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Inhaled preparation containing calcitriol and ciclesonide and preparation method thereof

A technology of calcitriol and ciclesonide, which is applied in the field of inhalation powder and mist and its preparation, can solve the problems of calcitriol application limitation, hypercalcemia, etc., and achieve long-term use and lower serum IgE , the effect of inhibiting bone density decline

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 160 mg of ciclesonide and 1 mg of calcitriol in ethanol. After filtration, the filtrate is spray-dried and micronized so that the average particle size reaches 2 μm. 10 g of lactose is micronized by a flow energy mill to an average particle size of 20 μm. After mixing, Sieve through a 200-mesh sieve for 3 times and mix well, then pack into No. 3 capsules. Each capsule contains ciclesonide 160μg and 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 80 mg of ciclesonide 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 with a flow energy mill to an average particle size of 30 μm, and mixed , mixed with a 200-mesh sieve for 3 times and distributed into No. 3 capsules. Each capsule contains 80 μg of ciclesonide 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, the ciclesonide and calcitriol were micronized with a fluid energy mill so that the average particle size reached 3 μm, and the carrier was changed to octaacetate-D-cellobiose with an average particle size of 35 μm Esters, according to the process of embodiment 2-1 to prepare powder spray.

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Abstract

The invention discloses an inhaled preparation containing calcitriol and ciclesonide and a preparation method thereof. The inhaled preparation containing calcitriol and ciclesonide is composed of calcitriol, ciclesonide and one or several of medical auxiliary materials suitable for inhaling drug administration, wherein the calcitriol and ciclesonide serve as active ingredients, and the mass ratio of ciclesonide to calcitriol is (80-640):1. The inhaled preparation containing calcitriol and ciclesonide is used for treating bronchial diseases of people 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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IPC IPC(8): A61K31/593A61K31/58A61K9/72A61P11/06
Inventor 孙亮陈松赵琳
Owner TIANJIN JINYAO GRP
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