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Compound doxofylline solution for inhalation and preparation method thereof

A technology of doxofylline and solution, which is applied in the field of compound doxofylline solution for inhalation and its preparation, which can solve problems such as bronchoconstriction, risk of research and development, and not recommended for long-term use, and achieve the effect of avoiding bronchoconstriction

Active Publication Date: 2021-04-09
HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

But the weak point of this document is: 1. the mode of combination medicine is that the medicine of two kinds of different dosage forms (doxofylline sodium chloride injection and the different third detropammonium bromide solution for inhalation) are administered in divided doses. Convenience; ②Because it is not developed into a compound preparation, the inherent pain and poor clinical compliance of injections still exist, and the clinical use is limited
The common shortcomings of the aforementioned patents are: ① the active ingredient involved in the inhalation solution is a single ingredient, which is doxofylline or ipratropium bromide, and does not involve the compound of the two; ② the patent only examines the stability of the preparation Sex, the safety impact on the preparation is unknown, and there are risks in research and development
For unilateral inhalation solutions, literature (Beasley R, Fishwick D, Miles J F, et al. Preservatives in Nebulizer Solutions: Risks Without Benefit. Pharmacotherapy: The Journal of HumanPharmacology and Drug Therapy, 1998,18(1):131-139. ) pointed out that the use of edetate disodium (EDTA) as a stabilizer in the ipratropium bromide inhalation solution is likely to cause dose-dependent bronchoconstriction, and there is a safety risk, and long-term use is not recommended

Method used

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  • Compound doxofylline solution for inhalation and preparation method thereof
  • Compound doxofylline solution for inhalation and preparation method thereof
  • Compound doxofylline solution for inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Embodiment 1: Prescription and technology of compound doxofylline solution for inhalation

[0031] See the table below for prescriptions:

[0032]

[0033] The preparation method is as follows:

[0034] Take 90% of the prescribed amount of water for injection, add the prescribed amount of doxofylline and ipratropium bromide, fill with nitrogen, stir for 30 minutes, then add the prescribed amount of edetate disodium, stir to dissolve, and then add an appropriate amount of chlorine Potassium chloride, and adjust the pH value to 5.5-6.0 with sulfuric acid and sodium hydroxide, add water to the full amount, and successively pass through a 0.45 μm filter membrane for coarse filtration, and then a 0.22 μm filter membrane for fine filtration.

[0035] The finely filtered solution was tested for pH value, osmotic pressure, content, etc. After passing the test, it was filled with nitrogen, filled with nitrogen, sterilized at 121°C for 15 minutes, and passed the light test to o...

Embodiment 2

[0036] Embodiment 2: Prescription and technology of compound doxofylline solution for inhalation

[0037] See the table below for prescriptions:

[0038]

[0039] The preparation method is the same as in Example 1, only the above-mentioned ingredients and prescription quantities are replaced.

Embodiment 3

[0040] Embodiment 3: Prescription and process of compound doxofylline solution for inhalation

[0041] See the table below for prescriptions:

[0042]

[0043] The preparation method is the same as in Example 1, only the above-mentioned ingredients and prescription quantities are replaced.

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PUM

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Abstract

The invention discloses a compound doxofylline solution for inhalation and a preparation method thereof. The compound doxofylline solution for inhalation comprises the following components: an active pharmaceutical ingredient, an isoosmotic adjusting agent, an antioxidant, a pH regulator and water for injection, and the active pharmaceutical ingredient comprises a mixture of doxofylline and ipratropium bromide. The compound doxofylline solution for inhalation disclosed by the invention is suitable for patients needing combined application of multiple bronchodilators, is used for treating reversible bronchospasm related to airway obstructive diseases, and has more stable quality and is safer and more convenient to use in comparison with the prior art.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, in particular to a compound doxofylline solution for inhalation and a preparation method thereof. Background technique [0002] Bronchial asthma (abbreviated as asthma, asthma) is a common chronic disease that threatens public health worldwide, and the prevalence rate varies from 0.13% to 17% in various countries in the world. And its morbidity and mortality are gradually increasing. According to the statistics of the Global Asthma Prevention and Control Agreement, 160 million people in the world suffer from this disease, and the incidence rate of asthma has doubled within 10-20 years in many areas. In many countries, the economic burden of asthma treatment is quite heavy both in terms of direct medical consumption and indirect medical consumption, which makes asthma prevention and treatment a priority in the government's health development strategy. The serious harm caused ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K47/02A61K47/26A61K31/46A61K31/522A61P11/08
CPCA61K31/46A61K31/522A61K9/08A61K9/0078A61K47/02A61K47/26A61P11/08A61K2300/00
Inventor 王磊曾智丽陶言彬卢豫商李园园肖艳茹
Owner HANGZHOU BIO SINCERITY PHARMA TECH CO LTD
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