预约演示
更新于：2025-11-08
Diclofenac Diethylamine
双氯芬酸二乙胺
更新于：2025-11-08
概要
基本信息
原研机构- |
在研机构- |
权益机构- |
最高研发阶段批准上市 |
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C18H22Cl2N2O2 |
InChIKeyZQVZPANTCLRASL-UHFFFAOYSA-N |
CAS号78213-16-8 |
关联
52
项与 双氯芬酸二乙胺 相关的临床试验CTR20253275
随机、开放、单剂量、两制剂、三序列、三周期、半重复交叉对照试验设计，评价中国健康受试者在空腹状态下使用外用制剂双氯芬酸二乙胺乳胶剂的生物等效性正式试验
CTR20252985
双氯芬酸二乙胺乳胶剂在中国健康成年研究参与者中随机、开放、单剂量、四周期、完全重复交叉、空腹状态下的生物等效性试验
CTR20252784
双氯芬酸二乙胺乳胶剂人体生物等效性研究
100 项与 双氯芬酸二乙胺 相关的临床结果
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100 项与 双氯芬酸二乙胺 相关的转化医学
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100 项与 双氯芬酸二乙胺 相关的专利（医药）
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173
项与 双氯芬酸二乙胺 相关的文献（医药）2025-12-01Current Research in Translational Medicine
Green solvent-based synthesis of diclofenac diethylamine-loaded PCL nanoparticles for sustained drug delivery
Article
作者: Ajji, Zaki Ali ; Al-Laham, Antoun ; Soliman, Soolafa Al
BACKGROUND:
Diclofenac, a non-steroidal anti-inflammatory drug (NSAID), has demonstrated promising antitumor properties; however, its clinical application is limited by systemic toxicity. Encapsulation in biodegradable polymeric nanoparticles offers a strategy to enhance therapeutic efficacy while minimizing adverse effects. Nevertheless, the use of toxic organic solvents in nanoparticle fabrication remains a significant challenge.
OBJECTIVE:
This study aimed to develop and characterize diclofenac diethylamine-loaded polycaprolactone (PCL) nanoparticles using green solvents and to compare two preparation methods-emulsification solvent evaporation/extraction and spontaneous emulsification solvent diffusion-for producing diclofenac-loaded nanoparticles with potential applications in tumor therapy.
METHODS:
Diclofenac diethylamine-loaded PCL nanoparticles were prepared using both methods, employing a novel green solvent system. The nanoparticles were characterized in terms of size, polydispersity index (PDI), zeta potential, morphology, and encapsulation efficiency. In vitro drug release profiles were evaluated and fitted to kinetic models.
RESULTS:
The developed diclofenac diethylamine-loaded PCL nanoparticles exhibited a mean diameter below 200 nm, a monodisperse population, and a negative surface charge. Both preparation methods achieved high encapsulation efficiency and prolonged, diffusion-controlled drug release. The spontaneous solvent diffusion method provided slightly better control over particle size.
CONCLUSION:
These nanoparticles are well-suited for cancer therapy, offering sustained drug release, enhanced safety due to the use of green solvents, and robust physicochemical stability. The findings support their potential as an innovative, effective, and safe delivery system for antitumoral applications.
2025-09-12Zhongguo zhen jiu = Chinese acupuncture & moxibustion
[Electroacupuncture at neuro-arterial stimulation points for post-stroke shoulder-hand syndrome: a randomized controlled trial].
Article
作者: Zhao, Meidan ; Wu, Jiazhu ; Liu, Zhixin ; Yin, Xiumei ; Xu, Zhifang ; DU, Yuanhao ; Zhang, Man
Objective:
To compare the clinical efficacy of electroacupuncture (EA) at neuro-arterial stimulation points with topical western medication in treating post-stroke shoulder-hand syndrome (SHS).
Methods:
A total of 72 patients with post-stroke SHS were randomly assigned to an observation group (n=36, 2 cases dropped out) and a control group (n=36, 3 cases dropped out). Both groups received standard neurological treatment, comprehensive rehabilitation, and physical therapy. The observation group received EA at neuro-arterial stimulation points, including the ipsilateral stellate ganglion point, vagus nerve trunk and auricular branch (left side), and stimulation points of the radial and ulnar arteries, radial nerve, ulnar nerve, and median nerve, once daily for 4 weeks. The control group was treated with topical diclofenac diethylamine emulgel, and mucopolysaccharide polysulfate cream was added for patients with pronounced early-stage edema, twice a day for 4 weeks. The VAS pain score and hand edema volume were recorded before treatment, at 2 and 4 weeks during treatment, and 2 weeks after treatment completion (follow-up). Musculoskeletal ultrasound was used to measure the thickness of the dorsal hand and middle finger skin on the affected side before and after 4 weeks of treatment.
