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Stable amorphous ambroxol hydrochloride compound

A ambroxol hydrochloride, amorphous technology, applied in the field of medicine, can solve problems affecting the quality and safety of drugs

Active Publication Date: 2012-10-03
天津梅花生物医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Because ambroxol hydrochloride has free ambroxol in the molecule under oxidative or alkaline conditions, the related substances increase during storage, which affects the quality and safety of the drug

Method used

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  • Stable amorphous ambroxol hydrochloride compound
  • Stable amorphous ambroxol hydrochloride compound
  • Stable amorphous ambroxol hydrochloride compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0058] The X-ray diffraction pattern of the powder is shown in figure 1 . Instrument model and measurement conditions: Rigaku D / max 2500 diffractometer; CuKa 40Kv 100mA; 2θ scanning range: 0-50 ° .

[0059] The infrared spectrum of the crystal is shown in figure 2 , Determination with KBr tablet.

[0060] Example 2

Embodiment 2

[0062] prescription:

[0063] Ambroxol Hydrochloride Amorphous 15g

[0064] Lactose 500g

[0065] Microcrystalline Cellulose 240g

[0066] Aspartame 15g

[0067] Croscarmellose Sodium 80g

[0068] Hydroxypropyl Methyl Cellulose 135g

[0069] Magnesium Stearate 5g

[0070] Appropriate amount of water, made into 1000 bags.

[0071] Process:

[0072] 1) Preparation: dry lactose, microcrystalline cellulose, aspartame, croscarmellose sodium, hydroxypropyl methylcellulose, and magnesium stearate at 80°C for 4 hours, and set aside;

[0073] 2) Weighing: Weigh the prescription amount of amorphous ambroxol hydrochloride, lactose, microcrystalline cellulose, aspartame, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate ;

[0074] 3) Mixing: Put the prescribed amount of amorphous ambroxol hydrochloride, lactose, microcrystalline cellulose, aspartame, croscarmellose sodium, and hydroxypropyl methylcellulose into a high-efficiency mixing granulator in, mix...

Embodiment 3

[0082] prescription:

[0083] Ambroxol Hydrochloride Amorphous 15g

[0084] Lactose 60g

[0085] Microcrystalline Cellulose 50g

[0086] Croscarmellose Sodium 30g

[0087] Hydroxypropyl Methyl Cellulose 15g

[0088] Magnesium Stearate 1g

[0089] Appropriate amount of water, made into 1000 capsules.

[0090] Process:

[0091] 1) Preparation: dry lactose, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl methylcellulose, and magnesium stearate at 80°C for 4 hours, and set aside;

[0092] 2) Weighing: Take amorphous ambroxol hydrochloride, lactose, microcrystalline cellulose, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate of prescription quantity;

[0093] 3) Mixing: put the prescription amount of amorphous ambroxol hydrochloride, lactose, microcrystalline cellulose, croscarmellose sodium, and hydroxypropyl methylcellulose into a high-efficiency mixing granulator, and mix evenly;

[0094] 4) Granulation: Add an appropriate amoun...

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Abstract

The invention belongs to the technical field of medicine, and particularly relates to an amorphous ambroxol hydrochloride compound and a preparation method thereof. The amorphous ambroxol hydrochloride compound has high purity and stability, does not have obvious moisture absorption and weight increase even under the condition of high humidity, ensures that relative substances do not grow, and has higher dissolution rate than crystalline ambroxol hydrochloride. The invention also relates to an application of the amorphous ambroxol hydrochloride compound in preparation of medicine for the treatment of acute and chronic pulmonary diseases with the symptom of ropy sputum and difficult expectoration, phlegm eliminating treatment of acute exacerbation of chronic bronchitis, asthmatic bronchitis and bronchial asthma, prophylactic treatment of lung complication after an operation, and treatment of infant respiratory distress syndrome (IRDS) of premature infants and neonates.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to an amorphous ambroxol hydrochloride compound and a preparation method thereof. Background technique [0002] Ambroxol hydrochloride is a mucus dissolving agent, also known as bromcycline hydrochloride, which is widely used in clinical practice due to its strong effect on eliminating phlegm and improving lung function. The drug can act on secretory cells, regulate the secretion of serous and mucus, increase serous secretion, dissolve and dilute mucus, strengthen the swing of cilia, increase the clearance ability of mucus transport system, and make sputum easy to discharge. Ambroxol hydrochloride is also a protective agent for the respiratory system, which has anti-oxidation, inhibits the release of inflammatory mediators, relaxes airway smooth muscle, and promotes the synthesis and secretion of pulmonary surfactant. Ambroxol hydrochloride can also increase the drug c...

Claims

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Application Information

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IPC IPC(8): C07C215/44C07C213/10A61K31/137A61K9/08A61P11/10A61P11/00A61P29/00
Inventor 梅开忠黄欣
Owner 天津梅花生物医药科技有限公司
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