Ursodeoxycholic acid soft capsules and preparation method thereof

A technology for ursodeoxycholic acid and soft capsules, applied in the field of ursodeoxycholic acid soft capsules and their preparation, can solve the problems of one-sided evaluation standards, unresearched quality stability during shelf life, lack of product stability inspection, etc. Good stability, avoid decomposition and oxidation, high dissolution effect

Active Publication Date: 2018-11-23
安士制药(中山)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, this invention only compares the dissolution rate, and the release and absorption of the drug in the human body are closer to the dissolution curve of the drug, so the evaluation criteria for the comparative study are relatively one-sided; the invention lacks the stability of the product. The quality stability of its shelf life is yet to be studied

Method used

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  • Ursodeoxycholic acid soft capsules and preparation method thereof
  • Ursodeoxycholic acid soft capsules and preparation method thereof
  • Ursodeoxycholic acid soft capsules and preparation method thereof

Examples

Experimental program
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Embodiment 1

[0040] As an embodiment of the ursodeoxycholic acid soft capsules of the present invention, the ursodeoxycholic acid soft capsules described in this embodiment include soft capsule contents and soft capsule rubber, wherein the soft capsule contents include the following Components in percentage by weight: ursodeoxycholic acid 26.5%, soybean oil 67%, glyceryl monostearate 5% and poloxamer 1.5%; the soft capsule rubber includes the following components in percentage by weight: gelatin 60% , Glycerin 30%, Tartrazine 0.5%, Calcium Carbonate 1.0%, Methylparaben 0.5% and Water 8%.

[0041] The preparation method of the ursodeoxycholic acid soft capsule described in the present embodiment comprises the following steps:

[0042] (1) Chemical glue: Use a shear emulsification mixer to prepare an aqueous suspension of calcium carbonate; dissolve tartrazine in water to make a pigment solution; put water and glycerin into the chemical glue tank, stir, and heat to 60°C, add Methylparaben, ...

Embodiment 2

[0049] As an embodiment of the ursodeoxycholic acid soft capsules of the present invention, the ursodeoxycholic acid soft capsules described in this embodiment include soft capsule contents and soft capsule rubber, wherein the soft capsule contents include the following Components in percentage by weight: ursodeoxycholic acid 24%, peanut oil 70%, glyceryl distearate 4% and phospholipids 2%; the soft capsule rubber skin includes the following components in percentage by weight: gelatin 63.5%, sorbitol 25%, Talc 1.0%, Ethylparaben 0.5%, and Water 10%.

[0050] The preparation method of the ursodeoxycholic acid soft capsule described in the present embodiment comprises the following steps:

[0051] (1) Chemical glue: Use a shear emulsification mixer to prepare an aqueous suspension of talc powder; put water and sorbitol into the chemical glue tank, stir, and heat to 70°C, add ethyl paraben, stir until dissolved, add Gelatin, continue to stir and heat, vacuumize to make the vacuu...

Embodiment 3

[0058] As an embodiment of the ursodeoxycholic acid soft capsules of the present invention, the ursodeoxycholic acid soft capsules described in this embodiment include soft capsule contents and soft capsule rubber, wherein the soft capsule contents include the following Components in percentage by weight: ursodeoxycholic acid 25%, corn oil 46.8%, peanut oil 25%, glyceryl monostearate 3% and Tween 0.2%; the soft capsule rubber includes the following components in percentage by weight: Gelatin 67.8%, Propylene Glycol 25%, Iron Oxide Red 0.2%, Titanium Dioxide 0.5%, Propylparaben 0.5%, and Water 6%.

[0059] The preparation method of the ursodeoxycholic acid soft capsule described in the present embodiment comprises the following steps:

[0060] (1) Chemical glue: use a shear emulsification mixer to prepare the aqueous suspensions of titanium dioxide and iron oxide red respectively, and set aside; put water and glyceryl monostearate into the glue tank, stir, and heat to 75°C, add...

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Abstract

The invention provides ursodeoxycholic acid soft capsules and a preparation method thereof. Each ursodeoxycholic acid soft capsule provided by the invention comprises capsule contents and a soft capsule skin, wherein the capsule contents are prepared from the following components in percentage by weight: 10 to 40 percent of ursodeoxycholic acid, 45 to 84 percent of vegetable oil, 1 to 10 percent of a stabilizing agent and 0.1 to 5 percent of an emulsifier; the soft capsule skin is prepared from the following components in percentage by weight: 45 to 80 percent of gelatin, 10 to 40 percent of aplasticizer, 0 to 0.5 percent of a coloring agent, 0 to 2.0 percent of an additive, 0 to 1.0 percent of a bacterium-inhibition agent and 5 to 15 percent of water. According to the ursodeoxycholic acid soft capsules, the ursodeoxycholic acid is prepared into the soft capsules, so that the ursodeoxycholic acid is more easily dissolved out; meanwhile, the ursodeoxycholic acid soft capsules have goodisolation performance and decomposition and oxidization of effective components are avoided; the ursodeoxycholic acid soft capsules provided by the invention have the advantages of simple components,strong adaptability and good stability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to ursodeoxycholic acid soft capsules and a preparation method thereof. Background technique [0002] Ursodeoxycholic acid (UDCA) for short is the main component of bear bile. to isomers. Since it was discovered in the 1980s that ursodeoxycholic acid can effectively dissolve cholesterol gallstones, new studies have shown that ursodeoxycholic acid has a positive effect on gallbladder benefit and liver protection. In recent years, it has been reported abroad that UDCA not only has a good effect on the treatment of primary biliary cirrhosis, primary sclerosing cholangitis, and chronic active hepatitis, but also can be used to treat chronic hepatitis and rejection after liver transplantation. At present, ursodeoxycholic acid is mainly used in the treatment of various hepatobiliary and digestive tract diseases in clinical practice. With the continuous advancement o...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/44A61K31/575A61P1/16A61P1/04
CPCA61K9/4808A61K9/4825A61K9/4858A61K31/575A61P1/04A61P1/16
Inventor 桂茹艺代孔恩张丁酉李海燕梁倩婷
Owner 安士制药(中山)有限公司
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