Dexketoprofen trometamol quick-release sustained-release double-layer tablet and its preparation process

Abstract

The invention relates to a dexketoprofen trometamol quick-release / sustained-release double-layer tablet and a preparation method thereof, and provides a simple and convenient preparation process method for pressing the double-layer tablet consisting of a quick-release layer and a sustained-release layer, wherein the quick-release layer mainly comprises dexketoprofen trometamol, a sustained-release, a diluent, a binding agent and a lubricant. According to the dexketoprofen trometamol quick-release / sustained-release double-layer tablet provided by the invention, due to release of the quick-release part, the medicine is enabled to rapidly achieve effective blood concentration, the sustained-release part can be released slowly, and the effect that the dexketoprofen trometamol can be continuously released for 12 hours when being taken once is achieved. The defects that the conventional dexketoprofen trometamol preparation needs to be taken for multiple times in clinical treatment, and the blood concentration is not stable are made up, so that the effects of improving compliance of patients, stable curative effect and small toxic and side effects are achieved. The tablet is simple in preparation method, raw materials and auxiliaries can be easily obtained, and the tablet is applicable to industrial production and has a good application prospect.

Description

technical field [0001] The present invention relates to a new type of pharmaceutical preparation in the category of non-steroidal anti-inflammatory pharmaceutical preparations, in particular to the preparation process of dexketoprofen trometamol quick-release sustained-release double-layer tablet, which is characterized in that it consists of an immediate-release layer and The invention relates to a double-layer tablet made by co-compressing sustained-release layers, which belongs to the field of medicine. Background technique [0002] A double-layer sustained-release tablet is a tablet dosage form in which one or two drugs are made into two parts, an immediate-release layer and a sustained-release layer. The immediate-release layer and the sustained-release layer can be the same drug, or two drugs with synergistic effects. The quick-release layer can quickly relieve or treat the disease in a short period of time, reducing the harm to the patient caused by the onset of the ...

AI Technical Summary

Problems solved by technology

[0004] But clinically existing dexketoprofen trometamol preparations have a short half-life, common dosage forms need to be taken three to four times a day, and the blood drug concentration fluctuates greatly, while its sustained-release preparations release slowly and cannot rapidly release drug activity. composition, so that the maximum blood concentration is lower; and the dexketoprofen trometamol in the quick-release layer after oral administration of the double-layer sustained-release preparation developed by us dissolves quickly and relieves symptoms quickly, and the sustained-release layer then releases slowly, so that The analgesic and anti-inflammatory effect lasts for 12 hours, reduces the number of medications, improves patient compliance, and reduces adverse reactions

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