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Bromhexine hydrochloride injection and preparation method and application thereof

A technology of bromhexine hydrochloride and injection, applied in the pharmaceutical field, can solve the problems of safety risk, high substance content, poor stability, etc., and achieve the effects of reducing potential safety hazards, simple preparation process and improving stability

Active Publication Date: 2015-01-28
HEBEI RENHE YIKANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] Add cosolvent ethanol and stabilizing agent poloxamer, hydroxypropyl cellulose etc. in the disclosed bromhexine hydrochloride injection of CN100409835C, and poloxamer, hydroxypropyl cellulose are polymer materials, there is certain safety sexual risk
[0005] CN1184963C uses hot absolute ethanol to dissolve bromhexine hydrochloride, but as an expectorant, bromhexine hydrochloride is often used in combination with antibiotics, which will increase the incidence of disulfiram reactions
[0006] CN102293741B discloses a prescription for ethanol-free bromhexine hydrochloride large-capacity injection, which prepares a clear solution through an ultrasonic treatment process, but its related substances are relatively high (>0.5%)
CN101502494B also pointed out that "the (bromhexine hydrochloride) lyophilized preparation without adding meglumine has little effect on improving the stability of the filler or pH regulator"
[0008] Bromhexine hydrochloride injection product listed by Boehringer Ingelheim There are also the disadvantages of high content of related substances and poor stability
[0009] Therefore, the existing bromhexine hydrochloride injection has the disadvantages of high related substances, poor stability, etc., or there is a safety risk, and a kind of bromhexine hydrochloride injection with low content of related substances, high stability, high safety and simple process is prepared. Liquid is a technical problem that needs to be solved by those skilled in the art

Method used

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  • Bromhexine hydrochloride injection and preparation method and application thereof
  • Bromhexine hydrochloride injection and preparation method and application thereof
  • Bromhexine hydrochloride injection and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1～6

[0030] The preparation of embodiment 1~6 bromhexine hydrochloride injection

[0031] prescription:

[0032]

[0033]

[0034] Wherein, the weight content ratio of embodiment 1-3 tartaric acid and stabilizer is 1:10-50, and the corresponding content ratio of comparative example is in the above-mentioned range, namely 1:5 and 1:80.

[0035] Preparation Process:

[0036] Heat 60-80% injection with water to 60°C, add raw and auxiliary materials according to the prescription, stir to dissolve, cool to room temperature, adjust the pH to 2.0-5.0 with sodium hydroxide, add water to the full amount, add activated carbon to absorb bacterial endotoxin, filter to remove Charcoal, finely filtered, subpackaged, sterilized at 121°C for 15 minutes, packaged, and ready to use.

[0037] During the preparation process, the above-mentioned embodiments of the present invention can also be filled with nitrogen to further enhance the stability of the preparation.

experiment example

[0038] Experimental example Stability study of bromhexine hydrochloride injection

[0039] According to Chinese Pharmacopoeia 2010 edition two appendices XIX C stability test guiding principle requirement, investigate the bromhexine hydrochloride oral liquid that embodiment 1~5 makes and The stability, related substances and content adopt high performance liquid chromatography, and the results are shown in Table 1-3.

[0040] Table 1 Bromhexine hydrochloride injection 0-day test results

[0041]

[0042] Table 2 bromhexine hydrochloride injection accelerated test results

[0043] (simulating commercially available packaging, temperature 60°C, storage for 10 days)

[0044]

[0045]

[0046] The accelerated test shows that the stability of the bromhexine hydrochloride injection (embodiment 1-3) of the present invention is obviously better than that of the control example (embodiment 4-5). In particular, Example 1 has the highest stability.

[0047] Table 3 bromhexi...

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Abstract

The invention provides bromhexine hydrochloride injection and a preparation method thereof. The bromhexine hydrochloride injection comprises an active component bromhexine hydrochloride, and tartaric acid, a stabilizing agent, sodium hydroxide and water for injection. The bromhexine hydrochloride injection has the advantages of low contents of relevant materials, high stability and the like.

Description

technical field [0001] The invention relates to the field of pharmacy, in particular to a bromhexine hydrochloride injection composition, a preparation method thereof and an application in preparing expectorant drugs. 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] Bromhexine hydrochloride is very slightly soluble in water. Although it has good solubility under acidic conditions, its stability is poor. Five impurities (A, B, C, D, E) are recorded in the European Pharmacopoeia Version 7.0. The prior art all adopts methods such a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/137A61K47/10A61K47/12A61K47/26A61P11/10
Inventor 李国英
Owner HEBEI RENHE YIKANG PHARMA
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