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, which can solve problems such as protein denaturation, destruction, and human harm, and achieve low cost, high drug safety, and stability sex good effect

Inactive Publication Date: 2016-04-06
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 respi...

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

[0038] Embodiment 1 sucks bromhexine hydrochloride solution of the present invention

[0039] prescription:

[0040] Bromhexine Hydrochloride 0.4g,

[0041] Tartaric acid 0.1g,

[0042] Add water for injection to 1000ml.

[0043] Preparation:

[0044] (1) Heat the water for injection of 60-80% of the prescription amount to 60-80°C, add bromhexine hydrochloride and tartaric acid, stir and dissolve, adjust the pH to 4.5 with sodium hydroxide, and add water to the full amount;

[0045] (2) Sterilize by filtration with a 0.22 μm microporous membrane, fill with nitrogen gas, and pack aseptically.

Embodiment 2

[0046] Embodiment 2 sucks bromhexine hydrochloride solution of the present invention

[0047] prescription:

[0048] Bromhexine hydrochloride 2g,

[0049] Tartaric acid 1g,

[0050] Add water for injection to 1000ml.

[0051] Preparation:

[0052] (1) Heat the water for injection of 60-80% of the prescription amount to 60-80°C, add bromhexine hydrochloride and tartaric acid, stir and dissolve, adjust the pH to 3.5 with sodium hydroxide, and add water to the full amount;

[0053] (2) Inflate with nitrogen, sub-package, sterilize at 121°C for 15 minutes, pack, and get ready.

Embodiment 3

[0054] Embodiment 3 suction bromhexine hydrochloride solution of the present invention

[0055] prescription:

[0056] Bromhexine hydrochloride 4g,

[0057] Tartaric acid 4g,

[0058] Add water for injection to 1000ml.

[0059] Preparation:

[0060] (1) Add bromhexine hydrochloride and tartaric acid to the water for injection of 60-80% of the prescription amount, stir and dissolve, adjust the pH to 2.5 with sodium hydroxide, and add water to the full amount;

[0061] (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. A bromhexine hydrochloride solution for inhalation is prepared from bromhexine hydrochloride, tartaric acid and water for injection. The bromhexine hydrochloride solution for inhalation has the advantages of being simple in prescription 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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IPC IPC(8): A61K9/08A61K31/137A61K47/12A61P11/10
CPCA61K9/08A61K9/0078A61K31/137A61K47/12
Inventor 牛涛涛
Owner HEBEI RENHE YIKANG PHARMA
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