Vonoprazan fumarate enteric-coated composition and preparation method thereof
A technology of vonoprazan fumarate and enteric-coated layer, which is applied in the field of medicine, can solve problems such as unstable release of vonoprazan fumarate, and achieve the goal of improving bioavailability, increasing stability, and reducing adverse reactions Effect
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Embodiment 1
[0027] Embodiment 1 prescription:
[0028]
[0029] Preparation Process:
[0030] Preparation of Blank Ball Cores
[0031] Crush the sucrose and pass through an 80-mesh sieve. Under the condition of high-speed rotation in the centrifugal granulator, gradually spray the adhesive made by adding sucrose, then pass through a 50-mesh sieve, collect the wet blank sugar pellets, and then dry them;
[0032] Drug-containing layer preparation:
[0033] Slowly add hypromellose under stirring in purified water, add vonoprazan fumarate after dissolution is complete, add purified water to the required amount, stir evenly, pass through a 60-mesh sieve to obtain the coating solution, and blank The ball core is placed in a fluidized bed coating device to carry out bottom spraying and drug coating, drying, and passing through a 40-mesh sieve to obtain micro-pills of the main drug layer;
[0034] Isolation layer preparation:
[0035] Slowly add hypromellose under stirring in purified wat...
Embodiment 2
[0040] Example 2 Preparation of Vonorazan Fumarate Enteric-Coated Capsules
[0041]
[0042] The preparation of pellets and determination of the content of the active substance vonoprazan fumarate were the same as in Example 1, and they were filled into capsules with a specification of 20 mg.
Embodiment 3
[0043] Example 3 Preparation of Vonorazan Fumarate Enteric-Coated Capsules
[0044]
[0045] The preparation of pellets and determination of the content of the active substance vonoprazan fumarate were the same as in Example 1, and they were filled into capsules with a specification of 15 mg.
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