更新于：2024-12-17

Phenylephrine Hydrochloride

盐酸去氧肾上腺素

更新于：2024-12-17

概要

概要

基本信息

简介苯肾上腺素是一种小分子药物，其作用为α-1肾上腺素能受体激动剂。它主要用于扩张眼瞳以进行眼科检查和手术。通过与虹膜扩张肌中的α-1肾上腺素受体结合，苯肾上腺素盐酸盐引起肌肉收缩，导致瞳孔扩张。这种药物通常用于眼科诊断，例如检查视网膜或测量眼内压。苯肾上腺素盐酸盐以滴眼剂的形式局部给药，通常在10到20分钟内起效，扩张效果可持续数小时

药物类型

小分子化药

别名

(-)-m-hydroxy-α-(methylaminomethyl)benzyl alcohol、fenilefrine、l-(3-Hydroxyphenyl)-N-methylethanolamine

+ [21]

靶点

ADRA1

作用机制

ADRA1激动剂(肾上腺素能受体α-1家族激动剂)

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

Paragon BioTeck, Inc.

Exela Pharma Sciences LLCHikma Pharmaceuticals USA, Inc.

+ [5]

非在研机构

S.L.A. Pharma AG

University of Wisconsin

RDD Pharma Ltd.

最高研发阶段批准上市

首次获批日期

日本 (1954-10-11),

低血压休克心动过速

最高研发阶段(中国)批准上市

特殊审评孤儿药 (欧盟)

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结构

分子式C9H14ClNO2

InChIKeyOCYSGIYOVXAGKQ-FVGYRXGTSA-N

CAS号61-76-7

关联

355

项与盐酸去氧肾上腺素相关的临床试验

NCT06151470 / Not yet recruitingN/AIIT

90% Effective Dose of Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment in Preeclamptic Patients During Cesarean Section

The objective of this study is to investigate the 90% effective dose of phenylephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section

开始日期2025-07-01

申办/合作机构

宁夏医科大学总医院

NCT06158035 / Not yet recruitingN/AIIT

ED90 of Norepinephrine and Phenylephrine Boluses for Treating Postspinal Anesthesia Hypotension Under Intensive Treatment in Preeclamptic Patients During Cesarean Section

The objective of this study is to investigate the ED90 of norepinephrine and phenylephrine boluses for treating postspinal anesthesia hypotension under intensive treatment in preeclamptic patients during cesarean section

开始日期2025-07-01

申办/合作机构

宁夏医科大学总医院

NCT06151522 / Not yet recruitingN/AIIT

90% Effective Dose of Phenylephrine Infusions for Preventing Postspinal Anesthesia Hypotension Under Intensive and Standard Treatment During Cesarean Section

开始日期2025-04-01

申办/合作机构

宁夏医科大学总医院

100 项与盐酸去氧肾上腺素相关的临床结果

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100 项与盐酸去氧肾上腺素相关的转化医学

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100 项与盐酸去氧肾上腺素相关的专利（医药）

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16,662

项与盐酸去氧肾上腺素相关的文献（医药）

2025-02-01·INTERNATIONAL JOURNAL OF OBSTETRIC ANESTHESIA

Anesthetic management for fetal surgery: Lessons from a single-center experience (2019–2023)

Article

作者: Idelson, A. ; Tenenbaum-Gavish, K. ; Fein, S. ; Idelson, A ; Fein, S ; Duvdevani, N R ; Duvdevani, N.R. ; Faruja, A. ; Azem, K ; Orbach-Zinger, S. ; Gielchinsky, Y ; Tenenbaum-Gavish, K ; Faruja, A ; Gielchinsky, Y. ; Orbach-Zinger, S ; Azem, K. ; Yosef, L. ; Yosef, L

Fetal surgery presents distinctive anesthetic challenges due to the need to balance maternal and fetal safety. This retrospective study evaluates the anesthetic management strategies used at a single center for various fetal interventions, including fetoscopic laser photocoagulation, fetal endoluminal tracheal occlusion, bipolar cord coagulation, and fetoscopic spina bifida repair. We reviewed 195 fetal procedures performed between 2019 and 2023 at Rabin Medical Center. Data collected included maternal and fetal characteristics, anesthetic techniques (spinal, combined spinal-epidural, general), intraoperative hypotension, and perioperative complications. We examined the evolution of anesthetic practice, particularly focusing on hemodynamic management and postoperative pain control. Spinal anesthesia was increasingly preferred for shorter procedures such as fetoscopic laser photocoagulation and bipolar cord coagulation, while general anesthesia was used exclusively for spina bifida repair. Intraoperative hypotension was a significant issue, leading to the implementation of prophylactic phenylephrine infusions, which improved blood pressure control. A shift from volatile anesthesia to total intravenous anesthesia in spina bifida repair resulted in fewer complications, including reduced bleeding. Postoperative pain management was optimized with a multimodal approach, improving pain scores. This study underscores the importance of tailoring anesthetic techniques to the specific fetal surgery. Key improvements in hypotension management, adopting total intravenous anesthesia for complex surgeries, and optimized postoperative pain control have contributed to better maternal and fetal outcomes. Ongoing reassessment and adaptation of anesthetic protocols remain critical as fetal surgery evolves.

