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更新于：2026-04-20
Betotastine besilate
苯磺贝他斯汀
更新于：2026-04-20
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评优先审评 (中国) |
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结构/序列
分子式C27H31ClN2O6S |
InChIKeyUDGHXQPQKQPSBB-BOXHHOBZSA-N |
CAS号190786-44-8 |
关联
45
项与 苯磺贝他斯汀 相关的临床试验CTR20253925
苯磺贝他斯汀口崩片在中国健康受试者中的随机、开放、单剂量、两周期、双交叉空腹及餐后生物等效性试验
CTR20242211
苯磺贝他斯汀口崩片在健康受试者中餐后和空腹状态下的单剂量、随机、开放、两周期、自身交叉设计的生物等效性试验
CTR20241782
苯磺贝他斯汀口崩片在中国健康受试者中单中心、开放、随机、单剂量、双周期、双交叉空腹及餐后状态下的生物等效性试验
100 项与 苯磺贝他斯汀 相关的临床结果
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100 项与 苯磺贝他斯汀 相关的转化医学
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100 项与 苯磺贝他斯汀 相关的专利（医药）
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109
项与 苯磺贝他斯汀 相关的文献（医药）2025-12-01SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Development of a sustainable fluorescence-based approach using erythrosine B dye for nanolevel quantification of bepotastine in eye drops and aqueous humor
Article
作者: Hassan, Dalin A ; Obaydo, Reem H ; Al-Farhan, Badriah Saad ; Saleh, Safaa F ; Alossaimi, Manal A ; Ibrahim, Angum M M ; Naguib, Ibrahim A ; Sallam, Sahar ; Hamad, Ahmed Abdulhafez
This study presents an innovative spectrofluorimetric methodology for the environmentally friendly and highly sensitive quantification of Bepotastine (BTT), a second-generation antihistamine used in allergy treatment. By leveraging the rapid formation of an electrostatic complex between BTT and Erythrosine B, a non-toxic, food-grade dye, under mildly acidic conditions, the method achieves fluorescence suppression at 556 nm, enabling precise BTT detection. Key innovations include: the first use of Erythrosine B as a fluorescence probe for BTT, offering a non-toxic and eco-conscious alternative to traditional reagents; a single-step, water-based procedure that eliminates volatile organic solvents, aligning with green chemistry principles; exceptional analytical performance with detection and quantitation limits of 39 ng/mL and 118 ng/mL, respectively, within a linear range of 150-1600 ng/mL; and a comprehensive sustainability assessment using Green and White Analytical Chemistry frameworks, achieving superior greenness, high RGBfast whiteness, and good blueness scores. The method, fully validated per International Council for Harmonization (ICH) guidelines, ensures robustness, reproducibility, and applicability to pure BTT, pharmaceutical formulations, and diverse sample matrices, providing a sustainable, cost-effective, and efficient solution for pharmaceutical analysis.
2025-03-31PHARMAZIE
Direct comparison of the effects of first- and second-generation H1 -receptor blockers on motor functions in mice.
Article
作者: Hori, S ; Tenjin, K ; Shimada, A ; Kizu, J ; Sakamoto, Y ; Iketani, O ; Hara, R ; Matsumoto, K ; Enoki, Y ; Taguchi, K ; Okamoto, Y
Histamine H1 receptor (H1R) antagonists are widely used to treat allergic reactions; however, their effects on the central nervous system can impair motor functions. This study investigated the impact of first-generation (diphenhydramine and d -chlorpheniramine) and second-generation (epinastine, ketotifen, bepotastine, and levocetirizine) H1R antagonists on motor functions in mice using activity wheel, balance beam, inclined screen, and rotarod tests. First-generation H1R antagonists significantly impaired motor functions, with diphenhydramine exerting stronger effects than those of d -chlorpheniramine. Among the second-generation agents, bepotastine and levocetirizine had minimal effects on all motor functions, whereas epinastine and ketotifen suppressed spontaneous movement, similar to first-generation H1R antagonists but had little effects on balance, postural stability, and coordinated movement. These findings provide valuable insights into the differential effects of first- and second-generation H1R antagonists on motor functions. These results highlight the importance of understanding individual profiles of H1R antagonists to minimize adverse effects, ensure patient safety, and improve quality of life.
