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Medicinal transparent nano dispersant and preparation method thereof

A nano-dispersion and drug technology, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of transparent nano-dispersions without drugs, etc., and achieve excellent dissolution effects , easy transportation and storage, good stability effect

Active Publication Date: 2011-09-21
BEIJING UNIV OF CHEM TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

So far, there have been no reports of drug-transparent nanodispersions

Method used

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  • Medicinal transparent nano dispersant and preparation method thereof
  • Medicinal transparent nano dispersant and preparation method thereof
  • Medicinal transparent nano dispersant and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] A: Weigh 1g of silybin crude drug and dissolve it in 100mL ethanol;

[0037] B: Weigh 4g polyacrylamide, 1g hydroxypropyl methylcellulose and 0.01g sodium dodecylbenzene sulfonate and dissolve it in 4000mL water, put the beaker with the aqueous solution in an ice water bath, and control the temperature of the aqueous solution at about 3℃ ;

[0038] C: Under stirring conditions of 2000 rpm, pour the bulk drug solution prepared in step A into the aqueous solution in step B to obtain silybin nano-slurry;

[0039] D: Control the spray dryer (SD-Basic, Labplant, UK) with an inlet temperature of 100°C, an outlet temperature of 60°C, a feed rate of 5 mL / min, and a compressed air pressure of 0.6 MPa, and the silybin nano slurry Spray drying to obtain silybin drug compound powder.

[0040] E: Take 110 mg of the composite powder and add it to 1000 mL of water to form a transparent nano-dispersion, in which the drug concentration is 0.1 mg / mL and the average particle size is 75.1 nm.

Embodiment 2

[0042] A: Weigh 1g of silybin crude drug and dissolve it in 20mL ethanol;

[0043] B: Weigh 3.9g polyvinylpyrrolidone and 0.1g sodium dodecylbenzene sulfonate and dissolve in 100mL water, put the aqueous solution in a constant temperature water bath, and control the temperature of the aqueous solution at about 30°C;

[0044] C: Under stirring conditions of 1500 rpm, pour the bulk drug solution prepared in step A into the aqueous solution of step B to obtain silibinin nano-slurry;

[0045] D: Control the spray dryer (SD-Basic, Labplant, UK) with an inlet temperature of 160°C, an outlet temperature of 90°C, a feed rate of 40mL / min, and a compressed air pressure of 0.8MPa. The silibinin nano slurry Spray drying to obtain silybin drug compound powder.

[0046] E: Take 500 mg of the composite powder and add it to 10 mL of water to form a transparent nano-dispersion, in which the drug concentration is 10 mg / mL and the average particle size is 49.3 nm.

Embodiment 3

[0048] A: Weigh 1g of silibinin raw material and dissolve it in 50mL of acetone. The scanning electron micrograph of silibinin raw material particles is shown figure 1 , The particle morphology is uneven, and the particle size is very uneven, ranging from 2μm to 40μm;

[0049] B: Weigh 4.95g of polyvinylpyrrolidone and 0.05g of sodium lauryl sulfate and dissolve in 500mL of water, put the aqueous solution in a constant temperature water bath, and control the temperature of the aqueous solution at about 30°C;

[0050] C: Under the stirring condition of 1000rpm, pour the raw material solution prepared in step A into the aqueous solution of step B to obtain the silibinin nano-slurry. The scanning electron microscope image of the particles in the silibinin nano-slurry is shown figure 2 , The particle morphology is uniform spherical, the particle size is relatively uniform, and the average particle size is 24.3nm;

[0051] D: Control spray dryer (SD-Basic, Labplant, UK) inlet temperature ...

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Abstract

The invention relates to a medicinal transparent nano dispersant and a preparation method thereof. Water-insoluble medicinal nano particles are used as active ingredients, water is used as a dispersion medium, medicinal accessories are used as a colloidal dispersion system of a stabilizing agent, the concentration of the medicament is 0.1 to 10mg / mL, the mass ratio of the stabilizing agent to the medicament is (10-500): 100, and the average particle diameter of the medicinal particles is 20 to 90 nanometers. The method comprises the following steps of: dissolving the medicament into an organic solvent mutually soluble with water, adding the medicament solution into aqueous solution containing water-soluble medicinal accessories to obtain nano medicinal paste, performing spray drying on suspension, and adding the obtained nano and micro structure composite powder into the water to obtain the medicinal transparent nano dispersant. The method provided by the invention is simple in operation and low in cost, and has good industrialized production prospect; and the provided medicinal transparent nano dispersant has the advantages of good stability, high dissolution speed, high bioavailability and the like, and can be used for preparing soft capsules, injection and suspension.

Description

Technical field [0001] The invention relates to a transparent nano dispersion of a poorly water-soluble medicine and a preparation method thereof, and belongs to the field of medicine preparation. Background technique [0002] According to statistics, at least 40% of the drugs currently have poor water solubility. Such drugs are often difficult to achieve the required bioavailability after oral administration, or are difficult to prepare for intravenous administration, which greatly limits the application of drugs . Improving the solubility and bioavailability of poorly soluble drugs has always been a hot spot in pharmaceutical research. Although the solubility of the drug can be improved by making liposomes, solid dispersions, cyclodextrin inclusion compounds, etc., all of them have problems such as low drug loading, complex preparation processes and poor stability. [0003] Studies have shown that for poorly water-soluble drugs, the dissolution process is a key factor restricti...

Claims

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Application Information

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IPC IPC(8): A61K9/10A61K45/00A61K31/357A61K31/4184A61K31/496A61K47/38A61K47/36A61K47/34A61K47/32A61K47/10
Inventor 陈建峰张智亮张志兵王洁欣乐园
Owner BEIJING UNIV OF CHEM TECH
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