2025-02-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY

Green spectrophotometric approaches applied to tertiary mixture for management of common cold and COVID-19 symptoms

Article

作者: Soliman, Rabab M. ; Mostafa, Nadia M ; Rostom, Yasmin ; Soliman, Rabab M ; Mostafa, Nadia M. ; Fayez, Yasmin M. ; Fayez, Yasmin M ; Monir, Hany H. ; Monir, Hany H

Recently, cold and cough dosage forms have gained significant attention due to their use in the supportive protocols for managing COVID-19 symptoms. In this study, a pharmaceutical formulation containing Paracetamol (PAR), Guaifenesin (GUA), and Phenylephrine hydrochloride (PHE) was investigated for spectral resolution and quantification using advanced spectrophotometric methods. The spectra of these components were significantly overlapped and present in their combined tablet in a challenging ratio of 250:100:5 for PAR, GUA, and PHE, respectively. The established approaches were employed for the simultaneous determination of these drugs in their pharmaceutical formulation without interference from matrix excipients. The study involved various manipulation steps, allowing each component in the combination to be analyzed by more than one approach. Integrating these methods with smart mathematical techniques, the issue of spectral data overlap was resolved without the need for preliminary separation steps. The developed methods are dual wavelength, first derivative, derivative ratio, ratio difference, constant center coupled with spectrum subtraction, and constant multiplication paired with spectrum subtraction. The proposed methods were linear over the concentration range of 3.0-35.0 μg/mL for GUA and 3.0-30.0 μg/mL for PHE. While the PAR ranges for the first derivative and constant multiplication methods were 2.5-35.0 μg/mL and 2.5-25.0 μg/mL, respectively. Excellent linearity of the suggested methods was demonstrated by the high correlation coefficients (R2), ≥ 0.9998 for all the tested compounds. These methodologies were validated according to ICH guidelines. Validation results demonstrated excellent accuracy, with recovery percentages ranging from 98 to 102 %, and precision, with RSD values less than 2 %. The obtained results were statistically compared with the official ones using F-test, Student's t-test, and one-way ANOVA, revealing no significant differences. The proposed methods are accurate, green, smart, fast, and cost-effective. Their compliance with Green Analytical Chemistry principles was evaluated and compared to a published method using various tools to enable a more holistic evaluation from different perspectives. The promising results revealed that the investigated methods are superior green alternatives for routine analysis of the cited drugs in laboratories with limited resources and without access to expensive instruments.

2025-01-01·COMPUTER METHODS AND PROGRAMS IN BIOMEDICINE

Effect of myogenic tone on agonist-mediated vasoconstriction in isolated arteries: A computational study

Article

作者: Pradhan, Ranjan K ; Pradhan, Ranjan K.

BACKGROUND AND OBJECTIVE:

Vasoconstriction of the resistance artery is mainly determined by an integrated action of multiple local stimuli acting on the vascular smooth muscle cells, which include neuronal delivery of α-adrenoceptor agonists and intraluminal pressure. The contractile activity of the arterial wall has been extensively studied ex vivo using isolated arterial preparations and myography techniques. However, agonist-mediated vasoconstriction response is often confounded by local effects of other stimuli (e.g., pressure) and, it remained unclear whether the pressure-induced myogenic response has any implication on the efficacy of agonist-mediated vasoconstriction during blood flow regulation in tissues. A quantitative understanding of the influence of each stimulus is necessary to understand the interaction between multiple regulatory mechanisms, which is required to ensure timely oxygen delivery to meet tissue needs.

METHODS:

We developed a simple empirical model of isolated vessel vasoreactivity that includes passive vessel wall mechanics and a lumped representation of active smooth muscle activation as a function of agonist concentration and pressure. Pressure myograph data in dog renal arterioles and rat femoral arterioles, isovolumic myograph data in rat femoral arteries, and vasoactive data in rat skeletal muscle arterioles were analyzed using the model. The effect of physiological pressure changes on the sensitivities of vascular segments to adrenergic agonists phenylephrine and norepinephrine was evaluated.

RESULTS:

Model-based analysis of isolated vasoreactivity data, obtained due to changes in pressure and vasoconstricting agonists revealed that the strength of myogenic response of a resistance vessel has a strong influence on the sensitivity and dynamics of agonist response. An increase in intraluminal pressure was found to reduce the magnitude of agonist-mediated tone by lowering the sensitivity of the vessel segment to agonist. The passive mechanical properties of arterial wall considearably influence the agonist-mediated contraction in isolated arteries. These results demonstrate how passive vessel wall mechanics may dominate the vasoactive responses of the common myogenic and adrenergic pathways of smooth muscle contraction in blood flow regulation, supporting a long standing notion that there exists segment-specific vasoregulation in microvascular networks of various tissues.

