Montelukast sodium chewable tablets and preparation method thereof
A technology of montelukast sodium and chewable tablets, which is applied in the directions of pharmaceutical formulations, medical preparations of non-active ingredients, pill delivery, etc. Unqualified fragmentation, low dissolution rate, etc., to achieve the effect of ensuring effectiveness and safety, shortening drying time, and high dissolution rate
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Embodiment 1
[0079]Example 1: Montelukast sodium chewable tablets
[0080]1. Prescription composition:
[0081]
[0082]According to the prescription amount of 100,000 tablets, montelukast sodium chewable tablets were prepared, the same below.
[0083]4.2 mg of montelukast sodium is equivalent to 4 mg of montelukast; 5.2 mg of montelukast sodium is equivalent to 5 mg of montelukast, the same below.
[0084]2. Preparation method:
[0085]1. Preparation of raw and auxiliary materials: After mixing iron oxide red and montelukast sodium, pass through a 40-mesh sieve, and mannitol through a 40-mesh sieve for use;
[0086]2. Pre-mixing, wet granulation:
[0087]Pre-mixing: Add iron oxide red montelukast sodium mixed powder, mannitol, croscarmellose sodium, lactose, hydroxypropyl cellulose sodium, and microcrystalline cellulose into the wet granulator at a mixing speed of 150rpm, cutter speed is 1000rpm, premixed for 240 seconds;
[0088]Wet granulation: the stirring speed is 150 rpm, the cutter speed is 1500 rpm, and absolute e...
Embodiment 2
[0104]Example 2: Montelukast sodium chewable tablets
[0105]1. Prescription composition:
[0106]
[0107]2. Preparation method:
[0108]1. Preparation of raw and auxiliary materials: After mixing iron oxide red and montelukast sodium, pass through a 40-mesh sieve, and mannitol through a 40-mesh sieve for use;
[0109]2. Pre-mixing, wet granulation:
[0110]Pre-mixing: Add iron oxide red montelukast sodium mixed powder, mannitol, croscarmellose sodium, lactose, hydroxypropyl cellulose sodium, and microcrystalline cellulose into the wet granulator at a mixing speed of 160rpm, cutter speed is 1200rpm, pre-mixing is 210 seconds;
[0111]Wet granulation: the stirring speed is 160rpm, the cutter speed is 1700rpm, the absolute ethanol (4.96Kg) is sprayed into the granulation, and the granulation time is 240 seconds;
[0112]Wet granulation: stirring speed is 500rpm, screen is 6mm;
[0113]3. Drying and whole grain:
[0114]Dry at 55℃-65℃, the moisture content after drying is 1.7%, and the granules are sized with a 2m...
Embodiment 3
[0126]Example 3: Meng Luite sodium chewable tablets
[0127]First, the prescription composition:
[0128]
[0129]Second, the preparation method:
[0130]1, raw film preparation: iron oxide red and Meng Luzi sodium after 40 mesh sieve, mannitol over 40 mesh sieve, spare;
[0131]2, premix, wet granulation:
[0132]Premix: Mixed powder, mannitol, crosslinked carboxymethylcellulose, lactose, hydroxypropylcellulose, microcrystalline, and microcrystalline cellulose, stirring speed It is 150 rpm, the cutter speed is 1100 rpm, premixed 225 seconds;
[0133]Wet granulation: The stirring speed is 150 rpm, the cutter speed is 1600 rpm, and the absolute ethanol (3.92 kg) is sprayed into the granulation, the granulation time is 280 seconds;
[0134]Wet finite particles: The stirring speed is 600 rpm, the screen is 6mm;
[0135]3, dry, whole capsule:
[0136]Dry at 55 ° C-65 ° C, after drying, water is divided into 2.1%, dry particles with 2 mm screen after drying;
[0137]4, mixed:
[0138]The first step is mixed: add Aspaan, ch...
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