Nifedipine film-controlled slow-release pellet capsule
A technology of slow-release pellets and horizontal film, which is applied in the direction of medical preparations of non-active ingredients, cardiovascular system diseases, organic active ingredients, etc., and can solve the problems of film aging and release decline
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Embodiment 1
[0028] The nifedipine slow-release pellet capsule of embodiment 1 common ball core
[0029] 1. Prescription
[0030] 1. Pill core prescription (1000 capsules)
[0031]
[0032] 2. Prescription of sustained-release film coating solution
[0033]
[0034] 3. No. 0 stomach-soluble gelatin capsule shell 1000 capsules
[0035] Second, the preparation process:
[0036] 1. Ball core preparation process:
[0037] (1) Nifedipine is passed through an 80 mesh sieve;
[0038] (2) Take by weighing nifedipine, microcrystalline cellulose PH101, lactose, PEG 4000 of prescription quantity, put in wet granulator and mix uniformly;
[0039] (3) 2% carboxymethylcellulose sodium 10% ethanol solution to make soft material;
[0040] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;
[0041] (5) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;
[0042] (6) Sieve, and take ball cores between 16 and 30 mesh. ...
Embodiment 2
[0063] Embodiment 2 Containing 5% croscarmellose sodium nifedipine sustained-release pellet capsule
[0064] 1. Prescription
[0065] 1. Pill core prescription (1000 capsules)
[0066]
[0067] 2. Prescription of sustained-release film coating solution: same as in Example 1.
[0068] 3. No. 0 stomach-dissolving gelatin capsule shells, 1,000 capsules.
[0069] Second, the preparation process:
[0070] 1. Ball core preparation process:
[0071] (1) Nifedipine is passed through a 60 mesh sieve;
[0072] (2) Take nifedipine, microcrystalline cellulose PH101, lactose, PEG 4000, croscarmellose sodium of recipe quantity by weighing, put in the wet granulator and mix uniformly;
[0073] (3) make soft material with 2% carboxymethylcellulose sodium 10% ethanol solution;
[0074] (4) Extrude on the extruder, the screen aperture is 1.0mm, and the extrusion speed is 20-30rpm;
[0075] (5) spheronization, the spheronization speed is 900~1000rpm, drying in the fluidized bed;
[00...
Embodiment 3
[0093] Example 3 Nifedipine Sustained-release Pellet Capsules Containing 10% Croscarmellose Sodium
[0094] 1. Prescription
[0095] 1. Pill core prescription (1000 capsules)
[0096]
[0097] 2. Prescription of sustained-release film coating solution: same as in Example 1.
[0098] 3. No. 0 stomach-dissolving gelatin capsule shells, 1,000 capsules.
[0099] Second, the preparation process:
[0100] 1. Ball core preparation process: with embodiment 2.
[0101] 2. The preparation process of the slow-release film coating solution: the same as in Example 1.
[0102] 3. Coating (sustained release film):
[0103] The ball core is placed in a fluidized bed for coating, and the weight gain of the coating film is controlled, and the weight gain of the coating is 23.5% and 28.4%.
[0104] 4, heat treatment: with embodiment 1.
[0105] 5. Capsule filling: same as in Example 1.
[0106] 3. Release, content determination and results
[0107] Assay method: with embodiment 1, th...
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