Paroxetine hydrochloride time-controlled release pharmaceutical composition and preparation method thereof
A technology of paroxetine hydrochloride and its composition, which is applied in the field of paroxetine hydrochloride timed release pharmaceutical composition and its preparation, can solve the problems of paroxetine hydrochloride timed release, etc., and achieve the goal of solving the problem of timed release, stable product quality, and optimized prescription quantity Effect
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Embodiment 1
[0045] Prepare 1000 tablets of paroxetine hydrochloride time-release pharmaceutical composition, the composition formula is as follows:
[0046] A particle
[0047]
[0048] B particle isolation layer
[0049]
[0050] When making:
[0051] 1) Take the prescribed amount of paroxetine hydrochloride and pregelatinized starch, mix well, use 3% methylcellulose solution, granulate with a 20-mesh sieve, dry at 50±5°C, granulate, and set aside;
[0052] 2) Add the remaining prescription amount of pregelatinized starch, sodium carboxymethyl starch, crospovidone, and magnesium stearate to 1), and mix to make Granule A;
[0053] 3) Mix the hydroxypropyl cellulose K15M, hydroxypropyl cellulose K4, mannitol, talcum powder, and blue lake in the prescribed amount evenly, use 8% povidone ethanol solution, granulate with a 20-mesh screen, 50± Drying at 5°C and sizing the granules to obtain granules B;
[0054] 4) Tablet compression: compressed into a cylindrical three-layer tablet w...
Embodiment 2
[0058] Simulate the large-scale production scale, with each batch of 30,000 pieces, scale up and produce 3 batches.
[0059] Sample trial batch number
[0060] It has been proved by experiments that the product prescription process is simple and feasible. More than three batches of products have been packaged in the accelerated test conditions of 40°C±2°C and relative humidity of 75%±5% for 6 months and long-term test conditions for 6 months. The results show that the quality is relatively stable and meets the production requirements.
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