CONCLUSION:

The present model provides a simple and powerful tool for quantifying ex vivo vasoreactivity of asolated arteries to qualitatively study the interaction between myogenic and α-adrenergic control of vascular tone in isolated vessels. Analysis of pressure myography data and isovolumic myography data in different sizes of vessels and tissues, in response to norepinephrine and phenylephrine revealed the importance of passive vessel mechanics in arteriolar vasomotion and setting up of basal vasomotor tone at single vessel-level. The present study will be useful to quantify the extent to which myogenic tone may influence agonist-mediated vasoconstriction and agonist effect on pressure-mediated myogenic response in microvascular networks during blood flow regulation in tissues.

229

项与盐酸去氧肾上腺素相关的新闻（医药）

2024-12-15

·信狐药迅

仿制药上市申请11个、进口申请1个品规收到通知件；临床申请品种均默示许可| 新获批(12.9-12.15）

每周药品注册获批数据，分门别类呈现，一目了然。(12.9-12.15）新药上市申请无新药临床申请药品名称企业注册分类受理号HS-10384片常州恒邦药业有限公司1CXHL2401054HS-10384片常州恒邦药业有限公司1CXHL2401053CA1257胶囊南京中澳转化医学研究院有限公司1CXHL2401034CA1257胶囊南京中澳转化医学研究院有限公司1CXHL2401033CA1257胶囊南京中澳转化医学研究院有限公司1CXHL2401032GP-2102乳膏南京济群医药科技股份有限公司1CXHL2401023GP-2102乳膏南京济群医药科技股份有限公司1CXHL2401022伊匹乌肽滴鼻剂益承康泰(厦门)生物科技有限公司1CXHL2401019JMKX003948滴眼液上海济煜医药科技有限公司1CXHL2400989JMKX003948滴眼液上海济煜医药科技有限公司1CXHL2400988JMKX003948滴眼液上海济煜医药科技有限公司1CXHL2400987JMKX003948滴眼液上海济煜医药科技有限公司1CXHL24009861646A干混悬剂普照国康(湖北)药业有限公司2.2CXHL2401037TTYP01片上海澳宗生物科技有限公司2.2CXHL2400971TTYP01片上海澳宗生物科技有限公司2.2CXHL2400970布瑞哌唑口溶膜深圳市宇健生物医药有限公司2.2CXHL2400966布瑞哌唑口溶膜深圳市宇健生物医药有限公司2.2CXHL2400965地塞米松棕榈酸酯注射液广州绿十字制药股份有限公司2.4CXHL2401026注射用盐酸曲拉西利海南先声再明医药股份有限公司2.4CXHL2400994注射用盐酸曲拉西利海南先声再明医药股份有限公司2.4CXHL2400993复制缺陷型猴痘疫苗北京生物制品研究所有限责任公司1.2CXSL2400627重组呼吸道合胞病毒疫苗(CHO细胞)广州派诺生物技术有限公司1.2CXSL2400622重组呼吸道合胞病毒疫苗(CHO细胞)广州派诺生物技术有限公司1.2CXSL2400620注射用ZW25百济神州(苏州)生物科技有限公司1CXSL2400688HCB101注射液广州汉科生物有限公司1CXSL2400683注射用MHB036C明慧医药(杭州)有限公司1CXSL2400679注射用MHB036C明慧医药(杭州)有限公司1CXSL2400678注射用SHR-1681苏州盛迪亚生物医药有限公司1CXSL2400677EXG110注射液杭州嘉因生物科技有限公司1CXSL2400611 仿制药申请药品名称企业注册分类受理号甘油果糖氯化钠注射液江苏亚尧生物科技有限公司3CYHS2400653小儿复方氨基酸注射液(19AA-I)四川科伦药业股份有限公司3CYHS2400483吸入用盐酸氨溴索溶液北京韩美药品有限公司3CYHS2400419注射用硫酸多黏菌素B深圳华药南方制药有限公司3CYHS2400398阿伐那非片扬州市三药制药有限公司3CYHS2400348法莫替丁注射液江苏瑜兴医药科技有限公司3CYHS2302215布美他尼注射液杭州沐源生物医药科技有限公司3CYHS2301876地氯雷他定口服溶液岳阳新华达制药有限公司3CYHS2301748盐酸丙卡特罗口服溶液广东稳健药业有限公司3CYHS2301636盐酸丙卡特罗口服溶液广东稳健药业有限公司3CYHS2301635门冬氨酸钾注射液山东华鲁制药有限公司3CYHS2301622硫酸镁注射液金陵药业股份有限公司南京金陵制药厂3CYHS2301554盐酸多巴胺注射液仁合益康集团有限公司3CYHS2301335盐酸去氧肾上腺素注射液山东威智百科药业有限公司3CYHS2301113单硝酸异山梨酯缓释片鲁南制药集团股份有限公司3CYHS2300926氨溴特罗口服溶液海南天盛保和生物科技有限公司3CYHS2300746盐酸去氧肾上腺素注射液广州维奥康药业科技有限公司3CYHS2300680生理氯化钠溶液吉林省都邦药业股份有限公司3CYHS2300148洛度沙胺氨丁三醇滴眼液武汉先路