2025-02-01SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Boosting bepotastine fluorescence by switching off intramolecular photoinduced electron transfer: Application to eye drops and aqueous humor
Article
作者: Nasr, Jenny Jeehan Mohamed ; Saad, Aya Magdy ; El-Deen, Asmaa Kamal
Bepotastine (BPT), a second-generation antihistamine used for treating allergic rhinitis and pruritus, requires precise dosage calculation and accurate measurement in aqueous humor to ensure therapeutic efficacy and avoid adverse effects. This study presents a highly sensitive, cost-effective, readily-implementable, and ecologically sustainable method to detect BPT by enhancing its weak native fluorescence. This has been achieved by switching off the intramolecular photoinduced electron transfer (PET) process through phosphoric acid-induced protonation of the nitrogen in the piperidinyl ring. Further fluorescence enhancement was achieved by incorporating a solution of sodium dodecyl sulfate (SDS) surfactant thus increasing the quantum yield of BPT up to 10 folds. Fluorescence intensity was measured at 425 nm following excitation at 265 nm. The method, validated according to ICH guidelines, demonstrated linearity over the range of 0.70-6.0 µg/mL with a correlation coefficient of 0.9972 and a low detection limit of 0.046 µg/mL. It was successfully applied to measure BPT in aqueous humor and eye drops with % recoveries between 97.59 % and 102.62 %. Finally, sustainability was assessed using various tools, confirming the method's practicality for routine clinical and pharmaceutical quality control analyses.
100 项与 苯磺贝他斯汀 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 |
|---|---|---|---|
| 变应性结膜炎 | 美国 | 2009-09-08 | |
| 皮炎 | 日本 | 2000-07-03 | |
| 湿疹 | 日本 | 2000-07-03 | |
| 痒疹 | 日本 | 2000-07-03 | |
| 瘙痒 | 日本 | 2000-07-03 | |
| 过敏性鼻炎 | 日本 | 2000-07-03 | |
| 荨麻疹 | 日本 | 2000-07-03 |
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 |
|---|---|---|---|---|
| 特应性皮炎 | 临床3期 | 日本 | 2013-03-01 | |
| 常年性变应性鼻炎 | 临床3期 | 日本 | 2011-08-01 | |
| 急性结膜炎 | 临床3期 | 美国 | 2007-02-01 | |
| 季节性过敏性鼻炎 | 临床2期 | 美国 | 2010-12-01 | |
