Medicinal composition containing rivaroxaban and preparation method thereof
A technology of rivaroxaban and composition, applied in the field of oral solid pharmaceutical composition, capable of solving the problems of slow dissolution of rivaroxaban and complex preparation process, etc.
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Embodiment 1
[0033] The prescription composition was the same as that of Comparative Example 1. The lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and sodium lauryl sulfate were mixed uniformly in a high-shear wet granulator, and a binder solution was added. Go through a 2.0mm sieve and sizing, and dry in a fluidized bed until the loss on drying (LOD) is less than 3.0%. The dry granules are sized through a 1.2mm sieve, then add the micronized rivaroxaban and mix well, then add the hard Magnesium fatty acid blend. The mixed granules are compressed into tablets with a diameter of 6mm and a hardness of 2-6kp.
[0034] The tablet weight, hardness, disintegration time limit, and friability of the samples of Comparative Examples 1 to 2 and Example 1 were tested, and the results were as follows:
[0035] Sample
Average tablet weight / mg
Average hardness / kp
Disintegration time limit
Comparative Example 1
85.4
4.5
15s
0.19%
Comparative Example 2
85.0
4.9 ...
Embodiment 2
[0040]
[0041] Mix lactose monohydrate, microcrystalline cellulose, croscarmellose sodium and sodium lauryl sulfate in a high-shear granulator, and add povidone in ethanol (95%) solution to granulate. Go through a 2.0mm sieve and sizing, and dry in a fluidized bed until the loss on drying (LOD) is less than 3.0%. The dry granules are sized through a 1.2mm sieve, then add the micronized rivaroxaban and mix well, then add stearic acid Magnesium blend. The mixed granules are compressed into tablets with a diameter of 6mm and a hardness of 2-6kp.
Embodiment 3
[0043]
[0044] Povidone is dissolved in 95% ethanol to make a binder solution. The lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and polyoxyethylene hydrogenated castor oil are placed in a fluidized bed. In the fluidized state, spray the binder solution to granulate, and dry to LOD≤3.0%, pass through a 1.2mm sieve to obtain blank granules, add micronized rivaroxaban and mix well, then add magnesium stearate to mix . The mixed granules are compressed into tablets with a diameter of 6mm and a hardness of 2-6kp.
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