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Docusate sodium pellet and preparation method thereof

A technology of docusate sodium pellets and docusate sodium, which is applied in the field of pharmaceutical preparations and can solve the problems of poor drug compliance, large volume, and bad taste

Inactive Publication Date: 2021-04-20
HUNAN WARRANT PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The invention provides a kind of docusate sodium pellets to solve the technical problem of poor drug compliance caused by the existing docusate sodium dosage forms due to their large volume and bad taste (such as smelly, bitter, astringent, etc.)

Method used

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  • Docusate sodium pellet and preparation method thereof
  • Docusate sodium pellet and preparation method thereof
  • Docusate sodium pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The taste-masked pellets of docusate sodium of the present embodiment comprise the raw materials of following weight:

[0059]

[0060] The preparation method of the docusate sodium pellets of the present embodiment may further comprise the steps:

[0061] (1) Preparation of drug-loaded pellet core:

[0062] Step (1) Slurry preparation: take the prescribed amount of polyethylene glycol 4000, add it to the ethanol aqueous solution with a volume concentration of 50%, stir to make it fully dissolve; then weigh the prescribed amount of docusate sodium, and add it to the above-mentioned solution, stir to make it fully dissolved, docusate sodium solution, for subsequent use;

[0063] The consumption of the aqueous ethanol solution is such that the cosolvent and the bulk drug docusate sodium are dissolved. Changing the amount of ethanol-water solution will not affect the formulation process, because eventually the ethanol-water solution will be removed during the drying p...

Embodiment 2

[0073] The taste-masked pellets of docusate sodium of the present embodiment comprise the raw materials of following weight:

[0074]

[0075]

[0076] The preparation method of the docusate sodium pellets of the present embodiment may further comprise the steps:

[0077] (1) Preparation of drug-loaded pellet core:

[0078] Step (1) slurry preparation: take the docusate sodium solution of the prescribed amount, add it to an aqueous ethanol solution with a volume concentration of 50%, stir to make it fully dissolve, and prepare the docusate sodium solution for subsequent use;

[0079] The consumption of ethanol aqueous solution, so that bulk drug docusate sodium dissolves and gets final product. Changing the amount of ethanol-water solution will not affect the formulation process, because eventually the ethanol-water solution will be removed during the drying process.

[0080] Step (2) Mixing: Take microcrystalline cellulose, lactose, croscarmellose sodium, and hypromel...

Embodiment 3

[0090] The taste-masked pellets of docusate sodium of the present embodiment comprise the raw materials of following weight:

[0091]

[0092]

[0093] The preparation method of the docusate sodium pellets of the present embodiment may further comprise the steps:

[0094] (1) Preparation of drug-loaded pellet core:

[0095] Step (1) slurry preparation: take the polyethylene glycol 4000 of prescription quantity, join in the ethanol aqueous solution of volume concentration 55%, stir to dissolve; Add the docusate sodium of prescription quantity again, stir to make it fully dissolve, more Sodium coulate solution, for subsequent use;

[0096] The consumption of the aqueous ethanol solution is such that the cosolvent and the bulk drug docusate sodium are dissolved. Changing the amount of ethanol-water solution will not affect the formulation process, because eventually the ethanol-water solution will be removed during the drying process.

[0097] Step (2) Mixing: Take micro...

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Abstract

The invention discloses a docusate sodium pellet and a preparation method thereof. The docusate sodium pellet sequentially comprises a drug-loaded pellet core, an isolation layer and a taste masking layer from inside to outside. The docusate sodium pellet is prepared from docusate sodium and pharmaceutically acceptable auxiliary materials, wherein a filler accounts for 60-95% of the weight of the drug-loaded pellet core; a disintegrating agent accounts for 3-8% of the weight of the drug-loaded pellet core; a cosolvent and an adhesive can be added as required; the coating weight of the isolation layer is increased by 4%-9%; and the weight of the taste masking layer coating is increased by 7-15%. Extrusion-rounding pellet preparation and fluidized bed coating technologies are adopted in the invention. The docusate sodium pellet disclosed by the invention is stable in quality and uniform in in-vitro dissolution; and the bitterness and astringency of docusate sodium can be effectively masked, and the medicine taking compliance is improved.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a docusate sodium pellet and a preparation method thereof. Background technique [0002] At present, there is a large population of children with constipation in my country, and there is a large demand for medicines. However, most medicines are not suitable for children due to insufficient dosage forms, specifications, taking compliance and adverse reactions, resulting in a serious shortage of medicines for treating children's constipation. As a commonly used drug for treating constipation, docusate sodium reduces the surface tension of the feces through physical surface activity, and promotes the immersion of water and fat into the feces, thereby achieving the effect of softening the feces. It has mild action, remarkable curative effect and few adverse reactions, and is suitable for being developed as a medicine for children. [0003] Because the docusate sodi...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/50A61K31/22A61K47/38A61K47/32A61P1/10
Inventor 庞永清龙辉周志刚吕俊兰曹晓瑞
Owner HUNAN WARRANT PHARMA
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