Cyclosporine-containing soft capsule capsule shell composition and preparation method, and cyclosporine-containing soft capsule prepared therefrom

A technology of soft capsules and cyclosporine, which is applied in the directions of inactive components of polymer compounds, cyclic peptide components, and capsule delivery, etc., can solve the problems of unpleasant taste, easy deterioration, and affect the taste of oily components, and achieves the improvement of bioavailability. Effect

Inactive Publication Date: 2011-12-21
SHENZHEN SALUBRIS PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The prior art tries to solve this problem by changing the composition of the content, such as using oily components instead of ethanol or propylene glycol as the content, but the oily compon...

Method used

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  • Cyclosporine-containing soft capsule capsule shell composition and preparation method, and cyclosporine-containing soft capsule prepared therefrom
  • Cyclosporine-containing soft capsule capsule shell composition and preparation method, and cyclosporine-containing soft capsule prepared therefrom
  • Cyclosporine-containing soft capsule capsule shell composition and preparation method, and cyclosporine-containing soft capsule prepared therefrom

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] (1) Preparation of capsule-shell composition: Weigh 1.5kg of glycerin, 2.0kg of sorbitol, 2.2kg of propylene glycol, 12.0kg of purified water, 0.05kg of ethylparaben, and 0.02kg of talcum powder into a plastic tank, and stir evenly. When the temperature of the liquid in the tank reaches 50-60°C, add 13.0kg of gelatin and stir until it is completely dissolved. After evacuating the bubbles of the glue solution, filter it to make a glue solution, and keep it warm for later use.

[0031] (2) Preparation of the contents: Weigh 62.5g of cyclosporine, 70g of absolute ethanol, and 60g of propylene glycol, place them in the batching tank, stir and dissolve evenly, and add 252.5g of polyoxyethylene hydrogenated castor oil and 187.5 g, stirring evenly to make a content solution.

[0032] (3) Preparation of soft capsules: the above-prepared capsule-shell composition is made into rubber by a rolling mode soft capsule machine, and the content solution is wrapped into the rubber by a...

Embodiment 2

[0034] This example is the same as Example 1 except that the preparation of the capsule-shell composition is different.

[0035] Preparation of capsule-shell composition: Weigh 1.0 kg of glycerin, 2.0 kg of sorbitol, 2.0 kg of propylene glycol, 10.0 kg of purified water, 0.04 kg of ethylparaben, and 0.02 kg of talcum powder into a plastic tank, and stir evenly. When the temperature of the liquid in the tank reaches 50-60°C, add 12.0kg of gelatin and stir until it is completely dissolved. After evacuating the bubbles of the glue solution, filter it to make a glue solution, and keep it warm for later use.

Embodiment 3

[0037] This example is the same as Example 1 except that the preparation of the capsule-shell composition is different.

[0038] Preparation of capsule-shell composition: Weigh 2.0 kg of glycerin, 1.5 kg of sorbitol, 2.5 kg of propylene glycol, 12.0 kg of purified water, 0.05 kg of ethylparaben, and 0.02 kg of talcum powder into a plastic tank, and stir evenly. When the temperature of the liquid in the tank reaches 50-60°C, add 18.0kg of gelatin and stir until it is completely dissolved. After evacuating the bubbles of the glue solution, filter it to make a glue solution, and keep it warm for later use.

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Abstract

The invention relates to a technology of a soft capsule containing ciclosporin, in particular to a capsule shell composition suitably prepared into a soft capsule containing the ciclosporin as well as a preparation method thereof and the soft capsule containing the ciclosporin prepared thereby. Gelatin, glycerin, sorbierite, propanediol, water, hydroxyphenyl ethylester and talcum powder are addedin a glue digester and heated to be completely dissolved to obtain a capsule shell; and the capsule shell and a content solution are wrapped by a soft capsule machine to obtain the soft capsule. According to the capsule shell composition for the soft capsule containing the ciclosporin, which is disclosed by the invention, the contents of ethanol and the propanediol in the content of the soft capsule are ensured not to be greatly reduced in the storage process, the medicament dissolving of the ciclosporin can be ensured and the bioavailability of the ciclosporin is improved. Various raw materials provided for the capsule composition are common varieties and have low price, thus the capsule composition is suitable for large-scale industrial production.

Description

technical field [0001] The present invention relates to a kind of soft capsule preparation technology containing ciclosporin, more specifically, the present invention relates to a capsule shell composition suitable for being formulated into a soft capsule containing ciclosporin, a preparation method and a product made therefrom Soft capsules containing cyclosporine. Background technique [0002] Cyclosporin A is a cyclic polypeptide containing 11 amino acids produced by microorganisms. It has immunosuppressive effects and reversible and specific effects on lymphocytes. Animal experiments have shown that cyclosporine can prolong allogeneic organs (skin, heart, Kidney, pancreas, bone marrow, small intestine, and lung) transplant survival time, suppression of cell-mediated immune responses (including alloimmune responses, delayed skin anaphylaxis, experimental allergic encephalomyelitis, Freund's adjuvant arthritis, graft-versus-host reaction, and T-cell-dependent antibody pro...

Claims

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Application Information

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IPC IPC(8): A61K47/42A61K9/48A61K38/13A61P37/06
Inventor 谭岳尧王平
Owner SHENZHEN SALUBRIS PHARMA CO LTD
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