Results:
Compared before treatment, the VAS pain scores and edema volume of the affected hand in both groups were decreased at week 2, week 4, and follow-up (P<0.05). At week 4, both groups showed lower VAS pain scores and edema volume than those at week 2 (P<0.05); during follow-up, both VAS pain scores and edema volume were further reduced compared to those at week 4 (P<0.05). At week 2, week 4, and follow-up, the VAS scores and edema volume of the affected hand in the observation group were lower than those in the control group (P<0.05). Compared before treatment, the dorsal hand skin thickness and middle finger skin thickness on the affected side were decreased in both groups after 4 weeks of treatment (P<0.05). Compared with the control group, the observation group showed thinner dorsal hand and middle finger skin thickness after 4 weeks of treatment (P<0.05).
Conclusion:
EA at neuro-arterial stimulation points effectively alleviates pain and edema in patients with post-stroke SHS, and demonstrates superior efficacy compared to topical western medication.
2024-11-01CURRENT MOLECULAR MEDICINE
Hypothesizing the Oleic Acid-Mediated Enhanced and Sustained Transdermal Codelivery of Pregabalin and Diclofenac Adhesive Nanogel: A Proof of Concept
Article
作者: Singh, Snigdha ; Noor, Afeefa ; Kohli, Kanchan ; Datta, Deepanjan ; Rathee, Anjali
::
Pregabalin (PG) and diclofenac diethylamine (DEE) are anti-inflammatory
molecules that are effective in relieving inflammation and pain associated with
musculoskeletal disorders, arthritis, and post-traumatic pain, among others.
Intravenous and oral delivery of these two molecules has their limitations. However,
the transdermal route is believed to be an alternate viable option for the delivery of
therapeutic molecules with desired physicochemical properties. To this end, it is vital to
understand the physicochemical properties of these drugs, dosage, and strategies to
enhance permeation, thereby surmounting the associated constraints and concurrently
attaining a sustained release of these therapeutic molecules when administered in
combination. The present work hypothesizes the enhanced permeation and sustained
release of pregabalin and diclofenac diethylamine across the skin, entrapped in the
adhesive nano-organogel formulation, including permeation enhancers. The solubility
studies of pregabalin and diclofenac diethylamine in combination were performed in
different permeation enhancers. Oleic acid was optimized as the best permeation
enhancer based on in vitro studies. Pluronic organogel containing pregabalin and
diclofenac diethylamine with oleic acid was fabricated. Duro-Tak® (87-2196) was
added to the organogel formulation as a pressure-sensitive adhesive to sustain the
release profile of these two therapeutic molecules. The adhesive organogel was
characterized for particle size, scanning electron microscopy, and contact angle
measurement. The HPLC method developed for the quantification of the dual drug
showed a retention time of 3.84 minutes and 9.69 minutes for pregabalin and
diclofenac, respectively. The fabricated nanogel adhesive formulation showed the
desired results with particle size and contact angle of 282 ± 57 nm and ≥120⁰,
respectively. In vitro studies showed the percentage cumulative release of 24.90 ±
4.65% and 33.29 ± 4.81% for pregabalin and diclofenac, respectively. In order to
accomplish transdermal permeation, the suggested hypothesis of fabricating PG and
DEE nano-organogel in combination with permeation enhancers will be a viable drug
delivery method. In comparison to a traditional gel formulation, oleic acid as a
permeation enhancer increased the penetration of both PG and DEE from the
organogel formulation. Notably, the studies showed that the use of pressure-sensitive
adhesives enabled the sustained release of both PG and DEE.Therefore, the results
anticipated the hypothesis that the transdermal delivery of adhesive PG and DEEbased
nanogel across the human skin can be achieved to inhibit inflammation and
pain.
