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Naproxen hydrate crystal, preparation method thereof and pharmaceutical composition containing the crystal and sumatriptan
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A hydrate and naproxen technology, applied in the field of medicine, can solve problems such as low solubility, large gastrointestinal irritation, affecting drug dissolution effect and bioavailability
Inactive Publication Date: 2011-12-14
HAINAN JINRUI PHARMA
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[0016] But, because naproxen is almost insoluble in water, the solubility is also very low under the pH condition of gastric acid environment, and this has influe
Method used
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Embodiment 1
[0075] [Example 1] Preparation of naproxen hydrate crystals
[0076] (1) Cool the mixed solution of solvent ethanol 30ml and acetone 25ml to 6°C, add 10g naproxen to dissolve to obtain solution 1;
[0077] (2) In an ultrasonic field with a power of 0.5kw, add 48ml of deionized water dropwise to solution 1 until crystals precipitate; the temperature of solution 1 is controlled at 6°C during the dropping process;
[0078] (3) After dropping, close the ultrasonic field, maintain the above temperature and stir for 1.5 hours, then stand at 6°C for 3.5 hours, and filter; the filter cake is washed with 10ml purified water and 15ml ethyl acetate, and dried in vacuum to obtain naproxen Hydrate crystals.
[0079] The X-ray powder diffraction spectrum obtained by Cu-Kα ray measurement of the prepared naproxen hydrate crystals (see figure 1 The characteristic peaks in 2θ are displayed at 7.3°, 12.5°, 13.0°, 13.5°, 17.0°, 17.9°, 18.8°, 22.1°, 23.4°, 24.2°, 25.0° and 27.4°.
[0080] Using PE Pyris D...
preparation Embodiment 1
[0085] [Formulation Example 1] Preparation of Naproxen / Sumatriptan Tablets
[0086] The prescription is as follows:
[0087]
[0088]
[0089] Preparation:
[0090] 1) Preparation of naproxen and sumatriptan package
[0091] i) Crush the amount of sumatriptan through an 80 mesh sieve for use;
[0092] ii) Weigh the naproxen hydrate crystals of Example 1 according to the stated amount, and mix them with the above-mentioned crushed and sieved sumatriptan to obtain a mixture of naproxen and sumatriptan;
[0093] iii) Heat and melt the gelatin in the stated amount, add the above-mentioned mixture of naproxen and sumatriptan, stir evenly, and pulverize through an 80-mesh sieve after cooling to obtain the naproxen and sumatriptan package.
[0094] 2) Preparation of naproxen / sumatriptan tablets
[0095] i) The amount of pharmaceutical excipients compressible starch, microcrystalline cellulose, low-substituted hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, sodium carboxymethyl cellulo...
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Abstract
The invention relates to a naproxen hydrate crystal, a preparation method thereof and a medicinal composition containing the naproxen hydrate crystal and sumatriptan. The naproxen hydrate crystal has the molecular formula as follows: C14H14O3.1.5H2O. The medicinal composition comprises the following components in parts by weight: 125-750 parts of naproxen, 25-100 parts of sumatriptan, 130-200 parts of gelatine, 10-45 parts of compressible starch, 10-35 parts of microcrystalline cellulose, 10-30 parts of low-substituted hydroxy propyl cellulose, 10-30 parts of cross-linked polyvinylpyrrolidone, 10-20 parts of sodium carboxymethylcellulose, 20-40 parts of maltodextrin, 5-20 parts of lecithin, 5-20 parts of magnesium stearate and 10-20 parts of sodium bicarbonate. According to the crystal provided by the invention, the dissolubility of naproxen is obviously improved, the medicinal composition of the naproxen hydrate crystal is prepared by using a direct tabletting method and has better disintegration time and dissolution rate, and the bioavailability of the naproxen is obviously improved.
Description
Technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to a naproxen hydrate crystal, a preparation method thereof, and a pharmaceutical composition containing the crystal and sumatriptan. Background technique [0002] Migraine is a headache caused by neurovascular dysfunction that occurs periodically. It is a common and frequently-occurring disease characterized by diffuse or unilateral attacks, severe pain, and recurring. It often has a family history. This disease belongs to the category of headache and other diseases in Chinese medicine. Migraine is divided into migraine without aura (normal type) and migraine with aura (typical). Migraine attacks are generally confined to one side of the head and can last for several hours or even days. It has the characteristics of recurring attacks, often accompanied by nausea, vomiting, photophobia, dizziness and other symptoms. With the rapid economic development, the pace of life acce...
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