非洛地平/琥珀酸美托洛尔(Felodipine/Metoprolol Succinate) - 药物靶点：VDCCs x β1-adrenergic receptor_在研适应症：高血压_专利_临床

概要

基本信息

药物类型

小分子化药

别名

Logimax

靶点

VDCCs x β1-adrenergic receptor

作用机制

VDCCs阻滞剂(电压门控性钙通道复合体阻滞剂)、β1-adrenergic receptor激动剂(β1-肾上腺素能受体激动剂)

治疗领域

心血管疾病

在研适应症

高血压

非在研适应症-

原研机构-

在研机构-

非在研机构

广西博科药业有限公司

最高研发阶段批准上市

首次获批日期-

最高研发阶段(中国)暂停

特殊审评-

结构

分子式C18H19Cl2NO4

InChIKeyRZTAMFZIAATZDJ-UHFFFAOYSA-N

CAS号72509-76-3

查看全部结构式(2)

关联

2

项与非洛地平/琥珀酸美托洛尔相关的临床试验

CTR20191518 / Suspended临床1期

随机、开放、单剂量、两制剂、两周期、两序列方法开展非洛地平琥珀酸美托洛尔缓释片人体生物等效性研究

本试验旨在研究单次空腹和餐后口服广西厚德大健康产业股份有限公司研制、生产的非洛地平琥珀酸美托洛尔缓释片（5/47.5 mg）的药代动力学特征；以阿斯利康制药有限公司生产的非洛地平琥珀酸美托洛尔缓释片（Logimax ® ，5/47.5mg）为参比制剂，比较两制剂中药动学参数 C max 、AUC 0-t 、AUC 0-∞ ，评价两制剂的人体生物等效性。

开始日期-

申办/合作机构

广西博科药业有限公司

NCT01238705 / Unknown status临床4期IIT

Effect of Combined Antihypertensive Therapy on Blood Pressure and Sexual Function in Patients With Essential Hypertension

This randomized,active controlled study aimed to compare the effects on sexual function of treatment with combined antihypertensive drugs.
The researchers hypothesize that:
Both felodipine-irbesartan combination and felodipine-metoprolol combination are effective in lowing blood pressure in patients with essential hypertension.
Felodipine-metoprolol combination induces a worse sexual function and a reduction of sex hormone,whereas felodipine-irbesartan combination does not impair sexual function and does not change hormone levels.
Oxidative stress decline after both combination regimens. Felodipine-irbesartan combination has a greater impact on oxidative stress indicators than felodipine-metoprolol combination.

开始日期2008-04-01

申办/合作机构

兰州大学

100 项与非洛地平/琥珀酸美托洛尔相关的临床结果

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100 项与非洛地平/琥珀酸美托洛尔相关的转化医学

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100 项与非洛地平/琥珀酸美托洛尔相关的专利（医药）

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9

项与非洛地平/琥珀酸美托洛尔相关的文献（医药）

2020-07-01·Journal of AOAC INTERNATIONAL4区 · 农林科学

Development and Validation of RP-HPLC and an Ecofriendly HPTLC Method for Simultaneous Determination of Felodipine and Metoprolol Succinate, and their Major Metabolites in Human Spiked Plasma

4区 · 农林科学

Article

作者: Hassan, Eman S ; Emam, Aml A ; Abdelaleem, Eglal A ; Naguib, Ibrahim A

AbstractBackgroundFelodipine is a calcium channel blocker used together with metoprolol succinate for treatment of hypertension.ObjectiveTwo chromatographic methods were developed for simultaneous determination of felodipine (FEL) and metoprolol succinate (MET), and their major metabolites, dehydrofelodipine and metoprolol acid, respectively.MethodsThe first method was RP-HPLC which comprised separation of the studied components by gradient elution using a Phenomenex C8 column and a mobile phase composed of water (adjusted to pH 3.5 with o-phosphoric acid)–acetonitrile – methanol (45:40:15, by volume) for the first 6 min and (30:60:10, by volume) for the next 4 min at a flow rate of 1 mL/min followed by UV detection of the eluted peaks at 225 nm. The second method was an HPTLC method where separation was achieved using a mobile phase consisting of toluene–ethyl acetate–methanol–ammonia–formic acid (10:5:2.5:0.3:0.1, by volume) and scanning of the separated bands at 225 nm.ResultsValidation of the developed methods was done according to ICH guidelines. Successful application of the developed methods was carried out for determination of the studied drugs in human spiked plasma and in Logimax® tablets.ConclusionsThe developed RP-HPLC and HPTLC methods can be further applied for quality control testing of the studied drugs.HighlightsRP-HPLC and HPTLC methods for determination of FEL, MET and their major metabolites. The developed methods were successfully applied for determination of FEL and MET in Logimax® tablets.

2010-10-01·Pharmeuropa bio & scientific notes

Quality control of metoprolol extended-release formulations in the presence of ethanol.

Article

作者: Johansson, M ; Dawood, A ; Amini, A ; Thor, H ; Ragnarsson, G ; Hesselgren, A-M ; Jönsson, S ; Arvidsson, T

This paper presents in-vitro metoprolol release from four different extended-release (ER) formulations, i.e. Metoprolol GEA® Retard, Logimax® forte, Metoprolol Sandoz® and Seloken ZOC® in the presence of 10 to 40% (v/v%) ethanol at pH 1.2 and pH 6.8. The assay of metoprolol in the dissolution media was performed by reversed phase liquid chromatography (RP-LC) using a mixture of methanol and 100 mM phosphate buffer (pH 3.5) in 40:60 ratio as eluent. The dissolution data showed that the metoprolol contents of Metoprolol Sandoz® and Seloken ZOC® were released fast in the presence of 20% ethanol at the investigated conditions, while the other products demonstrated much more stability against ethanol. Unexpectedly it was discovered that the release of metoprolol from Metoprolol GEA® Retard and to some extent also from Logimax® forte decreased in the ethanol containing media.

2002-01-01·Terapevticheskii arkhiv4区 · 医学

[Prospects of use of the combined preparation logimax in patients with essential hypertension].

4区 · 医学

ArticleOA

作者: Ol'binskaia, L I ; Zheleznykh, E A ; Khapaev, B A

AIMTo study the effectiveness and tolerance of a combined drug logimax in patients with essential hypertension (EH).MATERIAL AND METHODSThe antihypertensive activity and safety of logimax was evaluated in 15 EH patients at week 10 of therapy.RESULTSLogimax has a good antihypertensive effect for 24 hours in 86.7% patients. This was evidenced by the lowered mean systolic and diastolic pressures shown during 24-hour monitoring. Logimax was well tolerated. There were no side effects in 73.3% of the patients.CONCLUSIONThe combined drug logimax is indicated for patients with EH as an antihypertensive agent to treat and prevent cardiovascular events.

100 项与非洛地平/琥珀酸美托洛尔相关的药物交易

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