Novel nimesulide sustained-release pharmaceutical composition and preparation method thereof
A composition and drug technology, applied in the sustained-release pharmaceutical composition of nimesulide and its preparation field, can solve the requirements of layer and layer cross-contamination yield, double-layer compression technology prescription and production process, and industrial production requirements Higher problems, to achieve the effects of fast drug onset, good patient compliance, and good bioavailability
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Embodiment 1
[0047] Embodiment 1: Nimesulide tablet containing alkalizing agent is prepared by direct compression method
[0048] Table 1: Prescription
[0049]
[0050] Among them, the alkalizing agent is magnesium hydroxide, magnesium silicate, sodium carbonate, sodium bicarbonate, calcium hydrogen phosphate, magnesium oxide, magnesium hydroxide, sodium citrate, trishydroxymethylaminomethane, meglumine, and acrylic resin.
[0051] Preparation:
[0052] Weigh the raw and auxiliary materials according to the prescription amount in Table 1, pass through an 80-mesh sieve, mix evenly, and tablet.
[0053] According to the prescription quantity of prescription 1-4 in table 1, apply above-mentioned method to prepare alkalizing agent respectively and be magnesium hydroxide, magnesium silicate, sodium carbonate, sodium bicarbonate, calcium hydrogen phosphate, magnesium oxide, magnesium hydroxide, citric acid Sodium, Tris, Meglumine, Acrylic Tablets.
[0054] One skilled in the art would als...
Embodiment 2
[0055] Embodiment 2: Nimesulide tablet or capsule containing alkalizing agent prepared by wet granulation process
[0056] Preparation:
[0057] Weigh nimesulide, alkalinizing agent sodium bicarbonate, and other solid preparation molding auxiliary materials hypromellose, lactose, and micropowder silica gel according to the prescription amount of prescription 3 in Table 1, and mix them through an 80-mesh sieve; Measure a non-aqueous solvent as a wetting agent (ethanol), make the above-mentioned mixture into a soft material, pass through a 20-mesh sieve to make wet granules, and dry the wet granules at 60°C to obtain dry granules. A certain amount of lubricant magnesium stearate is added to the dry granules, passed through a 16-mesh sieve, mixed, granulated, compressed into tablets whose main ingredient is nimesulide, or directly filled into capsules to prepare capsules.
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Abstract
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