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Ambroxol hydrochloride composition and preparation thereof

A technology of ambroxol hydrochloride and its composition, which is applied in the field of medicine, can solve problems such as complex formulas and increased hidden dangers of drug safety, and achieve the effect of simple operation and enhanced safety performance

Active Publication Date: 2013-01-16
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] Patent ZL200710059969.6 discloses an ambroxol hydrochloride injection, which is a stable pharmaceutical composition composed of ambroxol hydrochloride as the active ingredient and pharmaceutically acceptable carriers. These carriers include water-soluble fillers and pH regulators. , stabilizer, water for injection or osmotic pressure regulator, etc., the prescription disclosed in this patent uses a variety of excipients, and the formula is relatively complicated, which further increases the safety hazard of the drug

Method used

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  • Ambroxol hydrochloride composition and preparation thereof
  • Ambroxol hydrochloride composition and preparation thereof
  • Ambroxol hydrochloride composition and preparation thereof

Examples

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Effect test

Embodiment 1

[0028] An ambroxol hydrochloride composition comprises: 15 parts by weight of ambroxol hydrochloride, 50 parts by weight of mannitol, 1 part by weight of meglumine, and 0.05 parts by weight of disodium edetate.

[0029] The dosage form of the composition is injection, and each injection contains: 15 mg of ambroxol hydrochloride, 50 mg of mannitol, 1-mg of meglumine, 0.05 mg of disodium edetate, and 2 ml of water for injection.

[0030] The preparation method of the preparation is as follows: dissolve the prescribed amount of meglumine and mannitol in water for injection with a volume ratio of 80%, and heat to 35° C., then add the prescribed amount of ambroxol hydrochloride, stir evenly, and then Add the prescribed amount of disodium edetate; add medical activated carbon at 30°C, filter, then cool to room temperature; add water for injection to the full amount, filter with a 0.22 μm pore size filter membrane, cool the filtrate to 3°C and use The 0.22 μm pore size filter membran...

Embodiment 2

[0032] An ambroxol hydrochloride composition comprises: 15 parts by weight of ambroxol hydrochloride, 150 parts by weight of mannitol, 1 part by weight of meglumine, and 0.5 parts by weight of disodium edetate.

[0033] The dosage form of the composition is injection, and each injection contains: 15 mg of ambroxol hydrochloride, 150 mg of mannitol, 10 mg of meglumine, 0.5 mg of disodium edetate, and 2 ml of water for injection.

[0034] The preparation method of the preparation is as follows: dissolve the prescribed amount of meglumine and mannitol in water for injection with a volume ratio of 70%, and heat to 35°C, then add the prescribed amount of ambroxol hydrochloride, stir well, and then Add the prescribed amount of disodium edetate; add medical activated carbon at 30°C, filter, then cool to room temperature; add water for injection to the full amount, filter with a 0.22 μm pore size filter membrane, cool the filtrate to 5°C and use The 0.22 μm pore size filter membrane i...

Embodiment 3

[0036] An ambroxol hydrochloride composition comprises: 15 parts by weight of ambroxol hydrochloride, 80 parts by weight of mannitol, 2 parts by weight of meglumine, and 0.08 parts by weight of disodium edetate.

[0037] The dosage form of the composition is injection, and each injection contains: 15 mg of ambroxol hydrochloride, 80 mg of mannitol, 2 mg of meglumine, 0.08 mg of disodium edetate, and 2 ml of water for injection.

[0038] The preparation method of the preparation is as follows: dissolve the prescribed amount of meglumine and mannitol in water for injection with a volume ratio of 70%, and heat to 30°C, then add the prescribed amount of ambroxol hydrochloride, stir evenly, and then Add the prescribed amount of disodium edetate; add medical activated carbon at 35°C, filter, then cool to room temperature; add water for injection to the full amount, filter with a 0.22 μm pore size filter membrane, cool the filtrate to 0°C and use The 0.22 μm pore size filter membrane...

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Abstract

The invention belongs to the technical field of medicines and particularly relates to an ambroxol hydrochloride composition and a preparation thereof. The composition comprises the following components in parts by weight: 15 parts of ambroxol hydrochloride, 50-150 parts of mannitol, 1-10 parts of meglumine and 0.05-0.5 part of ethylene diamine tetraacetic acid disodium. The preparation is injection. Every injection contains 15mg of ambroxol hydrochloride, 50-150mg of mannitol, 1-10mg of meglumine, 0.05-0.5mg of ethylene diamine tetraacetic acid disodium and 2ml of water for injection. The invention provides the safe and stable ambroxol hydrochloride preparation. Proved by stability tests, the stability of the ambroxol hydrochloride preparation is superior to that of preparations in the prior art.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a composition of ambroxol hydrochloride and a preparation thereof. Background technique [0002] Ambroxol Hydrochloride (Ambroxol Hydrochloride), also known as Mu Shu Tan, is a respiratory lubricating expectorant and mucolytic drug, Ambroxol Hydrochloride, the chemical name is trans-4-[(2-amino-3,5- Dibromobenzyl)amino]cyclohexanol hydrochloride has the properties of promoting mucus elimination and dissolving secretions. It can promote the elimination of viscous secretions in the respiratory tract and reduce the retention of mucus, thus significantly promoting expectoration and improving respiratory condition. It can promote the secretion of pulmonary surfactant, the secretion of airway fluid and the movement of cilia. Ambroxol hydrochloride is widely used clinically for thick sputum and difficulty expectoration caused by various acute and chronic respiratory disea...

Claims

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Application Information

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IPC IPC(8): A61K47/26A61K47/18A61K31/137A61K9/08A61P11/10
Inventor 李明杰郭中明杨磊祥牛洪芬
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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