Solid preparation of azilsartan and amlodipine besylate composition and preparation method thereof
A technology of amlodipine besylate and amlodipine besylate, applied in the direction of drug combination, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problem of poor stability of compound preparations and other issues to achieve good stability
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[0046] The present invention provides a preparation method of the solid preparation of the present invention, comprising:
[0047] mixing the granules containing azilsartan, the granules containing amlodipine besylate and pharmaceutically acceptable auxiliary materials to obtain a solid preparation;
[0048] Or a solid preparation is obtained by mixing granules containing azilsartan, amlodipine besylate and pharmaceutically acceptable auxiliary materials;
[0049] Or by mixing granules containing amlodipine besylate, azilsartan and pharmaceutically acceptable auxiliary materials to obtain a solid preparation;
[0050] The azilsartan-containing particles include azilsartan and polyethylene glycol;
[0051] The granules containing amlodipine besylate include amlodipine besylate and starch.
[0052] According to the present invention, the granules containing azilsartan, the granules containing amlodipine besylate and pharmaceutically acceptable auxiliary materials are mixed to ...
Embodiment 1
[0075] Preparation process: Pass the auxiliary materials through a 60-mesh sieve respectively, mix amlodipine besylate and starch evenly according to the method of equal increments, add an appropriate amount of purified water to make a soft material, granulate with a 20-mesh sieve, dry at 60°C, and sieve with a 20-mesh sieve Whole grain, recorded as granule 1; mix azilsartan with microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl cellulose SL, polyethylene glycol 6000 evenly, add water to make soft material, sieve with 20 mesh granules, dried at 60°C, sieved with a 20-mesh sieve, and recorded as granule 2. Mix granules 1 and 2 evenly, add magnesium stearate, compress tablets or fill capsules, which is a solid preparation; wherein, the dosage of each raw material is shown in Table 5, and Table 5 is the azilsartan and The formulation of the solid preparation of amlodipine besylate composition.
[0076] The formula of the solid formulation of the azilsartan and a...
Embodiment 2
[0080] Preparation process: Pass the excipients through a 60-mesh sieve, mix amlodipine besylate and pregelatinized starch evenly by the method of equal increments, add an appropriate amount of purified water to make a soft material, granulate with a 20-mesh sieve, and dry at 60°C. 20-mesh sieve for granulation, recorded as granule 1; polyethylene glycol 1000 was added into water to dissolve to make a polyethylene glycol solution, azilsartan was mixed with lactose, hydroxypropyl cellulose, and povidone K30 evenly, and polyvinyl alcohol was added The ethylene glycol solution is made into a soft material, granulated with a 20-mesh sieve, dried at 60°C, and granulated with a 20-mesh sieve, which is recorded as granule 2. Mix granules 1 and 2 evenly, add magnesium stearate, and compress into tablets to obtain tablet cores. The film coating premix and purified water are prepared into a 12%-18% (w / w) suspension, and the tablet core is film-coated to obtain a coated tablet, which is ...
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