Medicinal composition containing vardenafil, and preparation method thereof

A technology of vardenafil and composition, which is applied in the field of pharmaceutical composition containing vardenafil and its preparation, and can solve problems such as compound preparations that have not yet been reported

Inactive Publication Date: 2015-10-14
天津市聚星康华医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] According to the search of patents and scientific literature, there is no relevant report on the compound preparation composed of vardenafil and trace element zinc

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] Prescription (1000 tablets):

[0034] Element Dosage / g Vardenafil 5 Zinc gluconate 10 polyethylene glycol 3 Polyvinyl Alcohol Polyethylene Glycol Copolymer 10 microcrystalline cellulose 6 lactose 5 Stevia 2 lemon zest 2 purified water 100

[0035] Preparation Process:

[0036] (1) Weigh each raw and auxiliary material according to the above prescription;

[0037] (2) Wet vardenafil and zinc gluconate with polyethylene glycol, add polyvinyl alcohol polyethylene glycol copolymer, microcrystalline cellulose, lactose, stevioside and water, stir well and place until swelling is complete ;

[0038] (3) Add essence and stir evenly;

[0039] (4) Coating, drying, and stripping.

Embodiment 2

[0041] Prescription (1000 tablets):

[0042] Element Dosage / g Vardenafil 10 zinc lactate 10 glycerin 5 povidone 15 pregelatinized starch 8 Sodium carboxymethyl cellulose 2 Glycyrrhizin 1 Refreshing fragrance 2 purified water 100

[0043] Preparation Process:

[0044] (1) Weigh each raw and auxiliary material according to the above prescription;

[0045] (2) Moisten vardenafil and zinc lactate with glycerin, add povidone, pregelatinized starch, sodium carboxymethylcellulose, glycyrrhizin and water, stir well and place until swelling is complete;

[0046] (3) Add essence and stir evenly;

[0047] (4) Coating, drying, and stripping.

Embodiment 3

[0049] Prescription (1000 tablets):

[0050] Element Dosage / g Vardenafil 15 Zinc citrate 2 Propylene Glycol 10 Hypromellose 10 Mannitol 4 dextrin 3 Sucralose 1 apple flavor 2 purified water 100

[0051] Preparation Process:

[0052] (1) Weigh each raw and auxiliary material according to the above prescription;

[0053] (2) Wet vardenafil and zinc citrate with propylene glycol, add hypromellose, mannitol, dextrin, sucralose and water, stir well and place until swelling is complete;

[0054] (3) Add essence and stir evenly;

[0055] (4) Coating, drying, and stripping.

[0056] The assay method of product melting time limit: get the test sample 6 film of preparation of embodiment 1-4 respectively, adopt disintegration time limit determination method (Chinese Pharmacopoeia 2010 edition two appendix X A) measure respectively, each film should be in All dissolved and passed through a sieve within 3 minutes.

...

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PUM

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Abstract

The invention discloses a medicinal composition containing vardenafil, and a preparation method thereof, and belongs to the pharmaceutical field. The medicinal composition is used for treating male sexual disfunction. Vardenafil is reasonably combined with a trace element zinc, and pharmaceutically acceptable auxiliary materials, such as a humectant, a film forming material, a filler, a sweetener, a disintegrating agent, an adhesive, a lubricant and a stabilizer are added to prepare an oral pellicle, a chewing tablet, an oral solution and various oral dosage forms for clinic application.

Description

technical field [0001] The invention belongs to the field of pharmacy and relates to a pharmaceutical composition containing vardenafil and a preparation method thereof. Background technique [0002] Generally speaking, male sexual dysfunction refers to the five stages of male sexual activities such as sexual desire, penile erection, sexual intercourse, orgasm, and ejaculation, among which abnormalities occur in a certain stage, several stages, or the entire stage and affect normal sexual activities. conduct. The most common male sexual dysfunction is abnormal penile erection and ejaculation. Patients suffering from such diseases often have great mental stress, and their self-esteem and willpower are greatly damaged. Therefore, it is easy to cause disharmony between husband and wife, family breakdown, and affect social stability. It has attracted great attention from the international medical community. [0003] Vardenafil (Tadalafi1) is a potent and highly selective phos...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/53A61P15/10A61K31/191A61K31/194A61K31/198A61K31/19
Inventor 李化淋
Owner 天津市聚星康华医药科技有限公司
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