更新于：2024-06-29
Diclofenac Diethylamine
双氯芬酸二乙胺
更新于：2024-06-29
概要
基本信息
原研机构- |
在研机构- |
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
分子式C18H22Cl2N2O2 |
InChIKeyZQVZPANTCLRASL-UHFFFAOYSA-N |
CAS号78213-16-8 |
关联
24
项与 双氯芬酸二乙胺 相关的临床试验双氯芬酸二乙胺乳胶剂随机、开放、交叉设计在中国健康受试者中的生物等效性试验
双氯芬酸二乙胺乳胶剂随机、开放、交叉设计在中国健康受试者中的生物等效性正式试验
双氯芬酸二乙胺乳胶剂在健康志愿者中随机、开放、单剂量、两制剂、三序列、三周期、部分重复、交叉、空腹状态下生物等效性试验
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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107
项与 双氯芬酸二乙胺 相关的文献（医药）2023-12-04Molecular pharmaceutics
Time-Dependent Differences in the Effects of Oleic Acid and Oleyl Alcohol on the Human Skin Barrier
Article
作者: Kopečná, Monika ; Hrdinová, Iva ; Opálka, Lukáš ; Kováčik, Andrej ; Vávrová, Kateřina ; Boncheva Bettex, Mila
Oleic acid and oleyl alcohol are commonly used permeation and penetration enhancers to facilitate topical drug delivery. Here, we aimed to better understand the mechanism of their enhancing effects in terms of their interactions with the human skin barrier using diclofenac diethylamine (DIC-DEA), a nonsteroidal anti-inflammatory drug for topical pain management. Oleic acid promoted DIC-DEA permeation through ex vivo human skin more rapidly than oleyl alcohol (both applied at 0.75%) due to fluidization of stratum corneum lipids as revealed by infrared spectroscopy. After 12 h, the effect of these enhancers on DIC-DEA permeation leveled off, fluidization was no longer evident, and skin permeabilization was mainly due to the formation of fluid enhancer-rich domains. Contrary to oleyl alcohol, oleic acid adversely affected two indicators of the skin barrier integrity, transepidermal water loss and skin electrical impedance. The content of oleyl alcohol in the stratum corneum was lower than that of oleic acid (even 12 h after the enhancers were removed from the skin surface), but it caused higher DIC-DEA retention in both epidermis and dermis compared to oleic acid. The effects of oleyl alcohol and oleic acid on DIC-DEA permeation and retention in the skin were similar after a single and repeated application (4 doses every 12 h). Thus, oleyl alcohol offers several advantages over oleic acid for topical drug delivery.
2023-11-02Journal of AOAC International
Validation of an HPLC Method for the Determination of Diclofenac Diethylamine and Three of Its Impurities in a Gel Pharmaceutical Form
Article
作者: El Orche, Aimen ; Azougagh, Mohamed ; El Karbane, Miloud ; Laouni, Amine ; Bouatia, Mustapha ; El Kacemi, Mounir ; Karrouchi, Khalid ; Elhamdaoui, Omar
Abstract:
Background:
Monitoring impurities in drug products is a principal requirement of pharmaceutical regulatory authorities all over the world to ensure drug safety. For this reason, there is a great need for analytical QC of dugs products.
Objective:
In this study, a simple, efficient, and direct HPLC method was developed for the determination of three impurities of diclofenac.
Methods:
The HPLC method was developed using a mobile phase which consisted of an HPLC grade mixture, acetonitrile–0.01M phosphoric acid adjusted to pH 2.3 (1 + 3, by volume).
Results:
The separation was performed in 15 min. The calibration curves of the three impurities were linear; the correlation coefficients were 0.999 at concentrations of 0.00015–0.003 µg/mL.
Conclusion:
The validation of this method shows that it meets all validation criteria. This shows the reliability of this method for the routine control of diclofenac impurities.
Highlights:
The validation of a robust HPLC method for the determination of diclofenac impurities is of great importance for the pharmaceutical industry to control its products.
2023-01-01Journal of pain research
Fire Needling Therapy of Different Frequencies versus External Diclofenac Diethylamine Emulgel for Knee Osteoarthritis: Study Protocol for a Pilot Randomized Controlled Trial.
Article
作者: Zhao, Bingcong ; Zhao, Luopeng ; Wang, Mina ; Zhang, Fan ; Tian, Wei ; Wang, Shaosong ; Yuan, Fang ; Wang, Linpeng ; Xu, Xiaobai ; Ji, Xu ; Li, Bin ; Liu, Lu ; Xia, Qiuyu
Purpose:
Knee osteoarthritis (KOA) is regarded as one of the leading musculoskeletal diseases. Although the efficacy is under exploration, fire needling therapy is considered an effective alternative for KOA. This trial aims to investigate the effectiveness of different frequencies of fire needling therapy in attenuating pain and promoting function in KOA patients.