医药科技股份有限公司3CYHS2200415国;CYHS2200415甲钴胺片海南倍吉康医药科技有限公司4CYHS2400594硫酸氨基葡萄糖胶囊海南斯达制药有限公司4CYHS2302902丙戊酸钠缓释片(I)湖南省湘中制药有限公司4CYHS2302854头孢泊肟酯片国药集团致君(深圳)制药有限公司4CYHS2302800二甲双胍恩格列净片(I)浙江华海药业股份有限公司4CYHS2302731氧(液态)昆明安宁梅塞尔气体产品有限公司4CYHS2302656卡铂注射液四川百利药业有限责任公司4CYHS2302625二甲双胍恩格列净片(VI)重庆希韦医药科技有限公司4CYHS2302607二甲双胍恩格列净片(I)重庆希韦医药科技有限公司4CYHS2302606骨化三醇注射液南京海融制药有限公司4CYHS2302587骨化三醇注射液南京海融制药有限公司4CYHS2302586注射用氯诺昔康浙江佰奥医药科技有限公司4CYHS2302345盐酸乌拉地尔注射液吉林四长制药有限公司4CYHS2302294地拉罗司分散片石家庄四药有限公司4CYHS2302285甲磺酸艾立布林注射液正大天晴药业集团股份有限公司4CYHS2302221碘普罗胺注射液杭州沐源生物医药科技有限公司4CYHS2302202盐酸乌拉地尔注射液山西德元堂药业有限公司4CYHS2302189盐酸乌拉地尔注射液山西德元堂药业有限公司4CYHS2302188布洛芬混悬液江苏万高药业股份有限公司4CYHS2302105硫酸镁钠钾口服用浓溶液浙江恒研医药科技有限公司4CYHS2302015注射用头孢他啶阿维巴坦钠苏州二叶制药有限公司4CYHS2301942左氧氟沙星氯化钠注射液石药银湖制药有限公司4CYHS2301924盐酸达泊西汀片武汉华尔生物科技有限公司4CYHS2301919依托咪酯中/长链脂肪乳注射液宜昌人福药业有限责任公司4CYHS2301866硫酸镁钠钾口服用浓溶液重庆健能医药开发有限公司4CYHS2301751依西美坦片上海安必生制药技术有限公司4CYHS2301726缬沙坦氨氯地平片(I)湖北午时药业股份有限公司4CYHS2301728罗库溴铵注射液华中药业股份有限公司4CYHS2301680罗库溴铵注射液华中药业股份有限公司4CYHS2301679硫酸氨基葡萄糖胶囊安徽省先锋制药有限公司4CYHS2301512小儿法罗培南钠颗粒济川药业集团有限公司4CYHS2301479司来帕格片杭州朱养心药业有限公司4CYHS2301459司来帕格片杭州朱养心药业有限公司4CYHS2301458司来帕格片杭州朱养心药业有限公司4CYHS2301457西甲硅油乳剂山东新鲁医药科技有限公司4CYHS2301364瑞巴派特片杭州奥默医药股份有限公司4CYHS2301236利丙双卡因乳膏河北新张药股份有限公司4CYHS2300553利丙双卡因乳膏杭州领业医药科技有限公司4CYHS2300507拉考沙胺注射液亿药通(河北)生物科技有限公司4CYHS2300033国;CYHS2300033拉考沙胺注射液亿药通(河北)生物科技有限公司4CYHS2300032国;CYHS2300032利丙双卡因乳膏海南紫程众投生物科技有限公司4CYHS2201788国;CYHS2201788司来帕格片常州恒邦药业有限公司4CYHS2101337国;CYHS2101337司来帕格片常州恒邦药业有限公司4CYHS2101338国;CYHS2101338注射用盐酸兰地洛尔山东化药医药科技有限公司3CYHL2400199琥珀酰明胶电解质醋酸钠注射液吉林省长源药业有限公司4CYHL2400193 进口申请药品名称企业注册分类受理号注射用牛肺表面活性剂Lyomark Pharma GmbH5.1JXHS2400028Vamorolone口服混悬液Santhera Pharmaceuticals (Deutschland) GmbH5.1JXHS2400026多替诺雷片FUJI YAKUHIN CO., LTD.5.1JXHS2400008多替诺雷片FUJI YAKUHIN CO., LTD.5.1JXHS2400007玻璃酸钠滴眼液URSAPHARM Arzneimittel GmbH5.1JXHS2200036国;JXHS2200036帕博利珠单抗注射液Merck Sharp & Dohme LLC2.2JXSS2300085注射用利纳西普Kiniksa Pharmaceuticals (UK), Ltd.3.1JXSS2400016注射用泰朗妥昔单抗ADC Therapeutics SA3.1JXSS2300057左炔诺孕酮片EXELTIS HEALTHCARE S.L.5.2JYHS2300010碳酸镧咀嚼片Natco Pharma Limited5.2JXHS2000108国;JXHS2000108碳酸镧咀嚼片Natco Pharma Limited5.2JXHS2000107国;JXHS2000107JNJ-77242113-AAC片Janssen Research & Development, LLC1JXHL2400267DD01注射液Neuraly Inc.1JXHL2400241Sotorasib 片Amgen Inc.2.4JXHL2400234ABBV-400注射用粉末AbbVie Inc.1JXSL2400191MEDI5752AstraZeneca AB1JXSL2400187JNJ-81201887Janssen Research & Development, LLC1JXSL2400180JNJ-81201887Janssen Research & Development, LLC1JXSL2400181 中药相关申请药品名称企业注册分类受理号柴金散结颗粒广东凯仲生物科技有限公司1.1CXZL2400064连花御屏颗粒北京以岭药业有限公司1.1CXZL2400063感咳颗粒盈科瑞(天津)创新医药研究有限公司1.1CXZL2400061参葛颗粒盈科瑞(天津)创新医药研究有限公司1.1CXZL2400060十味疏风颗粒山东省药学科学院1.1CXZL2400055 注：橙色字体部分结论为不批准或收到通知件；

