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A kind of solid dispersion matrix and its preparation method and application

A solid dispersion and matrix technology, applied in the field of medicine, can solve the problems of poor water solubility and difficult absorption

Active Publication Date: 2022-07-08
ZHEJIANG UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Poor water solubility, easily soluble in methanol, ethanol, chloroform and other organic agents; difficult to absorb through the gastrointestinal tract

Method used

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  • A kind of solid dispersion matrix and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Solid dispersion based on eutectic system: Weigh 0.2g choline chloride, 1.8g proline and 2.0g oxalic acid, 6.0g PEG200, 1.0g poloxamer, accurately weigh 200mg tacrolimus APIs.

Embodiment 2

[0027] Solid dispersion based on eutectic system: Weigh 0.5g choline chloride, 2.5g proline and 1.5g oxalic acid, 5.5g PEG200, 1.0g oligosaccharide, accurately weigh 200mg tacrolimus API .

Embodiment 3

[0029] Solid dispersion based on eutectic system: Weigh 0.6g choline chloride, 3.4g proline and 1.8g oxalic acid, 4.2g PEG200, 1.0g poloxamer, accurately weigh 200mg tacrolimus APIs.

[0030] Contrast column 1

[0031] Solid dispersion based on eutectic system: Weigh 3.0g choline chloride and 2.0g oxalic acid, 6.0g PEG200, 1.0g poloxamer, and accurately weigh 200mg tacrolimus API.

[0032] Contrast column 2

[0033] Solid dispersion based on eutectic system: Weigh 3.0g proline and 1.5g oxalic acid, 5.5g PEG200, 1.0g poloxamer, and accurately weigh 200mg tacrolimus API.

[0034] Contrast column 3

[0035] Solid dispersion based on eutectic system: take 0.2 g of choline chloride, 1.8 g of proline and 8.0 g of oxalic acid, 1.0 g of poloxamer, and accurately weigh 200 mg of tacrolimus API.

[0036] Contrast column 4

[0037] Solid dispersion based on eutectic system: take 0.2 g of choline chloride, 1.8 g of proline and 8.0 g of PEG200, and accurately weigh 200 mg of tacrolimu...

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PUM

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Abstract

The invention relates to the technical field of medicine, in particular to a solid dispersion matrix, a preparation method and application thereof, wherein the dispersion matrix is ​​a eutectic system composed of hydrogen bond acceptors, hydrogen bond donors and excipients , the hydrogen bond acceptors are choline chloride and proline; the hydrogen bond donors are oxalic acid and PEG200; the excipients are poloxamers, oligosaccharides and their derivatives one or more. In the present invention, choline chloride and proline are used as hydrogen bond acceptors to form a eutectic system with hydrogen bond donors of oxalic acid and PEG200, so as to achieve the effect of dispersing drugs. Compared with other hydrogen bond receptors, choline chloride has a certain effect on plant growth. As a commonly used additive, its safety performance has been recognized as one of the components of plant proteins, and can widely exist in the plant body in a free state. middle.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a solid dispersion matrix and a preparation method and application thereof. Background technique [0002] Tacrolimus (Tacrolimus, FK-506) is a 23-ring macrolide antibiotic (erythromycin family) isolated from the fermentation product of a Streptomyces strain in the soil of Tsukuba, Japan in 1979. The molecular formula is C 44 H 69 NO 12 , the molecular weight is 803.48. It has poor water solubility and is easily soluble in methanol, ethanol, chloroform and other organic agents; it is not easily absorbed through the gastrointestinal tract. FK-506 is a potent immunosuppressant, mainly used for the treatment of rejection in the body before and after organ and tissue transplantation. It has a similar but broader immunosuppressive effect to cyclosporine A (CsA), and is 10-100 more potent than CsA. times, and less toxic side effects. And the price of oral capsules (1mg / capsule) o...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K47/18A61K47/12A61K47/10A61K31/436A61P37/06
CPCA61K9/1617A61K9/1641A61K31/436A61P37/06
Inventor 王纯洁翟晚娜张雪王培鑫金志敏
Owner ZHEJIANG UNIV OF TECH