Sildenafil citrate tablet

A technology of sildenafil citrate and adhesive, which is applied in the field of chemical pharmacy, can solve the problems of reducing the risk of cancer, and achieve the effects of easy mass production operation, high safety and short drying time

Inactive Publication Date: 2014-07-09
司晓东
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Although the problem of stability of sildenafil citrate can be solved, it can be solved by adding a large amount of antioxidants and acid-causing agents, such as in humidity temperature Under the condition that the dry moisture no longer decreases, add Acidogens, Antioxidants can play a very good antioxidant effect, but, as a long-term medication, the amount of antioxidants and acid-causing agents need to be reduced to reduce the possible risk of cancer

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Sildenafil Citrate 100g

[0052] Butylated hydroxyanisole 0.1g

[0053] Tartaric acid 10g

[0054] Lactose 300g

[0055] Mannitol 250g

[0056] Low-substituted hydroxypropyl cellulose 20g

[0057] Polyacrylic resin No. IV 10g

[0058] Magnesium Stearate 5g

[0059] Silica 5g

[0060] Made in 1000 pieces.

[0061] Preparation:

[0062] (1) After mixing sildenafil citrate with filler and disintegrant, crush and sieve through 80 meshes;

[0063] (2) prepare the binder of recipe quantity, add antioxidant and acid-causing agent to dissolve in the binder simultaneously;

[0064] (3) Add the prepared adhesive to the pulverized and mixed materials, granulate with a 30-mesh nylon screen, dry with a fluidized bed, and control the humidity of the incoming air Inlet air temperature The drying time is controlled at 45 minutes, measured by an infrared heating rapid moisture analyzer, and the moisture content of the particles is controlled within the scope;

[0065] (4...

Embodiment 2

[0068] Sildenafil Citrate 100g

[0069] tert-butylmethylphenol 0.1g

[0070] Tartaric acid 10g

[0071] Lactose 300g

[0072] Mannitol 250g

[0073] Low-substituted hydroxypropyl cellulose 20g

[0074] Polyacrylic resin No. IV 10g

[0075] Magnesium Stearate 3.5g

[0076] Silica 3.5g

[0077] Made in 1000 pieces.

[0078] Preparation:

[0079] (1) After mixing sildenafil citrate with filler and disintegrant, crush and sieve through 80 meshes;

[0080] (2) prepare the binder of recipe quantity, add antioxidant and acid-causing agent to dissolve in the binder simultaneously;

[0081] (3) Add the prepared adhesive to the pulverized and mixed materials, granulate with a 30-mesh nylon screen, dry with a fluidized bed, and control the humidity of the incoming air Inlet air temperature The drying time is controlled at 45 minutes, measured by an infrared heating rapid moisture analyzer, and the moisture content of the particles is controlled within the scope;

[0082] ...

Embodiment 3

[0085] Sildenafil Citrate 100g

[0086] tert-butylmethylphenol 0.1g

[0087] Citric acid 10g

[0088] Lactose 300g

[0089] Mannitol 300g

[0090] Low-substituted hydroxypropyl cellulose 25g

[0091] Hydroxypropyl Methyl Cellulose 20g

[0092] Magnesium Stearate 5g

[0093] Silica 5g

[0094] Made in 1000 pieces.

[0095] The preparation method is the same as in Example 1, and the water content of the prepared sildenafil citrate tablets is controlled at 1.25% to 1.6%.

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PUM

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Abstract

The invention provides a stable sildenafil citrate tablet. The sildenafil citrate tablet is prepared from the components in percent by weight: 10-50 percent of sildenafil citrate, 0.01-0.03 percent of antioxidant, 0.3-1.0 percent of acidifying agent, 70-90 percent of filler, 5-10 percent of disintegrant, 0.5-2.5 percent of adhesive, 0.5-1.0 percent of lubricant and 0.5-1.0 percent of flow aid. The invention also provides a method of preparing the tablet. With the adoption of the method, by strictly controlling the moisture of a final finished product, the dosages of the antioxidant and the acidifying agent in the components are remarkably reduced, the product stability is better, and the safety is higher.

Description

field of invention [0001] The invention relates to the field of chemical pharmacy, in particular to a medicine for oral administration of sildenafil citrate tablets and for treating urological diseases, that is, a medicine for treating erectile dysfunction (ED) and premature ejaculation, and for erectile dysfunction and premature ejaculation Symptoms have improved significantly. Background of the invention [0002] Oral medication is the simplest and most acceptable form of treatment for erectile dysfunction (urological disorders). Sildenafil is an effective drug for the treatment of erectile dysfunction caused by objective and subjective reasons. It was approved by the FDA as a prescription drug in the United States in March 1997. Sildenafil is a highly selective phosphodiesterase 5 (PDE5 ) inhibitor, PDE5 is highly expressed in the corpus cavernosum, while its expression is low in other tissues (including platelets, blood vessels, visceral smooth muscle, and skeletal musc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K9/36A61K31/519A61K47/32A61K47/38A61K47/36A61J3/10A61P15/00
Inventor 司晓东杨荣辰
Owner 司晓东
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