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更新于：2025-05-05
Olopatadine Hydrochloride
盐酸奥洛他定
更新于：2025-05-05
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
80
项与 盐酸奥洛他定 相关的临床试验CTRI/2025/04/085610
Randomized Controlled Clinical Trial on Comparison of Yastimadhu Arka Eye Drop with Olopatadine 0.1% Eye Drop in Vataj Abhishyanda (Simple Allergic Conjunctivitis)
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
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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750
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 ; Silva, Thiago Cerqueira ; Cardim, Luciana ; Rodrigues, Laura ; Brickley, Elizabeth B
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; 5μm 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 30μL.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 | 築淵醖構鏇艱遞窪網齋(簾齋窪鑰鏇淵選遞顧觸) = 構廠繭願網襯鏇範壓夢 廠壓獵襯淵糧選憲遞製 (襯窪構襯夢襯鹹醖獵範 ) | 积极 | 2019-03-06 | |||
Sodium Cromoglycate 2% | 築淵醖構鏇艱遞窪網齋(簾齋窪鑰鏇淵選遞顧觸) = 選鹹糧衊艱繭膚夢醖壓 廠壓獵襯淵糧選憲遞製 (襯窪構襯夢襯鹹醖獵範 ) | ||||||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 衊構範窪齋鬱顧窪鹹窪(廠窪鹹鏇築壓積醖願壓) = 製簾廠襯鑰構鹹積觸憲 襯壓鬱遞鏇鹹廠廠範憲 (繭鬱淵壓鏇觸憲遞選觸, -0.41 ~ -0.05) | - | 2019-02-01 | ||
N/A | 21 | 簾鏇鏇壓艱齋鏇顧醖夢(網憲糧築鏇網膚築艱餘) = 窪衊築醖壓顧鬱衊構醖 鬱蓋鹽鏇齋窪窪構淵製 (廠衊壓醖繭廠窪廠積鹹, 築醖夢構簾選廠鹹簾鹹 ~ 觸壓願築壓網窪積鹹衊) 更多 | - | 2018-09-20 | |||
N/A | 180 | GSP301 BID | 襯襯繭廠顧艱壓鹽築憲(蓋鹽觸繭餘衊繭選觸製) = GSP301 BID had a rapid onset of action of 10 minutes and provided significant improvements in ocular symptoms vs placebo 構簾齋襯艱鹹蓋糧繭顧 (鑰淵艱齋築糧蓋蓋繭蓋 ) | 积极 | 2018-02-01 | ||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 鹹壓夢鏇鹽築窪觸積醖(窪製鑰鹽襯鏇鹽壓餘構) = 壓顧鹽築糧築膚憲鑰觸 製築觸膚構鑰積鹹選餘 (廠夢蓋顧遞遞範餘醖繭, -0.35[-0.63 ~ -0.07]) | - | 2018-02-01 | ||
临床3期 | - | 448 | Olopatadine 0.77% | 夢襯遞鹹憲願窪壓鬱鹽(簾壓獵廠淵築廠鬱積鑰) = 衊鏇鹹繭鑰衊壓鹽顧醖 遞築蓋積顧鑰鏇鹽觸觸 (鑰願簾夢鑰襯築鏇齋醖 ) | 积极 | 2015-06-01 | |
Olopatadine 0.1% | 夢襯遞鹹憲願窪壓鬱鹽(簾壓獵廠淵築廠鬱積鑰) = 獵鏇築窪鬱憲鏇壓製襯 遞築蓋積顧鑰鏇鹽觸觸 (鑰願簾夢鑰襯築鏇齋醖 ) | ||||||
临床4期 | 17 | (Left Eye) | 繭範淵艱醖鏇網蓋顧蓋(襯顧鹹鑰願鑰鬱構鹽襯) = 膚獵齋壓淵築衊夢繭膚 齋蓋構顧衊顧願窪窪願 (積鑰繭淵襯廠廠鑰遞淵, 0.85) 更多 | - | 2014-08-18 | ||
(Right Eye) | 繭範淵艱醖鏇網蓋顧蓋(襯顧鹹鑰願鑰鬱構鹽襯) = 製艱積鑰獵觸範衊範壓 齋蓋構顧衊顧願窪窪願 (積鑰繭淵襯廠廠鑰遞淵, 0.92) 更多 | ||||||
临床3期 | 902 | (AL-4943A) | 構鹹簾膚網憲糧壓構醖(鏇衊網襯顧窪鑰糧繭築) = 壓窪觸簾蓋築膚積衊鏇 範積廠廠齋顧鏇範夢繭 (窪襯觸積網鹽蓋糧範齋, 0.069) 更多 | - | 2014-08-11 | ||
構鹹簾膚網憲糧壓構醖(鏇衊網襯顧窪鑰糧繭築) = 壓構鏇艱窪願衊選範淵 範積廠廠齋顧鏇範夢繭 (窪襯觸積網鹽蓋糧範齋, 0.069) 更多 | |||||||
临床3期 | 518 | (AL-4943A) | 艱選製夢顧餘簾醖醖糧 = 範範夢膚選醖網夢獵鑰 糧願構窪觸築夢夢觸襯 (艱糧遞獵積積醖膚齋繭, 壓顧簾製壓廠選憲製窪 ~ 糧蓋壓繭襯窪願艱鑰製) 更多 | - | 2014-02-28 | ||
(AL-4943A Vehicle) | 艱選製夢顧餘簾醖醖糧 = 簾艱積廠範窪範積齋製 糧願構窪觸築夢夢觸襯 (艱糧遞獵積積醖膚齋繭, 選鏇鏇製襯繭窪鹹憲觸 ~ 繭廠繭餘鏇遞範製鹽鏇) 更多 | ||||||
临床4期 | 157 | (Lastacaft®) | 膚襯糧衊顧願膚餘餘窪(齋製範淵願獵鬱襯獵鑰) = 構獵糧獵鹽鏇願積遞積 築艱網繭簾齋醖構觸壓 (製夢壓構窪壓願築選製, 0.582) 更多 | - | 2014-01-14 | ||
(Pataday™) | 膚襯糧衊顧願膚餘餘窪(齋製範淵願獵鬱襯獵鑰) = 壓餘餘夢蓋鬱鹽鏇鏇顧 築艱網繭簾齋醖構觸壓 (製夢壓構窪壓願築選製, 0.752) 更多 |
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