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Inhalable ambroxol hydrochloride composition and application thereof

A kind of technology of ambroxol hydrochloride and composition, applied in the field of inhalation solution, can solve problems such as drug safety risk, unfavorable dosing accurate control and the like, and achieve the effects of simple and feasible preparation process, significant economic benefit, and high yield

Inactive Publication Date: 2021-08-31
南京恒道医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the inhalation solution preparations of ambroxol hydrochloride and procaterol hydrochloride, if the patient needs to use the two drugs in combination, they need to mix and use them together, and the inhalation preparations are usually administered in the community or at home, and the patients Self-mixing and compatibility operations are not conducive to the accurate control of the dosage, and to a certain extent bring the risk of drug safety

Method used

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  • Inhalable ambroxol hydrochloride composition and application thereof
  • Inhalable ambroxol hydrochloride composition and application thereof
  • Inhalable ambroxol hydrochloride composition and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1~5

[0022] Table 1: Formula table of inhalation preparations of Examples 1~5

[0023]

Embodiment 1

[0024] Embodiment 1 preparation process

[0025] Take an appropriate amount of water for injection to dissolve citric acid, sodium citrate, ambroxol hydrochloride, procaterol hydrochloride, sodium chloride, and benzalkonium chloride, and adjust the pH value to 3.0~5.5 with a pH regulator; Allow. During the preparation process, two 0.22 μm filter elements were used to sterilize and filter, and then aseptically filled in low-density polyethylene bottles and sealed with aluminum foil bags.

Embodiment 2

[0026] Embodiment 2 preparation technology

[0027] Take an appropriate amount of water for injection to dissolve citric acid, sodium citrate, ambroxol hydrochloride, procaterol hydrochloride, sodium chloride, and benzalkonium chloride, and adjust the pH value to 3.0~5.5 with a pH regulator; Allow. During the preparation process, two 0.22 μm filter elements were used to sterilize and filter, and then aseptically filled in low-density polyethylene bottles and sealed with aluminum foil bags.

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PUM

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Abstract

The invention relates to an inhalable ambroxol hydrochloride composition and application thereof. The ambroxol hydrochloride composition and procaterol hydrochloride injection comprises ambroxol hydrochloride, procaterol hydrochloride, auxiliary materials and water for injection, and is characterized by comprising the following components: 0.3%-0.9% (w / v) of ambroxol hydrochloride, 0.001%-0.05% (w / v) of procaterol hydrochloride, a pH regulator, a metal ion chelating agent, an osmotic pressure regulator and a solvent. The invention relates to a composition of ambroxol hydrochloride and procaterol hydrochloride, and the medicines are combined for use to achieve a synergistic effect; the dosage form is an inhalation preparation which directly reaches the lung through administration, the working speed is high, which is equivalent to intravenous injection, can avoid first pass elimination and the like, and has small side effect. The composition is mainly used for treating cough, sticky sputum, difficult sputum excretion, gasp and the like caused by acute and chronic respiratory diseases (such as acute and chronic bronchitis, emphysema and the like).

Description

technical field [0001] The invention relates to the field of inhalation solutions, in particular to an inhalable ambroxol hydrochloride composition and application thereof. Background technique [0002] Ambroxol hydrochloride is a mucolytic agent that can act on the alveolar secretory cells, regulate the secretion of serous and mucus, increase the secretion of serous, dissolve and dilute mucus, strengthen the swing of cilia, and improve the airway mucous membrane and cilia. The transport of sputum in the non-ciliated area increases the clearance ability of the mucus transport system and makes the sputum easy to discharge. Ambroxol hydrochloride is also a protective agent for the respiratory system, inhibiting leukocytes and mast cells from releasing histamine and leukotrienes to prevent lung damage, has anti-oxidation, inhibits the release of inflammatory mediators, relaxes airway smooth muscle, and promotes the synthesis of alveolar surfactant And secretion and other effec...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K9/08A61K31/137A61K31/4704A61P11/10A61P11/14A61P11/06A61P11/00
CPCA61K9/0078A61K9/08A61K31/137A61K31/4704A61K47/183A61P11/10A61P11/14A61P11/06A61P11/00
Inventor 陶义华韦燕黄迎春
Owner 南京恒道医药科技股份有限公司
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