疫苗申请上市临床申请

2024-12-11

·米内网

苑东口服止痛药剑指国产首家！拿下12个重磅新品，高端仿制药、1类新药……抢攻千亿市场

精彩内容近期，苑东生物新品捷报频传。CDE官网显示，成都苑东生物制药的硫酸吗啡盐酸纳曲酮缓释胶囊和维生素K1注射液报产在审，在此之前，磷酸芦可替尼片拿下首仿，枸橼酸钾缓释片是国产第3家和首家过评。苑东生物近年来保持高研发投入，打造差异化、前瞻性产品管线。今年以来，公司已有12个高端仿制药获批上市，截至目前过评品种已有超过40个；盐酸尼卡地平注射液拿下美国ANDA批件，是公司第2个制剂出海产品。此外，公司有22个产品报产在审，其中14个在今年报产；超10个1类新药在研。口服止痛药剑指国产首家，5亿注射剂冲刺首家过评日前，CDE官网显示，成都苑东生物制药的硫酸吗啡盐酸纳曲酮缓释胶囊和维生素K1注射液均以仿制3类报产在审，获批后视同过评。硫酸吗啡盐酸纳曲酮缓释胶囊用于严重到需要每天、连续不断、长期阿片类药物治疗且替代选择不充分的疼痛的治疗，可持续24小时缓解疼痛，并可有效防止阿片类药物引发的滥用问题。目前，该产品并无企业获批，仅有成都苑东生物制药报产在审。维生素K1注射液用于维生素K缺乏引起的出血，如梗阻性黄疸、胆瘘、慢性腹泻等所致出血，香豆素类、水杨酸钠等所致的低凝血酶原血症，新生儿出血以及长期应用广谱抗生素所致的体内维生素K缺乏。米内网数据显示，维生素K1注射液在2023年中国三大终端六大市场销售规模超过5亿元，目前有13家企业拥有生产批文，暂无企业过评，6家企业报产在审，其中成都苑东生物制药、齐鲁制药(海南)、石家庄四药等5家均在今年报产。今年以来，苑东生物已有14个产品报产在审，氨酚羟考酮缓释片为改良型新药，硫酸吗啡盐酸纳曲酮缓释胶囊、布瑞哌唑片、盐酸纳呋拉啡口崩片有望拿下首仿。拿下12个重磅新品！第2个制剂扬帆出海，超40款过评产品亮眼 11月22日，苑东生物连发两则公告，公司的磷酸芦可替尼片和其全资子公司成都硕德药业的枸橼酸钾缓释片均以新分类报产获批。来源：米内网一键检索芦可替尼是Incyte开发的的一款JAK1/JAK2抑制剂，用于治疗骨髓纤维化、移植物抗宿主病等，2023年全球销售额超过40亿美元。米内网数据显示，磷酸芦可替尼片在2023年中国三大终端六大市场销售规模超过7亿元，2024年上半年同比增长近10%。目前，该产品仅1家企业拥有生产批文，成都苑东生物制药为国内首家仿制药获批上市，南京正大天晴制药、山东新时代药业、青峰医药等7家企业报产在审。枸橼酸钾缓释片用于肾小管性酸中毒伴钙结石、任何病因引起的低枸橼酸尿所致的草酸钙肾结石、伴有或不伴有钙结石的尿酸结石。米内网数据显示，枸橼酸钾缓释片在近年中国三大终端六大市场销售规模快速增长，2022年-2024年上半年分别同比增长258.20%、41.00%、59.03%，而2024年上半年销售额已超过2022年全年，潜力惊人。目前，该产品有3家企业拥有生产批文，仅成都硕德药业过评。苑东生物今年以来获批产品来源：米内网中国申报进度（MED）数据库今年以来，苑东生物已有12个产品获批上市，数量超过2023年全年。其中，磷酸芦可替尼片、比索洛尔氨氯地平片为首仿，奥卡西平口服混悬液为国产第2家，贝前列素钠片和枸橼酸钾缓释片为国产第3家。值得一提的是，盐酸尼卡地平注射液拿下美国ANDA批件，是苑东生物继盐酸纳美芬注射液后第2个制剂出海产品，迎来公司国际化战略的又一里程碑。苑东生物表示，此次盐酸尼卡地平注射液获批，在丰富公司国际化的产品管线同时，进一步加快国际化战略的实施步伐，对公司经营发展具有积极作用。苑东生物通过/视同通过一致性评价品种来源：米内网一致性评价数据库目前，苑东生物已有超过40个产品通过/视同通过一致性评价，其中，伊班膦酸钠注射液、布洛芬注射液、盐酸纳洛酮注射液、瑞格列奈二甲双胍片(Ⅰ)、盐酸去氧肾上腺素注射液等超过10个首家过评。在前九批国采中，苑东生物有10个产品中标，多个产品的市场份额位居前列，其中，伊班膦酸钠注射液、依托考昔片、枸橼酸咖啡因注射液、盐酸法舒地尔注射液在2024年上半年中国公立医疗机构终端苑东生物的市场份额均位居第一。12月12日，第十批国采即将开标，苑东生物有注射用尼可地尔、舒更葡糖钠注射液等6个过评品种符合申报资格，如公司顺利中标则有望快速抢占市场。重磅新品不断，高端仿制药、1类新药……抢攻千亿市场苑东生物报产在审产品情况来源：米内网中国申报进度（MED）数据库苑东生物近年来保持高研发投入，打造差异化、前瞻性产品管线，平均占比在20%以上，高于行业平均水平，2024年前三季度研发投入超过2亿元，同比增长19.76%。截至目前，苑东生物有22个产品报产在审，涵盖多个治疗大类，包括9个神经系统药物，4个心脑血管系统药物，抗肿瘤和免疫调节剂和肌肉-骨骼系统各有3个，血液和造血系统药物、杂类、呼吸系统用药各有1个。米内网数据显示，抗肿瘤和免疫调节剂、心脑血管系统药物和神经系统药物在2023年中国三大终端六大市场销售规模均超过1000亿元，分别是TOP1、TOP5、TOP6治疗大类。此外，苑东生物有超过10个1类创新药在研，其中，优格列汀片III期单药临床试验已取得临床试验报告并达到预期目标；EP-0108胶囊获CDE临床试验默示许可，用于治疗恶性血液系统肿瘤；EP-0146片获CDE和FDA临床试验默示许可，用于治疗晚期实体瘤；EP-9001A单抗注射液正在进行Ib/II期临床研究。资料来源：米内网数据库等注：米内网《中国三大终端六大市场药品竞争格局》，统计范围是：城市公立医院和县级公立医院、城市社区中心和乡镇卫生院、城市实体药店和网上药店，不含民营医院、私人诊所、村卫生室，不含县乡村药店；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

