Oral solid preparation of dihydropyridine medicine and preparation method of oral solid preparation
A technology of dihydropyridines and solid preparations, which is applied in the direction of drug combinations, pharmaceutical formulas, medical preparations of non-active ingredients, etc. Dipine unstable crystal form and other problems, to achieve the effect of simple and feasible preparation process, stable and controllable quality, and good oral absorption
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Embodiment 1
[0066] prescription:
[0067] Felodipine microparticles (average particle size: 20 μm) 15g lactose 163g microcrystalline cellulose 32g corn starch 56g Hypromellose 1.0g Magnesium stearate 3.0g
[0068] Sample preparation: Add felodipine particles, microcrystalline cellulose, corn starch, and lactose into the wet granulator, turn on the stirring function and shearing function to make the mixing uniform, and add the concentration of 3% (wt / wt) hydroxypropyl fiber granulated from an aqueous solution, drying the above-mentioned drug-containing granules, and then using Screen the granules, mix them with the prescribed amount of magnesium stearate, and use a rotary tableting machine to prepare tablets with a felodipine content of 5 mg. (Tablet weight difference is less than 7.5%).
[0069] The dissolution curves of the samples in 0.02% Tween 80-pH4.0 medium and 0.02% Tween 80-pH1.2 medium were determined, and the results are shown in T...
Embodiment 2
[0071] prescription:
[0072] Felodipine microparticles (average particle size: 10 μm) 15g lactose 163g microcrystalline cellulose 32g corn starch 56g Hypromellose 1.0g Magnesium stearate 3.0g
[0073] Compared with Example 1, the only difference is that the D50 of felodipine is 10 μm, and other parameters are the same as those of Example 1.
[0074] The dissolution curves of the samples in 0.02% Tween 80-pH4.0 medium and 0.02% Tween 80-pH1.2 medium were determined, and the results are shown in Table 1. From the dissolution results, it can be seen that the samples are rapidly dissolved in the above two media.
Embodiment 3
[0076] prescription:
[0077] Felodipine microparticles (average particle size: 5 μm) 15g lactose 163g microcrystalline cellulose 32g corn starch 56g Hypromellose 1.0g Magnesium stearate 3.0g
[0078] Compared with Example 1, the only difference is that the D50 of felodipine is 5 μm, and other parameters are the same as those of Example 1.
[0079] The dissolution curves of the samples in 0.02% Tween 80-pH4.0 medium and 0.02% Tween 80-pH1.2 medium were determined, and the results are shown in Table 1. From the dissolution results, it can be seen that the samples are rapidly dissolved in the above two media.
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