Nifedipine controlled release composition and preparation method thereof
A composition and nitrobenzene technology, applied in the field of medicine, can solve the problems of affecting product quality, organic solvent residues, not being well solved, etc., and achieve the effects of avoiding raw material aggregation, removing acetone residues, and improving production efficiency
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[0070] Example 1
[0071] For the preparation of the drug-containing layer, the specific prescription components are as follows:
[0072] .
[0073] i) Preparation of suspension for granulation: weigh purified water, add prescription amount of binder while stirring, stir until the binder is fully swelled, add nifedipine while stirring to form a suspension, pass 200 mesh Sieve, rinse the sieve with purified water, merge into the suspension, keep stirring, and set aside;
[0074] ii) Weigh polyoxyethylene into the fluidized bed granulator and preheat;
[0075] iii) Top spray granulation;
[0076] iv) After stopping spraying, dry, and the particles pass through a 24 mesh sieve;
[0077] v) Add the prescription amount of magnesium stearate and mix well.
[0078] The particle size distribution is shown in the following table:
[0079] .
Example Embodiment
[0080] Example 2
[0081] The preparation of the booster layer, the specific prescription components are as follows:
[0082] .
[0083] i) Preparation of granulation solution and suspension
[0084] ① Preparation of sodium chloride solution: the prescribed amount of sodium chloride is dissolved in purified water for use;
[0085] ② Adhesive solution: Weigh purified water, add the prescribed amount of adhesive while stirring, stir until completely dissolved, and set aside;
[0086] ii) Weigh polyoxyethylene into the fluidized bed granulator and preheat;
[0087] iii) Top spray granulation, spray sodium chloride solution and binder solution into polyoxyethylene successively;
[0088] iv) After stopping spraying, dry, and the particles pass through a 24 mesh sieve;
[0089] v) Add the prescription amount of magnesium stearate and mix well.
[0090] The particle size distribution is shown in the following table:
[0091] .
Example Embodiment
[0106] Example 3 Comparison of tablet pressing
[0107] The granules in the formulation B of Example 1 and the formulation B of Example 2 and the mixed powders in Comparative Example 1 and Comparative Example 2 were selected respectively, and the double-layer tablet was pressed using the same double-layer tablet press with the same parameters. The results are as follows Shown:
[0108] Numbering Medicated layer Boost layer result Ⅰ Example 1 Prescription B Example 2 Prescription B There is no mixed color of the two layers, and almost no flakes are found. Ⅱ Comparative example 1 Comparative example 2 The colors are mixed, and the phenomenon of flower pieces is obvious. Ⅲ Example 1 Prescription B Comparative example 2 There are white spots and patches on the surface of the yellow layer. Ⅳ Comparative example 1 Example 2 Prescription B There are yellow spots on the surface of the white layer.
[0109] Using the drug-containing layer and booster layer obtained by the preparatio...
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