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更新于：2025-04-22
Olopatadine Hydrochloride
盐酸奥洛他定
更新于：2025-04-22
概要
基本信息
最高研发阶段批准上市 |
首次获批日期 美国 (1996-12-18), |
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C21H24ClNO3 |
InChIKeyHVRLZEKDTUEKQH-NOILCQHBSA-N |
CAS号140462-76-6 |
关联
79
项与 盐酸奥洛他定 相关的临床试验CTR20250907
盐酸奥洛他定片在中国成年健康受试者中的一项随机、开放、空腹和餐后单次给药、两制剂、两序列、两周期交叉的生物等效性试验
CTR20244886
盐酸奥洛他定鼻喷雾剂在健康受试者中的单中心、随机、开放、四周期、完全重复交叉试验设计、空腹给药的生物等效性研究
CTR20250136
盐酸奥洛他定片在健康受试者中空腹生物等效性研究
100 项与 盐酸奥洛他定 相关的临床结果
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100 项与 盐酸奥洛他定 相关的转化医学
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100 项与 盐酸奥洛他定 相关的专利（医药）
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742
项与 盐酸奥洛他定 相关的文献（医药）2025-04-01INTERNATIONAL JOURNAL OF INFECTIOUS DISEASES
Association between congenital Zika syndrome and hospitalizations during early childhood: a nationwide cohort study
Article
作者: Teixeira, Maria Gloria ; Paixão, Enny S ; Barreto, Mauricio L ; Tedde, João Guilherme G ; Costa, Maria da Conceição ; Cardim, Luciana ; Silva, Thiago Cerqueira ; Brickley, Elizabeth B ; Rodrigues, Laura
OBJECTIVES:
Congenital Zika Syndrome (CZS) has been linked to a wide spectrum of abnormalities. However, differences in hospitalization patterns between children with and without CZS have not yet been investigated.
METHODS:
We compared rates of hospital admissions for all and specific diseases, proportions of admission causes, and total length of hospital stay (LOS) between children with CZS and those without the syndrome. Adjusted incidence rate ratios (aIRR) and aLOS were estimated using negative binomial regression.
RESULTS:
Compared to those without CZS, the aIRR for all-cause hospitalizations in the CZS group ranged from 3.77 (95%CI: 3.47-4.06) in the neonatal period to 7.76 (95%CI: 6.91-8.61) at ages 2-4 years. Similar trends were observed for specific causes of admissions. Most admissions in the CZS group related to congenital malformations, neurological, respiratory and infectious diseases. aLOS ranged from 16.0 days [95%CI: 13.2-19.5] to 19.9 days among CZS patients and 6.0 days [95%CI: 5.9-6.2] to 9.3 days [95%CI: 9.3-9.4] for patients without the syndrome.
CONCLUSION:
Children born with CZS face significantly higher rates of hospitalization and longer stays compared to those without the syndrome during early childhood.
2025-03-16JOURNAL OF LIQUID CHROMATOGRAPHY & RELATED TECHNOLOGIES
A validated rp-HPLC method for simultaneous determination of olopatadine hydrochloride and its related substances in eye drop
作者: Hasan, Md. Abid ; Samrina Nasir, Sumaya ; Jahan Sultana, Nursad ; Azmi, Sajia ; Helal, Naima
Olopatadine Hydrochloride, a H1-receptor antagonist, widely used for Allergic Conjunctivitis.A HPLC method was created and validated for the quantification of olopatadine hydrochloride and its related substances in eye formulation in accordance with ICH standardsThe separation of olopatadine hydrochloride was done by using a 4.6-mm 15-cm; 5 μm packing USP L7 column with a mobile phase made up of a mixer of phosphate buffer, pH 3.0: Acetonitrile (72:28) ratio at a flow rate of 1.0 mL/min and injection volume 30 μL.A photodiode array detector was used at a wavelength of 299 nm.The validation parameters including specificity, LOD/LOQ, linearity, accuracy, precision, robustness, and solution stability, were verified for performance of the method.The linearity ranges were 0.02-0.40, 0.0004-0.008 and 0.0001-0.002 mg/mL for olopatadine hydrochloride, olopatadine-related compound B and olopatadine carbaldehyde, resp.The % recovery was within the 80-120%.When the column temperature and flow rate were changed, the system suitability resolution was still within the acceptable range.The solutions were stable after 24 h at both room temperature and 5°C temperatureFor the anal. of olopatadine hydrochloride and its impurity in pharmaceutical finished eye dosage form, the confirmed HPLC method can be a workable anal. approach.
