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A kind of 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: 2022-06-14
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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  • A kind of ursodeoxycholic acid capsule and preparation method thereof
  • A kind of ursodeoxycholic acid capsule and preparation method thereof
  • A kind of ursodeoxycholic acid capsule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment approach

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

[0031]

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

[0033] Part of the corn starch was dissolved in partially purified water at a constant temperature for a fixed time to obtain a starch slurry with a mass concentration of 6%, wherein the part of the corn starch accounted for 11% of the mass of the total corn starch, and the partially purified water had Preheat to a fixed temperature;

[0034] Mixing ursodeoxycholic acid and remaining corn starch, placing them in a wet granulator, adding 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 to a moisture content of less than 2wt% at 50-...

Embodiment 2

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

[0039]

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

[0041] Part of the corn starch was dissolved in partially purified water at a constant temperature for a fixed period of time to obtain a starch slurry with a mass concentration of 8%, wherein the part of the corn starch accounted for 13.7% of the total mass of the corn starch, and the partially purified water had Preheat to a fixed temperature;

[0042] Mixing ursodeoxycholic acid and remaining corn starch, placing them in a wet granulator, adding 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 to a moisture conten...

Embodiment 3

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

[0047]

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

[0049] Part of the corn starch was dissolved in partially purified water at a constant temperature for a fixed time to obtain a starch slurry with a mass concentration of 10%, wherein the part of the corn starch accounted for 16% of the mass of the total corn starch, and the partially purified water had Preheat to a fixed temperature;

[0050] Mixing ursodeoxycholic acid and remaining corn starch, placing them in a wet granulator, adding 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 to a moisture content of less than...

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Abstract

The invention provides a ursodeoxycholic acid capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. When the present invention prepares ursodeoxycholic acid capsules, the auxiliary materials only adopt conventional pharmaceutical auxiliary materials cornstarch, colloidal silicon dioxide and magnesium stearate, and the preparation process only adopts a common wet granulation process and does not add a solubilizer during the preparation process. That is, a robust dissolution effect can be achieved, and the production cost of the ursodeoxycholic acid 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 the secretion of bile acids, change the composition of bile, reduce cholesterol and cholesterol lipids in bile, and help to gradually dissolve 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 it is made into a traditional tablet, and its efficacy will be affected. Capsules are more favorable for drug dissolution than tablets. SUMMARY OF THE INVENTION [0004] In order to overcome the above-mentioned shortcomings and deficiencies of the p...

Claims

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Application Information

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Patent Type & Authority Patents(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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