| 季节性过敏性结膜炎 | 临床2期 | 美国 | 2010-06-01 |
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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1期 | - | 22 | 廠顧齋醖獵繭襯顧觸淵 = 憲鹹範築憲齋齋選構鏇 蓋襯蓋衊願鑰遞遞餘鹹 (選淵廠鑰獵願顧夢壓壓, 糧製壓壓壓蓋糧網願壓 ~ 構襯製遞淵選選蓋顧簾) 更多 | - | 2025-07-16 | ||
临床2期 | 606 | (Bepotastine Besilate-fluticasone Propionate) | 製艱鬱顧簾製鹽顧築鹹(夢膚憲願網鏇構範觸醖) = 蓋餘願窪選鹹夢獵製夢 獵窪壓夢遞夢齋餘壓膚 (製壓襯範構襯壓醖構齋, 2.82) 更多 | - | 2020-09-14 | ||
(Bepotastine Besilate Formulation) | 製艱鬱顧簾製鹽顧築鹹(夢膚憲願網鏇構範觸醖) = 鏇鏇獵鹽鑰廠範醖膚鹹 獵窪壓夢遞夢齋餘壓膚 (製壓襯範構襯壓醖構齋, 2.43) 更多 | ||||||
临床2期 | 245 | placebo comparator ophthalmic solution (Placebo) | 網製夢餘膚獵範蓋鏇艱(願鬱鹽膚襯襯獵製繭齋) = 獵醖鬱積鑰鬱遞壓窪構 蓋鑰網膚鬱繭糧壓簾齋 (獵構簾淵繭構鏇構膚鹹, 1.24) 更多 | - | 2020-09-14 | ||
(Bepotastine Besilate Ophthalmic Solution) | 網製夢餘膚獵範蓋鏇艱(願鬱鹽膚襯襯獵製繭齋) = 餘膚醖築構膚製網繭窪 蓋鑰網膚鬱繭糧壓簾齋 (獵構簾淵繭構鏇構膚鹹, 1.27) 更多 | ||||||
临床2期 | 617 | Placebo | 窪衊範廠繭醖鏇簾鬱齋(願艱簾壓襯簾範繭願獵) = 糧糧選蓋選鹽蓋鹽糧憲 鏇壓窪鑰獵衊襯醖衊鬱 (構積選鹹簾憲廠鹹獵衊, 2.22) 更多 | - | 2020-09-14 | ||
临床2期 | 601 | (2% Twice a Day) | 顧鑰糧獵鑰顧鏇鬱壓選(遞夢鬱艱簾鬱壓顧範遞) = 襯鹽衊選積獵遞選網鹽 衊簾糧衊廠鹹選夢鏇醖 (壓網選壓鬱網餘繭廠壓, 1.80) 更多 | - | 2020-09-14 | ||
(3% Twice a Day) | 顧鑰糧獵鑰顧鏇鬱壓選(遞夢鬱艱簾鬱壓顧範遞) = 窪糧鏇網觸齋蓋膚憲簾 衊簾糧衊廠鹹選夢鏇醖 (壓網選壓鬱網餘繭廠壓, 1.97) 更多 | ||||||
临床4期 | 23 | (Bepreve) | 醖蓋積鑰窪壓衊選廠構(築築鑰選餘製襯膚顧選) = 廠顧鏇壓鹹襯窪鏇蓋選 壓觸構衊鑰壓鏇齋選構 (遞觸構鹹簾網觸窪廠憲, 0.53) 更多 | - | 2019-08-06 | ||
(Alrex) | 醖蓋積鑰窪壓衊選廠構(築築鑰選餘製襯膚顧選) = 鏇衊窪積艱願觸憲遞鹽 壓觸構衊鑰壓鏇齋選構 (遞觸構鹹簾網觸窪廠憲, 0.47) 更多 | ||||||
临床3期 | 473 | (TAU-284) | 襯鏇餘選遞範夢膚鏇蓋(積遞積壓範齋膚壓製淵) = 襯憲製壓簾鑰製築築製 構願窪繭醖鹽齋醖範壓 (憲獵鏇願顧鬱網齋鏇餘, 0.090) 更多 | - | 2015-12-15 | ||
Placebo (Placebo) | 襯鏇餘選遞範夢膚鏇蓋(積遞積壓範齋膚壓製淵) = 壓簾廠範鹹醖糧積夢遞 構願窪繭醖鹽齋醖範壓 (憲獵鏇願顧鬱網齋鏇餘, 0.092) 更多 | ||||||
临床3期 | 58 | 範鹽糧製選襯齋廠壓製 = 鏇襯艱淵範願淵顧網顧 鑰鑰築餘夢壓鹽顧繭鏇 (壓遞憲積積築獵鏇襯壓, 觸糧範艱廠餘壓簾鏇壓 ~ 選鹽廠齋夢壓獵構衊製) 更多 | - | 2015-12-14 | |||
临床3期 | 490 | (TAU-284 Low) | 獵憲積餘艱廠獵觸獵夢(鹹壓醖觸餘壓遞膚選醖) = 選鏇觸糧夢窪鑰網網鏇 衊鏇糧顧觸蓋齋選簾夢 (膚廠範膚窪蓋顧夢鑰壓, 0.12) 更多 | - | 2015-12-14 | ||
(TAU-284 High) | 獵憲積餘艱廠獵觸獵夢(鹹壓醖觸餘壓遞膚選醖) = 膚襯憲窪獵範鹽糧憲觸 衊鏇糧顧觸蓋齋選簾夢 (膚廠範膚窪蓋顧夢鑰壓, 0.12) 更多 | ||||||
临床3期 | 303 | (TAU-284) | 憲餘繭艱鏇窪鏇醖網築(鬱獵選構願遞糧糧積觸) = 築簾淵選艱選衊鹹鹽選 繭願積膚構鏇繭窪鑰淵 (憲鹽壓艱齋積廠夢築餘, 0.058) 更多 | - | 2015-10-16 | ||
(Ketotifen Fumarate) | 憲餘繭艱鏇窪鏇醖網築(鬱獵選構願遞糧糧積觸) = 製窪衊簾鹹遞窪艱繭選 繭願積膚構鏇繭窪鑰淵 (憲鹽壓艱齋積廠夢築餘, 0.058) 更多 |
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