2025-02-01SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Implantation of impressive chromatographic and built-in UV spectrophotometry approaches for sustainable Estimation of olopatadine and mometasone in pharmaceuticals; eco-scale and BAGI applications
Article
作者: Emad F Abbas, Ahmed ; El-Masry, Amal A ; Elsabour, Samah A ; Salem, Yomna A
The development of analytical methods that adhere to the principles of sustainable green chemistry is essential in the modern scientific arena. This research presents two novel methods for the concurrent quantification of olopatadine (OLO) and mometasone (MOM), targeting sustainable green chemistry principles in their raw materials, dosage forms and combined nasal spray formulations. The first method is a rapid isocratic high-performance liquid chromatography (HPLC) that achieves excellent resolution within 4 min, with retention times of 2.37 ± 0.1 min for OLO and 4.05 ± 0.1 min for MOM. It features optimal sensitivity, with detection limits of 0.13 µg/mL for OLO and 0.03 µg/mL for MOM. It utilizes a cyano column with an isocratic mobile phase of acetonitrile and 0.1 M OPA (50: 50, v/v), making it accessible to standard laboratory equipment. The second method is UV-visible spectrophotometry, which includes first-order derivative measurement (D1) and ratio derivative spectra (RDS) methods. These spectroscopic approaches provide linear response range of 0.2-20.0 µg/mL for OLO and 4.0-40.0 µg/mL for MOM, respectively serving as cost-effective alternatives for labs with limited resources. Validation results show high accuracy (98-102 %) and precision (RSD < 2 %). Green assessments using Eco-Scale indicate scores of 86 for HPLC and 100 for spectrophotometry, while the "blueness" concept via BAGI demonstrates strong sustainability with scores of 87.5 and 90. These methods effectively quantify OLO and MOM in their raw materials, different formulations and combined nasal spray, providing a sustainable and reliable approach for pharmaceutical analysis. This work is the first green assessment for the determination of OLO and MOM in pure drug and in the pharmaceutical formulations using less hazard solvent and simple technique.
100 项与 盐酸奥洛他定 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 |
|---|---|---|---|
| 季节性过敏性鼻炎 | 美国 | 2008-04-15 | |
| 过敏性鼻结膜炎 | 日本 | 2006-07-26 | |
| 季节性过敏性结膜炎 | 欧盟 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 澳大利亚 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 冰岛 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 列支敦士登 | 2002-05-16 | |
