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Cross-linked food protein stabilized nanometer medicament delivery system capable of being solidified directly

A drug delivery system and solidification technology, which is applied in the direction of non-active components of polymer compounds, freeze-dried delivery, powder delivery, etc., can solve the problems of low drug loading, such as high toxicity, poor stability, etc., to promote absorption and safety Sexual ideals, overcoming toxic effects

Inactive Publication Date: 2013-10-23
FUDAN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In the present invention, food protein is used to construct cross-linked O / W novel DDS, and at the same time, it is directly "solidified" by freeze-drying and fluidized bed layering technology, ("solidified" nanoparticles can be redispersed well In water, while the particle size remains unchanged) to promote the absorption of poorly soluble drugs, while overcoming the shortcomings of traditional DDS such as high toxicity, low drug loading and poor stability

Method used

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  • Cross-linked food protein stabilized nanometer medicament delivery system capable of being solidified directly
  • Cross-linked food protein stabilized nanometer medicament delivery system capable of being solidified directly
  • Cross-linked food protein stabilized nanometer medicament delivery system capable of being solidified directly

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Take: Soy Protein Isolate 300mg

[0035] Labrafil M1944CS or Labrafil M2125CS or hydrogenated corn oil 1600mg

[0036] Calcium chloride solution (4M) 100μl

[0037] Drug Fenofibrate 150mg

[0038] Prepared by the following steps:

[0039] (1) Protein denaturation: Disperse the prescribed amount of protein in 30ml of water, stir for about 1 hour, and heat at 50-110°C for 30-60min;

[0040] (2) Water phase: Add the prescribed amount of water into (1), and stir evenly;

[0041](3) Oil phase: add the drug fenofibrate into the oil, dissolve the drug by ultrasonication, add a cross-linking agent and mix well;

[0042] (4) After adding (3) to (2), stir at 10000-30000rpm for 1-2min, and homogenize at 400-800bar for 5-10 times under high pressure to obtain a cross-linked nanoparticle suspension.

[0043] (5) Solidification of nanosuspension: pre-freeze the product obtained in (4) at -80°C for 1-3h, then freeze-dry at -20-0°C for 48 hours; or add the above-mentioned suspensi...

Embodiment 2

[0046] Take: Whey Protein Isolate 300mg

[0047] Labrafil M1944CS or Labrafil M2125CS or hydrogenated corn oil 1600mg

[0048] Calcium chloride solution (4M) 100μl

[0049] Drug Fenofibrate 150mg

[0050] Prepared by the following steps:

[0051] (1) Protein denaturation: Disperse the prescribed amount of protein in 30ml of water, stir for about 1 hour, and heat at 50-110°C for 30-60min;

[0052] (2) Water phase: Add the prescribed amount of water into (1), and stir evenly;

[0053] (3) Oil phase: add the drug fenofibrate into the oil, dissolve the drug by ultrasonication, add a cross-linking agent and mix well;

[0054] (4) After adding (3) into (2), stir at 10000-30000rpm for 1-2min, and homogenize at 400-800bar high pressure for 5-10 times to obtain a cross-linked nanoparticle suspension,

[0055] (5) Solidification of nanosuspension: pre-freeze the product obtained in (4) at -80°C for 1-3h, then freeze-dry at -20-0°C for 48 hours; or add the above-mentioned suspension...

Embodiment 3

[0058] Take: beta-lactoglobulin 300mg

[0059] Labrafil M1944CS or Labrafil M2125CS or hydrogenated corn oil 1600mg

[0060] Calcium chloride solution (4M) 100μl

[0061] Drug Fenofibrate 150mg

[0062] According to the preparation method of Example 1 or 2, a cross-linked food protein stabilized nano drug delivery system that can be directly "solidified" was prepared.

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Abstract

The invention belongs to the technical field of medicament preparations and relates to a cross-linked food protein stabilized nanometer medicament delivery system capable of being 'solidified' directly. The medicament delivery system is prepared from food protein, an oil phase, a cross-linking agent and water by adopting the steps of modifying the protein, adding the oil phase containing the cross-linking agent, dispersing at high speed, homogenizing at high pressure, and 'solidifying' the product by a nanometer suspension. The medicament delivery system is used for promoting oral absorption of indissolvable medicaments, can obviously reduce the toxicity of the medicaments to human body, and can obviously improve the nanometer particle production efficiency and prevent aggregation problem in crosslinking by adding the cross-linking agent into the internal oil phase to cause crosslinking. The prepared nanometer suspension can be directly freeze-dried or laminated on the surface of a small pellet by a fluidized bed and then transformed into a solid preparation; re-solidified nanometer particles are easy to be re-dispersed in water, and the particle size is kept unchanged. According to the medicament delivery system, the stability is improved for a long time, and the compliance of patients is improved; and the preparation process is simple and easy for industrialization.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations and relates to a cross-linking-food protein stabilized nano drug delivery system. , especially relates to a cross-linked food protein stabilized nano drug delivery system that can be directly "solidified" and a preparation method thereof. The drug delivery system is mainly used to promote the oral absorption of poorly soluble drugs. Background technique [0002] In clinical treatment, oral administration is most easily accepted by patients and is the preferred route of administration for the development of pharmaceutical preparations. However, the drug itself must have sufficient solubility and membrane permeability in order to obtain high bioavailability and clinical efficacy. According to incomplete statistics, about 50% of the existing drugs have solubility problems. Studies have shown that about 40% of the compounds obtained by modern drug screening techniques were elimin...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/19A61K9/14A61K47/42
Inventor 吴伟何伟卢懿戚建平
Owner FUDAN UNIV
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