上市批准医药出海申请上市

2024-11-21

·Business Wire

Nasal Sprays Help Alleviate Nasal Congestion

AMERICAN FORK, Utah--( BUSINESS WIRE )--Today, Nathan Jones, CEO of Xlear Inc., a consumer hygiene products company, released this statement regarding the FDA’s proposal to remove popular over-the-counter decongestants, which contain the drug phenylephrine, from the market: “With the FDA concluding that this common decongestant isn’t effective, as we enter cold and flu season, and as families prepare to celebrate the holidays, many Americans need a new answer for the discomfort of sinus congestion,” Jones noted. “For people looking for help, the U.S. Centers for Disease Control (CDC) Guidance, ‘Relief for Symptoms of Colds and Coughs’, ‘instructions’ say to ‘use saline nasal spray to relieve congestion.’ i Similarly, CDC’s ‘Sinus Infection Basics’ say ‘How to Feel Better’ ‘use a . . . saline nasal spray,’” ii he pointed out. “You experience congestion because there is an irritant or pathogen in your upper airway that your body is trying to trap and wash away—your runny nose is your body flushing it out. Saline-based nasal sprays can help speed up that flushing, reduce pathogen load, and make it more effective. It’s commonsense: The faster the bad stuff is gone, the faster you feel better,” Jones added. “For congestion caused by pathogens—like colds and flus—people can enhance that effect by using a nasal spray that contains xylitol. A series of studies show xylitol (a natural sugar) deactivates and/or blocks the adhesion of many types of viruses and bacteria, to your airway cells,” iii Jones continued. Adhesion is the process by which a pathogen attaches to your tissue to initiate infection. Using a nasal spray with xylitol helps block adhesion of these pathogens. For example, a Randomized Controlled (clinical) Trial published in 2022, determined that a saline-nasal spray containing xylitol and other ingredients reduced the rate of COVID-19 infections by 62 percent above placebo. iv “Using a basic saline would be comparable to rinsing your hands with water; using a nasal spray with xylitol, like Xlear , would be comparable to washing your hands with soap. Expect more from your nasal hygiene products. Make sure they have xylitol so you can better and faster clean out the bad stuff while alleviating the congestion,” Jones added. Xlear nasal spray is a saline-based nasal spray containing xylitol. Xlear 12 Hour Nasal Decongestant is a saline-based nasal spray containing xylitol and the decongestant Oxymetazoline HCL. For more information on Xlear please visit www.xlear.com . ____________________________ i https://www.cdc.gov/antibiotic-use/media/pdfs/HCP-Relief-Colds-Cough-85by11-P.pdf ii https://www.cdc.gov/sinus-infection/about/index.html iii For example: T Kontiokari, M Uhari, M Koskela, Antiadhesive effects of xylitol on otopathogenic bacteria., Journal of Antimicrobial Chemotherapy , Volume 41, Issue 5, May 1998, Pages 563–565, https://academic.oup.com/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext - google_vignette ; Kontiokari, T., Uhari, M., & Koskela, M. (1998). Antiadhesive effects of xylitol on otopathogenic bacteria. The Journal of Antimicrobial Chemotherapy , 41 (5), 563–565, https://academic.oup.com/jac/article-abstract/41/5/563/652694?redirectedFrom=fulltext&login=false ; Jung, Kie Hoon. (2021). Antiviral Efficacy Against Virus Infections in Human-Derived Tracheal/Bronchial Epithelial Cells. Utah State University, https://xlrtmp.com/wp-content/uploads/2023/05/Antiviral-efficacy_USU2021.pdf ; Vega, J. C., et al., (2020). Iota carrageenan and xylitol inhibit SARS-CoV-2 in Vero cell culture. BioRxiv , https://professionals.xlear.com/portfolio/anti-adherence-of-viruses/ ; Ruiz, V., Rodríguez-Cerrato, V., Huelves, L. et al. Adherence of Streptococcus pneumoniae to Polystyrene Plates and Epithelial Cells and the Antiadhesive Potential of Albumin and Xylitol. Pediatr Res 69, 23–27, https://www.nature.com/articles/pr920116 - citeas . iv Damian Balmforth, et al., Evaluating the efficacy and safety of a novel prophylactic nasal spray in the prevention of SARS-CoV-2 infection: A multi-centre, double blind, placebo-controlled, randomised trial., Journal of Clinical Virology, 155; 2022, https://www.sciencedirect.com/science/article/pii/S1386653222001809 .

