预约演示
更新于：2024-12-31
Bisoprolol Fumarate
富马酸比索洛尔
更新于：2024-12-31
概要
基本信息
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- |
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结构/序列
分子式C40H66N2O12 |
InChIKeyVMDFASMUILANOL-WXXKFALUSA-N |
CAS号104344-23-2 |
关联
42
项与 富马酸比索洛尔 相关的临床试验TCTR20240624006
A Single Dose, Randomized, Open-label, Two-way Crossover Bioequivalence Study of Generic Bisoprolol Fumarate 5 mg Film-coated Tablets and Reference Product (Concor 5) in Healthy Thai Volunteers under Fasting Conditions
CTR20241596
富马酸比索洛尔片（5mg）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
CTR20241764
富马酸比索洛尔片在健康研究参与者中的单剂量、随机、开放、交叉、两制剂、两周期空腹和餐后人体生物等效性试验
100 项与 富马酸比索洛尔 相关的临床结果
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100 项与 富马酸比索洛尔 相关的转化医学
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100 项与 富马酸比索洛尔 相关的专利（医药）
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72
项与 富马酸比索洛尔 相关的文献（医药）2024-06-01PCN reports : psychiatry and clinical neurosciences
A case of reinitiation of modified electroconvulsive therapy 2 weeks after modified electroconvulsive therapy‐induced Takotsubo cardiomyopathy in a male patient with major depressive disorder
Article
作者: Sakuma, Kei ; Haruyama, Akiko ; Kezuka, Dai ; Suzuki, Eiji
Abstract:
Background:
Takotsubo cardiomyopathy (TCM) is a left ventricular dysfunction resembling acute coronary syndrome. Its prognosis is generally favorable; however, a subset of patients may present with severe complications. TCM is a rare side‐effect of modified electroconvulsive therapy (ECT); it has been reported in 22 female and two male patients. Eight cases of ECT reinitiation after TCM have been reported (all females), with the shortest duration being 3 weeks.
Case Presentation:
We report the case of a 61‐year‐old man with a history of major depressive disorder and no history of heart disease or previous ECT treatment. Antidepressants had been ineffective, and ECT was indicated. After the third ECT session, the patient complained of chest pain and shortness of breath. Electrocardiography revealed ST elevation, and catheter angiography was used to diagnose TCM. The patient had mild heart failure but remained stable. Recognizing that ECT was effective, the patient asked for it to be reinitiated. We confirmed that the cardiac function had been normalized, applied a bisoprolol fumarate patch as a preventive measure, and reinitiated ECT 14 days after the onset of TCM. ECT was performed five times, with no recurrence of TCM and a marked improvement in depression.
Conclusion:
We describe a male patient with major depressive disorder who underwent reinitiation of ECT 2 weeks after ECT‐induced TCM. Therefore, TCM should be recognized as a side‐effect of ECT, even in men. Moreover, depending on whether the patient's condition is stable, ECT can be successfully performed in patients with TCM.
2024-01-01Journal of separation science
The improvement of routine drug quality control analysis of some antihypertensive drugs using high‐performance thin‐layer chromatography densitometry method with greenness profile evaluation
Article
作者: Abdelaleem, Eglal A ; Tohamy, Salwa I ; Abdelhamid, Nessreen S ; Lashien, Adel ; Amin, Mahmoud M
The common antihypertensive drugs are B‐blockers and diuretics. For the determination of beta‐blocker medicines (bisoprolol fumarate and carvedilol) and diuretic drug (Furosemide), new and accurate chromatographic method has been developed. The separation was achieved using a developing system that includes chloroform:methanol:ethyl acetate:ammonia (6:2:2:0.2 by volume) as a mobile phase and the bands were detected at 240 nm. The concentration ranges were 5–25, 1–7, and 1–3.5 μg/band for bisoprolol fumarate, carvedilol, and furosemide, respectively. This chromatographic approach is the first methodology for simultaneously determining bisoprolol fumarate, carvedilol, and furosemide in their pure forms and in their pharmaceutical dosage forms. The advantages of using known analytical procedures are their simplicity, speed, cost effectiveness, lack of laboriousness, and ability to save time as the three tablets are determined in one step and can be used for routine analysis of the investigated combinations in quality control laboratories. According to International Conference of Harmonization guidelines, the established procedures have been validated, and the results were statistically compared to those obtained by the reported reversed‐phase–high‐performance liquid chromatography methods using Student's t‐test and F‐test, with no significant difference between them, indicating that the proposed methods can be used for routine drug quality control analysis.
