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更新于：2025-07-15
Itopride Hydrochloride
盐酸伊托必利
更新于：2025-07-15
概要
基本信息
权益机构- |
最高研发阶段批准上市 |
首次获批日期 日本 (1995-06-30), |
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C20H27ClN2O4 |
InChIKeyZTOUXLLIPWWHSR-UHFFFAOYSA-N |
CAS号122892-31-3 |
关联
39
项与 盐酸伊托必利 相关的临床试验NCT07031479
Efficacy of Enteral Itopride Versus Intravenous Metoclopramide in Hospitalized Medicine Patients With Feeding Intolerance Causing by High Gastric Residual Volume: a Prospective Randomized Controlled Trial
TCTR20241012004
A Bioequivalence Study of Open-label, Randomized, Single Oral Dose, Two-way Crossover Design of Generic Itopride Hydrochloride 50 mg Film Coated Tablets and Reference Product (Ganaton) in Healthy Thai Subjects under Fasting Conditions
CTR20241978
盐酸伊托必利片在健康受试者中单剂量、随机、开放、空腹两周期/餐后四周期、两序列、交叉设计的生物等效性试验
100 项与 盐酸伊托必利 相关的临床结果
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100 项与 盐酸伊托必利 相关的转化医学
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100 项与 盐酸伊托必利 相关的专利（医药）
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428
项与 盐酸伊托必利 相关的文献（医药）2025-05-05CURRENT PHARMACEUTICAL DESIGN
The Quantitative Analysis of Solid Dosage Forms of Itopride using Raman Spectroscopy
Article
作者: Saif, Ayesha ; Majeed, Muhammad Irfan ; Fatima, Rida ; Akbar, Haseeb ; Ijaz, Tehseen ; Nawaz, Haq ; Alshammari, Abdulrahman ; Naheed, Iqra ; Ali, Arslan ; Albekairi, Norah A. ; Ehsan, Maida ; Aziz, Aleena
Objective::
This study explores the application of Raman spectroscopy for identifying and quantifying
itopride in solid dosage forms with varying concentrations of active ingredients and excipients. Raman
spectroscopy provides a non-invasive, rapid, and accurate detection method that is ideal for pharmaceutical
analysis.
Method::
The Raman spectral features of itopride in solid dosage forms were analyzed using Principal Component
Analysis (PCA) and Partial Least Squares Regression Analysis (PLS-RA) as multivariate data analysis
techniques.
Results::
PCA effectively distinguished Raman spectral data of various itopride drug samples. PLS-RA facilitated
quantitative analysis, yielding an R2 value of 0.999%, indicating an excellent explanation of model variability.
The root mean square error of calibration and prediction were 0.23 mg and 3.02 mg, respectively. Furthermore,
PLS-RA accurately determined the active pharmaceutical ingredient concentration in unknown
formulations, with a calculated concentration of 79.66/80 mg (w/w) compared to the actual concentration of
80/140 mg (w/w).
Conclusion::
These findings demonstrated that the concentration of itopride in pharmaceutical samples using
an established Partial Least Squares Regression calibration model can be determined with reliability.
2025-04-01Nigerian Postgraduate Medical Journal
An Extremely Rare Case of Gastroptosis Treated Successfully with Itopride in a Patient with Parkinson’s Disease
Article
作者: Cömert, Kübra Yildiz ; Güven, Alper Tuna
A rare condition known as gastroptosis causes the major curvature of the stomach to shift downward and towards the pelvis. While some are asymptomatic, others experience symptoms. Cross-sectional imaging, or barium X-rays, are diagnostic. The main treatment strategy is conservative, and gastric motility stimulants, including dopamine antagonists, are the mainstay of the treatment. Herein, we describe an elderly patient with multimorbidity, polypharmacy and Parkinson’s disease admitted to our clinic with nausea, vomiting and unintentional weight loss complaints who was diagnosed with gastroptosis and treated successfully with itopride, a dopamine antagonist, without worsening Parkinson’s disease. This exceedingly rare condition should be kept in mind in patients with gastrointestinal symptoms whose initial diagnostic search is unrevealing. Although the presence of Parkinson’s disease casts doubt on the use of dopamine antagonists, itopride has a very low central nervous system (CNS) pass and CNS-related side effects. Moreover, the absence of effective and safe measures other than dopaminergic antagonists and interventional methods renders their use compulsory.
