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Oral liquid composition of bromhexine hydrochloride

A technology of bromhexine hydrochloride and oral liquid, which is applied in the field of pharmacy, can solve the problems of difficult filtration process, etc., and achieve the effect of simple preparation process, scientific formula and improved stability

Active Publication Date: 2014-07-02
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Patent CN103052384A uses no more than 10% w / v sugar alcohol as a stabilizer, and contains a thickener, which in turn brings about technical inconvenience such as difficulty in filtration

Method used

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  • Oral liquid composition of bromhexine hydrochloride
  • Oral liquid composition of bromhexine hydrochloride
  • Oral liquid composition of bromhexine hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0018] The preparation of embodiment 1-5 bromhexine hydrochloride oral liquid

[0019] prescription:

[0020] Example

1

2

3

4 (comparative example)

5 (comparative example)

bromhexine hydrochloride

0.4g

0.8g

1.6g

0.4g

1.6g

Refreshing alcohol

0.5g

0.7g

1.0g

0.3g

1.5g

Maltitol

250g

300g

350g

200g

400g

Xylitol

50g

70g

100g

30

120

Add purified water to

1000ml

1000ml

1000ml

1000ml

1000ml

[0021] Preparation Process:

[0022] Heat an appropriate amount of purified water to 60-90°C, add bromhexine hydrochloride, lentil alcohol, maltitol and xylitol, and stir to dissolve. After cooling, add purified water to the full amount; Adjust the pH to 2.0-4.0 with hydrochloric acid, pass through a microporous membrane below 8 μm, and fill to obtain bromhexine hydrochloride oral liquid.

Embodiment 6

[0023] The stability research of embodiment 6 bromhexine hydrochloride oral liquid of the present invention

[0024] According to Chinese Pharmacopoeia 2010 edition two appendices XIX C stability test guiding principle requirement, investigate the stability of the bromhexine hydrochloride oral liquid that embodiment 1~5 makes, relevant substance and content adopt high performance liquid chromatography, the results are shown in table 1-3.

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Abstract

The invention provides an oral liquid composition of bromhexine hydrochloride and a preparation method of the oral liquid composition. The oral liquid composition of the bromhexine hydrochloride contains bromhexine hydrochloride, cool alcohol, maltitol and newtol. The oral liquid composition of the bromhexine hydrochloride has the advantages of low related substance content and good stability.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to an expectorant, in particular to a bromhexine hydrochloride oral liquid composition and a preparation method thereof. Background technique [0002] Bromhexine Hydrochloride (BRH), that is, N-methyl-N-cyclohexyl-2-amino-3,5-dibromobenzylamine hydrochloride, is a modified structure of Vasicine The obtained semi-synthetic product has a strong effect of dissolving mucus, 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 degrades slowly during storage. European Pharmacopoeia version 7.0 contains 5 kinds of impurities (A, B, C, D, E), a...

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
Inventor 刘淑景
Owner HEBEI RENHE YIKANG PHARMA
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