Melatonin orally disintegrating tablet and preparation method thereof
A technology of orally disintegrating tablets and melatonin, which is applied in pharmaceutical formulations, medical preparations containing active ingredients, drug delivery, etc., can solve problems that have not been reported yet, and achieve improved bioavailability and short production cycles , low-cost effect
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Embodiment 1
[0028] Weigh 3 parts of melatonin, 6 parts of microcrystalline cellulose (SMCC), 8 parts of cross-linked polyvinylpyrrolidone (PVPP), 8.18 parts of sodium bicarbonate (NaHCO3), 9.82 parts of sodium citrate, 2.5 parts of lemon flavor, 0.75 parts of aspartame, 2 parts of magnesium stearate, 59.75 parts of mannitol for use. Grind the raw materials separately, pass through an 80-mesh sieve, and dry at 50°C. Use the equal volume addition method to mix the raw materials evenly and pass through a 60-mesh sieve; use the direct compression method to weigh the mixed powder Compression into tablets, the average tablet weight is set to 100mg, namely melatonin orally disintegrating tablets.
[0029] After testing, the hardness of the disintegrating tablet is between 14 and 16 Newtons; the disintegration time in the body is between 25 and 28 seconds; the dissolution amount in artificial gastric juice and intestinal juice at 37°C in 1 minute is 40%, and the dissolution rate in 6 minutes is up to...
Embodiment 2
[0031] Weigh 3 parts of melatonin, 3 parts of microcrystalline cellulose (SMCC), 13 parts of cross-linked polyvinylpyrrolidone (PVPP), 10 parts of sodium bicarbonate (NaHCO3), 12 parts of sodium citrate, 2.5 parts of lemon flavor, 0.75 parts of aspartame, 2 parts of magnesium stearate, 53.75 parts of mannitol for use. Grind each raw material separately, pass 80 mesh sieve, dry at 60℃, use equal volume addition method to mix the raw materials evenly, pass 60 mesh sieve; adopt direct compression method, weigh the mixed powder Compression into tablets, the average tablet weight is set to 100mg, namely melatonin orally disintegrating tablets.
[0032] After testing, the hardness of the disintegrating tablet is between 14 and 16 Newtons; the disintegration time in the body is between 28 and 30 seconds; the amount of dissolution in artificial gastric juice and intestinal juice at 37℃ in 1 minute is 30%, and the amount of dissolution in 6 minutes is up to 81%.
Embodiment 3
[0034] Weigh 3 parts of melatonin, 9 parts of microcrystalline cellulose (SMCC), 5 parts of cross-linked polyvinylpyrrolidone (PVPP), 8.18 parts of sodium bicarbonate (NaHC03), 9.82 parts of sodium citrate, 2 parts of lemon flavor, 1.25 parts of aspartame, 2 parts of magnesium stearate, 59.75 parts of mannitol for use. Grind the raw materials separately, pass through an 80 mesh sieve, and dry at 70 ℃. Use equal volume addition method to mix the raw materials uniformly and pass through a 60 mesh sieve; use the direct compression method to weigh the mixed powder Compression into tablets, the average tablet weight is set to 100mg, namely melatonin orally disintegrating tablets.
[0035] After testing, the hardness of the disintegrating tablet is between 14 and 16 Newtons; the disintegration time in vivo is between 24 and 28 seconds; the amount of dissolution in artificial gastric juice and intestinal juice at 37°C in 1 minute is 35%, and the amount of dissolution in 6 minutes is up t...
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