2025-01-02Expert Opinion On Drug Safety
Risk of drug-induced delirium in older patients- a pharmacovigilance study of FDA adverse event reporting system database
Article
作者: Li, Jiayu ; Zhou, Ying ; Jia, Boying ; Zhou, Shuang ; Wan, Liyan ; Cui, Yimin
BACKGROUND:
Drug-induced delirium is known risk factors associated with increased morbidity and mortality in older patients. The objective was to evaluate the risk of drug-related delirium in older patients based on the FDA Adverse Event Reporting System (FAERS).
RESEARCH DESIGN AND METHODS:
Delirium reports in older patients (age ≥65) extracted from the FAERS database using Open Vigil 2.1. The reported odds ratio and the proportional reported ratio were calculated to detect the adverse reaction signal of delirium. Combined with published evidence, suspected drugs were categorized as known, possible, or new potential delirium-risk-increasing drugs.
RESULTS:
Of the 130,885 reports (including 28,850 delirium events and 1,857 drugs) analyzed for this study, 314 positive signal drugs were detected. Positive signal drugs are mainly concentrated on the drug of nervous system, cardiovascular system , alimentary tract and metabolism and anti-infectives for systemic use. Of the positive signal drugs, 26.11% (82/314) were known delirium-risk increasing drugs, 44.90% (141/314) were possible and 28.98% (91/314) were new potential.
CONCLUSION:
Drug-induced delirium risk is prevalent in older patients, according to the FAERS. The risk level of drug-induced delirium should be taken into account to optimize drug therapy in clinical practice.
100 项与 盐酸伊托必利 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 |
|---|---|---|---|
| 胃肠道疾病 | 印度 | 2003-01-20 | |
| 慢性胃炎 | 日本 | 1995-06-30 | |
| 心脏衰竭 | 中国 | - | - |
| 高血压 | 中国 | - | - |
| 恶心 | - | - | - |
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 |
|---|---|---|---|---|
| 餐后窘迫综合征 | 临床3期 | 亚美尼亚 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 马来西亚 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 菲律宾 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 泰国 | 2024-02-28 | |
| 餐后窘迫综合征 | 临床3期 | 越南 | 2024-02-28 | |
| 胃灼热 | 临床3期 | 美国 | 2006-10-01 | |
| 肠道疾病 | 临床3期 | 美国 | 2005-11-01 | |
| 腹部膨胀 | 临床3期 | 加拿大 | 2004-07-01 | |
| 消化不良 | 临床3期 | 德国 | 2000-12-01 | |
| 便秘型肠易激综合征 | 临床2期 | 巴基斯坦 | 2008-06-01 |
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临床结果
临床结果
适应症
分期
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N/A | 798 | 鑰積壓壓衊遞壓夢淵醖(餘艱構餘憲鏇齋遞廠淵) = The majority of adverse events were gastrointestinal. Prolactin elevations occurred in 3% of the cases but were not clinically significant. No ECG changes were identified. 餘餘遞顧選艱窪襯願範 (積艱憲鑰窪襯窪醖鏇獵 ) | 积极 | 2025-01-01 | |||
Placebo | |||||||
N/A | - | - | 網膚遞願顧窪願築憲鑰(構範製鹽觸築夢築壓淵) = 選窪鬱製願鹹糧遞衊夢 願壓鬱鏇膚網網艱蓋膚 (積遞艱淵鑰獵襯糧齋鹹, 25) | - | 2018-10-01 | ||
網膚遞願顧窪願築憲鑰(構範製鹽觸築夢築壓淵) = 範鏇製製鹹鹽夢遞製衊 願壓鬱鏇膚網網艱蓋膚 (積遞艱淵鑰獵襯糧齋鹹, 32) | |||||||
N/A | - | 範鹹簾衊淵簾網觸鹽積(簾觸簾築艱鏇鏇鏇觸築) = 壓壓廠壓鏇淵範獵襯鹽 衊獵鏇繭鹽廠選願鏇構 (鏇繭憲觸製齋構鹹壓積 ) 更多 | - | 2005-06-01 | |||
Placebo | 範鹹簾衊淵簾網觸鹽積(簾觸簾築艱鏇鏇鏇觸築) = 夢鑰構壓鹽窪簾築壓憲 衊獵鏇繭鹽廠選願鏇構 (鏇繭憲觸製齋構鹹壓積 ) 更多 |
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