更新于：2024-05-16

Diclofenac Sodium

双氯芬酸钠

更新于：2024-05-16

概要

概要

基本信息

简介双氯酚酸钠是苯乙酸衍生物，是一种非甾体抗炎药（NSAID），具有镇痛、抗炎和解热作用。和其他NSAIDs一样，双氯酚酸钠的作用机制尚未完全理解，但涉及抑制环氧化酶（COX-1和COX-2）。FDA于1988年7月28日批准双氯酚酸钠（VOLTAREN ）上市，其原产公司为Ciba-Geigy公司，现已并入诺华。这种药物已经长期用于管理多种疼痛症状，并且有处方和非处方制剂

药物类型

小分子化药

别名

DICLOFENAC、Diclfenac Sodium、Diclofanac Sodium

+ [120]

靶点

COX

作用机制

COX抑制剂(环氧化酶抑制剂)

治疗领域

免疫系统疾病神经系统疾病皮肤和肌肉骨骼疾病+ [5]

在研适应症

滑囊炎颈臂综合征腰痛+ [18]

非在研适应症

光化性角化病贫血踝损伤+ [11]

原研机构

Novartis Pharma AG

在研机构

Hisamitsu Pharmaceutical Co., Inc.

Dojin Iyaku-Kako Co., Ltd.

四川天德制药有限公司

+ [8]

非在研机构

Novartis AG

University of Rijeka

Novartis Pharmaceuticals Corp.

+ [3]

最高研发阶段批准上市

首次获批日期

日本 (1973-08-08),

炎症疼痛

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C14H11Cl2NO2

InChIKeyDCOPUUMXTXDBNB-UHFFFAOYSA-N

CAS号15307-86-5

查看全部结构式(2)

关联

304

项与双氯芬酸钠相关的临床试验

NCT06373978 / Not yet recruiting临床4期

A Randomized Controlled Trial: Alternative Post Procedural Analgesia With NSAIDs vs Opioids in Percutaneous Needle Tenotomy of Elbow

This study is a double-blind, randomized controlled trial comparing the effectiveness of oral Diclofenac and Tramadol in reducing the consumption of narcotic pills (primary outcome) and minimizing patients' exposure to narcotics (secondary outcome) following an ultrasound-guided percutaneous needle tenotomy procedure on the lateral elbow.
The primary objective of this study is to illustrate a reduction in the consumption of narcotic pills following a percutaneous needle tenotomy procedure on the lateral elbow.
The secondary aim is to assess the proportion of patients who have been randomly assigned to Diclofenac and successfully refrain from using the Tramadol rescue medication, measured at the 10 day (+/- 4 days) postoperative mark.
The third objective is to uphold consistent early recovery outcomes as measured by the Patient-Rated Tennis Elbow Evaluation (PRTEE) and Quick Disability of Arm, Shoulder, and Hand (QuickDASH) scores after percutaneous needle tenotomy of the lateral elbow, while also investigating the relationship between resiliency and pain catastrophizing in relation to Tramadol usage and response to Diclofenac.

开始日期2024-06-01

申办/合作机构

The Cleveland Clinic Foundation

NCT06342648 / Not yet recruitingN/AIIT

Comparison Between Intracutaneous Sterile Water and Diclofenac Sodium Injections in Renal Colic: A Randomized Controlled Clinical Trial

Renal colic is a serious and excruciatingly painful condition that frequently presents itself in the emergency department. In this trial, patients with renal colic who have received intramuscular diclofenac sodium injection or intracutaneous sterile water injection will have their Visual Analogue Scale (VAS) measured and compared.

开始日期2024-05-01

申办/合作机构

Suez Canal University

CTRI/2024/04/065803 / Not yet recruiting临床3期IIT

A Randomized Controlled Clinical Trial to Evaluate the Comparative Efficacy of Gudavarti of Trailokya Vijaya Vati with Diclofenac Sodium Suppository for Post-Operative Pain Management in Antra Vriddhi W.S.R. to Inguinal Hernia - NIL

开始日期2024-04-25

申办/合作机构-

100 项与双氯芬酸钠相关的临床结果

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100 项与双氯芬酸钠相关的转化医学

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100 项与双氯芬酸钠相关的专利（医药）

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3,794

项与双氯芬酸钠相关的文献（医药）

2024-12-31·Journal of Enzyme Inhibition and Medicinal Chemistry

Discovery of new thymol-3,4-disubstituted thiazole hybrids as dual COX-2/5-LOX inhibitors with in vivo proof

