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 abroa

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

Example Embodiment

[0028] Example 1-7

[0029] The preparation methods of the bromhexine hydrochloride solution for inhalation in Examples 1-7 are the same, but the prescriptions are different. Refer to Table 1 for the specific dosages of bromhexine hydrochloride and tartaric acid in the prescription.

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

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

[0032] Table 1 Specific dosages of b...

Example Embodiment

[0034] Example 8

[0035] prescription

[0036] Bromhexine hydrochloride 1.5mg / ml

[0037] Tartaric acid 0.75mg / ml

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

[0039] (2) The pre-inhalation solution obtained in step (1) is finely filtered with a 0.22μm filter membrane to obtain the bromhexine solution; before and after filling the bromhexine solution, the ampoules are filled with nitrogen for protection, and under aseptic conditions Next, fill the bromhexine solution in an ampoule, seal it, and package to obtain the bromhexine hydrochloride solution preparation for inhalation of the present invention, with a pH of 2.65.

Example Embodiment

[0040] Example 9

[0041] prescription

[0042] Bromhexine hydrochloride 3mg / ml

[0043] Tartaric acid 0.9mg / ml

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

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