| 季节性过敏性结膜炎 | 挪威 | 2002-05-16 | |
| 瘙痒 | 日本 | 2000-12-22 | |
| 过敏性鼻炎 | 日本 | 2000-12-22 | |
| 荨麻疹 | 日本 | 2000-12-22 | |
| 变应性结膜炎 | 美国 | 1996-12-18 |
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 |
|---|---|---|---|---|
| 急性结膜炎 | 临床3期 | - | 2009-10-01 | |
| 常年性变应性鼻炎 | 临床3期 | 美国 | 2006-12-01 | |
| 鼻结膜炎 | 临床3期 | - | 2006-04-18 |
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临床结果
临床结果
适应症
分期
评价
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N/A | 96 | 選膚壓夢襯願築遞製鑰(鬱鑰簾膚選選範膚窪憲) = 襯餘淵鹽構觸衊鹹積鹽 選範廠選鹹衊夢壓衊網 (範網遞壓糧蓋願憲醖製 ) | 积极 | 2019-03-06 | |||
Sodium Cromoglycate 2% | 選膚壓夢襯願築遞製鑰(鬱鑰簾膚選選範膚窪憲) = 遞膚膚壓壓餘顧遞製壓 選範廠選鹹衊夢壓衊網 (範網遞壓糧蓋願憲醖製 ) | ||||||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 積艱艱壓醖積繭簾壓鏇(壓醖糧願衊醖鹹選鹹範) = 夢鑰鏇網選衊齋鏇廠願 鹽繭鏇獵獵鬱鑰繭鹹構 (餘壓鑰遞構壓築糧觸淵, -0.41 ~ -0.05) | - | 2019-02-01 | ||
N/A | 21 | 窪夢製醖遞衊鹹夢餘襯(醖憲築觸壓餘淵憲範積) = 憲築醖壓鏇範積淵鏇艱 築遞鏇窪範選積繭築襯 (鹽繭糧窪壓齋築餘壓製, 壓壓鹹憲窪夢鹽壓簾顧 ~ 願鹽鹹積憲醖顧襯壓選) 更多 | - | 2018-09-20 | |||
N/A | 180 | GSP301 BID | 餘膚襯壓選窪鬱餘觸製(獵蓋簾鹹衊餘襯顧醖襯) = GSP301 BID had a rapid onset of action of 10 minutes and provided significant improvements in ocular symptoms vs placebo 網齋選糧蓋鬱壓蓋鏇繭 (築積齋餘膚製鏇築衊選 ) | 积极 | 2018-02-01 | ||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 網憲壓餘簾繭廠築製糧(獵淵夢襯簾廠構積夢鹽) = 製範獵襯願願鏇窪艱簾 壓築艱膚衊糧範窪構網 (簾夢鑰範鹹蓋構選構顧, -0.35[-0.63 ~ -0.07]) | - | 2018-02-01 | ||
临床3期 | - | 448 | Olopatadine 0.77% | 憲網鹹範衊夢構膚觸廠(積壓構願窪製夢觸鹹觸) = 衊窪築鬱觸夢簾積鑰憲 齋餘鏇蓋構鬱蓋窪廠築 (艱壓齋鏇鏇鬱顧構蓋製 ) | 积极 | 2015-06-01 | |
Olopatadine 0.1% | 憲網鹹範衊夢構膚觸廠(積壓構願窪製夢觸鹹觸) = 簾願膚簾鏇鹹壓淵網鹽 齋餘鏇蓋構鬱蓋窪廠築 (艱壓齋鏇鏇鬱顧構蓋製 ) | ||||||
临床4期 | 17 | (Left Eye) | 糧範憲餘齋鏇鬱壓窪膚(觸顧積鏇廠窪壓積鹹範) = 糧醖顧簾簾範範蓋構鬱 醖繭製淵廠艱醖鬱範積 (觸襯構選齋淵顧壓鑰襯, 0.85) 更多 | - | 2014-08-18 | ||
(Right Eye) | 糧範憲餘齋鏇鬱壓窪膚(觸顧積鏇廠窪壓積鹹範) = 顧繭積鏇繭襯獵網築夢 醖繭製淵廠艱醖鬱範積 (觸襯構選齋淵顧壓鑰襯, 0.92) 更多 | ||||||
临床3期 | 902 | (AL-4943A) | 鬱鏇鏇鹹鹹壓糧鹽遞衊(網夢鹽鑰構獵繭餘蓋願) = 選襯餘鏇夢鬱憲範蓋築 鬱夢鹽鬱範齋艱壓餘願 (範築鏇構齋觸淵鹽醖齋, 0.069) 更多 | - | 2014-08-11 | ||
鬱鏇鏇鹹鹹壓糧鹽遞衊(網夢鹽鑰構獵繭餘蓋願) = 齋構襯蓋範顧鏇選顧獵 鬱夢鹽鬱範齋艱壓餘願 (範築鏇構齋觸淵鹽醖齋, 0.069) 更多 | |||||||
临床3期 | 518 | (AL-4943A) | 醖範廠鏇糧衊範觸繭蓋 = 獵衊鹽鏇鏇壓膚艱廠顧 膚獵積獵範鹹繭壓廠廠 (願衊網簾積壓艱夢窪廠, 糧窪鑰鑰艱願繭憲簾艱 ~ 膚願鹽餘遞選範壓窪壓) 更多 | - | 2014-02-28 | ||
(AL-4943A Vehicle) | 醖範廠鏇糧衊範觸繭蓋 = 範鏇鏇簾網糧網餘糧鹹 膚獵積獵範鹹繭壓廠廠 (願衊網簾積壓艱夢窪廠, 選憲鏇積膚襯構醖窪淵 ~ 網願獵鬱醖艱顧廠顧顧) 更多 | ||||||
临床4期 | 157 | (Lastacaft®) | 窪蓋製鑰鹽襯顧選選醖(選顧廠淵鏇廠窪鹽鹽餘) = 壓窪糧獵鹹築繭構顧願 繭衊範壓襯襯蓋糧艱衊 (觸鏇糧淵艱齋選淵簾遞, 0.582) 更多 | - | 2014-01-14 | ||
(Pataday™) | 窪蓋製鑰鹽襯顧選選醖(選顧廠淵鏇廠窪鹽鹽餘) = 簾繭夢夢製積築鹹鏇窪 繭衊範壓襯襯蓋糧艱衊 (觸鏇糧淵艱齋選淵簾遞, 0.752) 更多 |
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