[Translation] Study on the tolerance and pharmacokinetics of single and multiple doses of D(-) sulbenicillin sodium for injection in healthy subjects and its pharmacokinetics compared with sulbenicillin sodium for injection

1) 评价注射用D(-)磺苄西林钠在健康受试者中单次和多次给药的安全性、耐受性和药代动力学特征，为II期临床试验给药方案提供安全剂量范围，为制定合理的临床方案提供依据。 2）比较注射用D(-)磺苄西林钠和含有相同D(-)磺苄西林钠剂量的注射用磺苄西林钠在健康受试者中单次给药的药代动力学特征和尿药排泄情况。

[Translation]

1) To evaluate the safety, tolerability and pharmacokinetic characteristics of single and multiple administrations of D(-) sulbenicillin sodium for injection in healthy subjects, to provide a safe dosage range for the dosing regimen of Phase II clinical trials, and to provide a basis for the formulation of a reasonable clinical regimen. 2) To compare the pharmacokinetic characteristics and urinary drug excretion of single administration of D(-) sulbenicillin sodium for injection and sulbenicillin sodium for injection containing the same dose of D(-) sulbenicillin sodium in healthy subjects.

Start Date-

Sponsor / Collaborator

Hunan Sanqing Pharmaceutical Co., Ltd.

[+1]

100 Clinical Results associated with Sulbenicillin Sodium

100 Translational Medicine associated with Sulbenicillin Sodium

100 Patents (Medical) associated with Sulbenicillin Sodium

154

Literatures (Medical) associated with Sulbenicillin Sodium

01 Feb 2022·Journal of pharmaceutical and biomedical analysisQ3 · MEDICINE

Analysis of polymerized impurities in mezlocillin sodium and sulbenicillin sodium using two chromatographic separation mechanisms coupled to tandem mass spectrometry

Q3 · MEDICINE

Article

Author: Zhou, Ping ; Tang, Kaixian ; Ren, Xiaojuan ; Wang, Jian

To effectively control the polymerized impurities in mezlocillin sodium and sulbenicillin sodium, a HPSEC method with TSK-gel G2000SWxl column and a RP-HPLC method with C18 analytical column were established to replace the classical gel filtration chromatography with Sephadex G-10 gel as stationary phase. By studying the chromatographic behavior of polymerized impurities in both methods with different chromatographic separation mechanisms, the polymerized impurities in mezlocillin sodium and sulbenicillin sodium were separated and detected effectively. The column switching two-dimension liquid chromatography ion trap/time-of-flight mass spectrometry was applied to characterize the structures of polymerized impurities eluted from the HPSEC method and RP-HPLC method for both drugs. The structures of the polymerized impurities in mezlocillin sodium and sulbenicillin sodium were deduced based on the MSⁿ data. The results showed that the polymerized impurities detected by HPSEC method and RP-HPLC method were completely different. Therefore, two methods should be used meanwhile to control the polymerized impurities in mezlocillin sodium and sulbenicillin sodium.

01 Dec 2020·Microbiology (Reading, England)Q4 · BIOLOGY

MexXY RND pump of Pseudomonas aeruginosa PA7 effluxes bi-anionic β-lactams carbenicillin and sulbenicillin when it partners with the outer membrane factor OprA but not with OprM

Q4 · BIOLOGY

Article

Author: Li, Yanqi ; Singh, Manu ; Kumar, Ayush ; Sykes, Ellen M. E.

Antibiotic resistance in Pseudomonas aeruginosa is a serious concern in healthcare systems. Among the determinants of antibiotic resistance in P. aeruginosa, efflux pumps belonging to the resistance–nodulation–division (RND) family confer resistance to a broad range of antibacterial compounds. The MexXY efflux system is widely overexpressed in P. aeruginosa isolates from cystic fibrosis (CF) patients. MexXY can form functional complexes with two different outer membrane factors (OMFs), OprA and OprM. In this study, using state-of-the-art genetic tools, the substrate specificities of MexXY–OprA and MexXY–OprM complexes were determined. Our results show, for the first time, that the substrate profile of the MexXY system from P. aeruginosa PA7 can vary depending on which OM factor (OprM or OprA) it complexes with. While both MexXY–OprA and MexXY–OprM complexes are capable of effluxing aminoglycosides, the bi-anionic β-lactam molecules carbenicillin and sulbenicillin were found to only be the substrate of MexXY–OprA. Our study therefore shows that by partnering with different OMF proteins MexY can expand its substrate profile.

01 Oct 2017·MedicineQ4 · MEDICINE

Amputation of the first metatarsophalangeal joint due to a giant gouty tophi

Q4 · MEDICINE

ArticleOA

Author: Wang, Yi ; Zhou, Chenchen ; Wang, Wutao ; Xue, Cheng ; Huang, Fang ; Xu, Yanqiu ; Yang, Bo

RATIONALE:

The first metatarsophalangeal joint (MTP1) is the most frequent site of gouty tophi. We report an unusual case with a giant skin-perforating tophi. This is the first case of gouty tophi at MTP1 which accepts surgical debulking and amputation.

PATIENT CONCERNS:

A 42-year-old man presented with a seven-year history of gout and a giant tophi at MTP1. The patient was referred to hospital due to persistent pain and ulcerations on the surface of the left MTP1. This rounded, giant, swelling, tophaceous tophi severely interfered with his normal walking.

DIAGNOSES:

The patient was diagnosed with gouty arthritis seven years ago, and did not receive regular anti-gout treatments.

OUTCOMES:

Biochemical examination showed he had raised serum uric acid (SUA, 11.92 mg/dl) and creatinine (258 μmol/l). There was a severe joint destruction of MTP1 by X-ray examination. We controlled the skin infection by sulbenicillin. He was given febuxostat to reduce SUA. After 3 months of treatment, SUA fell to 6.8 mg/dl. Then we performed surgical debulking of MTP1 and amputation of hallux. Surgical operations obviously relieved the pain, and improved the function of his left foot. The visual closure after amputation was good.

CONCLUSION:

Surgical amputation of the gout lesion at MTP1 maximized the function, and reduced the pain of this patient. In the case of giant tophi with severe gouty arthritis or skin infections, surgical decisions need to weigh gains and losses carefully.

100 Deals associated with Sulbenicillin Sodium

External Link

KEGG	Wiki	ATC	Drug Bank
D01489	Sulbenicillin Sodium	J01CA16	DB13693

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Complicated skin and soft tissue infection	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	01 Jan 1985
Pneumonia	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	01 Jan 1985
Sepsis	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	01 Jan 1985
Urinary Tract Infections	CN	Hunan Er-Kang Pharmaceutical Co., Ltd.	01 Jan 1985
Bacterial Infections	JP	Takeda Pharmaceutical Co., Ltd.	10 Aug 1972

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Soft Tissue Infections	Phase 1	CN	Hunan Sanqing Pharmaceutical Co., Ltd.	17 Jul 2019
Soft Tissue Infections	Phase 1	CN	Changsha Huamei Medical Technology Co., Ltd.	17 Jul 2019

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