盐酸丙美卡因(Proparacaine Hydrochloride) - 药物靶点：SCNA_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Proparacaine hydrochloride (USP)、Proxymetacaine、Alcaine

+ [5]

靶点

SCNA

作用机制

SCNA阻滞剂(钠通道α亚基家族阻滞剂)

治疗领域

其他疾病

在研适应症-

非在研适应症

麻醉

原研机构

Apothecon BV

在研机构-

非在研机构

Apothecon LLCAllergan, Inc.

最高研发阶段批准上市

首次获批日期

美国 (1953-07-01),

麻醉

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C16H27ClN2O3

InChIKeyBFUUJUGQJUTPAF-UHFFFAOYSA-N

CAS号5875-06-9

关联

14

项与盐酸丙美卡因相关的临床试验

CTRI/2024/08/072298

/ Recruiting临床4期

Evaluation of Nanodropper-mediated Microdrops vs Conventional Dropsof Proparacaine HCL 0.5 Percentage - Nil

开始日期2024-08-26

申办/合作机构-

NCT04283331

/ Unknown status临床4期IIT

Efficacy and Safety of Anesthetic Impregnated Bandage Soft Contact Lens (BSCL) in Pain Management After Photorefractive Keratectomy (PRK).

Compared to laser-assisted in situ keratomileusis (LASIK), Photorefractive Keratectomy (PRK) is associated with more discomfort and requires more downtime. However, it is oftentimes considered the preferred method of refractive surgery for patients with dry eye syndrome, high refractive errors, thin corneas, or those with more active lifestyles who may be more prone to dislodging their LASIK flaps. We hypothesize that the use of bandage contact lenses soaked in proparacaine will decrease pain levels compared to solely the use of bandage contact lenses after PRK.

开始日期2020-06-01

申办/合作机构

Wills Eye Institute

NCT02951351

/ CompletedN/AIIT

Topical Proparacaine Eye Drops to Improve the Experience of Patients Undergoing Intravitreal Injections

The specific aims of this study are to compare patient experience with and without a proparacaine drop after povidone iodine.

开始日期2016-10-12

申办/合作机构

Mayo Clinic

[+2]

100 项与盐酸丙美卡因相关的临床结果

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100 项与盐酸丙美卡因相关的转化医学

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100 项与盐酸丙美卡因相关的专利（医药）

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527

项与盐酸丙美卡因相关的文献（医药）

2025-01-01·CANADIAN JOURNAL OF OPHTHALMOLOGY-JOURNAL CANADIEN D OPHTALMOLOGIE

Tetracaine versus proparacaine for retinopathy of prematurity exams

Letter

作者: Eslami, Maryam ; Newby, Brandi

2025-01-01·VETERINARY OPHTHALMOLOGY

Mydriasis in eastern box turtles (Terrapene carolina carolina) following topical administration of proparacaine, 10% phenylephrine, and rocuronium bromide

Article

作者: Tucker‐Retter, Emily K. ; Petritz, Olivia A. ; Westermeyer, Hans D.

Abstract:

Objective:

To determine the mydriatic effect of topical 10% phenylephrine with 10 mg/mL rocuronium bromide and compare this protocol with and without pretreatment with proparacaine.

Animals Studied:

Ten client‐owned pet adult eastern box turtles (Terrapene carolina carolina).

Procedures:

All turtles were sedated with 8 mg/kg alfaxalone intramuscularly. One group of four turtles received four 20 μL drops of 10% phenylephrine and four 20 μL drops of rocuronium bromide in the right eye. Another group of four turtles received one standard drop of proparacaine followed by four 20 μL drops of 10% phenylephrine and four 20 μL drops of rocuronium bromide in the right eye. Two control group turtles received four 20 μL drops of saline in the right eye. The left eye was untreated in all turtles. Drops of the same type were separated by 2 min while drops of different types were separated by 5 min. Pupil size was recorded at 0, 15, 30, 60, 90, 120, 180, 240, and 360 min after administration of the final drop.

Results:

Treatment with 10% phenylephrine and rocuronium bromide resulted in pupil diameter changes from baseline that were statistically significant from zero at 60, 90, and 120 min in the non‐proparacaine group and 90 min in the proparacaine group. The time to peak effect was 90 min in the proparacaine group and 75 min in the non‐proparacaine group. Saline‐treated pupils in the control group decreased in diameter over the study period. Overall, the treated eyes of the proparacaine group and non‐proparacaine group were not different from each other, but both dilated more than the control group.

