gene in N. farcinica and blaAST-1 gene in N. cyriacigeorgica, respectively. The MIC90s of the four fluoroquinolones were 1 mg/L for sitafloxacin, 4 mg/L for nemonoxacin, 4 mg/L for moxifloxacin and 16 mg/L for ciprofloxacin, respectively. The susceptibility rate of Nocardia species to ciprofloxacin was low except for N. farcinica. The resistance to fluoroquinolones arise from mutations in the gyrA gene.
Conclusions:
Nocardia spp. exhibited varying patterns of susceptibility to carbapenems and fluoroquinolones respectively. Importantly, different Nocardia spp. exhibited different patterns of susceptibility to carbapenems and fluoroquinolones, respectively.
2025-07-01BIOSENSORS & BIOELECTRONICS
Screening broad-spectrum aptamers for cephalosporin antibiotics using real samples and development of a DNA walker-driven dual-mode aptasensor
Article
作者: Guo, Yemin ; Sun, Xia ; Chen, Dongfei ; Han, Lu ; Sun, Zhicong ; Tian, Yuhang ; Mou, Yaoting ; Yin, Yanhao ; Wu, Yanfang ; Li, Falan ; Zhang, Wanqi
Cephalosporin antibiotics are commonly used to treat mastitis in dairy cattle, but their overuse often results in excessive residues in milk, posing a significant food safety concern. Aptasensors provide a promising solution for the simultaneous detection of these residues. However, differences between screening conditions and real-world detection environments can affect aptamer performance. In this study, a broad-spectrum aptamer (Apt-93) with high affinity and specificity for cephalosporin antibiotics was successfully screened using a milk dilution-assisted graphene oxide (GO)-SELEX technique, achieving binding dissociation constants (Kd) of 27.21-43.45 nM. Leveraging Apt-93, we developed a DNA walker-based dual-mode aptasensor for detecting cephalosporin residues in milk. The sensor utilized streptavidin magnetic beads (SA-MBs) functionalized with hairpin chain-1 (H1) and a walking strand (aptamer hybridized with complementary DNA). Upon selective binding of cephalosporin antibiotics, the walking strand was released, triggering the opening of the H1 hairpin structure and exposing an enzymatic cleavage site. The enzymatic process cleaved carboxyfluorescein (FAM)-labeled H1, generating a fluorescent signal. Subsequently, the remaining H1 sequence bound to hairpin chain-2 (H2), releasing a G-rich sequence, which formed a G-quadruplex structure in the presence of hemin and K+, catalyzing a colorimetric reaction with 3,3',5,5'-tetramethylbenzidine (TMB). The dual-mode aptasensor achieved detection limits of 8.10 nM (fluorescence) and 20.3 nM (colorimetric). High recoveries in both pretreated and untreated milk samples demonstrated the robustness of the aptamer in terms of specificity and interference resistance. The dual-mode aptasensor offers a rapid and effective platform for detecting antibiotic residues, demonstrating a potential to enhance food safety monitoring.
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研发状态
批准上市
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 细菌感染 | 中国 | 2008-05-04 | |
| 膀胱炎 | 日本 | 2001-10-02 | |
| 出血性败血症 | 日本 | 2001-10-02 | |
| 肺脓肿 | 日本 | 2001-10-02 | |
| 腹膜炎 | 日本 | 2001-10-02 | |
| 肺炎 | 日本 | 2001-10-02 | |
| 肾盂肾炎 | 日本 | 2001-10-02 | |
| 继发感染 | 日本 | 2001-10-02 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 复杂的尿路感染 | 临床2期 | 中国 | 2009-06-19 | |
| 呼吸道感染 | 临床2期 | 中国 | - |
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