Metformin hydrochloride sustained-release tablet and preparation method thereof
A technology for metformin hydrochloride and sustained-release tablets, which can be applied to pharmaceutical formulations, medical preparations containing no active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as unstable release of metformin hydrochloride sustained-release tablets and complex production processes , to achieve the effect of stable release curve, good reproducibility and stable release curve
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Embodiment 1
[0056] 1) Crush and sieve
[0057] Metformin hydrochloride and sodium carboxymethylcellulose were crushed through 80-mesh sieve before feeding into production; hydroxypropyl methylcellulose K100M, microcrystalline cellulose, and hydroxypropyl methylcellulose E5 were passed through 60-mesh sieve, and the remaining materials Weigh directly for use.
[0058] 2) Granulation
[0059] Mixing: add the sieved metformin hydrochloride and carmellose sodium into the boiling drying granulator, set the fan at 35Hz, turn off the heating, and mix for 10 minutes.
[0060] Granulation: set the fan frequency to 35Hz, the air inlet temperature to 80.0°C, set the atomization pressure to 0.35MPa in the inner layer and 0.30MPa in the outer layer (or the inner layer is 0.05MPa larger than the outer layer, but the outer layer is not less than 0.2MPa), set the supply The liquid speed is 300r / min. When the temperature of the material reaches 45°C±5°C, it starts to spray water and granulate, and it in...
Embodiment 2-4
[0074] Using the same method as in Example 1, Metformin Hydrochloride Sustained-release Tablets were prepared. The types and dosages of the various raw materials are shown in Table 1, and 250,000 Metformin Hydrochloride Sustained-release Tablets were prepared, which are denoted as S2-S4.
Embodiment 5
[0076] The type and amount of raw materials are the same as S1, the difference is that in the preparation method, the hydroxypropyl methylcellulose K100M is not added in stages, but in step 3) the total mixing stage, all the hydroxypropyl methylcellulose K100M is added . The types and dosages of the various raw materials are shown in Table 1, and 250,000 metformin hydrochloride sustained-release tablets were prepared, which were denoted as S5.
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