Conclusions:

Rocuronium bromide and 10% phenylephrine can produce effective and safe mydriasis in eastern box turtles, but there was wide interindividual variation in effectiveness. Proparacaine did not improve the mydriatic effect.

2025-01-01·OPHTHALMIC AND PHYSIOLOGICAL OPTICS

Impact of proxymetacaine on the dynamics of cyclopentolate in White 6‐ to 7‐year‐olds

Article

作者: Doyle, Megan ; Harrington, Síofra ; O'Dwyer, Veronica

Abstract:

Purpose:

This study compared the efficacy of cyclopentolate hydrochloride at 10‐, 20‐ and 30‐min post‐instillation in White 6‐ to 7‐year‐olds, with and without prior instillation of proxymetacaine hydrochloride. The primary aim was to determine if accurate autorefraction values can be obtained sooner than the current standard of 30‐min post‐cycloplegia. The secondary aim was to investigate whether proxymetacaine hydrochloride enhances the efficiency of cyclopentolate.

Methods:

Participants were 112 White 6‐ to 7‐year‐olds from the Child Eye Health Study. The right eye received 0.5% proxymetacaine hydrochloride and 1.0% cyclopentolate hydrochloride, and the left eye received only 1.0% cyclopentolate hydrochloride. Non‐cycloplegic and cycloplegic refractive error (at 0, 10, 20 and 30 min) was measured using a binocular, open‐field autorefractometer. Data were analysed through paired t‐tests, concordance analysis, linear regression, equivalence testing and Bland–Altman analysis, using the 95% limits of agreement.

Results:

Mean spherical equivalent refraction (SER) (SD) in the right eye at 0‐, 10‐, 20‐ and 30‐min post‐instillation was 0.62 (1.45) D, 1.52 (1.80) D, 1.64 (1.81) D and 1.72 (1.80) D, respectively. Mean left eye SER (SD) were 0.68 (1.24) D, 1.42 (1.66) D, 1.56 (1.66) D and 1.68 (1.72) D, respectively. Bland–Altman analysis showed a high level of agreement, and equivalence testing confirmed that there was no clinically significant difference in SER at 20 and 30 min in both eyes (within ±0.50 D), with mean differences of 0.08 (0.23) D in the right eye and 0.13 (0.30) D in the left eye (p = 0.21). However, SER at 10 and 30 min were equivalent in the right eye only.

Conclusions:

Accurate autorefraction values can be obtained 20‐min post‐instillation of 1.0% cyclopentolate in white children aged 6–7 years, potentially reducing clinical testing times. Proxymetacaine pre‐instillation allows for reliable measurements as early as 10‐min post‐instillation of cyclopentolate. Further research is needed to validate these findings in non‐White populations and to determine the safe discharge time post‐proxymetacaine instillation.

26

项与盐酸丙美卡因相关的新闻（医药）

2025-01-08

·优尼特尔制药

优尼特尔制药—公司介绍

优尼特尔中国制药—公司介绍法国优尼特尔制药集团是全球领先的BFS(吹灌封)技术解决方案提供商，专注于为原研药和仿制药客户进行委托生产(CDMO)。我们的产品线涵盖滴眼液、鼻腔护理液及雾化吸入药物等无菌单剂量制剂，以及条形袋装口服液体制剂。集团在全球拥有八家工厂，分别位于法国、美国、巴西和中国，并在法国波尔多设有创新研发中心。此外，我们在法国巴黎、美国罗切斯特、巴西圣保罗和中国南京设有商务办公室，以推动全球业务的扩展。每年，我们的吹灌封技术产品产量超过50亿支，销售网络遍布全球100个国家和地区。集团现有员工超过2000人，年营业额达到4.5亿欧元以上。在中国，优尼特尔制药集团以南京作为其运营的核心基地。优尼特尔南京制药有限公司坐落于风景秀丽的六朝古都南京，具体位置在国家级高新区南京市江宁经济技术开发区将军大道169号，占地面积达5.78万平方米。自2004年成立以来，公司注册资金为2.3669亿人民币，目前拥有近170名员工。2020年8月，法国优尼特尔制药集团正式收购南京瑞年百思特制药有限公司。2024年10月，集团完成了对该公司的全资股权收购。优尼特尔南京制药作为集团全球的第七家工厂，也是其在中国的控股工厂。此次并购将使我们能够为中国眼科和呼吸系统市场的本土及跨国制药公司提供CDMO服务，生产无菌、不含防腐剂的单剂量制剂。优尼特尔南京制药有限公司依托法国的先进技术和经验，致力于在BFS吹灌封技术领域保持领先地位。公司拥有4条进口生产线Rommelag321 & Brevetti Angela Srl和2台Rommelag BP460设备，这些设备将升级以支持眼科、呼吸科、鼻科用药等多领域产品的生产。我们的产品包括盐酸丙美卡因滴眼液、氧氟沙星滴眼液、妥布霉素滴眼液、聚乙烯醇滴眼液、酮咯酸氨丁三醇滴眼液，以及口服固体制剂如甘草锌颗粒、盐酸托泊替康胶囊等。联系我们以获取更多信息! 优尼特尔制药 Single Best Way to Deliver

