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Preparing method of salmeterol and fluticasone super fine particles

An ultra-fine particle, fluticasone propionate technology, which is applied in the fields of chemical production and chemical pharmaceutical preparation production, can solve the problems of large particle size, bulkiness and uniformity of dry powder, and achieves good uniformity and fine particle size. , allocate reasonable effects

Inactive Publication Date: 2017-03-08
ZHANGJIAGANG HUACHANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, the preparation method of salmeterol-ticasone dry powder usually adopts ball milling or jet milling process. The particle size of the dry powder prepared by this process is larger. For compound preparations, the bulkiness and uniformity are also difficult to achieve.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Weigh 125g of salmeterol, add 1750ml of ethanol to dissolve; add 250g of fluticasone propionate, 12g of acesulfame potassium, add 1750ml of deionized water to dissolve. Then mix the two solutions evenly to make a mixed solution. The temperature of the hot air outlet of the spray dryer is controlled at 160 degrees, the temperature of the air outlet is controlled at 60 degrees, the speed of the centrifugal spray head is 16,000 rpm, and the speed of the peristaltic pump is 2.5 liters / hour. After the spray dryer runs for 4.5 hours, 312 g of salmeterolica is obtained Loose dry powder.

Embodiment 2

[0022] Weigh 50g of salmeterol, add 1500ml of ethanol to dissolve; add 250g of fluticasone propionate, 10g of acesulfame potassium, add 1500ml of deionized water to dissolve. Then mix the two solutions evenly to make a mixed solution. The temperature of the hot air outlet of the spray dryer is controlled at 165 degrees, the temperature of the air outlet is controlled at 70 degrees, the speed of the centrifugal spray head is 18,000 rpm, and the speed of the peristaltic pump is 2.0 liters / hour. After the spray dryer runs for 4.5 hours, 268 g of salmeterolica is obtained Loose dry powder.

Embodiment 3

[0024] Weigh 35g of salmeterol, add 1500ml of ethanol to dissolve; add 350g of fluticasone propionate, 12g of acesulfame potassium, add 2000ml of deionized water to dissolve. Then mix the two solutions evenly to make a mixed solution. The temperature of the hot air outlet of the spray dryer is controlled at 170 degrees, the temperature of the air outlet is controlled at 75 degrees, the speed of the centrifugal spray head is 18,000 rpm, and the speed of the peristaltic pump is 2.5 liters / hour. After the spray dryer runs for 4.5 hours, 356 g of salmeterolica is obtained Loose dry powder.

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PUM

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Abstract

The invention relates to a preparing method of salmeterol and fluticasone super fine particles. The preparing method comprises the steps of dissolving the raw materials for preparing the super fine particles into a solvent to prepare a solution, and then adding the solution into a spray dryer to be subjected to spray drying, so that the salmeterol and fluticasone super fine particles are prepared, wherein the raw materials comprise salmeterol, fluticasone propionate and auxiliaries, the volume added quantity of the solution is 10%-30% of the total capacity of the spray dryer, and the mass concentration of the solution is 5%-10%. According to the preparing method of the salmeterol and fluticasone super fine particles, the salmeterol and fluticasone dry particles are finer, uniformity is better, and distribution of the two medicines is more reasonable.

Description

technical field [0001] The invention relates to the technical field of chemical production and the production of chemical pharmaceutical preparations, in particular to a preparation method of salmeterol-ticasone dry powder superfine particles. Background technique [0002] Salmeterol is a new type of selective long-acting β2-receptor agonist asthma drug. Fluticasone propionate is a glucocorticoid drug with local anti-inflammatory and anti-allergic effects. The combination of salmeterol and ticasone is a dry powder inhaler, which is currently one of the most commonly used and most effective drugs for the treatment of bronchial asthma. At present, the preparation method of salmeterol-ticasone dry powder usually adopts ball milling or jet milling process. The dry powder particle size prepared by this process is larger. For compound preparations, the bulkiness and uniformity are also difficult to achieve. Contents of the invention [0003] The technical problem to be solved ...

Claims

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Application Information

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IPC IPC(8): A61K31/56A61K31/137A61K9/16A61P11/06A61P37/08
CPCA61K9/1617A61K31/137A61K31/56A61K2300/00
Inventor 李苑庞靖丁敬敏陈永奇朱春杰王平
Owner ZHANGJIAGANG HUACHANG PHARMA
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