Pharmaceutical composition containing phenyl pyrimidone hydrochloride, pharmaceutical preparation containing pharmaceutical composition, and preparation method and application of pharmaceutical composition
A technology of phenylpyrimidinone hydrochloride and pharmaceutical preparations, which is applied in the field of medicine, can solve the problems of slow dissolution of finished preparations, and achieve the effects of rapid disintegration, rapid dissolution, and good uniformity
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[0059] [Preparation method of pharmaceutical composition]
[0060] The present invention provides a preparation method of the above pharmaceutical composition, which comprises the following steps: mixing the compound of formula I-A and a pharmaceutically acceptable carrier.
[0061] [pharmaceutical preparations]
[0062] The present invention provides a pharmaceutical preparation made from the above pharmaceutical composition.
[0063] In one embodiment, the pharmaceutical preparation is tablet, capsule, granule, pill, powder or dry suspension.
[0064] In a preferred embodiment, the pharmaceutical preparation is a tablet or a capsule.
[0065] [Preparation method of pharmaceutical preparation]
[0066] The present invention provides the preparation method of the above-mentioned pharmaceutical preparation, which can choose the preparation method of direct mixing, wet granulation or dry granulation, preferably the preparation method of direct mixing.
[0067] Described prep...
Embodiment 1
[0089] Example 1: Tablet formulation (direct compression)
[0090]
[0091] Preparation Process:
[0092] (1) Material pretreatment: the compound of formula I-A is pulverized, and the particle size D is measured 90 =18.8 μm; the auxiliary materials are passed through an 80-mesh sieve for later use.
[0093] (2) Weighing: Weigh the compound of formula I-A, lactose, microcrystalline cellulose, sodium carboxymethyl starch, povidone, and magnesium stearate according to the prescription amount.
[0094] (3) Mixing: Add other ingredients except magnesium stearate into a hopper mixer, and mix for 10 minutes at a rotating speed of 10 rpm / min.
[0095](4) Lubrication: Add magnesium stearate, set the rotating speed at 10rpm / min, and mix for 5 minutes to obtain a total blended powder; sample 10 points at different positions of the mixer to measure the mixing uniformity. Determine the particle content and calculate the tablet weight.
[0096] (5) Tablet compression: Rotary tablet p...
Embodiment 2
[0098] Example 2: Tablet formulation (wet granulation)
[0099]
[0100] Preparation Process:
[0101] (1) Material pretreatment: the compound of formula I-A is pulverized, and the particle size D is measured 90 =18.8 μm; the auxiliary materials are passed through an 80-mesh sieve for later use.
[0102] (2) Weighing: Weigh the compound of formula I-A, lactose, microcrystalline cellulose, sodium carboxymethyl starch, povidone, and magnesium stearate according to the prescription amount.
[0103] (3) Adhesive solution preparation: add the prescribed amount of povidone K30 into 50% ethanol solution, stir continuously, and prepare a clear 5% (w / w) povidone ethanol solution for later use.
[0104] (3) Pre-mixing: Add other ingredients except magnesium stearate into a high-speed wet granulator, stir at a speed of 180 rpm / min, and mix for 10 minutes.
[0105] (4) Granulation: set the stirring speed at 180rpm / min, the shearing speed at 1200rpm / min, add the binder solution for g...
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Abstract
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