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Compound containing polacrilin potassium-paroxetine

A technology of polacrine potassium and compound, which is applied in the directions of non-active ingredient medical preparation, drug combination, pill delivery, etc., can solve the problems of large compound loss, poor stability, sticking and punching, etc.

Inactive Publication Date: 2015-03-04
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

Patent CN1140411A discloses a method of stirring polacrilin potassium and paroxetine in water and then adding other auxiliary materials to prepare paroxetine oral liquid. To prepare solid preparations, the formed polacrilin potassium-paroxetine complex needs to be solidified. Generally, the precipitate is obtained by suction filtration after stirring, and then dried, but this method has the following disadvantages: 1. The formed composite particles are very small, and it is very easy to form a dense filter cake during the filtration process, which requires continuous Replacement and cleaning filter holes, the efficiency of suction filtration is extremely low; and, due to the cleaning and replacement of filter holes, the loss of the complex is relatively large, and the yield is low, generally below 70%; 2, because polacrilin potassium itself is a A kind of ion exchange resin, which has the property of absorbing water and swelling, and it is not easy to dry after absorbing water. If water is used alone to granulate, the granules are not easy to dry. Generally, it is more than 5%, which will lead to sticking and punching during the tableting process, and the stability will deteriorate.

Method used

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  • Compound containing polacrilin potassium-paroxetine
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  • Compound containing polacrilin potassium-paroxetine

Examples

Experimental program
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Effect test

Embodiment 1

[0012] In this embodiment, the ratio of paroxetine to polacrilin potassium is 1:1, the ratio of polacrilin potassium and paroxetine solid to water is 1:50, the selected organic solvent is ethanol, and the ratio of alcohol to water is 1:5.

[0013]

[0014] Preparation process: Add 100g of polacrilin potassium and 114g of paroxetine hydrochloride into 10kg of water and stir for 1 hour to fully disperse and form a complex. Add 2000L of ethanol and let stand for 12h. Remove the supernatant, and then Add 536g mannitol and 100g microcrystalline cellulose to the precipitate, stir and granulate using a wet granulator, granulate with a 24-mesh sieve, dry in a fluidized bed at 50°C, and after sizing, add 100g microcrystalline cellulose, 2g Cross-linked povidone, 1g magnesium stearate, 1g silicon dioxide, 1g acesulfame K, mix evenly, calculate the tablet weight according to the content of paroxetine in the granules and press the tablet, the yield can reach more than 90%, and the disin...

Embodiment 2

[0016] In this embodiment, the ratio of paroxetine to polacrilin potassium is 1:3, and the ratio of polacrilin potassium and paroxetine solid to water is 1:30.

[0017]

[0018] Preparation process: Weigh 114g of paroxetine hydrochloride and 300g of polacrilin potassium, add them to 2000g of water, stir to make them fully dispersed, and form a complex. After standing still, remove the supernatant, then add 60ml of ethanol, and add 200g of Microcrystalline cellulose, 356g mannitol, stirred evenly with a wet granulator, granulated with a 24-mesh sieve, spray-dried at 50°C and granulated, then added 200g microcrystalline cellulose, 2g crospovidone, 1g stearin magnesium oxide, 1g silicon dioxide, 1g acesulfame K, mixed evenly, according to the content of paroxetine in the granules, the tablet weight was converted and pressed into tablets, the yield could reach more than 90%, the disintegration speed was 15±3s, the taste was slightly sweet and cool feeling.

Embodiment 3

[0020] In this embodiment, the ratio of paroxetine to polacrilin potassium is 1:2, and the ratio of polacrilin potassium and paroxetine solid to water is 1:60.

[0021]

[0022] Preparation process: Weigh 114g of paroxetine hydrochloride and 200g of polacrilin potassium, add them to 1.8kg of water, stir to make them fully dispersed, and form a complex. After standing still, remove the supernatant, then add 40ml of ethanol, and add 100g of microcrystalline cellulose, 446g of lactose, stirred evenly with a wet granulator, granulated with a 20-mesh sieve, dried in an oven at 50°C and granulated, then added 100g of microcrystalline cellulose, 2g of low-substituted hydroxypropyl cellulose, and 1g of hard Magnesium fatty acid, 1g of acesulfame K, mixed evenly, according to the content of paroxetine in the granules, the weight of the tablet was converted and compressed, the yield can reach more than 90%, the disintegration speed is 15±3s, the taste is slightly sweet and cool.

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Abstract

The invention discloses an orally disintegrating tablet of a compound containing polacrilin potassium-paroxetine, and a preparation method of the orally disintegrating tablet. The orally disintegrating tablet is characterized in that an ion exchange compound is prepared from paroxetine hydrochloride and polacrilin potassium by adopting a precipitation method; and the orally disintegrating tablet is prepared by adopting a wet granulation process. Through the process, the taste of the medicine can be significantly improved, meanwhile, an organic solvent is added to the preparation process, so that the compound is low in moisture content, and is capable of effectively improving the yield of the compound and the drying efficiency in the preparation process, preventing the sticking problem in the tabletting process, and improving the stability.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an orally disintegrating tablet containing polacrilin potassium-paroxetine complex and a preparation method thereof, which is characterized in that the ion exchange complex is prepared by a precipitation method, and is produced by a wet granulation process 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", that is, high ...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K47/32A61K31/4525A61P25/24
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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