Minocycline hydrochloride sustained release tablet and preparation method thereof

Abstract

The invention relates to a minocycline hydrochloride sustained release tablet and a preparation method thereof. In the technical scheme, the minocycline hydrochloride sustained release tablet is composed of a tablet core and a film coat, the tablet core is composed of minocycline hydrochloride, a sustained release material, a bonding agent, a filling agent and a lubricating agent, the film coat is composed of a film forming material, in the preparation method, the granule is manufactured by means of the high shear wet method and obtained through the drying of a boiling bed, the temperature ofthe material dried by a fluidized bed is controlled to be 25-35 DEG C, and the moisture content of the granule is controlled to be 2.0-4.0 percent. The invention belongs to the technical field of pharmaceutical preparation, which aims to provide an available preparation process for the minocycline hydrochloride sustained release tablet and greatly reduce the relevant materials introduced druing the preparation by controlling the key parameters in the preparation process. The preparation method of the minocycline hydrochloride sustained release tablet and the method for controlling of the relevant materials aim to develop a sustained release formulation of minocycline hydrochloride, and various specifications can be issued based on the body weight of a patient, thereby reducing the peak valley fluctuation of the blood concentration, effectively controlling the adverse drug reaction, and improving the drug bioavailability.

Description

technical field [0001] The invention relates to a minocycline hydrochloride sustained-release tablet and a preparation method thereof, belonging to the field of medicine. technical background [0002] Minocycline hydrochloride is a semi-synthetic tetracycline broad-spectrum antibiotic with high efficiency and long-lasting effect. Among the tetracycline antibiotics, this product has the strongest antibacterial effect. The antibacterial spectrum is similar to that of tetracycline. It has a strong effect on Gram-positive bacteria, including tetracycline-resistant Staphylococcus aureus, Streptococcus, etc., and Neisseria gonorrhoeae in Gram-negative bacteria; the effect on Gram-negative bacilli is generally weak; this product is effective on trachoma Chlamydia and Ureaplasma urealyticum also have good inhibitory effect. The mechanism of action of this product is to bind to the A position of the ribosomal 30S subunit to prevent the elongation of the peptide chain, thereby inhib...

AI Technical Summary

Problems solved by technology

In particular, the present invention controls the key parameters in the preparation process of the preparation, which solves the problem that in the preparation process of the sustained-release preparation, as the preparation process increases and the time increases, the content of related substances, especially minocycline, increases. , greatly reducing the content of related substances introduced in the preparation process, especially the anisotropic minocycline, which is more conducive to industrialization and ensures the quality of the product. At the same time, it can also realize the slow and full release of the drug and improve the bioavailability , improve the safety and effectiveness of medication for patients, and better meet the needs of the domestic market

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