Article

作者: El-Miligy, Mostafa M M ; Al-Kubeisi, Ahmed K ; Hazzaa, Aly A ; Nassra, Rasha A ; El-Zemity, Saad R

New thymol-3,4-disubstitutedthiazole hybrids were synthesised as dual COX-2/5-LOX inhibitors. Compounds 6b, 6d, 6e, and 6f displayed in vitro inhibitory activity against COX-2 (IC₅₀= 0.037, 0.042, 0.046, and 0.039 µM) nearly equal to celecoxib (IC₅₀= 0.045 µM). 6b, 6d, and 6f showed SI (379, 341, and 374, respectively) higher than that of celecoxib (327). 6a-l elicited in vitro 5-LOX inhibitory activity higher than quercetin. 6a-f, 6i-l, 7a, and 7c possessed in vivo inhibition of formalin induced paw edoema higher than celecoxib. 6a, 6b, 6f, 6h-l, and 7b showed gastrointestinal safety profile as celecoxib and diclofenac sodium in the population of fasted rats. Induced fit docking and molecular dynamics simulation predicted good fitting of 6b and 6f without changing the packing and globularity of the apo protein. In conclusion, 6b and 6f achieved the target goal as multitarget inhibitors of inflammation.

2024-06-01·Toxicology Reports

Investigating the teratogenic potential of diclofenac sodium on chick embryos: A warning for pregnant women

Article

作者: Mazari, Fiaz Ahmad ; Khan, Sana ; Ahmad, Khalil ; Khan, Muhammad Nadeem ; Ahmad, Shakeel ; Arif, Muhammad ; Khalid, Awais ; Nazir, Muhammad Altaf ; Farooq, Muhammad ; Iman, Ayesha ; Sabir, Hafiz Muhammad

Teratogenic and embryotoxic effect of diclofenac sodium (DS) on different developmental stages of the chick-embryos was investigated by examining different parameters such as its mortality rate, hatching, morphological measurements, weighing its internal organs and calculation of different indices. Experiment was divided into four trials with different dose (0.1 mL, 0.2 mL, 0.3 mL in groups A, B, and C, respectively and group D received 0.3 mL saline solution (0.9% NaCl) and group E remained un-injected) administration and observation. Results of first and second trial showed statistically (p<0.01) significant difference in bodyweight, body-length, forelimb and hindlimb length between experimental and control groups. In third trial, diclofenac sodium administration showed a statistically (p<0.01) significant difference in the bodyweight, body-length, forelimb, hindlimb length, liver weight, egg weight (EE ratio) and kidney somatic index (KSI). The beak-size, heart weight, kidney weight, cardiac somatic index (CSI) and hepato somatic index (HSI) were not significant (p>0.05) when compared with the control groups. In trial 4, forelimb, hindlimb length, heart weight, CSI and HSI were statistically (p<0.01) significant. Body-length and liver weight were significant (p<0.05). While bodyweight, beak size, kidney weight and KSI were non-significant (p>0.05). The mortality rate was increased with increase dose of DS and also affected the hatching. DS effect on chick embryos can be applied to humans because the early development of mammals and birds are closely related. So, it was concluded that DS should be used with caution during pregnancy especially during first trimester of pregnancy.

2024-06-01·Journal of Ethnopharmacology

In silico and in vivo study of anti-inflammatory activity of Morinda longissima (Rubiaceae) extract and phytochemicals for treatment of inflammation-mediated diseases

Article

作者: Thu Huong, Tran ; Ngoc Khanh, Pham ; Thi Ha, Vu ; Mehallah, Hafidha ; Xuan Ha, Nguyen ; Djebli, Noureddine ; Manh Cuong, Nguyen ; Dinh Tung, Do

