Sumatriptan succinate compound preparation and preparation method thereof

Abstract

The invention discloses a sumatriptan succinate compound preparation, which comprises sumatriptan succinate pellets and naproxen sodium pellets; the active components in part by mass are 119 parts of sumatriptan succinate and 500 parts of naproxen sodium. The sumatriptan succinate pellets comprise 87 to 97 weight percent of medicament-containing pellet core, 1 to 5 weight percent of isolation layer and 2 to 8 weight percent of coating layer; and the naproxen sodium pellets comprise 99 to 99.9 weight percent of medicament-containing pellet core and 0.1 to 1 weight percent of isolation layer. Amethod for preparing the preparation comprises the following steps: respectively preparing the umatriptan succinate pellets and the naproxen sodium pellets; and mixing the umatriptan succinate pellets and the naproxen sodium pellets to prepare pharmaceutically acceptable formulation. The two medicaments in the compound preparation form a special independent release curve in the dissolving-out process so as to achieve the aim that the naproxen sodium is firstly released and absorbed and then the sumatriptan succinate is released and absorbed and further achieve better treatment effect.

Description

technical field [0001] The invention relates to a sumatriptan succinate compound preparation and a preparation method thereof. Background technique [0002] Migraine is a primary neurovascular headache with intermittent attacks and severe pain. It is a common clinical disease. The incidence of migraine is about 18% in women and 6% in men. The prevalence rate of migraine in my country is 985.2 / 100,000, and the annual incidence rate is 4.2%-14.6%. Because the disease recurs, it is more difficult to recover from illness, which brings great misery to the patient and indirectly has a serious impact on the social economy. [0003] Triptans developed on the basis of neurovascular theory provide a new option for the treatment of migraine. The most widely clinically used triptan drug at home and abroad is sumatriptan (trade name Imitrex), developed by GlaxoSmithKline, and currently has ordinary tablets, immediate-release tablets, injections and nasal sprays. [0004] Triptans suc...

AI Technical Summary

Problems solved by technology

[0006] a. After taking the double-layer tablet, sumatriptan and naproxen sodium start to be released at the same time, and the absorption of triptans such as sumatriptan will delay gastric emptying, thereby affecting the non-steroidal anti-inflammatory drug naproxen Gastrointestinal absorption of Sodium Sodium, thus affecting the curative effect;

[0007] b. During the preparation of the double-layer tablet, at least one tablet was pressurized twice, resulting in excessive hardness of the tablet, which affected the release of the drug, and it was difficult to release the drug from the connecting surface of the upper and lower double-layer tablets;

[0008] c. The preparation of double-layer tablets requires too much equipment and is difficult to produce industrially

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