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Nano-suspension of difficult-to-dissolve medicine as well as preparation method and application of nano-suspension

A technology for insoluble drugs and nanosuspensions, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve the problems of sedimentation, short storage time, and particle aggregation of nanosuspensions and other issues to achieve the effect of improving stability and extending storage time

Inactive Publication Date: 2019-03-08
FOURTH MILITARY MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] In order to overcome the defects of the prior art, the present invention provides nanosuspensions of insoluble drugs, which solves the problem that the existing nanosuspensions are prone to particle aggregation and sedimentation due to improper selection of stabilizers and single types. This in turn leads to the defect of short storage time

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] The nanosuspension of insoluble drug in this embodiment is composed of the following components: 10 parts of stabilizer, 40 parts of insoluble drug particles, and the rest is water;

[0031] Poorly soluble drugs include azithromycin, baicalin, sirolimus, valsartan, and resveratrol;

[0032] The stabilizer includes a nonionic stabilizer and an ionic stabilizer, and the stabilizer includes a nonionic stabilizer and an ionic stabilizer in a mass ratio of 2-5:1;

[0033] The mass ratio of described nonionic stabilizer and ionic stabilizer is 3:1;

[0034] Described nonionic stabilizer is made of polyethylene glycol 200, Tween 20 and Span 80, and the mass ratio of polyethylene glycol 200, Tween 40 and Span 80 is 1:1:1;

[0035] Described ionic stabilizer is made of sodium lauryl sulfate and cetyl trimethyl quaternary ammonium salt, and the mass ratio of sodium lauryl sulfate and cetyl trimethyl quaternary ammonium salt is 4:1 .

[0036] A preparation method corresponding ...

Embodiment 2

[0042] The invention provides a nanosuspension of insoluble drugs, which is composed of the following components: 15 parts of a stabilizer, 50 parts of insoluble drug particles, and the rest is water;

[0043] Poorly soluble drugs include azithromycin, baicalin, sirolimus, valsartan, and resveratrol;

[0044] Described stabilizing agent comprises nonionic stabilizing agent and ionic stabilizing agent, and the mass ratio of nonionic stabilizing agent and ionic stabilizing agent is 5:1;

[0045] The mass ratio of described stabilizing agent including non-ionic stabilizing agent and ionic stabilizing agent is 5:1;

[0046] Described nonionic stabilizer is made of polyethylene glycol 200, Tween 20 and Span 80, and the mass ratio of polyethylene glycol 200, Tween 40 and Span 80 is 3:1:1;

[0047] The ionic stabilizer is composed of sodium lauryl sulfate and cetyl trimethyl quaternary ammonium salt, and the mass ratio of sodium lauryl sulfate and cetyl trimethyl quaternary ammonium...

Embodiment 3

[0050] On the basis of Example 1, the concentration of the insoluble drug particles is 6-8%, preferably 8%, which cooperates with nonionic surfactants and ionic surfactants to further improve the concentration of drug particles in suspension. stability in liquid.

[0051] The preparation method of the nanosuspension of the poorly soluble drug in Example 3 is the same as that in Example 1.

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Abstract

The invention provides nano-suspension of a difficult-to-dissolve medicine as well as a preparation method and application of the nano-suspension. The nano-suspension is prepared from the following components: 10 to 15 parts of a stabilizer, 40 to 50 parts of difficult-to-dissolve medicine granules and the balance of water, wherein the stabilizer comprises a non-ionic stabilizer and an ionic stabilizer; the preparation method comprises the following steps: preparing raw materials according to the ratio; adding the stabilizer and the difficult-to-dissolve medicine granules into the water in sequence and stirring to obtain primary suspension; adding grinding beads and the primary suspension into a grinding pot in sequence and then putting the grinding pot into a grinding machine and grinding, so as to obtain the nano-suspension of the difficult-to-dissolve medicine. By adopting the nano-suspension of the difficult-to-dissolve medicine provided by the invention, the defects of existing nano-suspension that the stabilizer is not properly selected and the type is single, granule conglomeration and sedimentation of the nano-suspension are easy to occur so that the storage time is short are overcome; the nano-suspension of the difficult-to-dissolve medicine is used for preparing nano-suspension lyophilized powder and the nano-suspension is convenient to transport and preserve.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a nanosuspension of insoluble drugs, a preparation method and application thereof. Background technique [0002] It is estimated that about 40% of drugs have insoluble problems, and poor water solubility prevents potential drug compounds from being marketed or fully exerting their curative effect. Poorly soluble drugs have low solubility in the body, making it difficult to absorb the drug, resulting in low bioavailability of the drug. [0003] Nanosuspension technology is currently the cutting-edge technology to solve this problem. It improves the bioavailability of drugs by changing the saturation solubility and dissolution rate of drugs. [0004] As an intermediate suitable for insoluble drug preparations, nanosuspension is a submicron colloidal dispersion system with a particle size of <1 μm composed of a small amount of stabilizer, water an...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/10A61K47/10A61K47/26A61K47/20A61K47/18A61K31/7052A61K31/7048A61K31/41A61K31/05A61K31/436
CPCA61K9/10A61K9/19A61K31/05A61K31/41A61K31/436A61K31/7048A61K31/7052A61K47/10A61K47/186A61K47/20A61K47/26
Inventor 杨燕
Owner FOURTH MILITARY MEDICAL UNIVERSITY
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