Ambroxol hydrochloride injection

A kind of technology of ambroxol hydrochloride and injection, applied in the field of pharmaceutical preparations

Active Publication Date: 2009-04-29
天津康哲维盛医药科技发展有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] The ambroxol hydrochloride injection that is determined through systematic test research screening of the present invention, contains the best stable element, has not yet seen relevant reports so far

Method used

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  • Ambroxol hydrochloride injection
  • Ambroxol hydrochloride injection
  • Ambroxol hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0039] 1000 sticks

[0040] prescription:

[0041] Ambroxol Hydrochloride 15.0g,

[0042] Citric acid 2.0g,

[0043] Sodium dihydrogen phosphate 6.0g,

[0044] Sodium chloride 18.0g,

[0045] Add water for injection to 2000ml.

[0046] Process:

[0047] First add 1000ml of water for injection into the container, then add citric acid, sodium dihydrogen phosphate, and sodium chloride in sequence, stir and dissolve at room temperature for about 30 minutes, add 1mol / L hydrochloric acid or 1mol / L sodium hydroxide to adjust the pH to 3-5, Add ambroxol hydrochloride and stir thoroughly to dissolve it completely. Add 0.1% activated carbon, stir at room temperature for 20 minutes, filter to remove carbon, add remaining water for injection to make up the full amount, measure the content of the intermediate, fine filter, fill and sterilize with every 2ml to obtain Ambroxol Hydrochloride Injection.

Embodiment 2

[0048] 1000 sticks

[0049] prescription:

[0050] Ambroxol Hydrochloride 30.0g,

[0051] Phosphoric acid 1.0g,

[0052] Mannitol 40.0g,

[0053] Sorbitol 25.0g,

[0054] Sodium chloride 9.0g,

[0055] Add water for injection to 1000ml.

[0056] Process:

[0057] First add 800ml of water for injection into the container, then add mannitol, sorbitol, and sodium chloride in sequence and stir to dissolve at room temperature for about 30 minutes, add 0.1mol / L phosphoric acid or potassium hydroxide to adjust the pH to 3-5, add ambroxol hydrochloride fully Stir to dissolve completely. Add the remaining water for injection to make up the full amount, add 0.2% activated carbon, stir at room temperature for 20 minutes, decarburize, filter and sterilize with a microporous membrane, divide the filtrate into 1ml per tube, pre-freeze for 3 hours, and dry under reduced pressure under freezing After 15 hours, after the temperature of the sample reached room temperature, it was dried...

Embodiment 3

[0058] 100 sticks

[0059] prescription:

[0060] Ambroxol Hydrochloride 15.0g,

[0061] Hydrochloric acid 2.0g,

[0062] Sodium bicarbonate 6.0g,

[0063] Sodium chloride 90.0g,

[0064] Add water for injection to 10000ml.

[0065] Process:

[0066] First add 8000ml of water for injection into the container, then add sodium bicarbonate and sodium chloride in turn to dissolve at room temperature for about 30 minutes, add 1mol / L hydrochloric acid or 1mol / L ammonium hydroxide to adjust the pH to 3-5, add ambroxol hydrochloride fully Stir to dissolve completely. Add 0.1% activated carbon, stir at room temperature for 20 minutes, filter to remove carbon, add the remaining water for injection to make up the whole amount, measure the content of intermediates, fine filter, fill with 100ml each, and sterilize to obtain ambroxol hydrochloride sodium chloride injection liquid.

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PUM

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Abstract

The invention relates to a medicinal preparation, in particular to an ambroxol hydrochloride injection which is a stable medial composition taking ambroxol hydrochloride as an active ingredient to be combined with carriers acceptable in pharmacy. The carriers comprise a water-soluble filling agent, a pH regulating agent, a stabilizing agent, water used for injection or an osmotic pressure regulating agent and the like. As the carriers are adopted to carry out scientific preparation, the drug quality and medication safety of freeze-dried powder injections, small-needle injections and small infusion solutions are ensured, and the stability of the preparations during storage is improved.

Description

Technical field: [0001] The invention relates to a pharmaceutical preparation, more specifically, an expectorant drug-ambroxol hydrochloride injection. Background technique: [0002] The chemical name of ambroxol hydrochloride is: trans 4-[(2-amino-3,5 dibromo-phenyl) methyl-amino] cyclohexanol, and its structure is as follows: [0003] [0004] Ambroxol hydrochloride is a new generation of airway mucus regulator, which has excellent expectorant effect and can significantly promote the synthesis and secretion of alveolar surfactant. Ambroxol hydrochloride can stimulate bronchial mucous glands to secrete more fluid mucus, dilute sputum, reduce viscosity, and increase the production and secretion of pulmonary surfactant, thereby reducing airway resistance and mucus adhesion. Activates mucociliary blanket function and promotes mucociliary transport. Compared with the first-generation and second-generation expectorant drugs, ambroxol hydrochloride, in addition to its powerf...

Claims

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Application Information

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IPC IPC(8): A61K31/137A61K9/08A61K9/19A61K47/12A61P11/10
Inventor 邹美香孙歆慧任晓文吴疆张彩霞
Owner 天津康哲维盛医药科技发展有限公司
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