更新于：2023-11-01

Benoxinate Hydrochloride

盐酸奥布卡因

更新于：2023-11-01

概要

概要

基本信息

药物类型

小分子化药

别名

Oxybuprocaine Hydrochloride、Oxybuprocaine Hydrochloride Gel、Oxybuprocaine HydrochIoride Gel

+ [21]

靶点

SCNA(钠通道α亚基家族)

作用机制

SCNA调节剂(钠通道α亚基家族调节剂)

治疗领域

眼部疾病、其他疾病

在研适应症

多泪、麻醉

非在研适应症-

原研机构-

在研机构

Santen Pharmaceutical Co., Ltd.沈阳绿洲制药有限责任公司

ROHTO NITTEN Co., Ltd.

非在研机构-

最高研发阶段批准上市

首次获批日期(全球)

日本 (1966-06),

麻醉

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C17H29ClN2O3

InChIKeyPRGUDWLMFLCODA-UHFFFAOYSA-N

CAS号5987-82-6

查看全部结构式(2)

关联

项与盐酸奥布卡因相关的临床试验

NCT05733741 / Completed临床4期IIT

Preservative-free Topical Anesthetics for the Management of Postoperative Pain Following Photorefractive Keratectomy

The goal of this interventional comparative study is to assess the efficacy and safety of a novel regimen of preservative-free unit-dose topical anesthetics for controlling early postoperative pain following single-step transepithelial PRK surgery.
The main research questions to answer are:
Question 1: Are topical anesthetics effective in reducing post-PRK pain?
Question 2: Are short-term topical anesthetics toxic to the cornea?
Question 3: How to prevent abuse of topical anesthetics by patients at home?
Participants were planned to undergo a bilateral single-step transepithelial PRK surgery to correct their refractive errors and received a standard post-PRK treatment regimen for both eyes. Additionally, one eye was offered a preservative-free topical anesthetic as an experimental group and the other eye was offered a preservative-free artificial tear as a control group.

开始日期2023-01-30

申办/合作机构

Assiut University

NCT05666362 / RecruitingN/AIIT

Hemodynamic Response Of Premature Brain To Pain During Retinopathy Of Prematurity Screening: A Randomized Controlled Trial

Study of cerebral hemodynamic changes in preterm infant and the effect of topical anesthetic eye drops ( benoxinate hydrochloride 0.4% ) on PIPP score and cerebral hemodynamic changes during fundus examination in neonates with gestational age ≤ 34 weeks or birth weight ≤ 2.000 Kg regardless their gestational age , after postnatal day 28.

开始日期2022-03-20

申办/合作机构

Alexandria University

NCT05069350 / Completed早期临床1期IIT

A Double Blinded Randomized Controlled Study of Topical Anaesthetics Oxybuprocaine Versus Bupivacaine 0.5% in Intravitreal Injections

comparing two local anaesthetic agents, Bupivacaine 0.5% versus Oxybuprocaine used topically to provide surface anaesthesia before IVI procedures.

开始日期2021-09-01

申办/合作机构

Research Institute of Ophthalmology, Egypt

100 项与盐酸奥布卡因相关的临床结果

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100 项与盐酸奥布卡因相关的专利（医药）

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293

项与盐酸奥布卡因相关的文献（医药）

2023-09-29·Medicine

Chinese mini percutaneous nephrolithotomy for upper urinary calculi under local infiltration anesthesia.

Article

作者: Zhao-Lin Zhang ; Fang-Zhi Li ; Tian-Peng Xie ; Fo-Lin Liu ; Bo Jiang ; Yuan-Hu Yuan ; Ri-Hai Xiao ; Xiao-Ning Wang

Percutaneous nephrolithotomy is generally performed under general or regional anesthesia; however, it is rarely performed under local infiltration anesthesia (LIA). This study aimed to assess the safety and effectiveness of Chinese mini percutaneous nephrolithotomy (MPCNL) for upper urinary calculi under LIA. A retrospective analysis of 52 patients with upper urinary stones who underwent MPCNL under LIA from April 2019 to May 2022 was performed. Pethidine and Phenergan were intramuscularly injected 30 minutes preoperatively. Oxybuprocaine hydrochloride gel was applied to the urethra for lubricating and mucosal anesthesia. Ropivacaine hydrochloride and lidocaine were injected into the whole percutaneous channel for local anesthesia. An 8/9.8F ureteroscope and an 18F vacuum-assisted access sheath were applied in MPCNL. All 52 patients tolerated procedures and underwent operations successfully; none of them converted the anesthesia method or required additional analgesia. The mean visual analogue scale scores intraoperatively and at 6 hours, 24 hours, and 48 hours after surgery were 3.25 ± 0.52, 3.13 ± 0.69, 2.25 ± 0.56, and 1.58 ± 0.50, respectively. The stone free rate was 84.6%. Complications were seen in 6 (11.5%) patients, including fever in 2 patients (Clavien I), renal colic in 1 patient (Clavien I), clinically insignificant bleeding in 2 patients (Clavien I), and urinary tract infection in 1 patient (Clavien II). No severe complications were observed in any patients. Chinese MPCNL under LIA was a feasible option and achieved good outcomes in appropriately selected patients, and it may become the routine procedure for general patients.

2023-09-26·Spectrochimica acta. Part A, Molecular and biomolecular spectroscopy

Investigating fluorogenic labelling of amine coupled with first-order derivative spectrofluorimetry as a versatile analytical methodology: Application to estimation of benoxinate in its eye drops.

Article

作者: Rasha Aboshabana ; Heba Samir Elama ; Heba Elmansi ; Samah Abo El Abass

In this research, fluorogenic labelling followed by applying first-order derivative spectrofluorimetry for the developed fluorophore is discussed as an alternative, sensitive and selective analytical approach. Benoxinate, containing a primary amine and fluorescamine reagent were selected for the study. Then the proposed methodology relies on the reaction between the primary amine in benoxinate with fluorescamine that selectively reacts with primary amines to develop highly fluorescent products. The fluorescamine-benoxinate developed fluorophore is identified by its sharp first-order derivative peak at 465 nm following excitation at 386 nm in borate buffer, pH 8. The optimum reaction conditions were ascertained. Following ICH validation guidelines, the first order derivative of the relative fluorescence intensity for the developed fluorophore was linearly related to benoxinate concentration and ranged from 20.0 to 200.0 ng/mL with a detection limit of 3.36 ng/mL and a quantitation limit of 10.19 ng/mL, moreover, satisfying accuracy and precision values were obtained upon statistical analysis of results. The offered analytical method was successfully applied to quantify benoxinate in raw material and Benox® eye drops as a direct application to a commercial formulation.

2023-09-04·Ophthalmology and therapy

Preservative-Free Topical Anesthetic Unit-Dose Eye Drops for the Management of Postoperative Pain Following Photorefractive Keratectomy.

Article

作者: Mahmoud Abdel-Radi ; Zeiad Eldaly ; Sara Alattar ; Islam Goda

INTRODUCTION:

Ocular pain is a common complication following photorefractive keratectomy (PRK). The level of patient satisfaction with current pain control strategies is not high. This study aims to assess the efficacy and safety of a novel regimen of preservative-free oxybuprocaine hydrochloride 0.4% unit-dose eye drops for post-PRK pain control.

METHODS:

In a contralateral eye study, 144 eyes of 72 patients who underwent bilateral transepithelial PRK (TransPRK) were stratified into experimental and control groups. The experimental group received preservative-free oxybuprocaine hydrochloride 0.4% unit-dose eye drops five times daily postoperatively until complete epithelial healing, while the control group received sodium hyaluronate 0.2% instead. The main outcome measures were pain scores assessed by the verbal rating scale and visual analogue scale (VRS, VAS), the corneal epithelial defect (CED) area, epithelial healing duration evaluated by slit-lamp biomicroscopy and anterior segment optical coherence tomography (AS-OCT), and endothelial cell density (ECD) measured before and 1 month after surgery.

