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Pharmaceutical composition containing escitalopram oxalate and preparation method of pharmaceutical composition

A technology of escitalopram oxalate and composition, which is applied in the field of pharmaceutical composition containing escitalopram oxalate and its preparation, can solve the problems of uneven tablet content and poor material fluidity, and solve the problem of material flow poor sex effect

Inactive Publication Date: 2020-08-11
FUJIAN HAIXI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This method solves the problems of poor material fluidity and uneven tablet content

Method used

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  • Pharmaceutical composition containing escitalopram oxalate and preparation method of pharmaceutical composition
  • Pharmaceutical composition containing escitalopram oxalate and preparation method of pharmaceutical composition
  • Pharmaceutical composition containing escitalopram oxalate and preparation method of pharmaceutical composition

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Experimental program
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Effect test

experiment example

[0036]

[0037]

[0038] Weigh 13g of escitalopram oxalate and 41g of microcrystalline cellulose and mix them through a 80-mesh sieve to obtain mixture I; weigh 28.5g of lactose and the remaining 40g of microcrystalline cellulose and mix them through an 80-mesh sieve to obtain mixture II . Pass mixture I, mixture II and 0.75 g of talcum powder through a 60-mesh sieve, pre-mix with fluidized bed mixture for 5 minutes, mix 2.0% hydroxypropyl cellulose for fluidized bed granulation, and dry in a fluidized bed for 10 minutes. Sieve and adjust the granules to obtain granules, weigh 0.5 g of polyethylene glycol 6000 and mix for 3 minutes to make tablets.

[0039] According to the content uniformity determination method (Chinese Pharmacopoeia 2015 edition general rule 0941 content uniformity inspection method), according to the pharmacopoeia standard, if A+2.2S≤15 is qualified, the results are shown in Table 1

[0040] Table 1 Test results of content uniformity

[0041]

...

Embodiment 1

[0050] serial number Material name Dosage (g) 1 Escitalopram Oxalate 25 2 lactose 50 3 microcrystalline cellulose 155 4 Hydroxypropyl Cellulose 3.0 5 polyethylene glycol 1.0 6 talcum powder 2.0

[0051] Weigh 25.0 g of escitalopram oxalate and 100 g of microcrystalline cellulose and mix them through a 80-mesh sieve to obtain mixture I; weigh 50 g of lactose and the remaining 55 g of microcrystalline cellulose and mix them through an 80-mesh sieve to obtain mixture II . Pass mixture Ⅰ, mixture Ⅱ and 2.0 g of talcum powder through a 60-mesh sieve, pre-mix the mixed material in a fluidized bed for 8 minutes, mix 1.8% hydroxypropyl cellulose for fluidized bed granulation, and dry in a fluidized bed for 12 minutes. Sieve and adjust the granules to obtain granules, weigh 1.0 g of polyethylene glycol 6000 and mix for 3 minutes to make tablets.

Embodiment 2

[0053]

[0054]

[0055] Weigh 12.5g of escitalopram oxalate and 40g of microcrystalline cellulose to pass through a 60-mesh sieve to obtain mixture I; weigh 28g of lactose and the remaining 46g of microcrystalline cellulose to pass through a 60-mesh sieve to obtain mixture II . Pass mixture I, mixture II and 1.6 g of talcum powder through a 40-mesh sieve, pre-mix with fluidized bed mixture for 5 minutes, mix 5.0% hydroxypropyl cellulose for fluidized bed granulation, and fluidized bed dry for 5 minutes. Sieve and adjust the granules to obtain granules, weigh 0.5 g of polyethylene glycol 6000 and mix for 3 minutes to make tablets.

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Abstract

The invention discloses pharmaceutical composition containing escitalopram oxalate and a preparation method of the pharmaceutical composition. The pharmaceutical composition is tablets prepared from polyethylene glycol 6000 as a lubricant through fluidized bed granulation. The method well solves the problems of poor material flowability and non-uniform tablet content.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition containing escitalopram oxalate and a preparation method thereof. Background technique [0002] Escitalopram oxalate tablets (escitalopram oxalate), developed by Lundbeck, Denmark, was approved by the FDA in 2002, and was approved by the CFDA in 2005, and was launched in China. It is an oral serotonin reuptake inhibitor. Escitalopram oxalate is clinically used for the treatment of major depressive disorder and generalized anxiety disorder. It belongs to the class of selective serotonin reuptake inhibitors (SSRIs) that selectively inhibit the reuptake of serotonin from the synaptic cleft into nerve cells. Escitalopram oxalate has a highly selective inhibitory effect on the reuptake of serotonin (5-HT), with little effect on the reuptake of norepinephrine and dopamine. It increases the concentration of 5-hydroxytryptamine (5-HT) in...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/343A61K47/10A61P25/24A61P25/22
CPCA61K9/2031A61K31/343A61P25/22A61P25/24
Inventor 陈松垲钟小伟钟文鑫林舒丹冯岩康心汕
Owner FUJIAN HAIXI PHARMA
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