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Bromhexine hydrochloride solution preparation for inhalation and preparation method thereof

A technology of bromhexine hydrochloride and bromhexine hydrochloride, applied in the field of bromhexine hydrochloride solution preparation for inhalation and preparation thereof, can solve problems such as affecting safety, and achieve the effects of reliable quality, shortening the course of disease and low production cost

Pending Publication Date: 2020-03-24
BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although bromhexine hydrochloride atomized solution has been marketed abroad, the marketed product contains preservatives, which will affect its safety

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-7

[0029] Embodiments 1-7 have the same preparation method of bromhexine hydrochloride solution preparations for inhalation, but different prescriptions. The specific dosages of bromhexine hydrochloride and tartaric acid in the prescriptions are shown in Table 1.

[0030] (1) Take the prescribed amount of tartaric acid and bromhexine hydrochloride, add them to water for injection at 50°C in turn, stir until completely dissolved, and obtain a pre-inhalation solution;

[0031] (2) The pre-inhalation solution obtained in step (1) is fine-filtered with a 0.22 μm filter membrane to obtain a bromhexine solution; before and after filling the bromhexine solution, nitrogen protection is filled in the ampoule, and under aseptic conditions Next, the bromhexine solution is filled in the ampoule and sealed, and packed to obtain the bromhexine hydrochloride solution preparation for inhalation of the present invention.

[0032] The concrete consumption of bromhexine hydrochloride, tartaric acid...

Embodiment 8

[0035] prescription

[0036] Bromhexine Hydrochloride 1.5mg / ml

[0037] Tartaric acid 0.75mg / ml

[0038] (1) Take the prescribed amount of tartaric acid and bromhexine hydrochloride, add them to deionized water at 45°C in turn, and stir until completely dissolved to obtain a pre-inhalation solution;

[0039] (2) The pre-inhalation solution obtained in step (1) is fine-filtered with a 0.22 μm filter membrane to obtain a bromhexine solution; before and after filling the bromhexine solution, nitrogen protection is filled in the ampoule, and under aseptic conditions Next, the bromhexine solution is filled in the ampoule and sealed, and packed to obtain the bromhexine hydrochloride solution preparation for inhalation of the present invention, and its pH value is 2.65.

Embodiment 9

[0041] prescription

[0042] Bromhexine Hydrochloride 3mg / ml

[0043] Tartaric acid 0.9mg / ml

[0044] (1) Take the prescribed amount of tartaric acid and bromhexine hydrochloride, add them to distilled water at 58°C in turn, and stir until completely dissolved to obtain a pre-inhalation solution;

[0045] (2) The pre-inhalation solution obtained in step (1) is fine-filtered with a 0.22 μm filter membrane to obtain a bromhexine solution; before and after filling the bromhexine solution, nitrogen protection is filled in the ampoule, and under aseptic conditions Next, the bromhexine solution is filled in the ampoule and sealed, and packed to obtain the bromhexine hydrochloride solution preparation for inhalation of the present invention, and its pH value is 2.6.

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Abstract

The invention belongs to the field of pharmaceutical technology and specifically relates to a bromhexine hydrochloride solution preparation for inhalation and a preparation method thereof. The invention discloses the bromhexine hydrochloride solution preparation for inhalation. The bromhexine solution includes bromhexine hydrochloride, a pH adjusting agent and a solvent. The bromhexine hydrochloride solution preparation for inhalation has low impurity content and the solvent realizes a low degradation rate of bromhexine for long term storage. The content of impurity E can be controlled withinthe range of less than 0.05%. The solution preparation for inhalation provided by the invention has high stability, reliable quality and high safety and can be preserved for a long time. No preservative is added into the solution preparation so that the solution preparation has a higher safety factor and a pleasant mouthfeel which fully hides the bitter taste of the bromhexine.

Description

technical field [0001] The invention belongs to the field of pharmacy, and in particular relates to a bromhexine hydrochloride solution preparation for inhalation and a preparation method thereof. Background technique [0002] Bromhexine, chemical name N-methyl-N-cyclohexyl-2-amino-3,5-dibromobenzylamine, molecular formula C 14 h 2 0Br 2 N 2 , CAS: 3572-43-8, which is a semi-synthetic product obtained by structural modification of vasicine, white or off-white crystalline powder; odorless, tasteless; slightly soluble in ethanol or chloroform, Very slightly soluble in water. [0003] Bromhexine hydrochloride directly acts on bronchial glands, which can promote the release of lysosomes in mucus-secreting cells, and make the mucopolysaccharide fibers in sputum differentiate and crack; it can also inhibit the synthesis of acid glycoproteins in mucous glands and goblet cells , so that it secretes low-viscosity small molecule glycoproteins, thereby reducing the viscosity of sp...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/08A61K47/12A61K31/137A61P11/10
CPCA61K9/08A61K9/0078A61K47/12A61K31/137A61P11/10
Inventor 张保献胡杰李海朋宋艳威
Owner BEIJING INCREASE INNOVATIVE DRUG RESEARCH CO LTD
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