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Cyclosporin A semisolid skeleton capsule and its preparation method

A cyclosporin and semi-solid technology, which is applied in the field of medicine, can solve problems such as increasing costs, increasing process steps, and accelerating the cross-linking and curing reaction of capsule shell gelatin, and achieves the effect of stable properties and simple preparation methods

Inactive Publication Date: 2007-07-18
SHENYANG PHARMA UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, during the storage of soft capsule preparations, liquid alcohol solvents volatilize through the capsule shell, which accelerates the cross-linking and curing reaction of gelatin in the capsule shell and makes the disintegration time limit unqualified.
Hard capsule preparations have the problem of sealing between the capsule body and the cap, increasing process steps and increasing costs

Method used

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  • Cyclosporin A semisolid skeleton capsule and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Mix 1 g of cyclosporine, 3 g of polyoxyethylene castor oil diglyceride, 2 g of ethyl oleate, and 4 g of poloxamer, stir evenly, heat and dissolve, and make 100 capsules with a capsule liquid filling machine, and the content of cyclosporine is 0.100g / grain.

Embodiment 2

[0025] Mix cyclosporine 1g, polyoxyethylene castor oil, polyoxyethylene 6 sorbitan monoglyceride 6g, maisine 3g, polyethylene glycol-4000 6g, stir evenly, heat to dissolve, and make it with a capsule liquid filling machine 100 capsules, the content of cyclosporine is 0.100g per capsule.

Embodiment 3

[0027] Mix 1 g of cyclosporine, 2 g of polyoxyethylene castor oil and Tween-80 mixture (1:1, weight ratio), 2 g of soybean oil, and 5 g of polyethylene glycol, stir evenly, heat to dissolve, and use a capsule liquid filling mechanism Into 100 capsules, the cyclosporine content is 0.100g / capsule.

[0028] In the above-mentioned embodiment, cyclosporin A, oil phase, surfactant with HLB>12 and co-emulsifier are added according to the aforementioned ratio, and the rest is a semi-solid skeleton carrier.

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Abstract

A capsule of cyclosporin A and semi-solid skeleton is proportionally prepared from cyclosporin A, oil phase, emulsifier, emulsifying aid, and semi-solid carrier through fusing them except cyclosporin A in water bath at 60 deg.C, stirring, adding cyclosporin A, stirring for full dissolving, cooling and loading it in capsules.

Description

Technical field: [0001] The invention belongs to the technical field of medicine, and relates to a composition of cyclosporine A semi-solid matrix preparations, specifically cyclosporine A self-emulsifying / self-micro-emulsifying semi-solid matrix capsules and a preparation method thereof. . Background technique: [0002] Cyclosporine A, whose English name is Cyclosporine A, has the following structural formula: [0003] [0004] Cyclosporin A (cyc-A) is a fat-soluble cyclic undecapeptide compound produced by the fungus Tolypocladium inflatum. It can act selectively on the initial stage of T lymphocyte activation. Cyclosporine inhibits the production of the proliferation factor interleukin 2, which is activated by helper T cells; it has no effect on suppressor T cells. Another important role of it is to inhibit the production of interferon by lymphocytes. It has no effect on phagocytes of the reticuloendothelial system. Therefore, cyclosporine is different from the ac...

Claims

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Application Information

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IPC IPC(8): A61K38/13A61K9/48A61K47/44A61P37/06A61P37/02A61P29/00A61P27/02A61P21/04A61P19/02A61P19/04A61P17/06A61P13/12A61P7/00A61P3/10A61P1/00
Inventor 王东凯王丽君
Owner SHENYANG PHARMA UNIVERSITY
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