Supersaturated self-microemulsion as well as preparation method and application thereof

An emulsion preparation and a selected technology are applied in the field of supersaturated self-microemulsion preparations and their preparation, which can solve the problems of affecting clinical effect, low bioavailability, difficulty in indirubin and the like, and achieve simple preparation process, convenient administration and cost. low effect

Inactive Publication Date: 2011-11-02
SHANGHAI UNIV OF T C M
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] However, indirubin is insoluble in water, has low bioavailability for oral administration, poor absorption, and slow marked effect, which affects its clinical effect.

Method used

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  • Supersaturated self-microemulsion as well as preparation method and application thereof
  • Supersaturated self-microemulsion as well as preparation method and application thereof
  • Supersaturated self-microemulsion as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] prescription composition

[0035] Indirubin: 15mg

[0036] Glyceryl monolinoleate (Maisine 35-1): 7.46g

[0037] Polyoxyethylene castor oil (Cremophor EL): 19.9g

[0038] Monoethyl ether oxalate (Transcutol P): 22.38g

[0039] Polyvinylpyrrolidone K17 (PVP K17): 0.245g

[0040] Make 100 indirubin supersaturated self-microemulsion soft capsules.

[0041] Preparation process: Weigh the oil phase glycerol monolinoleate of the prescription amount, the surfactant polyoxyethylene castor oil and the co-surfactant monoethyl ether oxalate and mix evenly, add the prescription amount of indirubin and the prescription amount of PVPK17 , Stir at 10°C to 25°C for 30 minutes to 3 hours, until the drug is completely dissolved, and then made into soft capsules.

Embodiment 2

[0043] prescription composition

[0044] Indirubin: 25mg

[0045] Glyceryl monolinoleate (Maisine 35-1): 10g

[0046] Polyoxyethylene castor oil (Cremophor EL): 18.48g

[0047] Monoethyl ether oxalate (Transcutol P): 20g

[0048] Hydroxypropylmethylcellulose (HPMC): 1.5g

[0049] Make 100 indirubin supersaturated self-microemulsion capsules.

[0050] Preparation process: Weigh the oil phase glycerol monolinoleate of the prescription amount, the surfactant polyoxyethylene castor oil and the co-surfactant monoethyl ether oxalate and mix evenly, add the prescription amount of indirubin and the prescription amount of HPMC , Stir at 10°C to 25°C for 30 minutes to 3 hours, until the drug is completely dissolved, and then made into capsules.

Embodiment 3

[0052] prescription composition

[0053] Indirubin: 5mg

[0054] Glyceryl monolinoleate (Maisine 35-1): 5g

[0055] Polyoxyethylene castor oil (Cremophor EL): 22.5g

[0056] Monoethyl ether oxalate (Transcutol P): 21.995g

[0057] Polyethylene glycol 4000 (PEG4000): 0.5g

[0058] Made indirubin supersaturated self-microemulsion oral liquid.

[0059] Preparation process: Weigh the oil phase glycerol monolinoleate in the prescription amount, the surfactant polyoxyethylene castor oil and the co-surfactant monoethyl ether oxalate and mix evenly, add the prescription amount of indirubin and the prescription amount of PEG4000 , Stir at 10°C to 25°C for 30 minutes to 3 hours, until the drug is completely dissolved, and then made into an oral liquid.

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Abstract

The invention discloses a supersaturated self-microemulsion, comprising Indirubin, an oil phase, a surfactant, a cosurfactant and a supersaturation accelerant. The invention further discloses a preparation method for the supersaturated self-microemulsion and an application of the supersaturated self-microemulsion in the preparation for a medicine treating tumour. The supersaturated self-microemulsion of the invention remarkably increases the bioavailability of Indirubin and has an important significance to enhance the anti-tumour effect of Indirubin.

Description

technical field [0001] The invention relates to the technical field of medicine, in particular to a supersaturated self-microemulsion preparation and its preparation method and application. Background technique [0002] Self-microemulsion drug delivery system (SMEDDS) is a solid or liquid dosage form comprising an oil phase, a surfactant, and a co-surfactant, which is self-microemulsified into an oil-in-water (O / W) / W) type microemulsion with a particle size of less than 100nm, the microemulsion droplet has a large surface area, which increases the permeability of the drug in the epithelial cells of the gastrointestinal tract, thereby increasing the oral absorption and bioavailability of the drug, and enhancing the curative effect . [0003] However, when the conventional self-microemulsion drug delivery system is in contact with the gastrointestinal fluid, insoluble drugs tend to precipitate out after being released from the preparation, thereby reducing the dissolution an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/107A61K31/404A61K47/34A61K47/38A61P35/00A61K47/10A61K47/14A61K47/44
Inventor 冯年平陈志强赵继会刘颖
Owner SHANGHAI UNIV OF T C M
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