Bromhexine hydrochloride solution composition for inhalation and preparation method thereof

A technology of bromhexine hydrochloride and composition, which is applied in the field of bromhexine hydrochloride solution composition for inhalation and its preparation, can solve the problems of human body harm, destruction, protein denaturation, etc., and achieve high stability and high drug safety Effect

Active Publication Date: 2016-04-20
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

As a preservative, methylparaben can destroy the cell membrane of microorganisms, denature proteins in cells, and inhibit the activity of respiratory enzymes and electron transfer enzymes of microbial cells. It has strong antibacterial effect, but it may be harmful to human body. cause harm

Method used

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  • Bromhexine hydrochloride solution composition for inhalation and preparation method thereof
  • Bromhexine hydrochloride solution composition for inhalation and preparation method thereof
  • Bromhexine hydrochloride solution composition for inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Embodiment 1 sucks bromhexine hydrochloride solution of the present invention

[0030] prescription:

[0031]

[0032] Preparation:

[0033] (1) Add bromhexine hydrochloride, polyethylene glycol 400 and Tween 80 of the prescribed amount to 60-80% water for injection, stir and dissolve, adjust the pH to 3.0 with sodium hydroxide, and add water to the full amount;

[0034] (2) Sterilize by filtration with a 0.22 μm microporous membrane, fill with nitrogen gas, and pack aseptically.

Embodiment 2

[0035] Embodiment 2 sucks bromhexine hydrochloride solution of the present invention

[0036] prescription:

[0037]

[0038] Preparation:

[0039] (1) Add bromhexine hydrochloride, polyethylene glycol 400 and Tween 80 of the prescribed amount to 60-80% water for injection, stir and dissolve, adjust the pH to 4.0 with sodium hydroxide, and add water to the full amount;

[0040] (2) Inflate with nitrogen, sub-package, sterilize at 121°C for 15 minutes, pack, and get ready.

Embodiment 3

[0041] Embodiment 3 suction bromhexine hydrochloride solution of the present invention

[0042] prescription:

[0043]

[0044] Preparation:

[0045] (1) Add bromhexine hydrochloride, polyethylene glycol 400 and Tween 80 of the prescribed amount to 60-80% water for injection, stir and dissolve, adjust the pH to 5.0 with sodium hydroxide, and add water to the full amount;

[0046] (2) Inflate with nitrogen, sub-package, sterilize at 121°C for 15 minutes, pack, and get ready.

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PUM

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Abstract

The invention provides a bromhexine hydrochloride solution composition for inhalation and a preparation method thereof. The bromhexine hydrochloride solution composition for inhalation is prepared from bromhexine hydrochloride, polyethylene glycol 400, tween 80 and water for injection. The bromhexine hydrochloride solution composition for inhalation has the advantages of being simple in formula composition, high in stability, high in safety of drug application, suitable for industrial production and the like.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a bromhexine hydrochloride solution composition for inhalation and a preparation method thereof. Background technique [0002] Bromhexine Hydrochloride (BRH), that is, N-methyl-N-cyclohexyl-2-amino-3,5-dibromobenzylamine hydrochloride, is obtained by structural modification of Vasicine It is a semi-synthetic product that has a strong effect of dissolving mucus, which can crack mucopolysaccharide cellulose or mucin in sputum and reduce the viscosity of sputum. It is suitable for patients with chronic bronchitis, asthma and other patients with sticky sputum that is difficult to spit out. Bromhexine hydrochloride, a widely used mucolytic agent since the 1960s, also has free radical scavenging properties and in vitro antibacterial activity. [0003] Bromhexine hydrochloride is very slightly soluble in water. Although it has good solubility under acidic condition...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/10A61K47/26A61P11/10
CPCA61K9/0078A61K9/08A61K31/137A61K47/10A61K47/26
Inventor 牛涛涛
Owner HEBEI RENHE YIKANG PHARMA
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