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A kind of 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, can solve the problems of bronchoconstriction, injection pain, poor clinical compliance, inconvenient use, etc., and achieve the effect of avoiding bronchoconstriction

Active Publication Date: 2022-07-01
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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  • A kind of compound doxofylline solution for inhalation and preparation method thereof
  • A kind of compound doxofylline solution for inhalation and preparation method thereof
  • A kind of 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] The prescription is shown in the table below:

[0032]

[0033] The preparation method is as follows:

[0034] Take 90% of the water for injection of the recipe, add doxofylline and ipratropium bromide in the recipe, fill with nitrogen, stir for 30min, then add disodium edetate in the recipe, stir and 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 sequentially pass through a 0.45 μm filter membrane for coarse filtration and a 0.22 μm filter membrane for fine filtration.

[0035] Take the finely filtered solution for pH value, osmotic pressure, content and other tests. After passing the test, fill it with nitrogen, sterilize it for 15 minutes at 121 °C, and pass the lamp inspection, that is, compound doxofylline solution for inhalatio...

Embodiment 2

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

[0037] The prescription is shown in the table below:

[0038]

[0039] The preparation method is the same as that in Example 1, except that the above-mentioned components and recipe quantities are replaced.

Embodiment 3

[0040] Embodiment 3: prescription and technology of compound doxofylline solution for inhalation

[0041] The prescription is shown in the table below:

[0042]

[0043] The preparation method is the same as that in Example 1, except that the above-mentioned components and recipe 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 components of the compound doxofylline solution for inhalation include crude drug, isotonicity regulator, antioxidant, pH regulator and water for injection , the crude drug comprises a mixture of doxofylline and ipratropium bromide. The compound doxofylline solution for inhalation of the present invention is suitable for patients who need the combined application of multiple bronchodilators, and is used for the treatment of reversible bronchospasm related to airway obstructive diseases. Compared with the prior art, the quality is more stable , Medication is safer and more convenient.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a compound doxofylline solution for inhalation and a preparation method thereof. Background technique [0002] Bronchial asthma (asthma for short) is a common chronic disease that threatens public health worldwide, and the prevalence in countries around the world ranges from 0.13% to 17%. And its morbidity and mortality showed a gradually increasing trend. According to statistics from the Global Asthma Prevention and Control Protocol, 160 million people worldwide suffer from the disease, and the incidence of asthma has doubled in 10-20 years in many regions. In many countries, the economic burden of asthma treatment is quite heavy in both direct medical consumption and indirect medical consumption, making asthma prevention and treatment a priority in the government's health development strategy. The serious harm caused by asthma to humans has inc...

Claims

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Application Information

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Patent Type & Authority Patents(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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