Stable bromhexine hydrochloride sodium chloride injection composition

A technology of sodium chloride injection and bromhexine hydrochloride, which is applied in the field of bromhexine hydrochloride sodium chloride injection composition and its preparation, can solve problems such as low stability, low safety, and complicated preparation process, and achieve The effect of ensuring sterility

Active Publication Date: 2015-03-25
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the above-mentioned injections have not yet solved the problems of poor stability and the like.
[0006] Therefore, the existing bromhexine hydrochloride sodium chloride injection has the disadvantages of low safety, high related substances, complicated preparation proces...

Method used

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  • Stable bromhexine hydrochloride sodium chloride injection composition
  • Stable bromhexine hydrochloride sodium chloride injection composition
  • Stable bromhexine hydrochloride sodium chloride injection composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～5

[0034] The preparation of embodiment 1~5 bromhexine hydrochloride sodium chloride injection

[0035] prescription:

[0036] Example

Example 1

Example 2

Example 3

Example 4

Example 5

bromhexine hydrochloride

20mg

40mg

60mg

40mg

60mg

Sodium chloride

9g

9g

9g

9g

9g

Tartaric acid: glacial acetic acid (weight ratio)

0.5:1

0.7:1

0.8:1

1:1

1:1

water for injection, added to

1000ml

1000ml

1000ml

1000ml

1000ml

[0037] Preparation Process:

[0038] Add the prescribed amount of bromhexine hydrochloride and sodium chloride into the water for injection, adjust the pH to 4.0 with the prescribed ratio of tartaric acid and glacial acetic acid, stir to dissolve, adsorb on activated carbon, filter to remove carbon, fine filter, subpackage, and sterilize at 121°C 15 minutes, pack, promptly get bromhexine hydrochloride sodium chloride injection of the p...

Embodiment 6-9

[0039] The preparation of embodiment 6-9 (comparative example) bromhexine hydrochloride sodium chloride injection

[0040] prescription:

[0041]

[0042] Preparation Process:

[0043] Add the bromhexine hydrochloride and sodium chloride of the prescription amount in Example 6-9 into the water for injection, adjust the pH to 4.0 with tartaric acid, glacial acetic acid, citric acid, and lactic acid respectively, stir and dissolve, absorb with activated carbon, filter to remove carbon, and purify Filter, pack, sterilize at 121 DEG C for 15 minutes, pack, and obtain the bromhexine hydrochloride sodium chloride injection of the comparative example.

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PUM

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Abstract

The invention provides a high-capacity bromhexine hydrochloride sodium chloride injection composition. The bromhexine hydrochloride sodium chloride injection provided by the invention is prepared from bromhexine hydrochloride, sodium chloride, tartaric acid, glacial acetic acid and injection water. The bromhexine hydrochloride sodium chloride injection provided by the invention has the advantages of low content of related substances, high stability and the like.

Description

technical field [0001] The invention relates to the field of chemical pharmacy, in particular to a stable bromhexine hydrochloride sodium chloride injection 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. Bromhexine hydrochloride is suitable for treating chronic bronchitis, asthma and other patients with thick sputum that is difficult to spit out. [0003] Compared with small injections, it is very necessary to directly use bromhexine hydrochloride large-volume injection for the convenience of clinical medication and to prevent secondary pollution during dispensing. At present, there is bromhexine hydrochloride large-volume injection ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/137A61K47/12A61P11/10
Inventor 李国英
Owner HEBEI RENHE YIKANG PHARMA
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