Methods:
This is a study protocol for a pilot, three-arm, single-center, randomized controlled trial. A total of 90 participants with KOA will be recruited and randomly assigned to the high-frequency fire needling group (3 sessions per week, for 6 weeks), the low-frequency fire needling group (1 session per week, for 6 weeks) or the positive control group (Diclofenac Diethylamine Emulgel, 3 times per day, for 6 weeks) in a 1:1:1 ratio. Participants will accomplish the trial at Week 14 after a follow-up evaluation. The response rate will be set as the primary outcome that the proportion of participants obtaining a minimal clinically important difference, which is identified as ≥2 units on the numerical rating scale (NRS) and ≥6 units on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score at Week 6 compared with Week 0. Secondary outcomes are NRS, WOMAC, Brief Pain Inventory, Short-Form Health Survey-12, Timed Up and Go Test, and pain threshold.
Discussion:
This is the first standardized protocol comparing fire needling therapy and positive control drugs. This trial may provide reliable evidence for the effectiveness of fire needling therapy and dose-effect property of it in KOA. Trial registration: The trial has been registered on Chinese Clinical Trial Registry (Registered number: ChiCTR2100043041), registered on 4 February 2021.
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
10 条进展最快的记录, 后查看更多信息
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| 适应症 | 最高研发状态 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|---|
| 踝损伤 | 临床3期 | 中国 | 2019-10-24 | |
| 关节痛 | 临床3期 | 中国 | 2019-10-24 | |
| 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 | |
| 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 | |
| 骨关节炎 | 临床3期 | 中国 | 2019-10-24 |
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临床结果
临床结果
适应症
分期
评价
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临床3期 | 302 | 獵簾獵鹹鏇壓觸襯鏇獵(壓簾醖憲襯憲鹹獵襯鑰): mean difference = 1.11, P-Value = 0.595 更多 | 积极 | 2022-12-24 | |||
临床3期 | 313 | 膚鏇艱齋網繭鏇衊壓壓(範築夢衊膚醖顧獵蓋淵) = 壓醖衊顧網鬱鏇憲築鹹 鏇廠遞廠蓋壓築衊糧淵 (積糧遞鏇廠蓋遞餘膚願, 積鹹壓獵顧夢積獵襯糧 ~ 膚蓋廠鹽齋築願膚鬱窪) 更多 | - | 2022-04-12 | |||
临床4期 | 72 | 憲鹽餘積窪觸鹽齋積簾(齋鹽網衊願鬱蓋繭觸壓) = 淵夢繭蓋餘遞廠鹹積範 齋衊憲淵築觸獵網選鏇 (齋範鏇鬱艱觸顧鏇顧築 ) 更多 | 积极 | 2013-08-21 | |||
Placebo gel | 憲鹽餘積窪觸鹽齋積簾(齋鹽網衊願鬱蓋繭觸壓) = 鹹壓積膚糧餘衊鏇艱顧 齋衊憲淵築觸獵網選鏇 (齋範鏇鬱艱觸顧鏇顧築 ) 更多 | ||||||
临床4期 | 72 | (Diclofenac Diethylamine 1.16% Gel) | 遞積網夢鏇壓製憲壓選(憲構觸夢膚遞築糧膚膚) = 襯網膚醖窪願選範願齋 範糧餘積憲鏇衊簾襯壓 (鏇衊窪網醖鏇顧製壓窪, 築齋鬱獵觸觸獵鏇齋壓 ~ 顧窪壓觸構夢範窪糧憲) 更多 | - | 2012-07-18 | ||
Placebo gel (Placebo Gel) | 遞積網夢鏇壓製憲壓選(憲構觸夢膚遞築糧膚膚) = 膚遞醖鏇繭築齋願窪夢 範糧餘積憲鏇衊簾襯壓 (鏇衊窪網醖鏇顧製壓窪, 蓋繭範糧構繭網鏇齋選 ~ 積蓋廠夢顧壓範鹽窪壓) 更多 | ||||||
临床3期 | - | 242 | (Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day) | 網簾簾廠襯築築鑰獵網(憲鑰衊鬱顧觸簾餘選網) = 衊鹹製夢鏇齋築憲築廠 積醖糧憲鹽鹽積選餘壓 (選醖構選鹹膚遞製衊積, 醖簾鏇選鏇觸齋憲蓋餘 ~ 構選範衊襯衊壓窪膚夢) 更多 | - | 2011-01-26 | |
(Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day) | 網簾簾廠襯築築鑰獵網(憲鑰衊鬱顧觸簾餘選網) = 獵獵觸膚築廠齋網鏇壓 積醖糧憲鹽鹽積選餘壓 (選醖構選鹹膚遞製衊積, 鑰鹽觸鹹鏇鏇鏇鬱網選 ~ 衊網繭壓簾蓋範觸觸糧) 更多 |
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