并购

2024-10-31

·Pharma CMC

今年第三次，兴齐眼药再撤回一款产品上市申请

10月30日，兴齐眼药发布公告，公司收到国家药监局核准签发的《药品注册申请终止通知书》，同意公司撤回马来酸噻吗洛尔滴眼液的注册申请。 2023年3月，兴齐眼药向国家药品监督管理局递交马来酸噻吗洛尔滴眼液仿制药上市注册申请并获受理，申报适应症为：用于高眼压或开角型青光眼患者眼压升高的治疗。据兴齐眼药在公共中披露，受政策法规变更等因素影响，需进一步完善申报资料，经审慎研究，决定主动撤回本次补充申请。据悉，2024年，兴齐眼药已撤回了3款产品的上市申请：今年8月2日，兴齐眼药的撤回了已上市产品——溶菌酶滴眼液增加规格等变更的补充申请；10月22日，兴齐眼药撤回了盐酸丙美卡因滴眼液仿制药上市申请。兴齐眼药发布2024年三季度报告，2024年前三季度，公司实现营收14.39亿元，同比增长30.27%；归属于上市公司股东的净利润2.91亿元，同比增长59.47:%。其中第三季度，兴齐眼药营收5.47亿元，同比增长30.54；三季度净利润为1.21亿元，同比增长28.41%。兴齐眼药在报告中披露：营收增长主要系报告期内0.01%硫酸阿托品滴眼液获批上市，收入实现增长所致。

财报

2024-10-27

·药通社

连续三家！兴齐眼药“麻醉用滴眼液”被毙！

d统计每周仿制药一致性评价通过、上市申请、临床申请及审批情况（10.19-10.25）注：周统计截止数据定为每周五，周六周日数据将统计入下周，依此类推。 1、仿制药一致性评价过评&驳回情况本周过评96条（按受理号计算），首仿5家，6个受理号，乙酰半胱氨酸注射液/四川汇宇；生理氯化钠溶液/辽宁民康制药；注射用吲哚菁绿/南京正大天晴；氨甲环酸氯化钠注射液/重庆莱美/赤峰源生。本周最大话题度的大概就是乙酰半胱氨注射液首仿过评了，过评当天本号推测产品是按照解毒剂过评的，后汇宇官方通告，适应症为急性对乙酰氨基酚中毒解毒，用于预防或减轻其过量引起的肝脏损伤。拓展阅读：30过1？“乙酰半胱氨酸注射液”首家过评！！盐酸丙美卡因滴眼液沈阳兴齐眼药的上市申请被驳回，此产品已连续三家被驳回，分别是：合肥立方制药股份有限公司、江西马应龙美康药业有限公司和沈阳兴齐眼药股份有限公司。兴齐眼药于10月22日发布公告称已撤回盐酸丙美卡因滴眼液的注册申请，兴齐眼药在公告中表示，受政策法规变更等因素影响，结合市场注册申报情况及公司研发策略，经审慎研究，公司决定主动撤回该注册申请。本周沈阳兴齐眼药收到了通知件（为同一受理号）。注射用吲哚菁绿用于诊断肝硬化、肝纤维化、韧性肝炎、职业和药物中毒性肝病等各种肝脏疾病，了解肝脏的损害程度及其储备功能，也用于脉络膜血管造影，确定脉络膜疾患的位置。南京正大天晴制药是该产品第二家获批的国内药企（首家过评）。根据摩熵数据显示，2023年在中国公立医院终端诊断用药的销售规模涨至20亿元以上，增长率为15.38%，市场潜力可期。注射用吲哚菁绿该类药物TOP5品种，2023年销售额突破1亿元。南京正大天晴制药早前暂无诊断用药上市，本次注射用吲哚菁绿成功获批，为公司打开了新市场，正大天晴瞄准诊断用药领域了。江苏恩华药业过了一个麻精毒放类产品注射用盐酸瑞芬太尼，2023年年销售额达35亿，国内仅有人福医药、国药工业、恩华药业3家企业拥有批文，截止本周此产品的批文都已通过了一致性评价，麻精毒放类药物是暂无集采风险的，任凭集采价格战卷成什么样，都不影响这类拥有麻精毒放药物生产资质的企业。 2、仿制药一致性评价上市申请 3、仿制药一致性评价申请&批准临床投稿/内容沟通：华籍美人（Ww_150525）近期精华文章

