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Sildenafil citrate sublingual tablet and preparation method thereof

A technology of sildenafil citrate and sublingual tablets, applied in the direction of non-active ingredient medical preparations, pharmaceutical formulas, medical preparations containing active ingredients, etc., can solve the problem of sildenafil citrate Sublingual film reports and other issues

Inactive Publication Date: 2009-11-18
张睿
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] Searching the existing literature, there is no report on Sildenafil Citrate Sublingual Tablets

Method used

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  • Sildenafil citrate sublingual tablet and preparation method thereof
  • Sildenafil citrate sublingual tablet and preparation method thereof
  • Sildenafil citrate sublingual tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0076] 1. The preparation prescription is: sildenafil citrate 250g, mannitol 750g, polyethylene glycol 4000 220g, microcrystalline cellulose 226g, low-substituted hydroxypropyl cellulose 35g, magnesium stearate 10g, aspartame 3g, menthol 4g, povidone K30 2g;

[0077] 2. Take 250g of sildenafil citrate and 750g of mannitol and fully grind and disperse together to obtain 1000g of drug-mannitol dispersion;

[0078] 3. Dissolve 2g of povidone K30 in 100ml of 90% ethanol solution to make 2% of 90% ethanol solution;

[0079] 4. Take menthol 4g and dissolve it in 2% 90% ethanol solution;

[0080] 5. According to the prescription, take the disintegrant, the remaining diluent, and aspartame, crush them together, sieve, and set aside;

[0081] 6. Fully mix the drug-mannitol dispersion with the powder in step 5, spray the ethanol solution in step 4, pass through a 20-mesh sieve to make granules, dry at 40°C-60°C, and granulate with a 16-mesh sieve;

[0082] 7. Add lubricant to the dry...

Embodiment 2

[0084] 1. The preparation prescription is: sildenafil citrate 250g, mannitol 750g, polyethylene glycol 4000 460g, microcrystalline cellulose 460g, croscarmellose sodium 58g, magnesium stearate 13g, menthol 6g, povidone K30 3g;

[0085] 2. Take 250g of sildenafil citrate and 750g of mannitol and fully grind and disperse together to obtain 1000g of drug-mannitol dispersion;

[0086] 3. Dissolve 3g of povidone K30 in 150ml of 90% ethanol solution to make 2% povidone K30 in 90% ethanol solution;

[0087] 4. Get menthol 6g, dissolve in 90% ethanol solution of 2% povidone K30;

[0088] 5. Take the disintegrating agent and the remaining diluent according to the prescription, pulverize together, sieve, and set aside;

[0089] 6. Fully mix the drug-mannitol dispersion with the powder in step 5, spray the ethanol solution in step 4, pass through a 20-mesh sieve to make granules, dry at 40°C-60°C, and granulate with a 16-mesh sieve;

[0090] 7. add lubricant to the dry granules, mix w...

Embodiment 3

[0092] 1. The preparation prescription is: sildenafil citrate 250g, mannitol 750g, polyethylene glycol 4000 100g, microcrystalline cellulose 100g, crospovidone 30g, magnesium lauryl sulfate 10g, aspartame 3g, menthol 4g, povidone K30 2g;

[0093] 2. Take 250g of sildenafil citrate and 750g of mannitol and fully grind and disperse together to obtain 1000g of drug-mannitol dispersion;

[0094] 3. Dissolve 3g of povidone K30 in 100ml of 90% ethanol solution to make 2% povidone K30 in 90% ethanol solution;

[0095] 4. Take menthol 4g and dissolve it in 2% 90% ethanol solution;

[0096] 5. According to the prescription, take the disintegrant, the remaining diluent, and aspartame, crush them together, sieve, and set aside;

[0097] 6. Fully mix the drug-mannitol dispersion with the powder in step 5, spray the ethanol solution in step 4, pass through a 20-mesh sieve to make granules, dry at 40°C-60°C, and granulate with a 16-mesh sieve;

[0098] 7. Add lubricant to the dry granule...

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Abstract

The invention discloses a sildenafil citrate sublingual tablet and a preparation method thereof. The sildenafil citrate sublingual tablet is prepared from 1 part by weight of sildenafil citrate and 4 to 8 parts by weight of pharmaceutical adjuvant , wherein the pharmaceutical adjuvant comprises 2 to 4 percent of disintegrant, 94 to 96 percent of diluter, 0.5 to 1.2 percent of lubricator, 0.3 to 1 percent of corrective and 0.1 to 0.2 percent of binder, which are based on the total weight of the pharmaceutical adjuvant. Test results show that the prepared sublingual tablet has shorter disintegration time, higher dissolving speed in vitro and higher body bioavailability than the conventional tablets.

Description

technical field [0001] The invention belongs to the technical field of pharmacy, and more specifically relates to a sublingual tablet of a pharmaceutical composition for treating male erectile dysfunction with sildenafil citrate as an active ingredient and a preparation method thereof. Background technique [0002] According to relevant epidemiological surveys, the overall prevalence rate of male erectile dysfunction (ED) in the three major cities of China is 26.1%, and the prevalence rate of people aged 40 and above is 40.2%. According to this calculation, there are about 26 million ED patients in the urban population of the country. There are more than 300 million adult males in China, and more than half of them have different degrees of sexual dysfunction. Therefore, the total number of adult males suffering from sexual dysfunction should be more than 100 million. These sexual dysfunctions include loss of libido, erectile dysfunction, premature ejaculation and others. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/519A61K47/34A61K47/36A61K47/38A61P15/10A61K47/10A61K47/32
Inventor 张正生韩若锋
Owner 张睿
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