Atenolol pH independent sustained-release tablets and preparation method thereof

Abstract

The invention relates to the pharmaceutic preparation field and in particular relates to atenolol pH independent sustained-release tablets and a preparation method thereof. The atenolol pH independent sustained-release tablets are characterized by being prepared through the steps of evenly mixing a prescription amount of atenolol, HPMC (Hydroxy propyl methyl cellulose) K15M, eudragit RSPO, high-viscosity PEO (Polyethylene Oxide) and lactose monohydrate in such a manner of progressively increasing by equal amount, next, adding a small quantity of magnesium stearate and aerosil as the lubricant, and then forming the atenolol pH independent sustained-release tablets through a powder vertical-compression process. The pH independent sustained-release tablets are prepared effectively, and the slightly alkaline drug atenolol is provided to have similar release characteristic under different simulated gastrointestinal tract pH conditions. The HPMC stable in slow release performance is taken as the slow release framework of the pH independent sustained-release tablets, the eudragit RSPO is taken as the pH regulator of the pH independent sustained-release tablets, and the high-viscosity PEO is taken as the retardant of the pH independent sustained-release tablets; the preparation process is simple, the adverse effect of the drug is remarkably reduced and the compliance of the patient is improved; and besides, the pH independent sustained-release tablets have important economic value and social significance.

Description

Technical field [0001] The present invention relates to the field of pharmaceutical preparations, in particular to a pH-independent sustained-release tablet of atenolol, which is characterized in that 20-40 parts of HPMC K15M with stable sustained-release performance is the sustained-release matrix, and 15-35 parts of Yotech RSPO is a pH regulator, 10-20 parts of high-viscosity PEO (POLYOX) is used as a retarder, and atenolol pH-independent sustained-release tablets are prepared through a powder direct compression process. Background technique [0002] The environment of the gastrointestinal tract is more complicated than other routes of administration, and the relatively short residence time also limits the application and development of long-acting gastrointestinal preparations. At the same time, the changeable chemical environment of the entire gastrointestinal tract also makes the design of dosage forms more complicated. In fact, when the drug is absorbed in the gastrointest...

AI Technical Summary

Problems solved by technology

Li Lingbing et al. added organic acids to sustained-release tablets to make atenolol sustained-release tablets. By forming a local weak acidic environment in the tablet, the influence of gastrointestinal pH on drug release was reduced, but the amount of succinic acid in the prescription A small change will have a greater impact on the experimental results, which is not conducive to the reproduction of the experiment

Some researchers also made atenolol into single-layer osmotic pump tablets, and controlled drug release through microporous penetration. The drug is less affected by the external environment, but the process is more complicated.

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