Montelukast Sodium Chewable Tablets and Preparation Method of Powder Direct Compression Tablets
A technology of montelukast sodium and chewable tablets, which is applied in the field of chemical pharmacy, can solve problems such as high process requirements, unstable product preparation process, and complexity, so as to save the granulation process, simplify the production and preparation process, and improve production efficiency Effect
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Embodiment 1
[0017] Embodiment 1, the raw material of this montelukast sodium chewable tablet comprises 1.5 parts to 2 parts of montelukast sodium, 30 parts to 35 parts of mannitol, 15 parts to 20 parts of xylitol, microcrystalline 30 to 40 parts of cellulose, 6 to 12 parts of sodium carboxymethyl starch, 0.5 to 1.5 parts of magnesium stearate, 1.5 to 3 parts of micronized silica gel and 0.5 to 2 parts of red iron oxide. Described microcrystalline cellulose, mannitol, xylitol are diluents, are mainly used in increasing the weight and volume of tablet; Simultaneously, xylitol also has flavoring agent effect; Described sodium carboxymethyl starch is disintegrating The agent is mainly used to accelerate the rapid disintegration of the tablet into fine particles in the gastrointestinal fluid to accelerate the absorption; the micropowder silica gel and magnesium stearate are lubricants, and since the magnesium stearate has a certain influence on the stability of the drug, Therefore these two ar...
Embodiment 2
[0018] Embodiment 2, the raw material of this montelukast sodium chewable tablet comprises 1.5 parts or 2 parts of montelukast sodium, 30 parts or 35 parts of mannitol, 15 parts or 20 parts of xylitol, microcrystalline 30 or 40 parts of cellulose, 6 or 12 parts of sodium carboxymethyl starch, 0.5 or 1.5 parts of magnesium stearate, 1.5 or 3 parts of micronized silica gel and 0.5 or 2 parts of red iron oxide.
Embodiment 3
[0019] Embodiment 3, as the preference of the above-mentioned embodiment, the montelukast sodium chewable tablet is obtained by the following powder direct compression tablet preparation method: in the first step, the required amount of mannitol, xylitol, microcrystalline cellulose and sodium carboxymethyl starch through a 100-mesh sieve and mix uniformly to obtain the first mixture; in the second step, pass the required amount of micronized silica gel and magnesium stearate through a 100-mesh sieve and mix uniformly to obtain the second mixture; the third step , mix the required amount of montelukast sodium with red ferric oxide to obtain the third mixture; the fourth step, after mixing the first mixture and the second mixture, continue to add the third mixture to it and mix evenly Obtain the powdered medicine; the fifth step, pass the powdered medicine through an 80-mesh sieve, and then press into tablets to obtain montelukast sodium chewable tablets. During the tablet press...
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