100 项与盐酸去氧肾上腺素相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00511	盐酸去氧肾上腺素	C01CA06 R01BA03 S01FB01	DB00388

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
麻醉	美国	Dr. Reddy's Laboratories SA	2019-10-21
瞳孔散大	美国	Paragon BioTeck, Inc.	2013-03-21
低血压	日本	Kowa Co., Ltd.	1954-10-11
休克	日本	Kowa Co., Ltd.	1954-10-11
心动过速	日本	Kowa Co., Ltd.	1954-10-11

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
大便失禁	临床3期	英国	S.L.A. Pharma AG	2007-02-01
血管迷走神经性晕厥	临床2期	美国	University of Wisconsin Madison	2021-07-20
肿瘤	临床2期	美国	University of Wisconsin Madison	2015-05-14
放射性口腔黏膜炎	临床2期	美国	University of Wisconsin	2015-05-14
移植并发症	临床2期	美国	University of Wisconsin Madison	2015-05-14
尿失禁	临床2期	以色列	RDD Pharma Ltd.	2009-09-01
粘膜炎	临床1期	美国	University of Wisconsin Madison	2010-03-01
口腔炎	临床1期	美国	University of Wisconsin Madison	2010-03-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


Pubmed \| Int J Obstet Anesth	N/A	-	-	phenylephrine (Intermittent pneumatic compression (IPC))	構網糧願鏇築蓋壓鬱獵(膚淵獵鹽鏇淵膚製膚鹹) = 壓積願艱廠窪窪壓壓遞衊齋艱醖蓋願夢艱顧鹽 (憲製繭製糧觸顧膚獵壓 )	积极	2024-11-01
				phenylephrine (Control (no IPC))	構網糧願鏇築蓋壓鬱獵(膚淵獵鹽鏇淵膚製膚鹹) = 網膚繭夢選夢築鏇願壓衊齋艱醖蓋願夢艱顧鹽 (憲製繭製糧觸顧膚獵壓 )
NCT04419662 (Pubmed \| Acta Anaesthesiol Scand)	临床4期	麻醉	-	Phenylephrine infusion	觸鹽衊願願鹹獵窪壓選(憲獵觸積獵選淵選齋鹹) = 獵製積糧範憲淵糧壓築築蓋衊積繭醖窪簾鏇窪 (製鏇醖顧範膚醖襯範鏇, 3.6 ~ 5.4) 更多	-	2023-08-01
NCT03849508 (Pubmed \| Anesth Analg)	临床4期	麻醉维持	124	Norepinephrine	窪鏇鹽夢淵觸築醖艱選(艱獵範鬱糧選憲獵衊觸): ARD = -2.4 (95% CI, -4.4 ~ -0.5) 更多	积极	2022-10-24
				Phenylephrine
AAO2022	N/A	眼科外科手术	-	Epinephrine alone	構憲餘顧鏇築廠範選齋(襯築願齋艱獵鹹築膚壓) = 衊憲醖獵簾鹽鹽鹽願築選簾夢淵鏇積鏇製範鑰 (網選餘齋網獵鬱遞簾壓 ) 更多	-	2022-09-29
