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Ambroxol solution preparation for inhalation as well as preparation method and application of preparation

A technology of ambroxol and ambroxol hydrochloride is applied in the field of ambroxol solution preparation for inhalation and its preparation, achieving the effects of good safety, low production cost and simple preparation method

Active Publication Date: 2020-03-10
BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are few studies on the stability of ambroxol hydrochloride inhalation solution preparations from the perspective of packaging material compatibility and other aspects of the formulation.

Method used

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  • Ambroxol solution preparation for inhalation as well as preparation method and application of preparation
  • Ambroxol solution preparation for inhalation as well as preparation method and application of preparation
  • Ambroxol solution preparation for inhalation as well as preparation method and application of preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0028]

[0029] (1) Take by weighing 7.5g ambroxol hydrochloride, 0.1g disodium hydrogen phosphate, add in appropriate 50 ℃ water for injection, stir after ambroxol hydrochloride is completely dissolved, obtain pre-inhalation solution;

[0030] (2) Add 7g sodium chloride to the pre-inhalation solution prepared in step (1), stir to make it dissolve, settle to 1000ml, add an appropriate amount of citric acid to adjust the pH value=5.05, and obtain ambroxol hydrochloride solution;

[0031] (3) filling the ambroxol hydrochloride solution that described step (2) obtains in the 2ml borosilicate glass ampoule bottle, fusing and sealing, sterilizing to obtain the ambroxol solution preparation for inhalation of the present invention.

[0032] Among them, borosilicate glass ampoules have 6 specifications, specifically:

[0033] The mass fraction of ferric oxide in the borosilicate glass ampoule of label 1 is 1.0wt%, and the massfraction of titanium dioxide is 2.2wt%;

[0034] The ma...

Embodiment 2

[0046]

[0047] (1) Take by weighing prescription quantity ambroxol hydrochloride, disodium hydrogen phosphate, join in appropriate 40 ℃ water for injection, stir after making ambroxol hydrochloride dissolve completely, obtain pre-inhalation solution;

[0048] (2) add prescription amount sodium chloride to the pre-inhalation solution prepared by step (1), stir to make it dissolve, be settled to 1000ml, add an appropriate amount of citric acid to adjust pH value=5.50, get ambroxol hydrochloride solution;

[0049] (3) the ambroxol hydrochloride solution that described step (2) is obtained is filled in 2ml borosilicate glass ampoule (the massfraction of ferric oxide is 0.3wt%, the massfraction of titanium dioxide is 0.7wt%) In, melt seal, sterilize to obtain the ambroxol solution preparation for inhalation of the present invention.

Embodiment 3

[0051]

[0052] (1) Take by weighing prescription quantity ambroxol hydrochloride, disodium hydrogen phosphate, join in appropriate 50 ℃ water for injection, stir after making ambroxol hydrochloride dissolve completely, obtain pre-inhalation solution;

[0053] (2) add prescription amount sodium chloride to the pre-inhalation solution prepared by step (1), stir and make it dissolve, be settled to 1000ml, add an amount of citric acid to adjust pH value=5.25, get ambroxol hydrochloride solution;

[0054] (3) the ambroxol hydrochloride solution that described step (2) is obtained is filled in 2ml borosilicate glass ampoule (the massfraction of ferric oxide is 0.35wt%, the massfraction of titanium dioxide is 0.8wt%) In, melt seal, sterilize to obtain the ambroxol solution preparation for inhalation of the present invention.

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Abstract

The invention belongs to the field of preparation science, and particularly relates to an ambroxol solution preparation for inhalation as well as a preparation method and application of the preparation. The ambroxol solution preparation for the inhalation provided by the invention includes an ambroxol hydrochloride solution and a packaging material, and the ambroxol hydrochloride solution is placed in the packaging material. The invention also provides the preparation method of the ambroxol solution preparation for the inhalation. Compared with the prior art, the ambroxol solution preparationfor the inhalation provided by the invention has good compatibility between an inhalation solution and the packaging material, the solution preparation for the inhalation has the advantages of high stability, reliable quality, good safety, and long storage time, and the preparation method provided by the invention is simple and easy to operate, has low production costs, and is convenient for industrialized production.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to an ambroxol solution preparation for inhalation, a preparation method and application thereof. Background technique [0002] Ambroxol (chemical name trans-4-[(2-amino3.5-dibromobenzyl)amino]cyclohexanol, C 13 h 18 Br 2 N 2 O, CAS: 18683-91-5, and the CAS of its hydrochloride is 23828-92-4) was discovered by Boehringer Ingelheim in Germany in 1965 when studying bromhexine metabolites. Later studies have found that ambroxol hydrochloride can be used as a mucolytic agent, and its effect is stronger than that of bromhexine. It can increase the secretion of serous glands in the respiratory mucosa, reduce the secretion of mucous glands, reduce and break the mucopolysaccharide fibers in sputum, and make sputum The viscosity of the liquid is reduced, and the sputum becomes thinner and easier to cough up. Ambroxol hydrochloride can also activate alveolar epithelial type II cells t...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/72A61K31/137A61P11/12A61P11/00
CPCA61K9/08A61K9/007A61K31/137A61K47/12A61P11/12A61P11/00
Inventor 张保献胡杰李海朋宋艳威
Owner BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD