Preparation method of pharmaceutical composition for treating type II diabetes
A type 2 diabetes mellitus and a composition technology are applied in the field of preparation of pharmaceutical compositions for treating type 2 diabetes mellitus, can solve the problems of large fluctuation of blood drug concentration, large amount of auxiliary materials, large tablet volume and the like, and achieve the fluctuation of blood drug concentration. Small, improved compliance, and fewer doses
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Embodiment 1
[0086] The present invention is prepared according to the following steps.
[0087] A: Preparation of metformin hydrochloride osmotic pump core
[0088] prescription:
[0089] (1) Plain tablets
[0090] Metformin Hydrochloride 500g
[0091] Sodium Lauryl Sulfate 12.6g
[0092] Povidone K30 11.4g
[0093] 40% ethanol (V / V) 185mL
[0095] (2) Semi-permeable membrane layer
[0096] Dichloromethane 620g
[0097] Purified water 80g
[0098] Cellulose acetate 398-10 24g
[0099] Macrogol 400 2.5g
[0100] (1) Making granules Dissolve sodium lauryl sulfate and povidone K30 in 40% ethanol (V / V) as a wetting solution, put metformin hydrochloride in a wet granulator, and add a marketed wetting solution , the wet granules are passed through a 16-mesh sieve, placed in a fluidized bed, and the air inlet temperature is set to 65°C for drying until the water content is within 3%, granulated with a 16-mesh sieve, added with magnesium stearate, and mixed...
Embodiment 2
[0115] A: Preparation of Metformin Hydrochloride Tablets
[0116] prescription:
[0117] Metformin Hydrochloride 1000g
[0118] Polysorbate 80 17.4g
[0119] Povidone K90 18.6g
[0120] Purified water 400g
[0121] Sodium stearyl fumarate 10g
[0122] (1) Preparation of granules Dissolve polysorbate 80 and povidone K90 in purified water as a wetting solution, metformin hydrochloride is placed in a wet granulator, add a listed wetting solution, and the wet granules pass through a 16-mesh sieve. Place in a fluidized bed, set the air inlet temperature to 70°C for drying, until the water content is within 2.5%, granulate with 16 mesh, add sodium stearyl fumarate, and mix well.
[0123] (2) Tablet Take the above-mentioned granules, place them in a rotary tablet press, use an oval punched tablet with a diameter of 9×18mm, adjust the tablet weight and pressure, control the tablet weight at 1084mg, and control the hardness at 200-350N.
[0124] B: Coating of barrier layer 4
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