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Inhalation preparation containing calcitriol and budesonide and preparation method thereof

A technology of calcitriol and inhalation medicine, which is applied in the field of medicines for treating respiratory diseases, especially asthma, can solve problems such as application limitation of calcitriol, hypercalcemia, etc. good therapeutic effect

Inactive Publication Date: 2011-11-23
TIANJIN JINYAO GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the literature also pointed out that due to the large dose required for immunomodulatory therapy, long-term application is likely to cause side effects such as hypercalcemia, and the application of calcitriol is limited to a certain extent.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] Dissolve 200 mg of budesonide and 1 mg of calcitriol in ethanol. After filtration, the filtrate is spray-dried and micronized to an average particle size of 2 μm. 10 g of lactose is micronized to an average particle size of 20 μm by a flow energy mill. After mixing, pass The 200-mesh sieve was mixed for 3 times and divided into No. 3 capsules. Each capsule contains budesonide 200μg, calcitriol 1μg

[0038] The process conditions are: the inlet temperature is 105°C, the outlet temperature is 68°C, the air flow rate is 90%, the inner diameter of the nozzle outlet is 0.1cm, the air flow rate of the nozzle is 800ml / min, and the injection speed is 50mL / h

Embodiment 2-1

[0040] Dissolve 100 mg of budesonide and 1 mg of calcitriol in ethanol. After filtration, the filtrate is spray-dried and micronized so that the average particle size reaches 4 μm. Lactose 20 g is micronized by a fluid energy mill to an average particle size of 30 μm, and mixed evenly. Mix evenly with a 200-mesh sieve for 3 times and distribute into No. 3 capsules. Each capsule contains 100 μg of budesonide and 1 μg of calcitriol.

[0041] The process conditions are as follows: inlet temperature is 105°C, outlet temperature is 68°C, air flow rate is 90%, nozzle outlet inner diameter is 0.1cm, nozzle air flow rate is 800ml / min, and sample injection speed is 50mL / h.

Embodiment 2-2

[0043] According to the formula in Example 2-1, budesonide and calcitriol were micronized with a fluid energy mill to make the average particle size reach 3 μm, and the carrier was changed to octaacetate-D-cellobiose ester with an average particle size of 35 μm , according to the process of Example 2-1 to prepare powder spray.

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Abstract

The invention discloses an inhalation preparation containing calcitriol and budesonide and a preparation method thereof. The inhalation preparation containing calcitriol and budesonide comprises calcitriol and budesonide as active components and one or more pharmaceutic adjuvants suitable for inhaled drugs, wherein, the weight ratio of calcitriol to budesonide is 100-800:1. The inhalation preparation containing calcitriol and budesonide can be used for treating bronchial diseases in humans or mammals.

Description

Technical field: [0001] The invention relates to a medicine for treating respiratory diseases, especially asthma, in particular to an inhalation powder spray and a preparation method thereof. Background technique: [0002] Asthma is a chronic airway inflammation characterized by reversible airway obstruction and increased airway responsiveness. Airway obstruction is caused by two factors: increased secretions caused by bronchial mucosal inflammation, mucosal edema, and smooth muscle spasm stimulated by inflammation; while asthma Increased airway reactivity is also a result of damage to the bronchial epithelium due to airway inflammation. It is recognized that only by controlling the inflammation of the airway mucosa can the ultimate goal of reducing airway hyperresponsiveness and relieving asthma symptoms be achieved. At present, the drugs for the treatment of asthma and other lung diseases mainly include the following: (1) β2-receptor agonists, (2) xanthine drugs, (3) anti...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/593A61K31/58A61K9/72A61P11/06
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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