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Method for preparing solid dispersion

A solid dispersion and carrier technology, which can be applied to non-active ingredients medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve problems such as safety restrictions and applications, and achieve easy industrial production and good development prospects. , the effect of important practical significance

Inactive Publication Date: 2011-07-27
ZHEJIANG UNIV OF TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method of solvent removal can adopt methods such as vacuum evaporation, spray drying or freeze drying, but due to the use of organic solvents, the safety of its production and the residual amount of solvent limit the application of this method

Method used

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  • Method for preparing solid dispersion
  • Method for preparing solid dispersion
  • Method for preparing solid dispersion

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Weigh 20g of PEG6000, heat it in an oil bath, stir to melt it, and when the temperature reaches 120°C, add 2g of nitrendipine and stir to dissolve it, then pour the solution into the preheated spray device, the temperature at the nozzle is 110°C, compressed air The pressure is set to 0.3Mpa, and the powder is collected. Take an appropriate amount of powder, and measure the dissolution rate of the drug according to the second method of dissolution rate in the "Chinese Pharmacopoeia". The dissolution medium is 900 mL of an aqueous solution containing 0.3% sodium lauryl sulfate, and the rotation speed is 100 r min -1 , The sampling time is 3, 6, 10, 15, 25, 40, 60 minutes respectively.

[0021] In addition, prepare solid dispersion by melting method: take 18g of PEG6000, heat it in an oil bath, stir to melt it, and when the temperature reaches 120°C, add 3g of Nitrendipine and stir to dissolve it, and pour the solution into an aluminum box pre-cooled at -20°C Spread it fl...

Embodiment 2

[0024] Weigh 20g of PEG6000, heat it in an oil bath, stir to melt it, and when the temperature reaches 130°C, add 3.3g of nitrendipine and stir to dissolve, pour the solution into the preheated spray device, the temperature at the nozzle is 100°C, compress The air pressure is set to 0.3Mpa, and the powder is collected. Take an appropriate amount of powder, and measure the dissolution rate of the drug according to the second method of dissolution rate in the "Chinese Pharmacopoeia". The dissolution medium is 900mL aqueous solution containing 0.5% sodium lauryl sulfate, and the rotation speed is 100r min -1 , The sampling time is 5, 10, 20, 30, 45, 60 minutes respectively. As a result, the dissolution rate exceeded 70% at 30 minutes.

Embodiment 3

[0026] Weigh 20g of PEG6000, heat it in an oil bath, stir to melt it, and when the temperature reaches 130°C, add 0.33g Proxamer 188 and 3.3g Nitrendipine, stir to dissolve, pour the solution into the preheated spray device, The temperature at the nozzle is 100°C, the pressure of the compressed air is set to 0.1Mpa, and the powder is collected. Take an appropriate amount of powder, and measure the dissolution rate of the drug according to the second method of dissolution rate in the "Chinese Pharmacopoeia". The dissolution medium is 900mL aqueous solution containing 0.5% sodium lauryl sulfate, and the rotation speed is 100r min -1 , The sampling time is 5, 10, 20, 30, 45, 60 minutes respectively. As a result, the dissolution rate exceeded 80% at 30 minutes.

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Abstract

The invention provides a method for preparing solid dispersion. The method comprises the steps of: heating a carrier up till the carrier is fused; adding a medicament which is stirred to be dissolved completely; putting the obtained solution into a pre-heated spraying device to perform spraying and drying under the conditions of a spraying nozzle temperature of between 70 to 150 DEG C and a compression air pressure of between 0.05 and 0.3 MPa to prepare the solid dispersion. In the invention, a spraying condensation method is adopted to prepare solid dispersion powder, and the medicament and the carrier material are fused and sprayed into the cold air in a form of micro fog drops by a dual-channel spraying nozzle, so the medicament and the carrier are fast condensed and solidified in a few seconds to form the solid dispersion. The preparation method uses no organic solvent, is easy for industrial production, can obtain solid micro-powders with excellent performance, effectively solvesthe problem that it is difficult to crush the solid dispersion prepared by the low-melting point carrier and has a great practical significance and a good development prospect.

Description

(1) Technical field [0001] The invention relates to a preparation method of a solid dispersion. (2) Background technology [0002] Solid dispersion refers to the solid dispersion preparation made of drugs highly dispersed in suitable carrier materials in the state of molecules, colloids, microcrystals or amorphous substances. It was first proposed by Sekgushi et al. in 1961, which can significantly improve the solubility of insoluble drugs. Dissolution and stability, thereby improving the bioavailability of drugs and reducing the toxic and side effects of drugs, are of great significance in preparations. Because nearly 40% of the drugs are insoluble drugs, the solubility and dissolution rate in the gastrointestinal tract are very small, which makes the bioavailability after oral administration poor, which seriously limits the further development of the drug effect. Therefore, how to improve the bioavailability of poorly soluble drugs is one of the key points and hotspots of...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K31/435A61K31/4422A61K31/19A61K31/352A61K31/496A61K31/4164A61K47/34A61K47/10
Inventor 王文喜王融溶刘佳叶美玲
Owner ZHEJIANG UNIV OF TECH