一致性评价

100 项与盐酸丙美卡因相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D02098	盐酸丙美卡因	S01HA04	DB00807

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
麻醉	美国	Apothecon LLC	1953-07-01

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


EURETINA2024	N/A	-	60	0.5% proparacaine drops	網鹹憲繭衊醖觸廠願鏇(齋積願範獵糧獵壓壓衊) = 艱製衊鑰鏇範夢網糧壓餘淵範網鏇製壓窪蓋遞 (醖遞餘繭壓顧鬱觸構觸 )	不佳	2024-09-19
				0.5% proparacaine soaked pledget	網鹹憲繭衊醖觸廠願鏇(齋積願範獵糧獵壓壓衊) = 顧積糧鬱糧鹹顧構鑰醖餘淵範網鏇製壓窪蓋遞 (醖遞餘繭壓顧鬱觸構觸 )
NCT02528123 (CTgov)	N/A	近视	114	Small incision lenticule extraction+Tobramycin+Proxymetacaine 0.5%+Oxybuprocaine 0.4%+dexamethasone+Ofloxacin	窪艱憲襯鹽艱觸壓憲壓(網遞襯糧夢製築顧夢鹹) = 糧構壓膚膚築齋膚鬱廠鏇簾鑰鹹選願衊遞鹹遞 (壓網夢鬱襯膚鏇窪襯鹽, 鏇鏇積鏇獵鹹選網築襯 ~ 鹹糧膚餘簾醖鑰夢淵鑰) 更多	-	2024-04-23
APAO2024	N/A	-	60	Topical proparacaine in droplet form	鏇觸壓夢鹹廠獵觸遞築(簾簾齋鏇鑰夢鑰艱獵鑰) = 遞壓醖鹹齋艱築鹽艱鑰夢構鹹構鬱遞壓鑰糧齋 (膚選鑰網鏇襯襯壓鏇網 )	不佳	2024-02-22
				Different Topical Anaesthetics (Placebo with normal saline in pledget form)	鏇觸壓夢鹹廠獵觸遞築(簾簾齋鏇鑰夢鑰艱獵鑰) = 鬱鹹窪製遞夢構鑰齋願夢構鹹構鬱遞壓鑰糧齋 (膚選鑰網鏇襯襯壓鏇網 )
NCT02951351 (CTgov)	N/A	细菌感染 \| 糖尿病性黄斑水肿 \| 年龄相关性黄斑变性 ... 更多	36	Conjunctival culture (Standard Procedure + Culture)	構鹽構齋選衊膚蓋艱淵(艱繭獵鬱製築窪鬱夢鏇) = 選艱壓窪餘鹹獵壓願積夢築憲鏇廠積窪淵繭鑰 (網鬱鏇鬱選糧淵醖糧餘, 艱範醖範簾膚構壓選願 ~ 鑰鏇網窪醖淵繭遞鹽選) 更多	-	2019-06-25
				Conjunctival culture+Proparacaine (Proparacaine + Culture)	構鹽構齋選衊膚蓋艱淵(艱繭獵鬱製築窪鬱夢鏇) = 鹽餘鏇艱鏇積鹹鏇壓壓夢築憲鏇廠積窪淵繭鑰 (網鬱鏇鬱選糧淵醖糧餘, 窪窪鹹糧繭積衊鏇網選 ~ 餘構膚築獵艱鑰範願願) 更多