RESULTS:

Pain scores assessed by VRS and VAS were significantly lower in the experimental group 8 h after surgery, and 1, 2, and 3 days postoperatively (P < 0.001). The mean CED area showed no significant differences between the two groups at different follow-ups (P value > 0.05). The corneal epithelial healing had a mean duration of 3.32 ± 0.47 days in both studied groups and was parallel in both eyes of each patient. In each group, 49 eyes (68%) and 72 eyes (100%) had a fully epithelialized surface on the third and fourth postoperative days, respectively. No significant changes were observed in the mean ECD 1 month following surgery in both groups (P value > 0.05).

CONCLUSION:

Preservative-free oxybuprocaine hydrochloride 0.4% unit-dose eye drops are effective and safe in controlling early postoperative pain following TransPRK. The availability of the single-dose unit preparation can overcome the problem of topical anesthetic abuse.

TRIAL REGISTRATION:

ClinicalTrials.gov Identifier: NCT05733741.

项与盐酸奥布卡因相关的新闻（医药）

2022-03-04

·新浪医药

阿斯利康AZD5305国内启动临床

一、政策简报 1、江苏省四份文件同日下发！涉及医用耗材、药品撤销挂网等 4日，江苏省公共资源交易中心发布《关于公示药品阳光采购拟挂网产品的通知》、《关于公示拟撤销挂网药品的通知》，涉及利肝隆颗粒、双黄连口服液、盐酸奥布卡因滴眼液等药品。此外还发布了《关于公示高值医用耗材阳光采购拟挂网产品的通知》、《关于公示医用耗材备案采购拟入围产品的通知》，涉及骨科材料、眼科材料等医用耗材和高值医用耗材。 2、国家卫健委发布《关于组织申报中央财政支持公立医院改革与高质量发展示范项目的通知》 4日，财政部、国家卫健委联合发布《关于组织申报中央财政支持公立医院改革与高质量发展示范项目的通知》，明确中央财政对地方推进立医院改革与高质量发展示范项目支持重点、范围以及申报内容和程序。 3、福建省医保局等八部门发布《关于福建省医用耗材集中带量采购和使用的实施意见》 4日，福建省医保局等八部门联合发布《关于福建省医用耗材集中带量采购和使用的实施意见》，明确将部分临床用量较大、采购金额较高、临床使用较成熟、市场竞争较充分、同质化水平较高的医用耗材纳入集采范围。二、产经观察 1、海思科引进“渐冻人症”药物利鲁唑口腔膜中国独家权益 4日，海思科宣布，与Aquestive签署了治疗肌萎缩侧索硬化症的利鲁唑口腔膜Exservan的合作协议，海思科将独家负责该药在中国的注册和商业化活动，Aquestive将作为该产品的独家制造商和供应商。这项合作涉及首付款和监管里程碑付款总计数百万美元。 2、心脉医疗独立董事吴海兵辞职 4日，心脉医疗发布公告称，吴海兵因个人原因申请辞去公司第二届董事会独立董事，同时辞去公司第二届董事会专门委员会的相应职务。 3、方盛制药董事长兼总经理张庆华辞职 4日，方盛制药发布公告称，张庆华由于个人原因，申请辞去其所担任的公司董事长（法定代表人）、董事、董事会战略发展委员会主任以及总经理职务。 