Preparation method of docusate sodium controlled-release tablet

A technology for docusate sodium and controlled-release tablets, which is applied in the field of preparation of docusate sodium controlled-release tablets, can solve the problems of difficulty in pulverizing raw materials, easy agglomeration of raw materials, uneven mixing, etc. Easy-to-implement, low-cost effects

Inactive Publication Date: 2020-08-25
REYOUNG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to provide a preparation method of docusate sodium controlled-release tablets, which is scientific and reasonable in design, simple and easy to implement, solves the problems of difficult crushing of raw materials, uneven mixing, and easy caking of raw materials, and is suitable for large-scale production Production

Method used

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  • Preparation method of docusate sodium controlled-release tablet

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] The prescription composition of every 10,000 tablets of preparations is as follows: 2000 g of docusate sodium, 2300 g of microcrystalline cellulose PH101, 2300 g of hydroxypropyl methylcellulose K100M, 500 g of silicon dioxide, and 500 g of talcum powder.

[0023] Dissolve docusate sodium in 2.2kg of 90% ethanol as a wetting agent; add microcrystalline cellulose and hypromellose to the wet granulator, set the mixing knife speed to 75rpm, and the granulation knife speed 3000rpm, start the wet granulator, and mix for 3min; set the mixing knife speed to 140rpm, the granulation knife speed to 3000rpm, start the wet granulator, spray the wetting agent with a spray gun within 3min, and then stir for 2min; Granulate with a 20-mesh sieve; dry the wet granules with a fluidized granulation dryer. Set the air inlet temperature at 50°C, the outlet air temperature at 40°C, and dry for 30 minutes; use a 20-mesh sieve to sieve the granules; weigh the weight of the obtained dry granule...

Embodiment 2

[0025] The prescription composition of every 10000 tablets of preparation is as follows: 2000g of docusate sodium, 2700g of microcrystalline cellulose PH302, 2700g of hydroxypropyl methylcellulose K4M, 250g of silicon dioxide, and 250g of talcum powder.

[0026] Dissolve docusate sodium in 2.2kg of 90% ethanol as a wetting agent; add microcrystalline cellulose and hypromellose to the wet granulator, set the mixing knife speed to 70rpm, and the granulation knife speed 2800rpm, turn on the wet granulator, and mix for 6min; set the speed of the mixing knife to 130rpm, and the speed of the granulation knife to 2800rpm, turn on the wet granulator, and spray the wetting agent with a spray gun within 5min, and then stir for 2min; the obtained soft material is used Granulate with a 20-mesh sieve; dry the wet granules with a fluidized granulation dryer. Set the air inlet temperature to 50°C, the outlet air temperature to 40°C, and dry for 40 minutes; use a swing granulator to sieve the...

Embodiment 3

[0028] The prescription composition of every 10,000 tablets of preparations is as follows: 2000 g of docusate sodium, 2500 g of microcrystalline cellulose PH302, 2450 g of hydroxypropyl methylcellulose K4M, 300 g of silicon dioxide, and 300 g of talcum powder.

[0029] Dissolve docusate sodium in 2.2kg of 90% ethanol as a wetting agent; add microcrystalline cellulose and hypromellose to the wet granulator, set the mixing knife speed to 80rpm, and the granulation knife speed 3200rpm, turn on the wet granulator, and mix for 5min; set the speed of the mixing knife to 135rpm, and the speed of the granulation knife to 3200rpm, turn on the wet granulator, and spray the wetting agent with a spray gun within 5min, and then stir for 2min; the obtained soft material is used Granulate with a 20-mesh sieve; dry the wet granules with a fluidized granulation dryer. Set the air inlet temperature to 50°C, the outlet air temperature to 40°C, and dry for 35 minutes; use a swing granulator to si...

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Abstract

The invention relates to a preparation method of a docusate sodium controlled-release tablet, and belongs to the technical field of pharmaceutical preparations. The method comprises the following steps of (1) dissolving docusate sodium in ethanol; (2) adding microcrystalline cellulose and hydroxypropyl methylcellulose into a wet type granulator, setting the rotating speed of a mixing knife and therotating speed of a granulating knife, starting the wet type granulator, and performing mixing; (3) setting the rotating speed of the mixing knife and the rotating speed of the granulating knife, starting the wet type granulator, spraying a mixture obtained in the step (1) by using a spray gun, and then performing stirring; (4) granulating an obtained soft material by using a screen; (5) drying wet granules by using a boiling granulating dryer, and performing straightening granulation by using a screen of a swing straightening granulator; and (6) mixing and tabletting the obtained dry granules, silicon dioxide and talcum powder to obtain the docusate sodium controlled-release tablet. The method is scientific and reasonable in design, is simple and feasible, solves the problems of difficulty in raw material grinding, non-uniform mixing and easiness in raw material caking, and is suitable for large-scale production.

Description

technical field [0001] The invention relates to a preparation method of docusate sodium controlled-release tablets, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Docusate sodium is a surfactant. After oral administration, it promotes the infiltration of water and fatty substances into the feces in the intestinal tract, thereby softening the feces. Docusate sodium tablets are used for occasional constipation, taken orally, adults take 1 to 3 tablets a day, take a high dose before the first bowel movement, take a lower dose during the maintenance phase, and take effect after 1 to 3 days. Docusate sodium is approved for use in children abroad and is a safe and effective drug for treating constipation. [0003] At present, common tablets of docusate sodium are on the market, but there is no report on its controlled-release tablets. Because the raw material of docusate sodium is soft and easy to agglomerate, there are problems in ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/04A61K47/02A61K31/22A61P1/10
CPCA61K9/2004A61K9/2054A61K9/2095A61K31/22A61P1/10
Inventor 苗得足黄京山李伟邵伟宋尚龙王守坤
Owner REYOUNG PHARMA
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