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Quetiapine fumarate sustained-release tablet and preparation method thereof

A technology of quetiapine fumarate and quinolone fumarate, which is applied in the field of quetiapine fumarate sustained-release tablets and its preparation, can solve the problems of increased particle hardness, affecting sample dissolution, high viscosity, etc., to reduce contact time, easy control, and convenient operation

Inactive Publication Date: 2018-03-30
北京满格医药科技有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since hypromellose is used in a large amount in this preparation, it swells in cold water and has a high viscosity. After adding purified water and stirring for a long time, it is easy to increase the hardness of the prepared particles, which will affect the dissolution of the sample.

Method used

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  • Quetiapine fumarate sustained-release tablet and preparation method thereof
  • Quetiapine fumarate sustained-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1, quetiapine fumarate 40.15%, hypromellose 25.0%, lactose 10.50%, microcrystalline cellulose 17.00%, sodium citrate 6.35%, magnesium stearate 1.00%. Prepare as follows:

[0021] In the first step, quetiapine fumarate is crushed through a 100-mesh sieve, and hypromellose, lactose, microcrystalline cellulose, and sodium citrate are crushed through a 60-mesh sieve;

[0022] The second step weighs the first step of the prescription amount and sieves the raw and auxiliary materials, and mixes them evenly;

[0023] The third step and the second step mix the mixture evenly through a fluidized bed one-step granulator, the fan frequency is 10-13Hz, the spray frequency is 10Hz, the spray pressure is 0.15MPa, the material temperature is 30-60°C, and the air inlet temperature is 50-70 ℃, granulate with 50% ethanol aqueous solution as wetting agent;

[0024] In the fourth step, the fan frequency is 10-13Hz, the material temperature is 30-60°C, the air inlet temperature...

Embodiment 2

[0027] Example 2, quetiapine fumarate 40.15%, hypromellose 25.0%, lactose 10.50%, microcrystalline cellulose 17.00%, sodium citrate 6.35%, magnesium stearate 1.00%. Prepare as follows:

[0028] In the first step, quetiapine fumarate is crushed through a 100-mesh sieve, and hypromellose, lactose, microcrystalline cellulose, and sodium citrate are crushed through a 60-mesh sieve;

[0029] The second step weighs the first step of the prescription amount and sieves the raw and auxiliary materials, and mixes them evenly;

[0030] The third step and the second step mix the mixture evenly through a fluidized bed one-step granulator, the fan frequency is 10-13Hz, the spray frequency is 10Hz, the spray pressure is 0.15MPa, the material temperature is 30-60°C, and the air inlet temperature is 50-70 ℃, granulate with 40% ethanol aqueous solution as wetting agent;

[0031] In the fourth step, the fan frequency is 10-13Hz, the material temperature is 30-60°C, the air inlet temperature is...

Embodiment 3

[0034] Example 3, quetiapine fumarate 40.15%, hypromellose 25.0%, lactose 10.50%, microcrystalline cellulose 17.00%, sodium citrate 6.35%, magnesium stearate 1.00%. Prepare as follows:

[0035] In the first step, quetiapine fumarate is pulverized through a 100-mesh sieve, and hypromellose, lactose, microcrystalline cellulose, and sodium citrate are pulverized through a 60-mesh sieve;

[0036] The second step weighs the first step of the prescription amount and sieves the raw and auxiliary materials, and mixes them evenly;

[0037] The third step and the second step mix the mixture evenly through a fluidized bed one-step granulator, the fan frequency is 10-13Hz, the spray frequency is 10Hz, the spray pressure is 0.15MPa, the material temperature is 30-60°C, and the air inlet temperature is 50-70 ℃, granulate with 30% ethanol aqueous solution as wetting agent;

[0038] In the fourth step, the fan frequency is 10-13Hz, the material temperature is 30-60°C, the air inlet temperat...

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Abstract

The invention relates to a quetiapine fumarate sustained-release tablet and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. The technical scheme of theinvention is that the quetiapine fumarate sustained-release tablet comprises the following components in percentage by weight: 40.15% of quetiapine fumarate, 25.00% of hydroxypropyl methylcellulose,10.50% of lactose, 17.00% of microcrystalline cellulose, 6.35% of sodium citrate, and 1.00% of magnesium stearate, and the preparation method comprises the steps of sieving, granulating, straighteningand the like, wherein the granulating step uses 30-50% ethanol aqueous solution as a wetting agent for granulation. The preparation process of the quetiapine fumarate sustained-release tablet provided by the invention reduces the contact time between water and raw materials and ensures the dissolution quality of the product to the greatest extent.

Description

technical field [0001] The invention relates to a quetiapine fumarate sustained-release tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. technical background [0002] Quetiapine Fumarate (Quetiapine Fumarate), the chemical name is 11-[4-[2-(2-hydroxyethoxy)ethyl]-1-piperazinyl]dibenzo[b,f][1 ,4] Thiazepine hemifumarate. Its molecular formula is C 46 h 54 N 6 o 8 S 2 , the molecular weight is 883.09, and its compound structural formula is as follows: [0003] [0004] Quetiapine is an atypical antipsychotic with a structure similar to olanzapine, a diphenoxazepine drug that interacts with multiple neurotransmitter receptors. In the brain, quetiapine has a high affinity for five serotonin (5HT2) receptors, which is greater than the affinity for dopamine D1 and dopamine D2 receptors in the brain, and also has blocking effects on histamine receptors and adrenergic receptors. The existing preparation method is to...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K31/554A61K47/38A61K47/26A61P25/18
CPCA61K9/2018A61K9/2054A61K9/2095A61K31/554
Inventor 王海超李金花彭涛汪娟王立新贺星华宋文婕
Owner 北京满格医药科技有限公司
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