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Ursodeoxycholic acid capsule and preparation method thereof

A technology of ursodeoxycholic acid and capsules, which is applied in the field of ursodeoxycholic acid capsules and its preparation, can solve the problems of dissolution limitation and curative effect effect, and achieve the goal of lowering the price, simplifying the production process, and making the production process stable and controllable Effect

Active Publication Date: 2020-08-07
安士制药(中山)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Ursodeoxycholic acid is a poorly soluble drug, its dissolution rate will be limited when made into traditional tablets, and the curative effect will be affected

Method used

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  • Ursodeoxycholic acid capsule and preparation method thereof
  • Ursodeoxycholic acid capsule and preparation method thereof
  • Ursodeoxycholic acid capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0030] This example is an embodiment of the ursodeoxycholic acid capsule of the present invention, which is prepared from the following raw materials in parts by mass:

[0031]

[0032] The preparation method of the present embodiment ursodeoxycholic acid capsule comprises the following steps:

[0033] Part cornstarch is dissolved in part purified water under constant temperature condition in fixed time, obtains the starch slurry that mass concentration is 6%, wherein, described part cornstarch accounts for 11% of whole cornstarch quality, and described part purified water has been Preheat to a fixed temperature;

[0034] mixing ursodeoxycholic acid and the remaining cornstarch, placing them in a wet granulator, adding the remaining purified water, and then adding the starch slurry for granulation to obtain wet granules;

[0035] Pass the wet granules through a 5×5mm sieve, collect the sieved granules and dry them at 50-70°C until the water content is less than 2wt%, to ob...

Embodiment 2

[0038] This example is an embodiment of the ursodeoxycholic acid capsule of the present invention, which is prepared from the following raw materials in parts by mass:

[0039]

[0040] The preparation method of the present embodiment ursodeoxycholic acid capsule comprises the following steps:

[0041] Part cornstarch is dissolved in part purified water under constant temperature condition in fixed time, obtains the starch slurry that mass concentration is 8%, wherein, described part cornstarch accounts for 13.7% of whole cornstarch quality, and described part purified water has been Preheat to a fixed temperature;

[0042] mixing ursodeoxycholic acid and the remaining cornstarch, placing them in a wet granulator, adding the remaining purified water, and then adding the starch slurry for granulation to obtain wet granules;

[0043] Pass the wet granules through a sieve of 8×8mm, collect the sieved granules and dry them at 50-70°C until the water content is less than 2wt%, ...

Embodiment 3

[0046] This example is an embodiment of the ursodeoxycholic acid capsule of the present invention, which is prepared from the following raw materials in parts by mass:

[0047]

[0048] The preparation method of the present embodiment ursodeoxycholic acid capsule comprises the following steps:

[0049] Part cornstarch is dissolved in part purified water under constant temperature condition in fixed time, obtains the starch slurry that mass concentration is 10%, wherein, described part cornstarch accounts for 16% of whole cornstarch quality, and described part purified water has been Preheat to a fixed temperature;

[0050] mixing ursodeoxycholic acid and the remaining cornstarch, placing them in a wet granulator, adding the remaining purified water, and then adding the starch slurry for granulation to obtain wet granules;

[0051] Pass the wet granules through a 6×6mm sieve, collect the sieved granules and dry them at 50-70°C until the water content is less than 2wt%, to o...

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Abstract

The invention provides an ursodeoxycholic acid capsule and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations. When the ursodesoxycholic acid capsule is prepared, only conventional medicinal auxiliary materials including corn starch, colloidal silicon dioxide and magnesium stearate are adopted as auxiliary materials, only a common wet granulation process is adopted in the preparation process, and a solubilizer is not added in the preparation process, so that a stable dissolution effect can be achieved, and the production cost of the ursodesoxycholicacid capsule is greatly reduced.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and relates to a ursodeoxycholic acid capsule and a preparation method thereof. Background technique [0002] Ursodeoxycholic acid is used in medicine to increase bile acid secretion, change bile components, reduce cholesterol and cholesterol lipids in bile, and help the gradual dissolution of cholesterol in gallstones. Ursodeoxycholic acid is currently the only drug approved by the FDA (Food and Drug Administration) for various cholestatic liver diseases such as primary cholestatic cirrhosis and primary cholangitis. [0003] Ursodeoxycholic acid is a poorly soluble drug, and its dissolution rate will be limited when made into traditional tablets, and the curative effect will be affected. Compared with tablets, capsules are more conducive to the dissolution of drugs. Contents of the invention [0004] In order to overcome the above-mentioned shortcomings and deficiencies o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/36A61K47/12A61K47/04A61K31/575A61P1/16
CPCA61K9/4825A61K9/1652A61K9/1611A61K31/575A61P1/16
Inventor 杨立基代孔恩林纯李静杨燕梅邱科先
Owner 安士制药(中山)有限公司
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