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Orally disintegrating tablet containing polacrilin potassium-fluoxertine hydrochloride compound and preparation method of orally disintegrating tablet

A technology of fluoxetine hydrochloride and polacrilin potassium, applied in the field of orally disintegrating tablets and its preparation

Inactive Publication Date: 2016-01-13
万全万特制药江苏有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

There is no patent publication on the preparation of fluoxetine hydrochloride orally disintegrating tablets by this method

Method used

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  • Orally disintegrating tablet containing polacrilin potassium-fluoxertine hydrochloride compound and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing polacrilin potassium-fluoxertine hydrochloride compound and preparation method of orally disintegrating tablet
  • Orally disintegrating tablet containing polacrilin potassium-fluoxertine hydrochloride compound and preparation method of orally disintegrating tablet

Examples

Experimental program
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Effect test

Embodiment 1

[0013] In this embodiment, the ratio of fluoxetine hydrochloride and polacrilin potassium is 1:0.5, the ratio of polacrilin potassium and fluoxetine hydrochloride solid to water is 1:50, the selected organic solvent is ethanol, and the ratio of alcohol to water is 1:5, using the precipitation method and adding organic solvents to prepare the complex.

[0014]

[0015] Preparation process: Add 50g of polacrilin potassium and 100g of fluoxetine hydrochloride into 7.5kg of water and stir for 1 hour to fully disperse and form a complex, add 2000L of ethanol, let stand for 12h, and remove the supernatant , then add 550g mannitol and 150g microcrystalline cellulose to the sediment, use a wet granulator to stir and granulate, granulate with a 24-mesh sieve, dry on a fluidized bed at 50°C for 20min, reduce the water content to below 3%, and granulate Finally, add 100g of microcrystalline cellulose, 20g of crospovidone, 10g of magnesium stearate, 10g of silicon dioxide, and 10g of a...

Embodiment 2

[0017] In this example, the ratio of fluoxetine hydrochloride to polacrilin potassium is 1:3, the ratio of polacrilin potassium and fluoxetine hydrochloride solid to water is 1:30, and the complex is prepared by centrifugation.

[0018]

[0019]

[0020] Preparation process: Weigh 100g of fluoxetine hydrochloride and 300g of polacrilin potassium, add them into 12kg of water, stir to make them fully dispersed, and form a complex. After off-line, remove the supernatant, and then add 100g of microcrystalline fiber Su, 370g mannitol, stirred evenly with a wet granulator, granulated with a 24-mesh sieve, spray-dried at 50°C and granulated, then added 100g of microcrystalline cellulose, 10g of magnesium stearate, 10g of silicon dioxide, 10g of ammonium Saimi, mix evenly, according to the content of fluoxetine hydrochloride in the granules, convert the weight of the tablet and press the tablet, the yield can reach more than 90%, the disintegration speed is 15±3s, the taste is sl...

Embodiment 3

[0022] In this embodiment, the ratio of fluoxetine hydrochloride to polacrilin potassium is 1:2, and the ratio of polacrilin potassium and fluoxetine hydrochloride solid to water is 1:60.

[0023]

[0024] Preparation process: Weigh 100g of fluoxetine hydrochloride and 200g of polacrilin potassium, add them into 1.8kg of water, stir to make them fully dispersed, and form a complex, and then use the spray drying method to make the complex powder from the suspension liquid, Then add 100g of microcrystalline cellulose and 460g of lactose, use a wet granulator to mix evenly, add an appropriate amount of 30% ethanol to stir and granulate, and shake the granulator to pass through a 20-mesh sieve to granulate, dry in an oven at 50°C, and then granulate. Add 100g of microcrystalline cellulose, 20g of low-substituted hydroxypropyl cellulose, 10g of magnesium stearate, and 10g of sucralose, and mix well. According to the content of fluoxetine hydrochloride in the granules, the weight ...

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Abstract

The invention discloses an orally disintegrating tablet containing polacrilin potassium-fluoxertine hydrochloride compound and a preparation method of the orally disintegrating tablet. The orally disintegrating tablet is characterized in that fluoxertine hydrochloride and polacrilin potassium are prepared into an ion exchange compound through a precipitation method, and the ion exchange compound is prepared into the orally disintegrating tablet through a wet granulation technology. Through the technology, the mouthfeel of the medicine can be obviously improved, and meanwhile, an organic solvent is added in the preparation process, so that the water content of the compound is low, the yield of the compound and the drying efficiency in the preparation process can be obviously improved, the occurrence of the sticking problem in the tabletting process is prevented, and the stability is improved.

Description

technical field [0001] The invention relates to an orally disintegrating tablet containing polacrilin potassium-fluoxetine hydrochloride compound and a preparation method thereof, which is characterized in that the ion exchange compound is prepared by using polacrilin potassium as a taste-masking agent, and adopts wet granulation Process to make orally disintegrating tablets, so as to achieve taste masking, increase disintegration speed, increase yield, improve stability and other effects. Background technique [0002] Depression is a common mood disorder, which can be caused by various reasons. The main clinical feature is marked and persistent low mood, and the low mood is not commensurate with the situation, and there are symptoms such as slow thinking and decreased movement. Severe cases may appear Suicidal thoughts and behaviors. In addition, from the perspective of the onset characteristics of depression, depression also has "three highs", namely: "three highs" refer ...

Claims

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Application Information

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IPC IPC(8): A61K31/138A61K9/20A61K47/32A61P25/24
Inventor 刁媛媛马苏峰郭夏
Owner 万全万特制药江苏有限公司
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