更新于：2024-12-06
Drotaverine Hydrochloride
盐酸屈他维林
更新于：2024-12-06
概要
基本信息
非在研机构- |
最高研发阶段批准上市 |
首次获批日期- |
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C24H32ClNO4 |
InChIKeyJBFLYOLJRKJYNV-UHFFFAOYSA-N |
CAS号985-12-6 |
关联
18
项与 盐酸屈他维林 相关的临床试验Efficacy of drotaverine hydrochloride in reducing duration of labour in term pregnancies at NAUTH, Nnewi: a double-blind randomised controlled study
盐酸屈他维林片（40mg）在中国健康受试者中空腹和餐后给药条件下随机、开放、单剂量、两序列、两周期、双交叉生物等效性试验
盐酸屈他维林片生物等效性试验
100 项与 盐酸屈他维林 相关的临床结果
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100 项与 盐酸屈他维林 相关的转化医学
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100 项与 盐酸屈他维林 相关的专利（医药）
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127
项与 盐酸屈他维林 相关的文献（医药）2024-11-01Journal of fluorescence
Spectrofluorimetric Protocol for Estimation of Commonly Used Antispasmodic Drotaverine. Fluorescence Quenching Study
Article
作者: Mahmoud, Nihad A ; Attia, Tamer Z ; Noureldeen, Deena A M ; Derayea, Sayed M
Abstract:
A fast, simple, accurate, precise, and cheap fluorimetric protocol has been proposed for analysis of a phosphodiesterase-IV inhibitor, namely drotaverine hydrochloride. Fluorimetric protocol is based on estimating the decrease in the eosin Y fluorescence intensity by quantitative addition of drotaverine at pH 3.1 (acetate buffer). An ion pair complex is formed, which leads to quenching in the fluorescence intensity of the dye without need of prior extraction at 534 nm (λex. 339 nm). Different reaction perimeters which influence the production of complex (ion pair between drotaverine and eosin) were deeply investigated and optimized. The developed fluorimetric protocol is capable for quantitative estimation of drotaverine in linear range of 0.4 to 2.5 µg mL−1. After method validation in respect to ICH guidelines, it was applied to determine drotaverine in its commercial preparation. By comparing with other reported method, the developed and validated fluorimetric protocol is capable for estimation of drotaverine in commercial preparation with good accuracy and excellent precision.
2023-09-01Journal of AOAC International
Computer-Aided Design of Eco-Friendly Imprinted Polymer Decorated Sensors Augmented by Self-Validated Ensemble Modeling Designs for the Quantitation of Drotaverine Hydrochloride in Dosage Form and Human Plasma.
Article
作者: Abdelshakour, Mohamed A ; Elsonbaty, Ahmed ; Eissa, Maya S ; Attala, Khaled ; M Hadad, Ghada ; A Abdel Salam, Randa ; E Mostafa, Aziza
BACKGROUND:
Computationally designed molecular imprinted polymer (MIP) incorporation into electrochemical sensors has many advantages to the performance of the designed sensors. The innovative self-validated ensemble modeling (SVEM) approach is a smart machine learning-based (ML) technique that enables the design of more accurate predictive models using smaller data sets.
OBJECTIVE:
The novel SVEM experimental design methodology is exploited here exclusively to optimize the composition of four eco-friendly PVC membranes augmented by a computationally designed magnetic molecularly imprinted polymer to quantitatively determine drotaverine hydrochloride (DVN) in its combined dosage form and human plasma. Furthermore, the application of hybrid computational simulations such as molecular dynamics and quantum mechanical calculations (MD/QM) is a time-saving and eco-friendly provider for the tailored design of the MIP particles.
METHOD:
Here, for the first time, the predictive power of ML is assembled with computational simulations to develop four PVC-based sensors decorated by computationally designed MIP particles using four different experimental designs known as central composite, SVEM-LASSO, SVEM-FWD, and SVEM-PFWD. The pioneering AGREE approach further assessed the greenness of the analytical methods, proving their eco-friendliness.
RESULTS:
The proposed sensors showed decent Nernstian responses toward DVN in the range of 58.60-59.09 mV/decade with a linear quantitative range of 1 × 10-7 - 1 × 10-2 M and limits of detection in the range of 9.55 × 10-8 to 7.08 × 10-8 M. Moreover, the proposed sensors showed ultimate eco-friendliness and selectivity for their target in its combined dosage form and spiked human plasma.
CONCLUSIONS:
The proposed sensors were validated in accordance with International Union of Pure and Applied Chemistry (IUPAC) recommendations, proving their sensitivity and selectivity for drotaverine determination in dosage form and human plasma.
HIGHLIGHTS:
This work presents the first ever application of both the innovative SVEM designs and MD/QM simulations in the optimization and fabrication of drotaverine-sensitive and selective MIP-decorated PVC sensors.
2023-08-16Pharmaceutics
The Influence of the Intergranular Superdisintegrant Performance on New Drotaverine Orodispersible Tablet Formulations.
Article
作者: Pintea, Cezara ; Vlad, Robert-Alexandru ; Bîrsan, Magdalena ; Rédai, Emöke Margit ; Chirteș, Diana-Andreea ; Todoran, Nicoleta ; Ciurba, Adriana ; Antonoaea, Paula
The main objective of this study consists in establishing the influence of the intergranular superdisintegrant on the specific properties of drotaverine hydrochloride fast-dissolving granules (DROT-FDGs) and orodispersible tablets (DROT-ODTs). The orodispersible tablets were obtained by the compression of the FDGs and excipient mixture with an eccentric tableting machine. To develop DROT-ODTs, two types of superdisintegrant excipients in different concentrations (water-soluble soy polysaccharides (SSP) (1%, 5%) and water-insoluble soy polysaccharides-Emcosoy® STS IP (EMCS) (1%, 3%, 5%)) were used, resulting in five formulations (D1-D5). The DROT-FDGs and the DROT-ODTs were subjected to pharmacotechnical and analytical evaluation. All the orodispersible tablets obtained respect the quality requirements in terms of friability (less than 1%), crushing strength (ranging between 52 N for D2 and 125.5 N for D3), and disintegration time (<180 s). The in vitro release of drotaverine from ODTs showed that all formulations presented amounts of active substance released greater than 85% at 10 min. The main objective, developing 30 mg DROT-ODTs for children aged between 6 and 12 years by incorporating the API in FDGs, was successfully achieved.
100 项与 盐酸屈他维林 相关的药物交易
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研发状态
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 肌肉痉挛 | 中国 | - |
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临床结果
临床结果
适应症
分期
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临床3期 | 650 | (Experimental) | 製壓壓壓餘餘構襯繭築(餘願鬱襯選餘製獵廠鹹) = 遞襯淵壓範齋憲餘衊築 積鹹餘繭築醖鹽製顧鏇 (選範獵鑰蓋獵蓋夢廠醖, 艱鹽獵膚廠窪夢蓋觸製 ~ 齋獵簾顧鏇淵廠顧壓衊) 更多 | - | 2009-12-23 | ||
(Active Comparator) | 製壓壓壓餘餘構襯繭築(餘願鬱襯選餘製獵廠鹹) = 製艱衊窪壓鹹憲繭築艱 積鹹餘繭築醖鹽製顧鏇 (選範獵鑰蓋獵蓋夢廠醖, 衊蓋簾壓蓋遞鬱網選蓋 ~ 齋醖簾糧遞憲觸遞艱窪) 更多 |
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