Sodium-potassium citrate chewing tablet and preparation method thereof

Abstract

The invention provide a sodium-potassium citrate chewing tablet, of which the prescription is composed of the following components by mass percent: 33.0-33.1% of potassium citrate, 27.8-27.9% of sodium citrate, 28-32% of filling agent, 0.05-0.3% of adhesive, 1-1.5% of lubricant, 3-5% of flavoring agent, 0.1-0.3% of aromatizer and 3-4% of moistureproof film coating agent, wherein the filling agentis mannitol or a mixture of mannitol and sorbitol or xylitol; the adhesive is hydroxypropyl methylcellulose or polyvidone K30; the lubricant is magnesium stearate or a mixture of magnesium stearate and micropowder silica gel; the flavoring agent is citric acid or a mixture of citric acid and sodium saccharin, aspartame or steviosin; and the aromatizer is pharmaceutically acceptable essence. The invention also provides a preparation method of the sodium-potassium citrate chewing tablet. The preparation method is simple and convenient to operate, low in cost and suitable for industrial production. The obtained tablet has stable and controllable quality, fresh and cool mouthfeel, sourness and sweetness in taste, mint fragrance or fruit fragrance, smooth and beautiful surface, uniform color, moderate hardness and rapid dissolution, and has good application prospects in treatment of gout and hyperuricemia as well as improvement of children and adult in vivo acidosis symptom and other aspects.

Description

technical field

[0001] The invention belongs to the field of pharmacy, and relates to a pharmaceutical preparation and a preparation method of the preparation. Background technique

[0002] Statistical reports show that gout and hyperuricemia have become the fourth major diseases of middle-aged and elderly people in the world besides the "three high diseases". Gout is a disorder of purine metabolism in the human body. The synthesis of uric acid increases or the excretion decreases, resulting in hyperuricemia. When the concentration of uric acid in the blood is too high, uric acid is deposited in the joints, cartilage and kidneys in the form of sodium salt, causing inflammation of tissue foreign bodies. sexual response. Its clinical features are hyperuricemia and recurrent gouty acute arthritis caused by it, tophi deposition, tophi chronic arthritis and joint deformity, often involving the kidneys to cause chronic interstitial nephritis and uric acid nephrolithiasis. It can...

Examples

Embodiment 1

[0026] prescription:

[0027] components mass (g) Mass percentage (%) potassium citrate 231.5 33.07 sodium citrate 195.0 27.86 Mannitol 203.0 29.00 hypromellose 0.6 0.09 Magnesium stearate 7.0 1.00 Micropowder silica gel 3.5 0.50 citric acid 30.0 4.29 Orange Oil Flavor 1.4 0.20 Hydroxypropyl Cellulose 28.0 4.00 gross weight 700 100

[0028] Preparation:

[0029] a. Grind all components in the prescription except peppermint oil essence into fine powders with a fineness above 80 mesh, and dry at 50°C for 2 hours; dissolve the hypromellose in the prescribed amount with water to make Solution; the hydroxypropyl cellulose of recipe quantity is dissolved with ethanol and made mass fraction is the solution of 15%;

[0030] b. Take the prescribed amount of potassium citrate, sodium citrate, mannitol and citric acid, mix them evenly, make a soft material with a 2% hypromellose solution, granulate...

Embodiment 2

[0035] prescription:

[0036] components mass (g) Mass percentage (%) potassium citrate 231.5 33.07 sodium citrate 195.0 27.86 Mannitol 208.6 30.23 hypromellose 0.9 0.13 Magnesium stearate 7.0 1.00 Micropowder silica gel 2.5 0.36 citric acid 25.0 3.57 stevia 0.7 0.10 peppermint oil flavor 0.8 0.11 Methylcellulose 25.0 3.57 gross weight 700 100

[0037] Preparation:

[0038] a. Grind all components in the prescription except sweet orange oil essence into fine powder with a fineness above 80 mesh, and dry at 50°C for 2 hours; dissolve the hypromellose in the prescription amount with water to make the mass fraction 3% The solution; The methyl cellulose of recipe quantity is dissolved with ethanol and made mass fraction is the solution of 15%;

[0039] b. Take the prescribed amount of potassium citrate, sodium citrate, mannitol, citric acid and stevioside, mix them evenly, use a hypro...

