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Pharmaceutical composition preparation

A composition and drug technology, applied in the direction of drug combination, active ingredient of heterocyclic compound, pharmaceutical formula, etc., can solve the problems of poor drug compliance of patients

Inactive Publication Date: 2020-07-31
王兆霖
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] The inhalation preparation is a drug-device combination preparation. While adhering to standardized medication for a long time, the standardized operation of the inhalation device is equally important. There is no triple preparation of tiotropium bromide, arformoterol, and fluticasone in the prior art. When the three drugs are used in combination, the patient It is necessary to learn the use of different inhalers, and the patient's medication compliance is poor

Method used

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Examples

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Embodiment 1

[0048] The pharmaceutical composition preparation of the present embodiment is:

[0049] The bulk drug of tiotropium bromide monohydrate, arformoterol tartrate and fluticasone furoate are micronized in a jet mill, the pulverization pressure is 0.6 MPa, and the particle size D50 of the obtained product is below 5 μm.

[0050] Use a classifier to classify the purchased commercial lactose (DEF LH200), the classification feed rate is 1-2kg / h, the feed pressure is 0.55-0.65MPa, the classification speed is controlled at 6500-7500rpm, and the secondary air flow is controlled at 0.5-0.8Nm 3 / min.

[0051] According to the following ratio, take one-third of the required amount of lactose and weighed tiotropium bromide monohydrate API, arformoterol tartrate and fluticasone furoate (as shown in Table 1) in the mixing cup Mix for 10 minutes, then add the remaining lactose, put it into a mixing tank, use a single-arm mixer to mix for 30 minutes, then take it out, mix it manually for 10 m...

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Abstract

The invention provides a pharmaceutical composition preparation. The pharmaceutical composition preparation comprises an anticholinergic drug tiotropium or a hydrate thereof, a beta 2-receptor agonistarformoterol or a salt thereof, and an inhaled glucocorticoid fluticasone or an ester derivative thereof; tiotropium bromide acts on a muscarinic receptor on bronchial smooth muscles, the cholinergiceffect of acetylcholine released by the tail ends of parasympathetic nerves can be inhibited, and muscular tension is blocked; the arformoterol acts on a beta 2-receptor on an airway smooth muscle cell membrane, so that the release of degranulation and media of mast cells and basophils is reduced, the permeability of capillaries is reduced, and swinging of airway epithelial cilia is increased; the fluticasone is an effective anti-inflammatory drug, and when the three drugs are combined for use, the three mechanisms jointly exert the bronchus relaxing effect and the anti-inflammatory effect; the application range of the triple therapy is wider on the important clinical indexes of reducing acute exacerbation of patients suffering from chronic obstructive pulmonary disease, reducing total-cause mortality rate, improving the lung function of the patients suffering from chronic obstructive pulmonary disease, improving the living quality and the like.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a pharmaceutical composition preparation. Background technique [0002] Chronic Obstructive Pulmonary Diseases (COPD) is a chronic bronchitis and / or emphysema characterized by airflow obstruction, which can further develop into a common chronic disease of pulmonary heart disease and respiratory failure. Due to factors such as air pollution and the increase in the number of smokers, the morbidity and mortality of COPD have a tendency to increase gradually. [0003] Bronchial asthma (asthma for short) is a chronic airway disease characterized by airway inflammation, increased mucus secretion and airway hyperresponsiveness. Th2 cells, eosinophils, macrophages, neutrophils and some other inflammatory factors, chemokines, etc. are jointly involved in the inflammatory response of allergic asthma. [0004] Some patients with COPD or asthma are ineffective to single...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K45/06A61K31/56A61K31/46A61K31/167A61P11/00
CPCA61K31/167A61K31/46A61K31/56A61K45/06A61P11/00A61K2300/00
Inventor 王兆霖郑龙刘大为刘溪
Owner 王兆霖
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