Amisulpride tablet and preparation method thereof

Abstract

The invention discloses an amisulpride tablet. The amisulpride tablet is prepared from the following components in percentage by weight: 60-70% of amisulpride, 4-10% of lactose, 15-20% of microcrystalline cellulose, 3-5% of sodium carboxymethyl starch, 2-3% of hydroxypropyl methylcellulose, 0.1-0.5% of magnesium stearate, 0.5-1% of additive, 1-3% of methoxypolyethylene glycol acrylate and 0.2-0.5%of magnesium chloride. The amisulpride tablet prepared by the raw materials and the method is high in stability and can be rapidly dissolved; medication safety and effectiveness are improved; the occurrence rate of adverse effects is avoided.

Description

technical field

[0001] The invention belongs to the technical field of medicines, and in particular relates to an amisulpride tablet and a preparation method thereof. Background technique

[0002] Amisulpride is an atypical antipsychotic drug indicated for the treatment of paranoid progressive schizophrenia, acute delusional psychosis, and also for the treatment of deficit states in schizophrenia, residual psychotic evolution, and accompanying There is a sluggish inhibition state. Amisulpride is usually used orally in the form of tablets with doses of 100, 200 and 400 mg each. However, oral daily doses of amisulpride are frequently increased during acute psychotic episodes, reaching up to 1200 mg / day. Therefore, patients treated with amisulpride must swallow several tablets per day.

[0003] Due to the special pathological state of the patient, and the taste of the active ingredient amisulpride is very bitter, it may be difficult to correctly follow the doctor's advice to...

Examples

Embodiment 1

[0029] The amisulpride tablet comprises the following components and their weight percentages: 60% of amisulpride, 8% of lactose, 20% of microcrystalline cellulose, 5% of sodium carboxymethyl starch, and 2.7% of hypromellose , magnesium stearate 0.1%, additive 1%, methoxy polyethylene glycol acrylate 1%, magnesium chloride 0.2%, coating powder 2%; Said additive comprises the following components and their weight percentages: A 15% spartame, 45% essence, 40% sodium chloride.

[0030] The preparation method of the amisulpride tablet is as follows: 1) taking raw materials in proportion, mixing amisulpride, lactose, microcrystalline cellulose, sodium carboxymethyl starch and additives to obtain a mixture;

[0031] 2) Add hypromellose aqueous solution and methoxypolyethylene glycol acrylate with a mass percentage concentration of 5-6% to the mixture, mix well and then wet granulate in a boiling granulator, the granulation parameters For: the air inlet temperature is 110°C to ensur...

Embodiment 2

[0034] The amisulpride tablet comprises the following components and their weight percentages: 63% of amisulpride, 8% of lactose, 15% of microcrystalline cellulose, 4% of sodium carboxymethyl starch, and 2% of hypromellose , magnesium stearate 0.3%, additive 0.8%, methoxy polyethylene glycol acrylate 2.5%, magnesium chloride 0.4%, coating powder 3%; Said additive comprises the following components and weight percentages thereof: A 10% spartame, 40% essence, 50% sodium chloride.

[0035] The preparation method of the amisulpride tablet is as follows: 1) taking raw materials in proportion, mixing amisulpride, lactose, microcrystalline cellulose, sodium carboxymethyl starch and additives to obtain a mixture;

[0036] 2) Add hypromellose aqueous solution and methoxypolyethylene glycol acrylate with a mass percentage concentration of 5-6% to the mixture, mix well and wet granulate in a boiling granulator, the granulation parameters For: the air inlet temperature is 110°C to ensure...

Embodiment 3

[0039] The amisulpride tablet includes the following components and their weight percentages: 70% amisulpride, 4% lactose, 15.5% microcrystalline cellulose, 3% sodium carboxymethyl starch, and 1% hypromellose , magnesium stearate 0.5%, additive 0.5%, methoxy polyethylene glycol acrylate 3%, magnesium chloride 0.5%, coating powder 2%; Said additive comprises the following components and their weight percentages: A 10% spartame, 40% essence, 50% sodium chloride.