ETHNOPHARMACOLOGICAL RELEVANCETraditionally, the plant Morinda longissima Y.Z.Ruan (Rubiaceae) is used by ethnic people in Vietnam for the treatment of liver diseases and hepatitis.AIM OF THE STUDYThe study was designed to assess the efficacy of the 95% ethanolic extract of Morinda longissima roots (MLE) in experimental immune inflammation. The phytochemical variation of root extract and the chemical structures of natural compounds were also investigated using HPLC-DAD-HR-MS analysis.MATERIALS AND METHODSThree different doses (100, 200, and 300 mg/kg b.w.) of MLE were chosen to determine anti-inflammatory activity. The mice were given orally extracts and monitored their behavior and mortality for 14 days to evaluate acute toxicity. The volume of the paw and the histopathological evaluation were carried out. The polyphenolic phytoconstituents of MLE extract were identified using LC/MS analysis. The anti-inflammatory efficacy in silico and molecular docking simulations of these natural products were evaluated based on their cyclooxygenase (COX)-1 and 2 inhibitory effects.RESULTSThis investigation showed the 95% ethanolic extract of Morinda longissima roots was found non-toxic up to 2000 mg/kg dose level in an acute study, neither showed mortality nor treatment-related signs of toxicity in mice. Eight anthraquinones and anthraquinone glycosides of Morinda longissima roots were identified by HPLC-DAD-HR-MS analysis. In the in vivo experiments, MLE was found to possess powerful anti-inflammatory activities in comparison with diclofenac sodium. The highest anti-inflammatory activity of MLE in mice was observed at a dose of 300 mg/kg body weight. The in silico analysis showed that seven out the eight anthraquinones and anthraquinone glycosides possess a selectivity index R_COX-2/COX-1 lower than 1, indicating that these compounds are selective against the COX-2 enzyme in the following the order: rubiadin-3-methyl ether < morindone morindone-6-methyl ether < morindone-5-methyl ether < damnacanthol < rubiadin < damnacanthol-3-O-β-primeveroside. The natural compounds with the best selectivity against the COX-2 enzyme are quercetin (9), rubiadin-3-methyl ether (7), and morindone (4), with R_COX2/COX1 ratios of 0.02, 0.03, and 0.19, respectively. When combined with the COX-2 protein in the MD research, quercetin and rubiadin-3-methyl ether greatly stabilized the backbone proteins and ligands.CONCLUSIONIn conclusion, the anthraquinones and ethanolic extract of Morinda longissima roots may help fight COX-2 inflammation. To develop novel treatments for inflammatory disorders linked to this one, these chemicals should be investigated more in the future.

项与双氯芬酸钠相关的新闻（医药）

2024-05-14

·米内网

【瞩目】普利制药拿下23亿注射剂

精彩内容5月13日，NMPA官网显示，普利制药以仿制4类报产的注射用盐酸万古霉素获批上市并视同过评，为国产第4家。注射用盐酸万古霉素属于糖肽类抗菌药，2023年在中国公立医疗机构终端销售额超过23亿元。注射用盐酸万古霉素属于糖肽类抗菌药，用于治疗对万古霉素敏感的耐甲氧西林(β-内酰胺耐药)的葡萄球菌引起的严重或致命感染，以及由葡萄球菌、草绿色链球菌、牛链球菌或类白喉杆菌引起的心内膜炎。盐酸万古霉素由礼来从土壤中分离出来并完成研制，于1958年获得FDA批准上市。米内网数据显示，近年来注射用盐酸万古霉素国内市场持续扩容，2022年在中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额首次突破20亿元，2023年销售额超过23亿元，同比增长6.31%。中国公立医疗机构终端注射用盐酸万古霉素销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局目前注射用盐酸万古霉素已有4家本土企业获得了生产批文，其中浙江医药、海正药业、丽珠集团该产品已上市销售，此次普利制药该产品获批上市并视同过评，为国产第4家。注射用盐酸万古霉素国产情况来源：米内网中国上市药品（MID）数据库2023年至今，普利制药已有8个品种在国内获批上市并视同过评，包括注射用盐酸万古霉素、磷酸奥司他韦胶囊、氟康唑干混悬剂、伏立康唑干混悬剂、双氯芬酸钠缓释片、奥卡西平片、碘帕醇注射液、盐酸林可霉素注射液，进一步丰富了公司的产品线。资料来源：米内网数据库、NMPA官网注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。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