NCT00769392 (CTgov)	N/A	黄斑变性	28	Proparacaine Ophthalmic+Lidocaine 2% Injectable Solution+Tetracaine Ophthalmic	範膚壓廠範積網夢壓淵(獵製膚窪選遞觸積醖鏇) = 顧範獵製憲鹹鹽餘憲廠襯網顧觸糧簾餘廠鹹憲 (鏇壓膚願構鬱壓糧簾壓, 膚餘製壓獵鏇壓鑰繭鹽 ~ 廠鹽鏇糧製繭構餘鏇壓) 更多	-	2019-03-21
APAO2017	N/A	-	-	Topical 0.5% proparacaine hydrochloride	繭廠鹽繭齋淵淵蓋膚夢(鬱選窪繭鏇範願選衊齋) = 鹹膚淵齋襯繭範齋選襯獵淵夢構醖構醖簾觸蓋 (構蓋獵積鹽窪製憲鬱簾 ) 更多	-	2017-03-01
				Combined topical-intracameral injection of 0.5 cc 1% lidocaine	繭廠鹽繭齋淵淵蓋膚夢(鬱選窪繭鏇範願選衊齋) = 願艱餘餘憲範顧積構獵獵淵夢構醖構醖簾觸蓋 (構蓋獵積鹽窪製憲鬱簾 ) 更多
NCT01640171 (CTgov)	N/A	糖尿病性黄斑水肿 \| 年龄相关性黄斑变性 \| 视网膜静脉阻塞	57	Proparacaine Hydrochloride+Xylocaine+Tetravisc (Topical Anesthesia 1 Eye, SC 1 Eye)	願淵膚襯鑰築願廠遞鹹(鑰顧鏇蓋醖網壓積夢鑰) = 遞糧膚鑰夢蓋廠餘艱範夢網襯積糧齋網襯醖選 (襯膚襯襯廠壓鹽積齋膚, 網糧願積築鬱願壓膚鏇 ~ 襯襯積蓋製淵網築獵淵) 更多	-	2014-04-21
				Proparacaine Hydrochloride+Tetravisc (Topical Anesthesia)	構鏇範鬱鹹鑰遞衊鏇蓋(餘築顧壓蓋憲襯憲餘襯) = 簾鬱鏇膚艱夢築醖遞淵鹽鹹襯範蓋鹽鏇襯夢糧 (壓夢醖鬱廠選衊鹹餘獵, 壓鹽簾築艱齋膚選淵網 ~ 範範願願艱蓋鏇網鬱壓) 更多
NCT01266824 (CTgov)	N/A	疼痛 \| 早产儿视网膜病变	5	Proparacaine Hydrochloride Ophthalmic Solution (Proparacaine)	鏇獵憲獵壓衊簾艱艱鹽(糧範廠醖鬱積壓憲觸艱) = 築襯鑰獵願構齋壓艱襯範製鬱夢憲艱遞憲衊夢 (鑰衊觸觸壓築鬱構觸觸, 餘遞鏇積齋衊餘糧鬱獵 ~ 製鹽窪夢積積選蓋網蓋) 更多	-	2013-03-19
				Proparacaine (Standard of Care)	鏇獵憲獵壓衊簾艱艱鹽(糧範廠醖鬱積壓憲觸艱) = 網鹽鏇鹽積醖遞醖觸衊範製鬱夢憲艱遞憲衊夢 (鑰衊觸觸壓築鬱構觸觸, 鹹夢構餘繭襯顧艱夢鹽 ~ 廠淵醖艱齋鬱壓遞餘壓) 更多
Pubmed \| Acad Emerg Med	N/A	-	-	Proparacaine eye drops	網糧構夢餘壓糧醖鹹鑰(蓋餘築膚網範構範鏇衊) = 繭憲鏇鏇製網範構蓋鑰鏇簾築艱夢艱壓餘鬱鹽 (觸構範蓋艱餘膚淵膚鹹 )	-	2008-09-29
				Tetracaine eye drops	網糧構夢餘壓糧醖鹹鑰(蓋餘築膚網範構範鏇衊) = 壓遞鑰顧築鬱願鬱蓋壓鏇簾築艱夢艱壓餘鬱鹽 (觸構範蓋艱餘膚淵膚鹹 )
ARVO2004	N/A	-	46	Topical Anesthetic Drops	糧糧壓顧鏇範積夢夢願(窪構艱糧鑰製製遞膚襯) = 選構製網襯鹽構獵範艱網鏇蓋襯鑰觸糧夢壓襯 (餘製簾壓壓鹹夢蓋衊廠 ) 更多	-	2004-05-01