[0040] The preparation method of the amisulpride tablet is as follows: 1) taking raw materials in proportion, mixing amisulpride, lactose, microcrystalline cellulose, sodium carboxymethyl starch and additives to obtain a mixture;

[0041] 2) Add hypromellose aqueous solution and methoxypolyethylene glycol acrylate with a mass percentage concentration of 5-6% to the mixture, mix well and wet granulate in a boiling granulator, the granulation parameters For: the air inlet temperature is 110°C to ensure complete fluidiza...

technical field

[0001] The invention belongs to the technical field of medicines, and in particular relates to an amisulpride tablet and a preparation method thereof. Background technique

[0002] Amisulpride is an atypical antipsychotic drug indicated for the treatment of paranoid progressive schizophrenia, acute delusional psychosis, and also for the treatment of deficit states in schizophrenia, residual psychotic evolution, and accompanying There is a sluggish inhibition state. Amisulpride is usually used orally in the form of tablets with doses of 100, 200 and 400 mg each. However, oral daily doses of amisulpride are frequently increased during acute psychotic episodes, reaching up to 1200 mg / day. Therefore, patients treated with amisulpride must swallow several tablets per day.

[0003] Due to the special pathological state of the patient, and the taste of the active ingredient amisulpride is very bitter, it may be difficult to correctly follow the doctor's advice to...

Examples

Embodiment 1

[0029] The amisulpride tablet comprises the following components and their weight percentages: 60% of amisulpride, 8% of lactose, 20% of microcrystalline cellulose, 5% of sodium carboxymethyl starch, and 2.7% of hypromellose , magnesium stearate 0.1%, additive 1%, methoxy polyethylene glycol acrylate 1%, magnesium chloride 0.2%, coating powder 2%; Said additive comprises the following components and their weight percentages: A 15% spartame, 45% essence, 40% sodium chloride.

[0030] The preparation method of the amisulpride tablet is as follows: 1) taking raw materials in proportion, mixing amisulpride, lactose, microcrystalline cellulose, sodium carboxymethyl starch and additives to obtain a mixture;

[0031] 2) Add hypromellose aqueous solution and methoxypolyethylene glycol acrylate with a mass percentage concentration of 5-6% to the mixture, mix well and then wet granulate in a boiling granulator, the granulation parameters For: the air inlet temperature is 110°C to ensur...

Embodiment 2

[0034] The amisulpride tablet comprises the following components and their weight percentages: 63% of amisulpride, 8% of lactose, 15% of microcrystalline cellulose, 4% of sodium carboxymethyl starch, and 2% of hypromellose , magnesium stearate 0.3%, additive 0.8%, methoxy polyethylene glycol acrylate 2.5%, magnesium chloride 0.4%, coating powder 3%; Said additive comprises the following components and weight percentages thereof: A 10% spartame, 40% essence, 50% sodium chloride.

[0035] The preparation method of the amisulpride tablet is as follows: 1) taking raw materials in proportion, mixing amisulpride, lactose, microcrystalline cellulose, sodium carboxymethyl starch and additives to obtain a mixture;

[0036] 2) Add hypromellose aqueous solution and methoxypolyethylene glycol acrylate with a mass percentage concentration of 5-6% to the mixture, mix well and wet granulate in a boiling granulator, the granulation parameters For: the air inlet temperature is 110°C to ensure...

Embodiment 3

[0039] The amisulpride tablet includes the following components and their weight percentages: 70% amisulpride, 4% lactose, 15.5% microcrystalline cellulose, 3% sodium carboxymethyl starch, and 1% hypromellose , magnesium stearate 0.5%, additive 0.5%, methoxy polyethylene glycol acrylate 3%, magnesium chloride 0.5%, coating powder 2%; Said additive comprises the following components and their weight percentages: A 10% spartame, 40% essence, 50% sodium chloride.

[0040] The preparation method of the amisulpride tablet is as follows: 1) taking raw materials in proportion, mixing amisulpride, lactose, microcrystalline cellulose, sodium carboxymethyl starch and additives to obtain a mixture;

[0041] 2) Add hypromellose aqueous solution and methoxypolyethylene glycol acrylate with a mass percentage concentration of 5-6% to the mixture, mix well and wet granulate in a boiling granulator, the granulation parameters For: the air inlet temperature is 110°C to ensure complete fluidiza...

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