2024-05-13

·信狐药迅

仿制药上市申请有14个品规发通知件；临床申请品种均默示许可| 新获批（5.6-5.12）

每周药品注册获批数据，分门别类呈现，一目了然。(5.6-5.12）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号TQB2450注射液正大天晴药业集团南京顺欣制药有限公司1CXSS2300003新药临床申请药品名称企业注册分类受理号TQ05105片正大天晴药业集团股份有限公司1CXHL2400232TQ05105片正大天晴药业集团股份有限公司1CXHL2400231SPH7485片上海医药集团股份有限公司1CXHL2400219SPH7485片上海医药集团股份有限公司1CXHL2400220SPH7485片上海医药集团股份有限公司1CXHL2400221SPH7485片上海医药集团股份有限公司1CXHL2400222ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400216ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400215HS-10382片江苏豪森药业集团有限公司1CXHL2400207HS-10382片江苏豪森药业集团有限公司1CXHL2400206SIPI6398片上海中泽医药科技有限公司1CXHL2400205SSS39注射剂沈阳三生制药有限责任公司1CXHL2400204INR101注射液云核医药(天津)有限公司1CXHL2400200ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400184ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400183ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400181GP681干混悬剂江西青峰药业有限公司1CXHL2400185BW-20507注射液杭州舶临医药科技有限公司1CXHL2400176JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400167JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400166JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400165JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400164JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400163JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400162BIOS2207浙江赛默制药有限公司2.2CXHL2400229BIOS2207浙江赛默制药有限公司2.2CXHL2400228GBI268注射液广州智耀生物科技有限公司2.2CXHL2400230注射用瑞卢戈利诺桥制药(成都)有限责任公司2.2CXHL2400194布立西坦注射液江西银涛药业股份有限公司3CYHL2400040糠酸莫米松富马酸福莫特罗吸入气雾剂长风药业股份有限公司3CYHL2400038酒石酸匹莫范色林胶囊华中药业股份有限公司3CYHL2400037JP001片北京慧宝源生物技术股份有限公司2.4;2.3CXHL2400202BAT1308注射液百奥泰生物制药股份有限公司1CXSL2400161注射用BAT8006百奥泰生物制药股份有限公司1CXSL2400162QX013N注射液江苏荃信生物医药股份有限公司1CXSL2400165注射用BL-B16D1成都百利多特生物药业有限责任公司1CXSL2400159LAE102注射液来凯医药科技(上海)有限公司1CXSL2400155CM383注射液康诺亚生物医药科技(成都)有限公司1CXSL2400154混合活化杀伤(MAK)免疫细胞注射液北京拓华伟业生物科技有限公司1CXSL2400119异体人源脂肪间充质干细胞注射液江苏得康生物科技有限公司1CXSL2400111RJK002注射液上海瑞吉康生物医药有限公司1CXSL2400117仿制药申请药品名称企业注册分类受理号酮咯酸氨丁三醇注射液福建天泉药业股份有限公司3CYHS2301619盐酸哌罗匹隆片四川科瑞德制药股份有限公司3CYHS2301594恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301339恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301337恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301336双氯芬酸钠注射液北京世桥生物制药有限公司3CYHS2301043盐酸多巴胺注射液山东达冠医药科技有限公司3CYHS2300596盐酸多巴胺注射液山东达冠医药科技有限公司3CYHS2300594阿齐沙坦片浙江诺得药业有限公司3CYHS2300009国;CYHS2300009盐酸奥洛他定颗粒南京明生医药有限公司3CYHS2202150国;CYHS2202150盐酸丙卡特罗颗粒安徽百奥药业有限公司3CYHS2201846国;CYHS2201846盐酸苯达莫司汀注射液齐鲁制药有限公司3CYHS2201798国;CYHS2201798盐酸多柔比星脂质体注射液常州吾合生物医药有限责任公司3CYHS2201562国;CYHS2201562盐酸多柔比星脂质体注射液常州吾合生物医药有限责任公司3CYHS2201561国;CYHS2201561低钙腹膜透析液(乳酸盐-G2.5)安徽丰原药业股份有限公司3CYHS2201233国;CYHS2201233低钙腹膜透析液(乳酸盐-G1.5)安徽丰原药业股份有限公司3CYHS2201232国;CYHS2201232注射用甲氨蝶呤上海上药睿尔药品有限公司3CYHS2102209国;CYHS2102209卡络磺钠注射液康普药业股份有限公司3CYHS2101509国;CYHS2101509氟比洛芬凝胶贴膏江苏万高药业股份有限公司4CYHS2301698盐酸罗匹尼罗缓释片江西金水宝制药有限公司4CYHS2301463碘克沙醇注射液通用电气药业(上海)有限公司4CYHS2301166硝酸异山梨酯注射液河北东圣科宇医药科技有限公司4CYHS2300695氢溴酸伏硫西汀片福建省闽东力捷迅药业股份有限公司4CYHS2300559泮托拉唑钠肠溶片寿光富康制药有限公司4CYHS2300571他达拉非片安徽贝克生物制药有限公司4CYHS2300404多索茶碱注射液赤峰万泽药业股份有限公司4CYHS2300257盐酸帕罗西汀肠溶缓释片山东京卫制药有限公司4CYHS2300150盐酸帕罗西汀肠溶缓释片山东京卫制药有限公司4CYHS2300149二甲双胍维格列汀片(III)浙江诺得药业有限公司4CYHS2300142地氯雷他定片合肥国药诺和药业有限公司4CYHS2201952国;CYHS2201952沙库巴曲缬沙坦钠片常州制药厂有限公司4CYHS2201907国;CYHS2201907沙库巴曲缬沙坦钠片常州制药厂有限公司4CYHS2201906国;CYHS2201906替米沙坦氢氯噻嗪片南京海纳医药科技股份有限公司4CYHS2201841国;CYHS2201841盐酸二甲双胍缓释片河南羚锐制药股份有限公司4CYHS2201750国;CYHS2201750注射用美罗培南江苏睿实生物科技有限公司4CYHS2201715国;CYHS2201715注射用美罗培南江苏睿实生物科技有限公司4CYHS2201714国;CYHS2201714头孢泊肟酯片齐鲁制药有限公司4CYHS2201687国;CYHS2201687盐酸托莫西汀口服溶液长兴制药股份有限公司4CYHS2201404国;CYHS2201404盐酸帕罗西汀肠溶缓释片北京北陆药业股份有限公司4CYHS2201525国;CYHS2201525复方聚乙二醇电解质散(III)浙江诺得药业有限公司4CYHS2201517国;CYHS2201517吸入用乙酰半胱氨酸溶液扬子江药业集团江苏紫龙药业有限公司4CYHS2201444国;CYHS2201444苯磺酸左氨氯地平片平光制药股份有限公司4CYHS2200990国;CYHS2200990苯磺酸左氨氯地平片平光制药股份有限公司4CYHS2200989国;CYHS2200989注射用硫酸艾沙康唑江苏奥赛康药业有限公司4CYHS2200985国;CYHS2200985盐酸多奈哌齐口腔崩解片迪沙药业集团有限公司4CYHS2200968国;CYHS2200968盐酸多奈哌齐口腔崩解片迪沙药业集团有限公司4CYHS2200967国;CYHS2200967阿普米司特片江苏知原药业股份有限公司4CYHS2200944国;CYHS2200944阿普米司特片江苏知原药业股份有限公司4CYHS2200942国;CYHS2200942他达拉非片浙江康恩贝制药股份有限公司4CYHS2200884国;CYHS2200884碘佛醇注射液成都倍特药业股份有限公司4CYHS2200395国;CYHS2200395进口申请药品名称企业注册分类受理号注射用盐酸曲拉西利G1 Therapeutics, Inc.5.1JXHS2300075吡仑帕奈片Eisai Europe Limited5.1JXHS2300026吡仑帕奈片Eisai Europe Limited5.1JXHS2300025卡替拉韦注射液ViiV Healthcare Pty Ltd.5.1JXHS2200099国;JXHS2200099卡替拉韦钠片ViiV Healthcare Pty Ltd.5.1JXHS2200098国;JXHS2200098重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100014国;JXSS2100014重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100013国;JXSS2100013重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100012国;JXSS2100012盐酸昂丹司琼注射液Gland Pharma Limited5.2JYHS2000049国;JYHS2000049PF-07220060Pfizer Inc.1JXHL2400059PF-07220060Pfizer Inc.1JXHL2400058PF-07220060Pfizer Inc.1JXHL2400057注射用JR8603JiaRay Pharmaceuticals, Inc.1JXHL2400043镥[177Lu]Lu-NeoB注射液Novartis Pharma AG1JXHL2400032米罗那非片AriBio Co., Ltd.2.4JXHL2400048米罗那非片AriBio Co., Ltd.2.4JXHL2400047甲磺酸贝舒地尔片Kadmon Pharmaceuticals, LLC2.4JXHL2400045布地奈德硫酸沙丁胺醇吸入气雾剂AstraZeneca Pharmaceuticals LP2.4JXHL2400036注射用BL-8040冻干粉BioLineRx Ltd.5.1JXHL2400046DE-117B滴眼液Santen Pharmaceutical Co., Ltd.5.1JXHL2400033盐酸羟甲唑啉滴眼液Santen Pharmaceutical Co., Ltd.5.2JYHL2400001MEDI5752AstraZeneca AB1JXSL2400055Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400054Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400053AMG 451Amgen Inc.1JXSL2400047Itepekimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400044中药相关申请药品名称企业注册分类受理号宝心艾维西木口服液新疆维吾尔药业有限责任公司4CYZL2400001注：灰色字体部分结论为不批准或收到通知件；

