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Sildenafil citrate smell masking resin compound and application thereof

A technology of sildenafil citrate and resin compound, applied in the field of pharmaceutical preparations, can solve problems such as high cost, complicated preparation process, melt dispersion stability and the like, and achieve the effects of improving stability and good taste

Inactive Publication Date: 2017-06-20
CHINA PHARM UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this method has the following disadvantages: 1. The preparation process is complicated and the cost is high, requiring special equipment twin-screw extruder and impact mill; 2. High temperature treatment is required when preparing molten dispersions, which is not suitable for heat-sensitive drugs; 3. Prepared melt dispersions have stability issues

Method used

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  • Sildenafil citrate smell masking resin compound and application thereof
  • Sildenafil citrate smell masking resin compound and application thereof
  • Sildenafil citrate smell masking resin compound and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Embodiment one, preparation of sildenafil citrate drug resin compound

[0027] Prescription composition:

[0028] Sildenafil Citrate 8.4g

[0029] Ion exchange resin 8.4g

[0030] water 500mL

[0031] Preparation:

[0032] According to the above prescription, sildenafil citrate and water were used to form a drug solution, and the ion exchange resin passed through a 200-mesh sieve was added to it, and stirred continuously at 40°C for 8 hours until the exchange equilibrium was reached, and the resin salt and the resin salt were separated by suction filtration Liquid, wash the filter cake repeatedly, dry in a vacuum drying oven, and sieve to obtain the sildenafil citrate drug resin complex.

[0033] After dissociation, the content of sildenafil citrate in the sildenafil citrate drug resin complex is 66.7%.

Embodiment 2

[0034] Embodiment two, preparation of sildenafil citrate drug resin compound

[0035] Prescription composition:

[0036] Sildenafil Citrate 8.4g

[0037] Ion exchange resin 4.0g

[0038] water 500mL

[0039] Preparation:

[0040] According to the above prescription, sildenafil citrate and water were used to form a drug solution, and the ion exchange resin passed through a 200-mesh sieve was added to it, and stirred continuously at 40°C for 8 hours until the exchange equilibrium was reached, and the resin salt and the resin salt were separated by suction filtration Liquid, wash the filter cake repeatedly, dry in a vacuum drying oven, and sieve to obtain the sildenafil citrate drug resin complex.

[0041] After dissociation, the content of sildenafil citrate in the sildenafil citrate drug resin complex is 39.8%.

Embodiment 3

[0042] Embodiment three, preparation of sildenafil citrate drug resin compound

[0043] Prescription composition:

[0044] Sildenafil Citrate 6g

[0045] Ion exchange resin 6g

[0046] water 500mL

[0047] Preparation:

[0048] According to the above prescription, sildenafil citrate and water were used to form a drug solution, and the ion exchange resin passed through a 200-mesh sieve was added to it, and stirred continuously at 40°C for 8 hours until the exchange equilibrium was reached, and the resin salt and the resin salt were separated by suction filtration Liquid, wash the filter cake repeatedly, dry in a vacuum drying oven, and sieve to obtain the sildenafil citrate drug resin complex.

[0049] After dissociation, the content of the sildenafil citrate in the sildenafil citrate drug resin complex is 25.4%.

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Abstract

The invention discloses a sildenafil citrate smell masking resin compound and application thereof, and aims at solving the technical problems to shield the bad smell of the medicine active ingredient of sildenafil citrate, so that good mouthfeel can be realized. The medicine smell masking resin compound is prepared from sildenafil citrate and acid type cation exchange resin through a static exchange method; the weight ratio of the sildenafil citrate to the acid type cation exchange resin is 0.5:1 to 3:1. The prepared sildenafil citrate smell masking resin compound can be further prepared into chewable tablets, orally disintegrating tablets, granules and suspensions. Compared with the prior art, the sildenafil citrate smell masking resin compound has the advantages that an ion exchange technology is used; the bad smell of the sildenafil citrate can be effectively shielded; the patient compliance is improved; the preparation process is simple; the sildenafil citrate smell masking resin compound is suitable for industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a taste-masking resin compound of sildenafil citrate and an application thereof. Background technique [0002] Oral preparations are currently the most widely used preparations in clinical practice due to their convenience and safety. However, most of the drugs have varying degrees of bitter taste, resulting in bad taste, unacceptable to patients, and poor compliance. Commonly used taste-masking methods include adding flavoring agents and other excipients, modifying the chemical structure of bitter drugs, preparing microcapsules or microspheres for taste-masking, and preparing solid dispersions. Adding excipients is to reduce the bitterness by interfering with the taste buds. The method is the simplest and the cost is low, but the effect is limited. Overcome bad taste, its technical difficulty is bigger. [0003] Ion exchange resin (Ion Exchange Resin, IER) is a kind ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/14A61K31/519A61K47/32A61P15/10
CPCA61K9/146A61K31/519
Inventor 尹莉芳张珊韩晓鹏秦超朱春莉董阳雨
Owner CHINA PHARM UNIV
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