				Omidria (intracameral phenylephrine and ketorolac)	構憲餘顧鏇築廠範選齋(襯築願齋艱獵鹹築膚壓) = 餘襯夢遞鬱範鹽鏇憲願選簾夢淵鏇積鏇製範鑰 (網選餘齋網獵鬱遞簾壓 ) 更多
NCT05439460 (CTgov)	临床4期	肺动脉高压危象 \| 肺动脉高压	15	phenylephrine (Phenylephrine)	憲艱艱繭衊夢壓範繭繭(願憲鑰廠網鏇製簾製廠) = 積膚願鏇壓鹹築鬱遞廠襯願壓夢鑰艱簾齋蓋壓 (鹽選鹹襯願齋廠鬱餘鹽, 製願簾築糧壓窪鬱夢鹽 ~ 艱選鏇觸淵繭衊遞鹹觸) 更多	-	2022-08-05
				Arginine Vasopressin (Arginine Vasopressin)	憲艱艱繭衊夢壓範繭繭(願憲鑰廠網鏇製簾製廠) = 網範鏇淵膚繭膚憲齋夢襯願壓夢鑰艱簾齋蓋壓 (鹽選鹹襯願齋廠鬱餘鹽, 夢蓋衊鑰網夢壓鬱製鏇 ~ 襯齋鹹積築鏇鬱襯顧餘) 更多
NCT00458003 (CTgov)	N/A	子痫前症 \| 低血压	110	Phenylephrine (Phenylephrine)	簾顧壓網製膚餘獵蓋繭(顧鑰選蓋觸獵鹹壓構願) = 鬱廠繭觸築製壓積鹽膚選繭壓衊衊簾憲鑰鹹廠 (蓋衊夢齋積糧範遞鹹願, 壓願膚鹽醖艱廠膚壓夢 ~ 選鹹蓋夢鹽淵鏇蓋鏇襯) 更多	-	2022-06-02
				ephedrine (Ephedrine)	簾顧壓網製膚餘獵蓋繭(顧鑰選蓋觸獵鹹壓構願) = 鹽膚選選鏇壓鏇蓋衊製選繭壓衊衊簾憲鑰鹹廠 (蓋衊夢齋積糧範遞鹹願, 鹽醖簾網衊衊窪遞蓋鹽 ~ 獵鹽齋鹹壓簾齋醖簾夢) 更多
ATS2022	N/A	脓毒性休克	-	Norepinephrine with Phenylephrine	齋艱膚選選齋鬱觸顧艱(醖顧網鹽簾鹽構鑰艱鬱) = 艱鏇艱簾廠網襯鬱構鹽鬱獵壓製壓餘鑰鏇襯鹽 (憲鏇簾蓋壓鏇膚膚獵網, 2.6 ~ 16.2) 更多	-	2022-05-15
				Norepinephrine with Vasopressin	齋艱膚選選齋鬱觸顧艱(醖顧網鹽簾鹽構鑰艱鬱) = 願鏇夢積選醖壓鏇觸網鬱獵壓製壓餘鑰鏇襯鹽 (憲鏇簾蓋壓鏇膚膚獵網, 1.3 ~ 12.1) 更多
AAO2021	临床3期	麻醉	-	Intracameral fixed combination tropicamide 0.02%, phenylephrine 0.31%, lidocaine 1%	膚壓遞壓觸遞蓋膚憲繭(蓋顧顧願餘糧艱艱顧衊) = 廠膚積淵築窪積獵鏇夢選製鹽夢廠願鏇製願齋 (簾壓鑰餘醖簾鹽築獵築 )	积极	2021-11-13
NCT02025426 (CTgov)	临床4期	先兆子痫	13	Phenylephrine (Phenylephrine)	襯壓願範糧遞糧膚蓋衊(構餘餘製鏇夢鬱夢選築) = 鏇網齋築憲膚觸願遞積繭膚膚遞鏇廠鏇築鹽淵 (鑰鏇醖憲觸獵築醖襯衊, 餘膚遞膚艱淵艱餘繭鏇 ~ 觸夢襯鹹築憲鏇簾網鏇) 更多	-	2020-10-14
				Ephedrine (Ephedrine)	襯壓願範糧遞糧膚蓋衊(構餘餘製鏇夢鬱夢選築) = 壓糧願遞蓋夢襯憲壓願繭膚膚遞鏇廠鏇築鹽淵 (鑰鏇醖憲觸獵築醖襯衊, 醖膚憲築簾憲鬱衊憲觸 ~ 襯襯觸鹽網衊範鹽鑰衊) 更多
NCT03615508 (CTgov)	临床4期	霍纳综合征	1	10% phenylephrine	衊鑰艱襯壓觸餘選鹽夢(顧齋範齋醖簾築鬱膚簾) = 襯鹹襯選憲獵積鏇積構願艱鏇繭醖蓋觸夢鬱構 (膚構鏇壓簾願積窪膚憲, 築鏇顧製繭餘襯遞製艱 ~ 齋夢窪鏇齋製鑰網積衊) 更多	-	2020-10-14