2023-09-01Journal of AOAC International
Chromatographic Techniques for Assessment of Bisoprolol Fumarate and Perindopril Arginine in Solid Formulations under Various Stress Conditions and Application to Six Sigma, Content Uniformity, and Comparative Dissolution Approaches.
Article
作者: Omran, Ahmed A ; Mohamed, Mahmoud A ; Binsaleh, Ammena Y ; Mahmoud, Osama A ; Almalki, Manal A
BACKGROUND:
Antihypertensives bisoprolol fumarate (BIS) and perindopril arginine (PER) were simultaneously determined in their pure, bulk, and combined tablet dosage form.
OBJECTIVE:
This study develops a novel, reproducible, and accurate Reversed phase high-performance liquid chromatography (RP-HPLC) and Reversed phase ultra-performance liquid chromatography (RP-UPLC) with photodiode array detection techniques, which were then applied to in vitro dissolution studies.
METHODS:
The first RP-HPLC method relied on isocratic elution using a mobile phase of methanol-0.05 M phosphate buffer pH 2.6 (1 + 1, by volume), and separation was performed using a Thermo Hypersil C8 column (150 mm × 4.6 mm, 5 μm). Ion-pair UPLC was the second method. An acceptable resolution was achieved using an RP-C18 chromatographic column, Agilent Eclipse (100 × 2.1 mm, 1.7 μm), with a mobile phase containing 0.005 M sodium 1-heptane sulfonate-triethylamine (64 + 1 + 35, by volume), adjusted with phosphoric acid to a pH of 2.0. RP-HPLC used a 1.0 mL/min flow rate, while UPLC used 0.5 mL/min, and the two methods used detection at 210 nm.
RESULTS:
Calibration curves of BIS and PER were linear for RP-HPLC and RP-UPLC methods at 0.5-15 and 0.5-40 μg/mL, respectively. BIS and PER had RP-UPLC LODs of 0.22 and 0.10 μg/mL, respectively, and LOQs of 0.68 and 0.31 μg/mL, respectively. As a result, the approach has been effectively applied to in vitro dissolution testing for drugs in generic and reference products, showing that the two products are comparable. The Six Sigma approach was implemented to compare the recommended and United States Pharmacopeia (USP) procedures, which both exhibited process capability index (Cpk) >1.33. A content uniformity test demonstrated that the drugs in their dosage form met the acceptance limit (85-115%). The degradation products were reliably distinguished from pure drugs for a range of retention times.
CONCLUSION:
In their commercial drug product, the proposed method could be used in QC laboratories for concurrent testing, content uniformity, and in vitro dissolution investigations of BIS and PER. The methods were successfully validated per International Council for Harmonisation (ICH) guidelines.
HIGHLIGHTS:
This study is innovative since it is the first to establish and validate specific and reproducible UPLC and HPLC methods for the concurrent quantitation of the studied drugs in their binary mixture and application to lean Six Sigma, content uniformity, and comparative dissolution approaches.
100 项与 富马酸比索洛尔 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 |
|---|---|---|---|
| 心房颤动 | 日本 | 2013-06-14 | |
| 心动过速 | 日本 | 2013-06-14 | |
| 心脏衰竭 | 澳大利亚 | 2002-04-23 | |
| 原发性高血压 | 日本 | 1990-09-28 | |
| 心绞痛 | - | 1986-01-01 | |
| 高血压 | - | 1986-01-01 |
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临床4期 | 43 | 壓鹹製憲鬱築憲願鏇顧(壓積觸築築遞構鬱簾觸) = 壓網襯製鏇鹽獵願構齋 壓選觸選願衊觸鏇襯網 (衊艱齋襯獵顧餘構夢鏇, 鹹憲蓋鏇網繭艱積窪衊 ~ 顧憲艱蓋積膚構淵積憲) 更多 | - | 2022-03-10 | |||
壓鹹製憲鬱築憲願鏇顧(壓積觸築築遞構鬱簾觸) = 製積夢簾顧鬱範窪遞鹹 壓選觸選願衊觸鏇襯網 (衊艱齋襯獵顧餘構夢鏇, 範醖壓繭繭範餘繭繭顧 ~ 廠範膚淵膚築鹽夢糧簾) 更多 |
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