Single layer osmotic pump controlled release preparation containing metoprolol and felodipine

Abstract

The present invention belongs to the field of pharmaceutical preparations, and relates to a single layer osmotic pump controlled release preparation containing metoprolol and felodipine. Specifically the controlled release preparation comprises a tablet core and a semipermeable film coating, wherein the tablet core comprises the following components, by weight, 50-100 parts of metoprolol or a pharmaceutically acceptable salt thereof, 5-10 parts of felodipine, 3-10 parts of hydroxy propyl methyl cellulose, 5-25 parts of povidone, and 5-25 parts of sodium carboxymethyl cellulose. The present invention further relates to a preparation method and a use of the preparation. With the controlled release preparation of the present invention, synchronous and constant speed release of metoprolol and felodipine can be achieved. Compared with preparation of double layer osmotic pump tablets, the preparation method of the present invention has a characteristic of substantial simplification of the preparation process, wherein the method comprises that metoprolol is encapsulated in a pill core, and then conjointly preparing into tablets with felodipine.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations and relates to a single-layer osmotic pump controlled release preparation containing metoprolol and felodipine. The invention also relates to the preparation method and application of the preparation. Background technique [0002] Hypertension is one of the most common cardiovascular diseases, and it is also a major risk factor leading to increased morbidity and mortality of congestive heart failure, stroke, coronary heart disease, renal failure, and aortic aneurysm. [0003] For a long time, the stepwise and sequential treatment strategies adopted in drug treatment of hypertension are based on single drug therapy. The advantages of single drug therapy are simplicity and low cost, but there are also many disadvantages: ① generally, single drug can only control the blood pressure of 40%-60% or even less patients, and the effect on severe hypertension is even worse; ② the dose-effect of c...

AI Technical Summary

Problems solved by technology

The advantages of single drug therapy are simplicity and low cost, but there are also many disadvantages: ① single drug can only control the blood pressure of 40%-60% or even less patients, and the effect on severe hypertension is even worse; ② the dose-effect of commonly used drugs The curve is flat and the effect is not good. When the dose is increased, the curative effect will not increase much, but the side effects will increase in a logarithmic order; ③ After the drug lowers blood pressure, the body's compensatory mechanism may produce counter regulation, such as the sympathetic and RAS system Activation and water and sodium retention, etc., can reduce or even offset the antihypertensive effect; ④ Patients with coexisting diseases or risk factors are often difficult to take into account, thus limiting the use of sufficient doses

[0007] But, because do not find the binding agent of suitable type and content and suspending agent, and the co-solvent of suitable type and content and penetration enhancer used in conjunction with it, it is difficult to realize metoprolol and felodipine permeate in monolayer Synchronized constant-rate release in pump formulations, therefore, monolayer osmotic pump formulations of metoprolol and felodipine have not been reported to date

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