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Stable bromhexine hydrochloride solution for inhalation and preparation method thereof

A bromhexine hydrochloride solution technology, applied in the field of medicine, can solve problems such as large amount of excipients and drug safety issues, and achieve the effect of ensuring drug safety and improving stability

Active Publication Date: 2022-05-31
北京诺和德美医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Chinese patent application CN104306329A discloses a kind of bromhexine hydrochloride injection with higher stability, its adjuvant comprises tartaric acid and stabilizer (mannitol, xylitol and sorbitol Alcohol) etc., the shortcoming of this technical scheme is that the adjuvant consumption of injection is bigger, as the consumption of principal agent bromhexine hydrochloride is 1-4g, the addition amount of stabilizer reaches 40-60g, there is a certain degree of drug safety problem

Method used

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  • Stable bromhexine hydrochloride solution for inhalation and preparation method thereof
  • Stable bromhexine hydrochloride solution for inhalation and preparation method thereof
  • Stable bromhexine hydrochloride solution for inhalation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] prescription:

[0042] Bromhexine hydrochloride 2g

[0043] DL-tartaric acid 1g

[0044] L-serine 0.1g,

[0045] Water for injection was added to 1000mL,

[0046] Preparation:

[0047] 1) grinding after mixing bromhexine hydrochloride and L-serine to obtain the mixture of bromhexine hydrochloride and L-serine;

[0048] 2) Take 90% water for injection, add DL-tartaric acid under stirring, and after dissolving, add the mixture of bromhexine hydrochloride and L-serine and stir until completely dissolved, adjust pH to 3 with sodium hydroxide, and add water for injection to the full amount;

[0049] 3) Filtration and filling:

[0050] After constant volume, the liquid medicine is stirred evenly, filtered through a 0.22 μm polyethersulfone filter membrane, filled, filled with nitrogen, and melted and sealed.

Embodiment 2

[0052] Bromhexine hydrochloride 2g

[0053] DL-tartaric acid 1g

[0054] L-serine 0.2g,

[0055] Water for injection was added to 1000mL,

[0056] Preparation:

[0057] 1) grinding after mixing bromhexine hydrochloride and L-serine to obtain the mixture of bromhexine hydrochloride and L-serine;

[0058] 2) Take 90% water for injection, add DL-tartaric acid under stirring, and after dissolving, add the mixture of bromhexine hydrochloride and L-serine and stir until completely dissolved, adjust pH to 3 with sodium hydroxide, and add water for injection to the full amount;

[0059] 3) Filtration and filling:

[0060] After constant volume, the liquid medicine is stirred evenly, filtered through a 0.22 μm polyethersulfone filter membrane, filled, filled with nitrogen, and melted and sealed.

Embodiment 3

[0062] Bromhexine hydrochloride 2g

[0063] DL-tartaric acid 1g

[0064] L-serine 0.3g,

[0065] Water for injection was added to 1000mL,

[0066] Preparation:

[0067] 1) grinding after mixing bromhexine hydrochloride and L-serine to obtain the mixture of bromhexine hydrochloride and L-serine;

[0068] 2) Take 90% water for injection, add DL-tartaric acid under stirring, and after dissolving, add the mixture of bromhexine hydrochloride and L-serine and stir until completely dissolved, adjust pH to 3 with sodium hydroxide, and add water for injection to the full amount;

[0069] 3) Filtration and filling:

[0070] After constant volume, the liquid medicine is stirred evenly, filtered through a 0.22 μm polyethersulfone filter membrane, filled, filled with nitrogen, and melted and sealed.

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Abstract

The invention discloses a stable bromhexine hydrochloride solution for inhalation and a preparation method thereof. The pH value of the bromhexine hydrochloride solution for inhalation is 3.0, the bromhexine hydrochloride solution for inhalation is composed of 2 g of bromhexine hydrochloride, 1 g of DL-tartaric acid and 0.1-0.5 g of L-serine, and water for injection is added to 1000 mL. According to the bromhexine hydrochloride solution for inhalation, a large number of stabilizers do not need to be added, the stability of the bromhexine hydrochloride solution can be improved by adopting a trace amount of L-serine as an auxiliary agent, L-serine is an amino acid beneficial to a human body, no risk is caused, and the stability of the bromhexine hydrochloride solution is improved. The medication safety is ensured.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a stable solution of bromhexine hydrochloride for inhalation and a preparation method thereof. Background technique [0002] Bromhexine hydrochloride for inhalation developed by SANOFI was first listed in Belgium on September 30, 1990 under the trade name of The specifications are 0.2% (40ml, 100ml, 250ml), and the indications are acute bronchitis, tracheobronchitis, chronic bronchitis, chronic obstructive bronchopulmonary disease, bronchiectasis, acute sinusitis, and chronic sinusitis. [0003] Bromhexine Hydrochloride English name: Bromhexine Hydrochloride, chemical formula: [0004] [0005] Slightly soluble in methanol, slightly soluble in ethanol, very slightly soluble in water. Not hygroscopic and stable to light, but produces decomposition products when exposed to aqueous solutions. [0006] Chinese patent application CN104306329A discloses a kind of bromhexine h...

Claims

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Application Information

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IPC IPC(8): A61K9/72A61K9/08A61K31/137A61K47/18A61P11/00A61P11/02A61P11/08
CPCA61K31/137A61K9/08A61K47/183A61K9/007A61P11/00A61P11/02A61P11/08
Inventor 郑柏松郝靓钰张文龙童元峰谌宗永
Owner 北京诺和德美医药科技有限公司
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