4、迈普医学拟注销子公司中山迈普 4日，迈普医学发布公告称，为进一步整合和优化现有资源配置，迈普医学拟注销子公司中山迈普，并由公司管理层授权相关人员依法办理相关清算和注销事项。 5、中国医药称与某跨国制药公司新冠治疗药物合作事宜正在洽谈中 4日，中国医药早间发布股票交易异常波动公告称，公司关注到市场近期有公司与某跨国制药公司新冠病毒治疗药物合作事宜的传闻。经公司核查，目前相关事项正在沟通洽谈中，尚存在不确定性。三、药闻医讯 1、Aravive宣布batiraxcept在治疗肾透明细胞癌1b/2期临床试验中结果积极 3日，Aravive宣布，batiraxcept在治疗肾透明细胞癌的1b/2期临床试验中的1b期部分获得积极数据。截至2022年2月4日，实验关键结果如下：15mg/kg或20mg/kg剂量batiraxcept联合卡博替尼均未观察到剂量限制性毒性；中位随访期为4.9个月，92%的患者仍在接受治疗；意向治疗人群的最佳总缓解率为46%（12/26）；15 mg/kg剂量组最佳ORR为56%（9/16）；20mg/k剂量组最佳ORR为30%（3/10）；ITT人群的6个月无进展生存率为79%；尚未达到中位缓解持续时间；3个月DOR为100%。 2、天境生物双抗TJ-CD4B获FDA授予孤儿药资格认定 3日，天境生物宣布其创新双特异性抗体TJ-CD4B获得美国FDA授予针对治疗胃癌（包括胃食管交界处癌）的孤儿药资格认定。 3、亚宝药业甲钴胺注射液通过仿制药一致性评价 4日，亚宝药业发布公告称，公司于近日收到NMPA核准签发的关于甲钴胺注射液的《药品补充申请批准通知书》，批准该药品通过仿制药一致性评价。甲钴胺注射液主要用于周围神经病和因缺乏维生素B12引起的巨红细胞性贫血的治疗。 4、华润双鹤全资子公司盐酸氨溴索注射液通过仿制药一致性评价 4日，华润双鹤发布公告称，其全资子公司双鹤利民于近日收到了NMPA颁发的盐酸氨溴索注射液《药品补充申请批准通知书》，该药品通过仿制药一致性评价。盐酸氨溴索注射液适用于伴有痰液分泌不正常及排痰功能不良的急性、慢性肺部疾病。 5、正大清江盐酸右美托咪定注射液获批生产并视同过评 3日，NMPA官网显示，正大清江3类仿制药盐酸右美托咪定注射液获批生产并视同过评。盐酸右美托咪定属于α2-肾上腺素受体激动剂，具有镇静、镇痛、抗焦虑等作用，临床上用于行全身麻醉的手术患者气管插管和机械通气时的镇静。 6、阿斯利康AZD5305国内启动临床 3日，阿斯利康的PARP1选择性抑制剂AZD5305在中国首次登记启动临床试验。AZD5305是阿斯利康的第2款PAPR抑制剂。与已上市的PARP1/2抑制剂奥拉帕利不同，AZD5305对PARP1亚型有高选择性，因而有望克服已上市 PARP 抑制剂的副作用。 7、罗氏启动阿尔茨海默病抗体疗法新3期临床试验 4日，罗氏宣布，该公司已经与三家研究所达成合作协议，共同启动新的阿尔茨海默病预防性3期临床试验，检验其皮下注射抗淀粉样蛋白抗体gantenerumab，在尚未出现认知障碍，但是表现出阿尔茨海默病最早生物学征兆的患者中的效果。Gantenerumab是一款在研IgG1单克隆抗体，它与淀粉样蛋白的聚集形态相结合，清除大脑中的淀粉样蛋白沉积，这是阿尔茨海默病患者大脑的标志性特征之一。在多项临床试验中，gantenerumab显著降低患者大脑中的淀粉样蛋白沉积。 8、极目生物宣布锋脉®/Arcatus™在DME治疗临床试验中完成首例亚洲DME患者给药 3日，极目生物宣布，锋脉®/Arcatus™国内针对糖尿病性黄斑水肿治疗的临床试验，已完成首例患者给药，这也是亚洲区首例DME患者给药。内容来源于网络，如有侵权，请联系删除，谢谢。

仿制药一致性评价抗体孤儿药合作

100 项与盐酸奥布卡因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01768	盐酸奥布卡因	D04AB03 S01HA02	DB00892

研发状态

适应症	最高研发状态	国家/地区	公司
多泪	批准上市	日本更多	Santen Pharmaceutical Co., Ltd. 更多
-	批准上市	美国更多	-
麻醉	批准上市	中国更多	沈阳绿洲制药有限责任公司更多