Embodiment 3

[0044] prescription:

[0045] components mass (g) Mass percentage (%) potassium citrate 231.5 33.07 sodium citrate 195.0 27.86 Mannitol 150.0 21.43 Sorbitol 68.0 9.71 Povidone K30 1.5 0.21 Magnesium stearate 7.0 1.00 Micropowder silica gel 2.0 0.29 citric acid 21.0 3.00 sodium saccharin 1.6 0.23 Green Apple Powder Flavor 1.4 0.20 hypromellose 21.0 3.00 gross weight 700 100

[0046] Preparation Process:

[0047] a. Grind each component in the prescription into fine powder with a fineness of 80 mesh or more, and dry at 50°C for 2 hours; dissolve the prescribed amount of povidone K30 in water to make a solution with a mass fraction of 3%; add hypromellose The element is dissolved in ethanol to make a solution with a mass fraction of 15%;

[0048] b. Take the prescribed amount of potassium citrate, sodium citrate, mannitol, sorbitol and sodium saccharin, mix them evenly, make a...

technical field

[0001] The invention belongs to the field of pharmacy, and relates to a pharmaceutical preparation and a preparation method of the preparation. Background technique

[0002] Statistical reports show that gout and hyperuricemia have become the fourth major diseases of middle-aged and elderly people in the world besides the "three high diseases". Gout is a disorder of purine metabolism in the human body. The synthesis of uric acid increases or the excretion decreases, resulting in hyperuricemia. When the concentration of uric acid in the blood is too high, uric acid is deposited in the joints, cartilage and kidneys in the form of sodium salt, causing inflammation of tissue foreign bodies. sexual response. Its clinical features are hyperuricemia and recurrent gouty acute arthritis caused by it, tophi deposition, tophi chronic arthritis and joint deformity, often involving the kidneys to cause chronic interstitial nephritis and uric acid nephrolithiasis. It can...

Examples

Embodiment 1

[0026] prescription:

[0027] components mass (g) Mass percentage (%) potassium citrate 231.5 33.07 sodium citrate 195.0 27.86 Mannitol 203.0 29.00 hypromellose 0.6 0.09 Magnesium stearate 7.0 1.00 Micropowder silica gel 3.5 0.50 citric acid 30.0 4.29 Orange Oil Flavor 1.4 0.20 Hydroxypropyl Cellulose 28.0 4.00 gross weight 700 100

[0028] Preparation:

[0029] a. Grind all components in the prescription except peppermint oil essence into fine powders with a fineness above 80 mesh, and dry at 50°C for 2 hours; dissolve the hypromellose in the prescribed amount with water to make Solution; the hydroxypropyl cellulose of recipe quantity is dissolved with ethanol and made mass fraction is the solution of 15%;

[0030] b. Take the prescribed amount of potassium citrate, sodium citrate, mannitol and citric acid, mix them evenly, make a soft material with a 2% hypromellose solution, granulate...

Embodiment 2

[0035] prescription:

[0036] components mass (g) Mass percentage (%) potassium citrate 231.5 33.07 sodium citrate 195.0 27.86 Mannitol 208.6 30.23 hypromellose 0.9 0.13 Magnesium stearate 7.0 1.00 Micropowder silica gel 2.5 0.36 citric acid 25.0 3.57 stevia 0.7 0.10 peppermint oil flavor 0.8 0.11 Methylcellulose 25.0 3.57 gross weight 700 100

[0037] Preparation:

[0038] a. Grind all components in the prescription except sweet orange oil essence into fine powder with a fineness above 80 mesh, and dry at 50°C for 2 hours; dissolve the hypromellose in the prescription amount with water to make the mass fraction 3% The solution; The methyl cellulose of recipe quantity is dissolved with ethanol and made mass fraction is the solution of 15%;

[0039] b. Take the prescribed amount of potassium citrate, sodium citrate, mannitol, citric acid and stevioside, mix them evenly, use a hypro...

Embodiment 3

[0044] prescription:

[0045] components mass (g) Mass percentage (%) potassium citrate 231.5 33.07 sodium citrate 195.0 27.86 Mannitol 150.0 21.43 Sorbitol 68.0 9.71 Povidone K30 1.5 0.21 Magnesium stearate 7.0 1.00 Micropowder silica gel 2.0 0.29 citric acid 21.0 3.00 sodium saccharin 1.6 0.23 Green Apple Powder Flavor 1.4 0.20 hypromellose 21.0 3.00 gross weight 700 100

[0046] Preparation Process:

[0047] a. Grind each component in the prescription into fine powder with a fineness of 80 mesh or more, and dry at 50°C for 2 hours; dissolve the prescribed amount of povidone K30 in water to make a solution with a mass fraction of 3%; add hypromellose The element is dissolved in ethanol to make a solution with a mass fraction of 15%;

[0048] b. Take the prescribed amount of potassium citrate, sodium citrate, mannitol, sorbitol and sodium saccharin, mix them evenly, make a...