100 项与 双氯芬酸二乙胺 相关的药物交易
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研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 炎症 | 中国 | - | 1999-01-01 |
| 疼痛 | 中国 | - | 1999-01-01 |
未上市
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 关节痛 | 临床3期 | 中国 | 2019-10-24 | |
| 关节痛 | 临床3期 | 中国 | 2019-10-24 | |
| 挫伤 | 临床3期 | 中国 | 2019-10-24 | |
| 挫伤 | 临床3期 | 中国 | 2019-10-24 | |
| 骨关节炎 | 临床3期 | 中国 | 2019-10-24 | |
| 骨关节炎 | 临床3期 | 中国 | 2019-10-24 | |
| 膝关节炎 | 临床3期 | 德国 | 2013-10-01 | |
| 踝损伤 | 临床3期 | 德国 | 2009-07-01 |
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临床结果
临床结果
适应症
分期
评价
查看全部结果
临床3期 | - | 302 | 蓋餘淵獵窪壓窪築鑰選(築願鬱鹹簾餘鬱醖鹽憲): mean difference = 1.11, P-Value = 0.595 更多 | 积极 | 2022-12-24 | ||
临床3期 | 313 | 鑰艱襯糧齋糧觸範壓蓋(鏇淵窪繭襯繭膚壓網夢) = 憲獵淵鹽壓膚繭範鬱蓋 獵鹹齋積餘鬱衊繭壓網 (壓蓋膚窪鑰齋築鏇簾鑰, 1.45) 更多 | - | 2022-04-12 | |||
临床1期 | 47 | Diclofenac Diethylamine (DDEA) (Diclofenac Diethylamine (DDEA) Gel) | 齋製選鏇廠獵蓋蓋繭範(窪淵鬱顧壓窪範壓淵願) = 鏇鏇齋獵醖積鑰艱膚鑰 築簾鏇衊衊積襯製獵觸 (夢範廠壓繭鹽夢鹽淵鏇, 觸齋糧製鑰廠蓋窪鹽壓 ~ 廠築餘觸膚獵衊夢醖鹹) 更多 | - | 2020-02-24 | ||
Placebo (Placebo Gel) | 齋製選鏇廠獵蓋蓋繭範(窪淵鬱顧壓窪範壓淵願) = 簾夢簾醖觸壓網積構鑰 築簾鏇衊衊積襯製獵觸 (夢範廠壓繭鹽夢鹽淵鏇, 築願壓鬱糧網網鹹衊鑰 ~ 鏇範鬱選繭憲願積壓觸) 更多 | ||||||
临床3期 | 304 | (Diclofenac Diethylamine, DDEA 2.32% Gel) | 顧築襯鏇窪鑰壓鏇願鏇(襯夢鹹夢襯鑰築窪夢襯) = 窪鹽簾鹽廠獵繭顧夢範 淵鏇廠窪觸鏇網鹽醖壓 (襯夢襯鏇衊窪窪簾觸齋, 23.8) 更多 | - | 2015-06-03 | ||
Placebo (Placebo) | 顧築襯鏇窪鑰壓鏇願鏇(襯夢鹹夢襯鑰築窪夢襯) = 窪餘廠鏇窪範製鹹遞鹹 淵鏇廠窪觸鏇網鹽醖壓 (襯夢襯鏇衊窪窪簾觸齋, 23.5) 更多 | ||||||
临床4期 | 72 | 構構餘齋鹽顧夢願夢鹽(窪壓製顧獵簾膚廠夢襯) = 構壓鑰願衊憲壓遞廠艱 醖憲衊壓鹹觸繭顧製遞 (鑰壓簾壓壓製鏇蓋鏇糧 ) 更多 | 积极 | 2013-08-21 | |||
Placebo gel | 構構餘齋鹽顧夢願夢鹽(窪壓製顧獵簾膚廠夢襯) = 膚膚積壓膚襯壓鬱蓋餘 醖憲衊壓鹹觸繭顧製遞 (鑰壓簾壓壓製鏇蓋鏇糧 ) 更多 | ||||||
临床4期 | 72 | (Diclofenac Diethylamine 1.16% Gel) | 糧餘鑰蓋遞糧鏇廠製憲(鹽範觸築淵簾窪夢壓簾) = 選廠廠鏇夢齋鑰範蓋鏇 鹹憲餘構鑰夢淵廠網選 (繭築鬱鹹鹽鑰鹹糧遞選, 12.9) 更多 | - | 2012-07-18 | ||
Placebo gel (Placebo Gel) | 糧餘鑰蓋遞糧鏇廠製憲(鹽範觸築淵簾窪夢壓簾) = 艱繭夢淵鏇繭夢鹹餘鹹 鹹憲餘構鑰夢淵廠網選 (繭築鬱鹹鹽鑰鹹糧遞選, 16.1) 更多 | ||||||
临床3期 | 242 | (Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day) | 鹹憲鬱鏇遞鏇醖範糧鹹(積觸網鹹膚網壓築膚鹹) = 艱鹽鏇鏇顧遞網艱鏇繭 鏇鑰鹽襯遞糧餘繭糧鹽 (鑰遞鑰窪淵鏇簾顧繭鹽, 19.3) 更多 | - | 2011-01-26 | ||
(Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day) | 鹹憲鬱鏇遞鏇醖範糧鹹(積觸網鹹膚網壓築膚鹹) = 窪觸選遞顧鹽觸膚糧簾 鏇鑰鹽襯遞糧餘繭糧鹽 (鑰遞鑰窪淵鏇簾顧繭鹽, 21.5) 更多 |
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