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Ciclesonide nanometer freeze-dried powder and preparation method thereof

A technology of nano-freeze-dried powder and ciclesonide, which is used in freeze-dried transportation, powder transportation, pharmaceutical formulations, etc., can solve the problems of small particle size and polydispersity coefficient of nano-particle solution, poor stability, and difficulty in long-term storage. , to achieve the effect of improving stability, being conducive to absorption and preservation

Inactive Publication Date: 2013-05-01
台州百牛生物技术有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The nanoparticle solution prepared by this method has a small particle size and a small polydispersity index (PDI), and the product does not contain organic solvents, but the product exists in the state of a nanometer solution, which is difficult to preserve for a long time, and there will still be aggregation, precipitation, and unstable stability. good defect

Method used

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  • Ciclesonide nanometer freeze-dried powder and preparation method thereof
  • Ciclesonide nanometer freeze-dried powder and preparation method thereof
  • Ciclesonide nanometer freeze-dried powder and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Ciclesonide nano freeze-dried powder, the freeze-dried powder includes the weight of the following ingredients:

[0055] Ciclesonide: 10mg;

[0056] Lecithin: 53mg;

[0057] Glyceryl monostearate: 27mg;

[0058] Tween 40: 250mg;

[0059] Poloxamer 188: 40mg;

[0060] Lyoprotectant lactose: 10.2g;

[0061] Lyoprotectant mannitol: 15.0 g.

[0062] The ciclesonide nano freeze-dried powder of the present embodiment is obtained by the following preparation method:

[0063] Ciclesonide Nanoparticle Colloidal Solution:

[0064] Add 10mg of ciclesonide, 53mg of lecithin and 27mg of glyceryl monostearate into 15mL of ethyl acetate and dissolve to obtain an ethyl acetate solution, which can be accelerated by stirring or ultrasonic instrument;

[0065] Add 250mg of Tween 40 and 40mg of Poloxamer 188 into 300mL of water for injection and dissolve it with stirring or ultrasonic instrument to obtain the corresponding aqueous solution;

[0066] Add the ethyl acetate solution o...

Embodiment 2

[0069] Ciclesonide nano freeze-dried powder, the freeze-dried powder includes the weight of the following ingredients:

[0070] Ciclesonide: 10mg;

[0071] Lecithin: 53mg;

[0072] Glyceryl monostearate: 27mg;

[0073] Tween 40: 250mg;

[0074] Poloxamer 188: 40mg;

[0075] Lyoprotectant lactose: 3.0g;

[0076] Lyoprotectant mannitol: 3.0 g.

[0077] The ciclesonide nano freeze-dried powder of the present embodiment is obtained by the following preparation method:

[0078] The specific preparation method of the ciclesonide nanoparticle colloidal solution is consistent with the method in Example 1, and will not be repeated here.

[0079] Add 3.0g lactose and 3.0g mannitol to the ciclesonide nanoparticle colloidal solution prepared above, stir or ultrasonically dissolve, then use a 0.22 micron hydrophilic microporous membrane to filter, and use a hydrophilic microporous The porous filter membrane is used to better remove large particle impurities in the solution to improv...

Embodiment 3

[0081] Ciclesonide nano freeze-dried powder, the freeze-dried powder includes the weight of the following ingredients:

[0082] Ciclesonide: 10mg;

[0083] Lecithin: 53mg;

[0084] Glyceryl monostearate: 27mg;

[0085] Tween 40: 250mg;

[0086] Poloxamer 188: 40mg;

[0087] Lyoprotectant lactose: 21g;

[0088] Lyoprotectant mannitol: 18g.

[0089] The ciclesonide nano freeze-dried powder of the present embodiment is obtained by the following preparation method:

[0090] The specific preparation method of the ciclesonide nanoparticle colloidal solution is consistent with the method in Example 1, and will not be repeated here.

[0091]Add 21g of lactose and 18g of mannitol to the ciclesonide nanoparticle colloidal solution prepared above, stir or ultrasonically dissolve, then use a 0.22 micron hydrophilic microporous filter to filter. Membrane is in order to remove the big particle impurity in the solution better, to improve product quality, after filtration, obtain corre...

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Abstract

The invention relates to ciclesonide nanometer freeze-dried powder and a preparation method thereof and belongs to the technical field of medicinal preparation. The preparation method comprises the following steps: adding 2400-3900 weight parts of freeze-drying protecting agents into a ciclesonide nanometer grain colloidal solution, dissolving and filtering, and then pre-freezing and freeze-drying, thereby obtaining the ciclesonide freeze-dried powder, wherein the ciclesonide nanometer grain colloidal solution comprises 1 weight part of ciclesonide, 5.0-12 weight parts of carrier materials and 25-35 weight parts of hydrophilic surface active agents. The obtained ciclesonide nanometer freeze-dried powder is excellent in stability and solubility and high in safety and has the advantage of excellent appearance; after re-dissolving, the grain size of the solution is below 800nm and the medicine encapsulation efficiency is above 70%; and the technology provided by the invention has the advantages of simplicity and easiness in operation.

Description

technical field [0001] The invention relates to a ciclesonide preparation, in particular to a ciclesonide nano freeze-dried powder and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Ciclesonide, known in English as Ciclesonide (CIC), was first approved in Australia in 2004. The drug was developed by Sanofi-Aventis and Altana Pharmaceuticals in Germany. It is inactive and enters the lungs and is transformed into desisobutyryl ciclesonide with significant anti-inflammatory activity. It is used to treat adult and 4-year-old patients. Different degrees of asthma in children over the age of 10 and adolescents. The structural formula of ciclesonide is as follows: [0003] [0004] Ciclesonide is a new type of inhaled steroidal glucocorticoid that can be localized and activated. It has quick effect, good curative effect and high local anti-inflammatory properties. But, because ciclesonide is a kind ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/58A61K47/34A61P11/06
Inventor 石雷刘永丽潘佩瑶任张慧邹政何
Owner 台州百牛生物技术有限公司
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