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Solid dispersion composition of levocarnitine as well as preparation method and medical application of solid dispersion composition

A technology of solid dispersion and composition, which is applied in the directions of non-active ingredients of polymer compounds, drug delivery, medical preparations containing active ingredients, etc. Problems such as preparation, storage, and adverse effects of circulation

Inactive Publication Date: 2015-07-01
FUZHOU QIANZHENG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] However, the disadvantage is that levocarnitine and its salts are easy to absorb moisture, which has a serious adverse effect on the preparation, storage, and circulation of its preparations, especially for the production, processing, and storage of granules and powder products.

Method used

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  • Solid dispersion composition of levocarnitine as well as preparation method and medical application of solid dispersion composition
  • Solid dispersion composition of levocarnitine as well as preparation method and medical application of solid dispersion composition
  • Solid dispersion composition of levocarnitine as well as preparation method and medical application of solid dispersion composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0065] Embodiment 1, the granule of the solid dispersion of levocarnitine or its tartrate and sugar alcohol substance and preparation thereof

[0066] The prescription quantity is calculated by weight percentage and contains:

[0067] Levocarnitine or its tartrate 2% to 10%, preferably 3% of levocarnitine tartrate,

[0068] Polydextrose 25%~55%, preferably 38%,

[0069] Fructose or xylitol 45% to 65%, preferably 59% fructose;

[0070] Its preparation method includes: passing polydextrose, fructose or xylitol through 80 mesh sieves, preferably 100 meshes, weighing according to the prescription amount, mixing evenly, and dissolving levocarnitine or its tartrate in 75% ethanol Solution, the solution is evenly sprayed in the mixture of polydextrose and fructose or xylitol to make a soft material, wet granulated, dried at 45-70°C, granulated, bagged, sealed, and ready to be obtained;

[0071] Alternatively, the preparation method includes: taking levocarnitine or its tartrate, p...

Embodiment 2

[0077] Embodiment 2, the granule of the solid dispersion of levocarnitine or its tartrate and sugar alcohol substance and its preparation

[0078] The prescription quantity is calculated by weight percentage and contains:

[0079] Levocarnitine or its tartrate 2% to 10%, preferably 5% of levocarnitine tartrate,

[0080] fructooligosaccharide 25%~55%, preferably 30%,

[0081] Resistant dextrin 50% to 75%, preferably 65%;

[0082] Its preparation method includes: passing the fructooligosaccharide and resistant dextrin through 80-mesh sieve, preferably 100-mesh sieve, weighing according to the prescription amount, mixing evenly, and dissolving levocarnitine or its tartrate in 75% ethanol Solution, the solution is evenly sprayed in the mixture of fructooligosaccharide and resistant dextrin to make a soft material, wet granulated, dried at 45-70°C, granulated, bagged, sealed, and obtained;

[0083] Alternatively, the preparation method comprises: taking levocarnitine or its tart...

Embodiment 3

[0089] Embodiment 3, the granule of the solid dispersion of levocarnitine or its tartrate and sugar alcohol substance and its preparation

[0090] The prescription quantity is calculated by weight percentage and contains:

[0091] Levocarnitine or its tartrate 5% to 15%, preferably 10% of levocarnitine tartrate,

[0092] Mannose oligosaccharide 5%~10%, preferably 7.5%,

[0093] Sorbitol 50%~75%, preferably 65%;

[0094] The preparation method comprises: passing oligomannose and sorbitol through 80-mesh sieve, preferably 100-mesh sieve, weighing according to the prescription amount, mixing evenly, and dissolving levocarnitine or its tartrate in 75% ethanol Solution, the solution is uniformly sprayed in the mixture of mannose oligosaccharide and sorbitol to make a soft material, wet granulated, dried at 45-70°C, sized, bagged, sealed, and ready to be obtained;

[0095] Alternatively, the preparation method comprises: taking levocarnitine or its tartrate, mannose oligosacchari...

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Abstract

The invention provides a solid dispersion composition of levocarnitine and a preparation method of the solid dispersion composition. Sugar alcohol substances include one or more of fructose, xylitol, polydextrose, fructo-oligose, mannitol, cane sugar, glucose, resistant dextrin, sorbitol, maltose, isomaltulose alcohol, manoligosaccharides, dextrin, cyclodextrin, hydroxypropyl-beta-cyclodextrin, microcrystalline cellulose, carboxymethylcellulose, hydroxypropyl methylcellulose, pre-gelled starch, starch, starch sugar, lactose, sodium carboxymethyl starch, protein sugar, sucralose, aspartame, acesulfame potassium, stachyose, Neotame and stevioside; the sugar alcohol substances are combined with the levocarnitine in a weight ratio of (13-50):1; the levocarnitine further comprises levocarnitine tartrate or levocarnitine hydrochloride. The solid dispersion composition has excellent moisture absorption resisting quality stability and is significant for the improvement of the product quality.

Description

technical field [0001] The invention relates to a health product composition, its preparation method and application, in particular to a solid dispersion composition of levocarnitine, its preparation method and application. The health product composition of the present invention includes but not limited to medicine, nutritional health product, medical food, health food or functional food, general food and so on. Background technique [0002] L-carnitine, also known as L-carnitine, is an essential natural substance in the energy metabolism of mammals and humans, and its main function is to promote lipid metabolism. During ischemia and hypoxia, fatty acyl-CoA accumulates, long-chain fatty acyl-carnitine in mitochondria also accumulates, and free carnitine decreases due to massive consumption. Ischemia and hypoxia lead to a decrease in ATP levels, an increase in the permeability of cell membranes and subcellular membranes, and the accumulation of fatty acyl-CoA can cause chang...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K9/00A61K31/205A61K47/10A61K47/26A61K47/36A61K47/38A61K47/40
Inventor 张耿元王保红唐湘成
Owner FUZHOU QIANZHENG PHARMA
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