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Compound sildennafil dapoxetine slow-release capsule and preparation method thereof

A technology of sildenafil and sustained-release capsules, applied in the directions of pharmaceutical formulations, bulk delivery, drug delivery, etc., can solve the problems of different half-lives and the inability to exert drug effects at the same time, and achieve the effect of treating impotence and premature ejaculation

Inactive Publication Date: 2017-03-22
扬子江药业集团江苏紫龙药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] There is a difference in half-life between the premature ejaculation treatment dapoxetine and the impotence treatment sildenafil, if administered at the same time, due to the T max It is the same, the time of the drug effect is the same at the initial stage of taking, but because the half-life of the two drugs is different, the drug effect cannot be exerted at the same time after a period of time after administration, so it needs to be improved

Method used

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  • Compound sildennafil dapoxetine slow-release capsule and preparation method thereof
  • Compound sildennafil dapoxetine slow-release capsule and preparation method thereof
  • Compound sildennafil dapoxetine slow-release capsule and preparation method thereof

Examples

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Embodiment 1

[0025] The present invention specifically describes the materials and test methods used in the test. While many of the materials and procedures used in the experiments are well known in the art, the present invention is described here in as much detail as possible. Hereinafter, materials and operating methods used in the present invention are well known in the art unless otherwise specified. Example 1: Preparation of Compound Sildenafil Dapoxetine Sustained-release Capsules

[0026] Prescription of Dapoxetine Granules:

[0027] Dapoxetine Hydrochloride 67.16g Hydroxypropylmethylcellulose 100g microcrystalline cellulose 30g lactose 37.84g povidone (10% solution) 5g

[0028] Prescription for Sildenafil Granules:

[0029] Sildenafil Citrate 56.2g dry starch 15g microcrystalline cellulose 83.8g povidone (10% solution) 5g

[0030] a. Preparation of dapoxetine sustained-release granules:

[0031] Weigh the ...

Embodiment 2

[0036] Example 2: Preparation of Compound Sildenafil Dapoxetine Sustained-release Capsules

[0037] Prescription of Dapoxetine Granules:

[0038] Dapoxetine Hydrochloride 67.16g Hydroxypropylmethylcellulose 80g Ethyl cellulose 20g microcrystalline cellulose 30g lactose 37.84g povidone (10% solution) 5g

[0039] Prescription for Sildenafil Granules:

[0040] Sildenafil Citrate 56.2g Croscarmellose Sodium 15g microcrystalline cellulose 83.8g povidone (10% solution) 5g

[0041] With reference to the formula and method of Example 1 of the present invention, the only difference is that the type and content of auxiliary materials have been changed. In the obtained compound sildenafil dapoxetine sustained-release capsules, each capsule contains 50 mg of sildenafil and 60 mg of dapoxetine.

Embodiment 3

[0042] Example 3: Preparation of Compound Sildenafil Dapoxetine Sustained-release Capsules

[0043] Prescription of Dapoxetine Granules:

[0044] Dapoxetine Hydrochloride 67.16g Hydroxypropylmethylcellulose 100g Ethyl cellulose 20g microcrystalline cellulose 10g lactose 37.84g povidone (10% solution) 5g

[0045] Prescription for Sildenafil Granules:

[0046] Sildenafil Citrate 56.2g Croscarmellose Sodium 10g Sodium carboxymethyl starch 5g microcrystalline cellulose 83.8g povidone (10% solution) 5g

[0047] With reference to the formula and method of Example 1 of the present invention, the only difference is that the type and content of auxiliary materials have been changed. In the obtained compound sildenafil dapoxetine sustained-release capsules, each capsule contains 50 mg of sildenafil and 60 mg of dapoxetine.

[0048] The capsules manufactured in each example were dissolved by rotating a...

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Abstract

The invention discloses a compound sildennafil dapoxetine slow-release capsule and a preparation method thereof. Each capsule of the preparation contains immediate-release particles and slow-release particles. The immediate-release particles contain an active substance sildennafil or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient or auxiliary materials; the slow-release particles contain an active substance dapoxetine or the pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient or auxiliary materials. The preparation is prepared by the following steps: preparation of excipient immediate-release particles; preparation of dapoxetine slow-release particles; preparation of the compound sildennafil dapoxetine slow-release capsule. In the compound preparation, sildennafil is used as an immediate-release component, drug effects are rapidly performed, sexual desire of patients is satisfied in a short time, dapoxetine is used as a slow-release component for time-delay release, the effects are lasting for patients, and the capsule is suitable for treating erectile dysfunction and premature ejaculation of male.

Description

technical field [0001] The invention relates to a compound sildenafil dapoxetine sustained-release capsule and a preparation method thereof Background technique [0002] Premature ejaculation (PE) is one of the most common male sexual dysfunctions, with an incidence rate of 21-33%. Antidepressant serotonin reuptake inhibitors can effectively treat PE. Dapoxetine is a novel serotonin reuptake inhibitor that prolongs ejaculation time in PE patients. The English name of Dapoxetine is Dapoxetine, and its molecular formula is C 21 h 23 NO, the chemical name is (S)-(+)-N,N-dimethyl-1-phenyl-3-(1-naphthyloxy)-propylamine, and its chemical structure is as follows: [0003] [0004] Dapoxetine T max For 1h, half-life of 1.4h, premature ejaculation treatment. The drug is absorbed quickly and can quickly reach the blood concentration. [0005] Impotence (ED) is one of the common diseases that endanger the physical and mental health of adult men, and sildenafil is the most wide...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/52A61K9/16A61K31/519A61P15/10A61K31/138
Inventor 李海芬严彪段修玲闵翅驹
Owner 扬子江药业集团江苏紫龙药业有限公司
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