申请上市临床申请

2024-04-09

·药智网

中日透皮贴剂品种及市场对比

透皮贴剂，作为一种较新的药物递送技术，已在全球医药市场中崭露头角。其能够通过皮肤给药，让药物在人体内持续、稳定地释放，从而达到更好的治疗效果。相比于其他药物剂型，透皮贴剂具有诸多优势，如使用方便、副作用小、药效持久等。然而，由于透皮贴剂具有较高的技术壁垒，其在发达国家和发展中国家呈现出一定的差异性。本文将重点阐述中国与日本的透皮贴剂上市品种数量、上市产品的活性成分、市场规模进行对比分析。01中日透皮贴剂上市品种数量对比按品牌数计，中国上市透皮贴剂处方药产品有289个，产品类型集中在橡胶贴膏（活性成分主要为中成药）。化学药贴剂产品有凝胶贴膏、溶剂胶贴剂、贴剂（该类中国上市产品由于辅料信息披露不全，无法进行细分贴剂类型划分）、橡胶贴膏。与橡胶贴膏和凝胶贴膏多数产品发挥局部作用不同，中国已上市的溶剂胶贴剂产品可透过皮肤到达血液循环发挥全身作用。图1 中国上市透皮贴剂处方药产品类型及数量数据来源：药智数据，药智咨询整理日本上市的透皮贴剂处方药产品有166个，产品类型包括溶剂胶贴剂、热熔胶贴剂和凝胶贴膏，其中溶剂胶贴剂56个、热熔胶贴剂57个、凝胶贴膏53个。图2 日本上市透皮贴剂处方药产品类型数量数据来源：药智数据，药智咨询整理02中日透皮贴剂上市产品活性成分对比中国上市透皮贴剂处方化学药涉及30种单方或复方活性成分，其中硫酸新霉素+醋酸曲安奈德的复方药上市品牌数量最多。化学药的品牌竞争数量整体较少，仅硫酸新霉素+醋酸曲安奈德、可乐定、硝酸甘油上市品牌数大于5家，竞争数量相对较多。表1 中国上市透皮贴剂处方药产品活性成分TOP10（仅统计化学药）数据来源：药智数据，药智咨询整理日本上市的贴剂产品活性成分共有25种，TOP10为洛索洛芬钠、酮洛芬、双氯芬酸钠、联苯乙酸、妥洛特罗、吲哚美辛、利斯的明、芬太尼、氟比洛芬和水杨酸甲酯，其治疗领域主要为关节和肌肉疼痛局部用药。其中，活性成分为洛索洛芬钠产品有34个，占总产品数量的20.73%；酮洛芬产品数量有18个，占总产品数量的10.98%；双氯芬酸钠产品数量有14个，占比8.54%。表2 日本上市透皮贴剂处方药产品活性成分TOP10（按品牌数计）数据来源：药智数据，药智咨询整理03中日透皮贴剂市场规模对比中国透皮贴剂处方药市场处于成长期，近五年市场规模增长迅速。2022年中国透皮贴剂处方药医院和零售销售额约为61亿元（其中化学药53亿元，中成药8亿元），2018年-2022年5年复合增长率为28.4%。中国透皮贴剂处方药市场以化学药为主，相较于中成药，化学药具有起效快、无异味等优点。目前中国透皮贴剂处方药市场化学药贴剂对中成药贴剂的替代效应非常强，未来将继续抢占中成药贴剂市场。图3 中国透皮贴剂处方药市场销售额（亿元）数据来源：药智数据，药智咨询整理日本透皮贴剂处方药市场发展成熟，近五年销售额下降趋势明显，2022年日本透皮贴剂处方药市场销售额约67亿元，2018年-2022年5年复合增长率为-8.8%。销售额的下降主要来源于医保控费力度强，药品价格大幅下降。从1981年开始，日本主管药品价格的厚生劳动省开始对每两年对医保目录中的药品价格进行检视，药品价格平均每两年降价4%~5%，2016年日本厚生劳动省进一步将检视的时间频率从两年一次提升为一年一次。图4 日本透皮贴剂处方药市场销售额（亿元）数据来源：药智数据，药智咨询整理04结语全球透皮贴剂市场正处于充满机遇和挑战的发展阶段，如何抓住这个机会，对于制药企业来说，不仅需要持续加大研发投入、优化产品性能、更需要加强与发达中国家透皮贴剂企业的合作。另外，也需要密切关注市场动态和政策法规变化，灵活调整市场策略。声明：本内容为作者独立观点，不代表药智网立场。如需转载，请务必注明文章作者和来源。对本文有异议或投诉，请联系maxuelian@yaozh.com。责任编辑 | 金银花转载开白 | 马老师 18996384680（同微信）如需定制医药咨询服务，请扫描下方二维码咨询！阅读原文，是受欢迎的文章哦

