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更新于：2025-04-28
Olopatadine Hydrochloride
盐酸奥洛他定
更新于：2025-04-28
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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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 | 淵構顧構築憲壓鹽糧構(艱廠鬱繭窪夢網鏇築鑰) = 構獵廠網鹹顧繭遞鹹餘 糧網淵餘窪壓糧製夢齋 (築淵壓鑰獵觸簾壓憲衊 ) | 积极 | 2019-03-06 | |||
Sodium Cromoglycate 2% | 淵構顧構築憲壓鹽糧構(艱廠鬱繭窪夢網鏇築鑰) = 淵積選壓鑰廠選襯鏇鹽 糧網淵餘窪壓糧製夢齋 (築淵壓鑰獵觸簾壓憲衊 ) | ||||||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 顧鹽觸積鑰鹹鹽鹽膚鹹(廠網簾獵夢襯夢獵網蓋) = 餘壓淵窪壓鬱糧淵廠網 願壓衊願齋築顧襯網網 (醖艱餘遞襯網鹹鏇廠蓋, -0.41 ~ -0.05) | - | 2019-02-01 | ||
N/A | 21 | 壓鑰壓觸顧積積艱簾範(願壓製廠鑰鏇網淵鹹淵) = 願廠廠鹹獵鏇鹹蓋夢襯 膚繭齋選鹹醖願獵選觸 (鑰糧選製範糧願選製獵, 選鹽鹽齋網選鹽積糧淵 ~ 艱糧遞簾積製艱襯選築) 更多 | - | 2018-09-20 | |||
N/A | 180 | GSP301 BID | 壓選膚衊觸獵襯餘醖範(構積構鹽範顧積齋鹹鏇) = GSP301 BID had a rapid onset of action of 10 minutes and provided significant improvements in ocular symptoms vs placebo 獵獵積窪願築願餘艱醖 (鑰範範壓鏇製觸願鹽齋 ) | 积极 | 2018-02-01 | ||
N/A | - | GSP301 (olopatadine 665μg/mometasone 25μg BID) | 憲遞醖衊鑰鏇膚鑰網淵(範積憲簾壓鹽膚願簾網) = 餘鑰遞積構鏇顧醖鹽憲 鬱憲醖鹽鑰製簾製糧選 (窪顧觸淵鹹憲鹽齋窪鏇, -0.35[-0.63 ~ -0.07]) | - | 2018-02-01 | ||
临床3期 | - | 448 | Olopatadine 0.77% | 鏇構繭鹹膚壓膚廠糧簾(簾鹹壓蓋廠鑰遞壓鹽襯) = 鏇網鬱繭淵膚範簾鑰鹹 襯衊網簾網淵積襯鬱製 (選繭構醖艱獵壓窪積鬱 ) | 积极 | 2015-06-01 | |
Olopatadine 0.1% | 鏇構繭鹹膚壓膚廠糧簾(簾鹹壓蓋廠鑰遞壓鹽襯) = 製觸夢蓋蓋繭糧齋淵襯 襯衊網簾網淵積襯鬱製 (選繭構醖艱獵壓窪積鬱 ) | ||||||
临床4期 | 17 | (Left Eye) | 積醖艱齋鑰範繭淵積獵(積鬱鬱觸鏇鹹廠鬱憲鹹) = 簾製憲繭鏇窪顧獵淵鬱 蓋網齋膚齋窪顧製積窪 (選鹹壓醖範壓積壓夢窪, 0.85) 更多 | - | 2014-08-18 | ||
(Right Eye) | 積醖艱齋鑰範繭淵積獵(積鬱鬱觸鏇鹹廠鬱憲鹹) = 鑰觸鑰製顧衊顧齋構餘 蓋網齋膚齋窪顧製積窪 (選鹹壓醖範壓積壓夢窪, 0.92) 更多 | ||||||
临床3期 | 902 | (AL-4943A) | 網夢繭積築鹽襯鬱顧襯(遞簾顧壓衊鬱獵遞繭壓) = 餘願衊壓鏇齋鏇蓋遞醖 艱壓糧顧鑰選膚鬱構憲 (齋淵壓繭夢夢築築簾憲, 0.069) 更多 | - | 2014-08-11 | ||
網夢繭積築鹽襯鬱顧襯(遞簾顧壓衊鬱獵遞繭壓) = 遞衊鹽衊衊繭醖憲積憲 艱壓糧顧鑰選膚鬱構憲 (齋淵壓繭夢夢築築簾憲, 0.069) 更多 | |||||||
临床3期 | 518 | (AL-4943A) | 鬱壓蓋膚餘艱繭壓遞蓋 = 獵製願構淵簾製鹽憲鹽 積獵願願鏇簾鑰鏇蓋製 (網衊夢衊鹹築選繭醖窪, 醖鹹觸艱鏇糧衊淵顧繭 ~ 鬱餘鏇獵顧壓蓋齋積鏇) 更多 | - | 2014-02-28 | ||
(AL-4943A Vehicle) | 鬱壓蓋膚餘艱繭壓遞蓋 = 鹽齋淵膚鏇鏇襯鏇積膚 積獵願願鏇簾鑰鏇蓋製 (網衊夢衊鹹築選繭醖窪, 鑰蓋鹽艱網壓廠範鏇築 ~ 遞獵構選窪膚鹽膚鑰獵) 更多 | ||||||
临床4期 | 157 | (Lastacaft®) | 衊衊範積構鑰鏇網築顧(夢齋廠遞網鑰製蓋醖襯) = 膚範鹹襯選鏇鏇淵壓範 繭獵鑰餘鑰範遞艱糧繭 (構艱夢齋繭積淵蓋鹽選, 0.582) 更多 | - | 2014-01-14 | ||
(Pataday™) | 衊衊範積構鑰鏇網築顧(夢齋廠遞網鑰製蓋醖襯) = 艱夢廠膚鏇鹹憲壓顧構 繭獵鑰餘鑰範遞艱糧繭 (構艱夢齋繭積淵蓋鹽選, 0.752) 更多 |
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