Metoprolol controlled release mixed matrix tablet and preparation method thereof

Abstract

The invention discloses a metoprolol controlled release mixed matrix tablet, belonging to the pharmaceutical field, comprising the following components: 4-60% of metoprolol or metoprolol salt, 0.05-10% of lauryl sodium sulphate, 15-60% of high viscosity hydrophilic polymer and 2-60% of non-disintegration matrix material; the non-disintegration matrix material forms a matrix system with equal gaps; the mixture of the metoprolol or metoprolol salt and the high viscosity hydrophilic polymer is filled in the matrix system. The metoprolol matrix tablet can slowly release for 24 hours and can be taken one time per day; the blood concentration is in the range of the therapeutic window of the metoprolol, which is suitable for the request of the treatment. Simultaneously, the invention provides a method for preparing the metoprolol controlled release mixed matrix tablet; the other auxiliary materials and pharmaceutical preparations are mixed with the insoluble non-disintegration matrix material; the insoluble non-disintegration matrix material can form rigid matrix and effectively control the release speed of the drugs.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a method for preparing metoprolol sustained-release tablets, specifically designing a metoprolol controlled-release mixed matrix tablet and a preparation method thereof. Background technique [0002] Metoprolol is a selective β1-receptor antagonist. The drug has been on the market for 34 years since it was launched in 1975. It is mainly used in the treatment of hypertension and ischemic heart disease, and also in the prevention of angina pectoris and myocardial infarction. [0003] Due to the relatively short half-life of metoprolol (3-4 hours), some drug companies have developed some traditional sustained-release preparations in the 1980s, such as Betaloc SA, Lopressor SR, etc. These traditional sustained-release preparations can reduce the frequency of dosing, and also reduce adverse reactions to a certain extent, but because the peak value of the blood drug concentration is still high, ...

AI Technical Summary

Problems solved by technology

However, this method dissolves ethyl cellulose (EC) in high-concentration ethanol as a binder for wet granulation, causing it to become both a binder and a slow-release film, and the distribution in the material is uneven. Uniformity, resulting in poor reproducibility of the release pattern of the preparation, and at the same time, the obtained granules are relatively hard, so that the hardness of the extruded tablet is too large and the surface is not smooth enough, and it has an adverse effect on the tableting machine

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