Method for preparing potassium citrate sustained-release tablets

A technology of potassium citrate and sustained-release tablets, which is applied in the field of medicine and achieves the effects of excellent sustained-release characteristics, reduced administration times, and high yield

Inactive Publication Date: 2010-08-04
南京泽恒医药技术开发有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The present inventor has carried out a large amount of tests, has developed the formula and the technology for preparing potassium citrate slow-release tablet by adopting domestic high-quality and cheap adjuvant materials, effectively solved the large-dose water-soluble drug preparation sustained-release tablet problem, the result finds that adopts Stearic acid or stearic acid derivatives, ethyl cellulose, polyacrylic acid resin, and glycerol monostearate are insoluble skeleton materials, plus pharmaceutically acceptable porogens, fillers, lubricants, and colorants according to With a certain ratio, potassium citrate sustained-release tablets with beautiful appearance, stable drug release in various release media and stable release index for 6 months in the accelerated test at 40°C can be prepared

Method used

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  • Method for preparing potassium citrate sustained-release tablets
  • Method for preparing potassium citrate sustained-release tablets
  • Method for preparing potassium citrate sustained-release tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Potassium citrate 57.1g

[0033] Ethyl cellulose 25.0g

[0034] Polyethylene glycol 6000 5.0g

[0035] Povidone K 30 Appropriate amount (0.01%-3% of the above total weight)

[0036] Pigment Appropriate amount (0.001%-1% of the above total weight)

[0037] The preparation process is as follows: Potassium citrate, ethyl cellulose and polyethylene glycol 6000 are weighed according to the prescription and passed through a 80-mesh sieve. After mixing evenly, add the prepared 5% povidone K 30 Appropriate amount of aqueous solution to prepare soft materials, granulate with 16 mesh sieve, dry at 50-60°C for 2 hours, granulate with 18 mesh sieve, mix well, punch tablets with 12mm shallow concave, control the hardness at about 60-80N, and make 100 tablets.

Embodiment 2

[0039] Potassium citrate 571g

[0040] Stearic acid 200g

[0041] Macrogol 4000 40g

[0042] Magnesium Stearate 10g

[0043] Povidone K 30 Appropriate amount (0.01%-3% of the above total weight)

[0044] Pigment Appropriate amount (0.001%-1% of the above total weight)

[0045] The preparation process is as follows: Potassium citrate, stearic acid and polyethylene glycol 4000 are weighed according to the prescription and passed through an 80-mesh sieve. After mixing evenly, add the prepared 5% povidone K 30 Appropriate amount of aqueous solution, prepare soft material, granulate with 16 mesh sieve, dry at 50-60°C for 2 hours, granulate with 18 mesh sieve, add the prescribed amount of magnesium stearate, mix well, punch tablets with 12mm shallow concave, the hardness is controlled at 60~ About 80N, 100 pieces were prepared.

Embodiment 3

[0047] Potassium citrate 571g

[0048] Glyceryl monostearate 60g

[0049] Stearic acid 150g

[0050] Lactose 100g

[0051] Magnesium Stearate 10g

[0052] Povidone K 30 Appropriate amount (0.01%-3% of the above total weight)

[0053] Pigment Appropriate amount (0.001%-1% of the above total weight)

[0054] The preparation process is: weigh potassium citrate, stearic acid, glyceryl monostearate and lactose according to the prescription, put them into a fluidized one-step granulator, increase the temperature to 50-60 degrees, and spray 5% Povidone K 30 Appropriate amount of aqueous solution, prepare granules, dry at 50-60°C, repeat this process, sieve the prepared granules with 16 mesh, add the prescribed amount of magnesium stearate, mix well, punch tablets with 12mm shallow flat concave, the hardness is controlled at 60 ~80N or so, make 800 pieces.

[0055] Certainly the method for this preparation also can realize by the method for embodiment 2.

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Abstract

The invention relates to a formula and a process for preparing potassium citrate sustained-release tablets, belonging to the technical field of the medicine. The potassium citrate sustained-release tablets are prepared by mixing pore-forming agent, filler, lubricant and coloring agent which are pharmaceutically acceptable to stearic acid or stearic acid derivative, ethyl cellulose, polyacrylic acid resin and glyceryl monostearate which are used as insoluble framework materials according to a certain proportion. The potassium citrate sustained-release tablets have attractive appearance and can release stably in various release medium and even for 6 months in the acceleration test at 40 DEG C.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to a formula and preparation technology of potassium citrate slow-release tablets. Background technique [0002] The solubility of potassium citrate in water is 154g / 100mL, very soluble in water, almost insoluble in ethanol, and insoluble in organic solvents. Potassium citrate increases urinary potassium levels in addition to increasing urine pH and citrate. [0003] [0004] Potassium citrate, a potassium citrate, is clinically used in the treatment of renal tubular acidosis with symptoms such as calcium carbonate stones, calcium oxalate stones from any cause, and uric acid stones with or without calcium carbonate stones . At present, the domestic potassium citrate preparations for this disease are only granules. After the patient takes it, the potassium citrate will be released in the stomach quickly, which will greatly stimulate the gastrointestinal tract. However, if the hum...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/22A61K31/194A61K47/38A61K47/32A61K47/34A61K47/14A61K47/12A61P13/04A61P13/12A61K47/10
Inventor 张自强
Owner 南京泽恒医药技术开发有限公司
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