Lactase orally disintegrating tablet and preparation method thereof
The technology of oral disintegrating tablet and lactase is applied in the field of lactase oral disintegrating tablet and its preparation, which can solve the problems of restricted milk intake, poor solubility, increased water content, etc., and achieves improved bioavailability and cool taste. Slightly sweet, fast-acting effect
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Embodiment 1
[0041] Formula 1: Each 1000 tablets contains 30g of lactase:
[0042] Lactase 15%
[0043] Mannitol 56.5%
[0044] Sweet Orange Flavor 0.5%
[0045] Sodium Carboxymethyl Starch 5%
[0046] Citric Acid 10%
[0047] Sodium bicarbonate 10%
[0048] 5% PVP75% ethanol solution 2%
[0049] Micronized silica gel 0.5%
[0050] Magnesium Stearate 0.5%
[0051] Preparation:
[0052] 1. Pass the active ingredient lactase and all auxiliary materials through a 100-mesh sieve for later use, weigh the diluent, disintegrant and flavoring agent (additional can also be added), and mix them evenly with a suitable mixer;
[0053] 2. Weigh the amount of lactase in the above formula, add it to the mixed auxiliary materials by equal incremental dilution method and mix evenly;
[0054] 3. Prepare soft materials with 5% povidone and 75% ethanol solution, and granulate with 20 mesh sieves;
[0055] 4. After drying the wet granules obtained above at 60°C, use a 18-mesh sieve to sieve the granu...
Embodiment 2
[0063] Formula 2: Each 1000 tablets contains 60g of lactase:
[0064] Lactase 20%
[0065] Mannitol 39%
[0066] Sweet Orange Flavor 1%
[0067] Croscarmellose Sodium 5%
[0068] Citric Acid 15%
[0069] Sodium bicarbonate 15%
[0070] Hypromellose 4%
[0071] Micronized silica gel 0.2
[0072] Magnesium Stearate 0.8%
[0073] Preparation method is the same as embodiment 1
[0074] Test results: Test results: Tablet hardness: 10-40N
[0075] Disintegration time limit: within 30 seconds
[0076] Oral disintegration time and taste: Disintegrate within 40 seconds, without gritty feeling, unpleasant taste, and foreign body sensation.
[0077] Dissolving time limit and dissolving particle size: all meet the requirements.
Embodiment 3
[0079] Formula 3: Contains 90g of lactase per 1000 tablets:
[0080] Lactase 30%
[0081] Mannitol 17%
[0082] Sweet Orange Flavor 2%
[0083] Crospovidone 5%
[0084] Citric Acid 20%
[0085] Sodium bicarbonate 20%
[0086] Sodium Carmellose 5%
[0087] Micronized silica gel 0.4%
[0088] Magnesium Stearate 0.6%
[0089] Preparation method is the same as embodiment 1
[0090] Test results: Test results: Tablet hardness: 20-40N
[0091] Disintegration time limit: within 30 seconds
[0092] Oral disintegration time and taste: Disintegrate within 40 seconds, without gritty feeling, unpleasant taste, and foreign body sensation.
[0093] Dissolving time limit and dissolving particle size: all meet the requirements.
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