Compound naproxen esomeprazole medicine composition and preparation method thereof

Abstract

The invention discloses a compound naproxen esomeprazole medicine composition and a preparation method thereof. The medicine composition is bilayer tablets which are prepared by uniformly mixing and then pressing esomeprazole-containing quick release granules (1) and naproxen-containing slow release granules (2), wherein the esomeprazole-containing quick release granules are taken as a quick release layer, the naproxen-containing slow release granules are taken as a slow release layer, and naproxen is in a basically amorphous form. The medicine composition is simple in prescription, has good stability and is suitable for long-term storage. The compound naproxen esomeprazole slow release tablets provided by the invention has the advantages that the aim that naproxen and esomeprazole have synergic effect in a human body, curative effect is obviously improved, adverse effect is obviously reduced, daily administration frequency is reduced, administration cost is reduced, administration compliance of a patient is improved, blood concentration of medicine can be controlled, and bioavailability is effectively improved, thus important economic value and social significance are achieved.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a compound naproxen esomeprazole pharmaceutical composition and a preparation method thereof. Background technique [0002] naproxen [0003] English name: Naproxen; [0004] Chemical name: (+)-(S)-2-methyl-6-methoxy-2-naphthaleneacetic acid; [0005] Physical and chemical properties: white or off-white crystalline powder, almost odorless. Soluble in lipids, practically insoluble in low pH water, and freely soluble in water at high pH. The partition coefficient of naproxen at pH 7.4 octanol / water is 1.6 to 1.8; [0006] Melting point: 153 °C; [0007] Chemical formula: C 14 h 14 o 3 ; [0008] Molecular weight: 230.259 g / mol; [0009] CAS number: 22204-53-1; [0010] Chemical structure: . [0011] Naproxen belongs to the non-steroidal anti-inflammatory analgesic drug, which has strong anti-inflammatory and analgesic effects. In 1976, Naproxen began to be sold as a prescripti...

AI Technical Summary

Problems solved by technology

[0025] Chinese patent CN200810111831.0 discloses the dosage form of esomeprazole magnesium dripping pills, which solves the low deficiency of the bioavailability of the tablet, and also explains that it is easy to produce unstable phenomenon in its long-term storage, that is, aging phenomenon, so that the long-term Drug-related substances increase under room temperature storage conditions, reducing bioavailability and offsetting the superiority of dropping pills

For foreign marketed samples, naproxen is used to make tablet cores, and esomeprazole is quantitatively sprayed on the outside of the tablet cores. The preparation process is complex, and domestic implementation is difficult, requiring high equipment requirements and increasing costs.

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