上市批准核酸药物

100 项与双氯芬酸钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00904	双氯芬酸钠	M02AA15 D11AX18 M01AB05 S01BC03	DB00586

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
滑囊炎	日本	Hisamitsu Pharmaceutical Co., Inc.	2022-06-20
颈臂综合征	日本	Hisamitsu Pharmaceutical Co., Inc.	2022-06-20
腰痛	日本	Hisamitsu Pharmaceutical Co., Inc.	2022-06-20
癌症疼痛	日本	Hisamitsu Pharmaceutical Co., Inc.	2021-03-23
骨关节炎	日本	Dojin Iyaku-Kako Co., Ltd.	2004-02-27
关节周围炎	日本	Dojin Iyaku-Kako Co., Ltd.	2004-02-27
肌腱病	日本	Dojin Iyaku-Kako Co., Ltd.	2004-02-27
腱鞘炎	日本	Dojin Iyaku-Kako Co., Ltd.	2004-02-27
术后炎症	日本	Wakamoto Pharmaceutical Co., Ltd.	1989-03-31
炎症	日本	Fujisawa Pharmaceutical Co., Ltd.	1973-08-08
疼痛	日本	Fujisawa Pharmaceutical Co., Ltd.	1973-08-08

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
类风湿关节炎	临床前	美国	Novartis Pharmaceuticals Corp.	1988-07-28
膝关节炎	药物发现	美国	Horizon Therapeutics Ireland DAC	2014-01-16
强直性脊柱炎	药物发现	美国	Novartis Pharmaceuticals Corp.	1988-07-28

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临床结果

适应症

分期

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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


