Inhalation pharmaceutical composition used for treatment of chronic obstructive pulmonary disease (COPD) and asthma and preparation method thereof

A composition and drug technology, applied in the direction of drug combination, pharmaceutical formula, heterocyclic compound active ingredients, etc., can solve the problems of unsatisfactory existing treatments for asthma and COPD, difficulty in obtaining clinical curative effect, etc., and achieve the goal of reducing adverse effects Incidence, Avoidance of Respiratory Irritation, Effects of Ease of Manipulation

Inactive Publication Date: 2015-07-08
GUANGZHOU INST OF RESPIRATORY DISEASE +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] Existing treatments for asthma and COPD are unsatisfactory
Although inhaled corticosteroids, β2-adrenergic receptor agonists, M-receptor antagonists, phosphodiesterase IV inhibitors and other drugs currently used clinically are used to relieve asthma and COPD, the clinical treatment results show that It is difficult to achieve good clinical efficacy with a class of therapeutic drugs alone, especially for patients with moderate to severe asthma and COPD

Method used

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  • Inhalation pharmaceutical composition used for treatment of chronic obstructive pulmonary disease (COPD) and asthma and preparation method thereof
  • Inhalation pharmaceutical composition used for treatment of chronic obstructive pulmonary disease (COPD) and asthma and preparation method thereof
  • Inhalation pharmaceutical composition used for treatment of chronic obstructive pulmonary disease (COPD) and asthma and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] A pharmaceutical composition in dry powder form, its prescription is as shown in the following table:

[0031] Raw materials

Dosage (mg)

Formoterol Fumarate Dihydrate (A)

40

Budesonide (B)

800

Tiotropium bromide monohydrate (C)

100

lactose monohydrate

99060

production

10000 capsules

[0032] Preparation:

[0033] 1) (A), (C) and 9 times the amount of carrier lactose are mixed in equal increments and uniform, and then jet milled to less than 10 μm to make the particle part.

[0034] 2) (B) is pulverized to a particle size of less than 10 μm by air flow.

[0035]3) An appropriate amount of carrier lactose is ball milled to a particle size below 212 μm to prepare a fine particle carrier.

[0036] 4) Add the micropowder obtained in 1) and 2) to the fine granules obtained in 3) at one time, measure the content after mixing, and fill capsules according to the content.

Embodiment 2-129

[0038] It is basically the same as implementation 1, but the contained components of each corresponding embodiment use the amount of the composition shown in the table below:

[0039]

[0040]

[0041]

[0042]

[0043]

Embodiment 130

[0044] Example 130 Study on the therapeutic effect of the composition on mice with asthma

[0045] 1. Experimental animals and groups:

[0046] SPF grade BALB / c mice, female, 6-7 weeks old, weighing 18-20 grams. Ovalbumin-depleted (egg-free) special feed and water were given ad libitum. Randomly divided into the following groups:

[0047] Normal control group (n=8): normal saline sensitization, challenge and intervention; hereinafter referred to as the normal group;

[0048] Asthma control group (n=8): OVA sensitization, challenge, normal saline intervention; hereinafter referred to as the asthma group;

[0049] Budesonide group (n=8): OVA sensitization, challenge, budesonide saline solution (200ug / ml) intervention;

[0050] Formoterol group (n=8): OVA sensitization, challenge, formoterol fumarate dihydrate saline solution (10ug / ml) intervention;

[0051] Tiotropium bromide group (n=8): OVA sensitization, challenge, tiotropium bromide monohydrate saline solution (50ug / ml)...

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Abstract

The invention provides a pharmaceutical composition used for treating COPD and bronchial asthma, and a preparation method thereof. The pharmaceutical composition comprises active ingredients and a pharmaceutically-acceptable carrier, wherein the active ingredients comprise formoterol fumarate dihydrate, budesonide and tiotropium bromide hydrate, the weight percentages of formoterol fumarate dihydrate, budesonide and tiotropium bromide hydrate in the pharmaceutical composition are 0.001%-0.4%, 0.02%-4% and 0.005%-0.8%, respectively. The pharmaceutical composition provided by the invention is in a dry powder form and is used for inhalation treatment of patients, and the dry powder inhalant has obviously better characteristics compared with sprays and aerosols, and is convenient to carry and easy to operate; medicines in the dry powder form have better stability at room temperature and less susceptibility to microbial contamination; and the most significant progress of the pharmaceutical composition lies in synchronous entering of the medicine powder into a respiratory tract with spontaneous breathing of a patient, so the purpose of specific medicine delivery to the lung is achieved, and difficult coordination and cooperation in the medicine delivery do not exist.

Description

technical field [0001] The invention relates to a pharmaceutical composition for treating respiratory diseases, and further relates to a pharmaceutical composition for treating bronchial asthma and chronic obstructive pulmonary disease (COPD) and a preparation method thereof. Background technique [0002] Asthma is a common chronic respiratory disease. According to WHO (World Health Organization) statistics, there are as many as 275 million asthmatic patients worldwide. About 10% of the population in developed countries suffer from this problem. In my country, the current incidence of asthma is 1%, and the incidence of children is about 3-5%, which is a significant increase compared with 10 years ago. With the global air pollution and environmental deterioration, the morbidity and mortality of asthma are on the rise, and it has become a major chronic disease that threatens public health. More than 180,000 people die from asthma every year. At present, the commonly used drug...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61P11/06A61P11/00A61K31/46A61K31/167
Inventor 赖克方黎星术黄玲方章福苏涛钟伯年黄楚琴田婧陈荣昌钟南山
Owner GUANGZHOU INST OF RESPIRATORY DISEASE
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