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Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery

A technology of sildenafil citrate and urology, which is applied in the field of medicine, can solve the problems of large influence on drug stability, difficult preparation of preparations, etc., and achieves low moisture and impurity content, good stability and high dissolution Effect

Inactive Publication Date: 2015-12-16
QINGDAO HUAZHICAO PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Sildenafil citrate has strong hygroscopicity, and it is easy to absorb moisture and deteriorate under normal conditions. Therefore, the water content has a great influence on the stability of the drug. It is necessary to strictly control the product quality, which brings great difficulties to the preparation of the preparation.

Method used

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  • Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery
  • Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery
  • Pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028] Example 1: Preparation of Sildenafil Citrate Crystals

[0029] (1) Grind the crude sildenafil citrate, pass through an 80-mesh sieve, then add it to deionized water with a volume 6 times the weight of sildenafil citrate, and stir at 130 rpm for 10 minutes;

[0030] (2) Add methanol with a volume 5 times the weight of sildenafil citrate under stirring at 90 rpm, and raise the temperature to 35°C at the same time;

[0031] (3) After the solution is added, let it stand for 3 hours, and add dropwise a mixed solution of propyl ether and hexane with a volume of 8 times the weight of sildenafil citrate at 0°C under the condition of stirring at 180 rpm. , The volume ratio of hexane is 1:4, and the uniform dropwise addition is completed within 2 hours;

[0032] (4) After the dropwise addition, the temperature was lowered to -5°C, and the stirring was continued for 2 hours at a stirring rate of 110 rpm, and the crystals were precipitated after standing for 1 hour, filtered, wa...

Embodiment 2

[0034] Example 2: Preparation of Sildenafil Citrate Tablets

[0035] Prescription: in parts by weight

[0036]

[0037] Preparation:

[0038] (1) Processing of raw and auxiliary materials: crush sildenafil citrate through a 100-mesh sieve, and pass calcium sulfate through a 80-mesh sieve;

[0039] (2) Weighing: Weighing according to the process prescription;

[0040] (3) Adhesive preparation: prepare starch slurry with the prescribed amount of starch and purified water by cooking slurry method, and cool to room temperature for use;

[0041] (4) Mixing granulation: Add sildenafil citrate, microcrystalline cellulose, calcium sulfate, casein, and hydroxypropyl cellulose into the wet mixing granulator, turn on the stirring motor and dry mix for 10 minutes; add The prepared adhesive is wet-mixed and cut, and the soft material is made with an 18-mesh sieve;

[0042] (5) Drying: Add the wet granules obtained from granulation into a fluidized bed dryer, set the temperature at...

Embodiment 3

[0046] Example 3: Preparation of Sildenafil Citrate Tablets

[0047] Prescription: in parts by weight

[0048]

[0049] Preparation:

[0050] (1) Processing of raw and auxiliary materials: crush sildenafil citrate through a 100-mesh sieve, and pass calcium sulfate through a 80-mesh sieve;

[0051] (2) Weighing: Weighing according to the process prescription;

[0052] (3) Adhesive preparation: prepare starch slurry with the prescribed amount of starch and purified water by cooking slurry method, and cool to room temperature for use;

[0053] (4) Mixing granulation: Add sildenafil citrate, microcrystalline cellulose, calcium sulfate, casein, and hydroxypropyl cellulose into the wet mixing granulator, turn on the stirring motor and dry mix for 10 minutes; add The prepared adhesive is wet-mixed and cut, and the soft material is made with an 18-mesh sieve;

[0054] (5) Drying: Add the wet granules obtained from granulation into a fluidized bed dryer, set the temperature at...

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Abstract

The invention relates to pharmaceutical sildenafil citrate composition tablets for treating diseases of urinary surgery and belongs to the technical field of medicines. The pharmaceutical citric acid sildenafil composition tablets are prepared from sildenafil citrate, microcrystalline cellulose, calcium sulphate, casein, hydroxypropyl cellulose, starch, purified water and superfine silica powder. The sildenafil citrate is a novel crystal-form compound and is different from sildenafil citrate disclosed in the prior art, as shown in Figure 1 of an X-ray powder diffraction diagram obtained through Cu-KAlpha ray measurement. A test shows that the novel crystal-form compound improves moisture absorption, the tablets prepared by utilizing the sildenafil citrate crystal-form compound are high in dissolution rate, good in stability and low in moisture and impurity content compared with the prior art, and the safety of clinic application is improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a sildenafil citrate composition tablet for treating urological diseases. Background technique [0002] 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 muscle). Sildenafil selectively inhibits PDE5, enhances the nitric oxide (NO)-cGMP pathway, and increases the level of cGMP to cause the relaxation of the smooth muscle of the cavernous body of the penis, so that patients with erectile dysfunction can produce a natural erectile response to sexual stimulation. Erectile response generally inc...

Claims

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Application Information

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IPC IPC(8): A61K31/519A61K9/20C07D487/04A61P13/00A61P15/10
Inventor 刘学键
Owner QINGDAO HUAZHICAO PHARMA CO LTD
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