NCT02406014 (Pubmed)	临床4期	光化性角化病	502	Ingenol mebutate 0·015% gel	製糧襯窪艱獵網鬱蓋築(繭鏇蓋鹽艱繭簾遞齋蓋) = 襯糧繭夢願淵夢製夢壓選襯齋簾繭齋簾選遞衊 (願築繭鏇構膚衊遞壓窪 ) 更多	积极	2018-02-01
				Diclofenac sodium 3% gel	醖鑰構簾壓齋廠鑰鹽鹽(積醖糧鏇範窪鬱蓋鏇鬱) = 範壓簾壓築顧壓觸淵窪獵製齋艱鏇膚積鬱廠窪 (繭淵遞獵網齋願壓廠膚 ) 更多
NCT00171678 \| NCT00171626 \| NCT00426621 (Pubmed \| Drugs Aging)	N/A	膝关节炎	-	Topical diclofenac sodium 1% gel	(膚糧淵鏇簾糧夢鏇鑰鏇) = The incidence of any AE was greater with DSG than with vehicle among patients aged 25-64 years (56.6% vs 50.8%) and ≥65 years (55.8% vs 43.9%) 齋糧艱壓鬱鑰觸艱願衊 (窪願壓觸膚遞淵網構鹽 ) 更多	-	2011-01-01
				Vehicle
CTRI/2021/01/030592 (ASCO2023)	临床3期	手足综合症	263	Topical diclofenac gel	(夢構膚鑰鬱鏇壓淵襯網) = 憲繭網獵願獵築網襯餘獵範壓衊觸遞鏇窪觸膚 (餘蓋築淵願獵獵艱淵製 ) 更多	积极	2023-05-31
				Placebo gel	(夢構膚鑰鬱鏇壓淵襯網) = 醖鑰艱選夢築鬱獵憲網獵範壓衊觸遞鏇窪觸膚 (餘蓋築淵願獵獵艱淵製 ) 更多
ARVO2013	N/A	-	-	Bromfenac sodium 0.1%	(壓觸窪築壓顧壓網蓋鏇) = 築襯遞膚餘構窪窪襯憲齋網醖獵憲艱憲蓋繭觸 (顧網獵齋餘構構築範憲 )	-	2013-06-01
				Nepafenac 0.1%	(壓觸窪築壓顧壓網蓋鏇) = 壓醖餘築蓋餘廠製齋蓋齋網醖獵憲艱憲蓋繭觸 (顧網獵齋餘構構築範憲 )
NCT04683627 (Corporate Publications) 人工标引	临床3期	膝关节炎	370	HP-5000	(齋壓積壓鹹積願壓艱積) = The study did not meet its primary endpoint of statistically significant improvement in the osteoarthritis knee pain score (WOMAC) from baseline to week 12 醖積網選鹽窪簾顧淵襯 (淵淵鹹鑰淵鑰製築憲願 )	不佳	2022-10-28
				placebo
EDGE trial (Pubmed)	N/A	骨关节炎	7,111	Etoricoxib 90 mg	憲構鏇醖簾窪簾選憲窪(遞構網鹽齋獵範鹹夢遞) = 膚糧範觸艱衊製願膚鹹夢窪簾願製窪觸積糧餘 (網鹽衊繭醖簾鹽鬱範艱, -0.80, ~ 0.75) 更多	-	2007-02-01
				Diclofenac sodium 50 mg	憲構鏇醖簾窪簾選憲窪(遞構網鹽齋獵範鹹夢遞) = 衊鹹醖選構齋壓糧醖膚夢窪簾願製窪觸積糧餘 (網鹽衊繭醖簾鹽鬱範艱, -0.77, ~ 0.72) 更多
EUCTR2015-005240-33-GB (Pubmed \| J Int Med Res)	临床3期	肌肉骨骼损伤	182	Diclofenac gel	遞糧鑰製積範選積齋廠(襯遞鬱製艱廠齋觸醖餘) = 鹹積製鹹窪製觸憲鑰淵網衊積襯鹽構簾淵壓鑰 (簾鬱襯選窪繭齋衊襯鹽 )	-	2019-09-01
				Ibuprofen gel	遞糧鑰製積範選積齋廠(襯遞鬱製艱廠齋觸醖餘) = 簾齋憲積淵艱繭獵簾蓋網衊積襯鹽構簾淵壓鑰 (簾鬱襯選窪繭齋衊襯鹽 )
NCT01202799 (Pubmed \| Postgrad Med)	临床1期	-	76	Diclofenac sodium 2% topical solution	顧蓋醖醖獵獵衊顧簾壓(願鏇窪顧襯廠餘壓淵願) = Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac 鏇齋膚衊鬱淵築網鑰網 (築網蓋構鹹構鏇鹽構築 ) 更多	-	2015-08-01
				Diclofenac sodium 1.5% topical solution
EULAR2014	临床3期	肌肉骨骼损伤	697	SKP-021 (Ketoprofen)	(獵艱顧鏇顧鬱膚獵淵鏇) = 繭艱窪憲鬱鑰鹹齋觸壓蓋襯壓窪衊淵築衊鏇築 (衊顧鹹鹽壓鏇夢網鬱願, 46.6 ~ 57.1) 更多	积极	2014-06-11
				Diclofenac Sodium	(獵艱顧鏇顧鬱膚獵淵鏇) = 顧廠顧製鏇鏇膚簾築網蓋襯壓窪衊淵築衊鏇築 (衊顧鹹鹽壓鏇夢網鬱願, 45.3 ~ 55.8) 更多
NCT04391842 (Pubmed)	临床1期	膝关节炎	32	Sustained Acoustic Medicine (SAM) + 1% diclofenac ultrasound gel patch	(齋築鑰醖廠願廠艱簾獵) = 選壓鑰窪艱蓋鏇鏇築襯齋繭衊艱獵築構醖範鹽 (鏇鏇鏇鹽鬱蓋觸艱範衊 ) 更多	-	2020-01-01