Ambroxol hydrochloride freeze-dried powder composite used for injection and preparation method thereof

A technology of ambroxol hydrochloride and a composition, applied in the field of medicine, can solve problems such as airway stenosis, fixed airway obstruction, etc., and achieve the effects of alleviating wheezing, inhibiting glandular secretion, and improving stability

Inactive Publication Date: 2012-09-19
HAINAN WEI KANG PHARMA QIANSHAN
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Airway wall structural remodeling, increased collagen content, and scar tissue formation occur during the repair process, which narrows the airway and causes fixed airway obstruction

Method used

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  • Ambroxol hydrochloride freeze-dried powder composite used for injection and preparation method thereof
  • Ambroxol hydrochloride freeze-dried powder composite used for injection and preparation method thereof
  • Ambroxol hydrochloride freeze-dried powder composite used for injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Embodiment one, the preparation of ambroxol hydrochloride scopolamine freeze-dried powder for injection, in 1000

[0026] 1. Prescription

[0027]

[0028] 2. Preparation process

[0029] Add the prescribed amount of ambroxol hydrochloride, scopolamine and mannitol to the water for injection, stir and dissolve, add NaOH solution to adjust the pH value to 5.0, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and pass the liquid through 0.45μm Filter with 0.22μm microporous membrane, pack in cans, put into a freeze dryer, cool down to -40°C, keep warm for 2 hours, then slowly heat up to -5°C~0°C for sublimation and drying, then heat up to 35°C, keep warm After 3 hours, the freeze-drying was completed and the product was taken out of the box.

Embodiment 2

[0030] Embodiment two, the preparation of ambroxol hydrochloride scopolamine freeze-dried powder for injection, in 1000

[0031] 1. Prescription

[0032]

[0033] 2. Preparation process

[0034] Add the prescribed amount of ambroxol hydrochloride, scopolamine and mannitol to the water for injection, stir and dissolve, add NaOH solution to adjust the pH value to 5.0, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and pass the liquid through 0.45μm Filter with 0.22μm microporous membrane, pack in cans, put into a freeze dryer, cool down to -40°C, keep warm for 2 hours, then slowly heat up to -5°C~0°C for sublimation and drying, then heat up to 35°C, keep warm After 3 hours, the freeze-drying was completed and the product was taken out of the box.

Embodiment 3

[0035] Embodiment three, the preparation of ambroxol hydrochloride scopolamine freeze-dried powder for injection, in 1000

[0036] 1. Prescription

[0037]

[0038] 2. Preparation process

[0039] Add the prescribed amount of ambroxol hydrochloride, scopolamine and mannitol to the water for injection, stir and dissolve, add NaOH solution to adjust the pH value to 5.0, add 0.1% activated carbon and stir for 30 minutes, filter out the activated carbon, and pass the liquid through 0.45μm Filter with 0.22μm microporous membrane, pack in cans, put into a freeze dryer, cool down to -40°C, keep warm for 2 hours, then slowly heat up to -5°C~0°C for sublimation and drying, then heat up to 35°C, keep warm After 3 hours, the freeze-drying was completed and the product was taken out of the box.

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PUM

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Abstract

The invention discloses an ambroxol hydrochloride freeze-dried powder composite used for injection and a preparation method thereof, and relates to the field of the medicine. The main medicines of the composite are ambroxol hydrochloride and scopolamine. The preparation method for the freeze-dried powder composite comprises the following specific steps of: adding 0.1-99.9wt% of ambroxol hydrochloride, 99.9-0.1wt% of scopolamine and mannitol of which the volume is 5-10 times of the main medicine into water used for injection; after mixture is stirred and dissolved, adding NaOH solution to regulate a pH value to 5.0; adding activated carbon accounting for 0.1% of total volume to stir for 30 minutes; filtering to remove the activated carbon; filtering liquid medicine by microfiltration membranes of 0.45mu m and 0.22mu m; canning and sending into a freezer dryer; cooling to -40DEG C; after keeping temperature for 2 hours, slowly raising the temperature to -5-0DEG C, subliming and drying; after the temperature is raised to 35DEG C, keeping the temperature for 3 hours; and after the liquid medicine is frozen and dried, discharging out of a box to obtain the ambroxol hydrochloride freeze-dried powder composite used for injection. The preparation method for the ambroxol hydrochloride freeze-dried powder composite has the advantages that the liquid is convenient to process, a sterile operation process is simplified, the preparation stability is improved, moisture in a product can be removed without thermal treatment, and the rehydration (dissolving) capability of the preparation is enhanced.

Description

Technical field: [0001] The invention relates to the field of medicine, in particular to a composition of ambroxol hydrochloride freeze-dried powder for injection and a preparation method thereof. Background technique: [0002] Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterized by airflow limitation, which is not fully reversible and develops progressively. COPD mainly involves the lungs, but it can also cause systemic (or extrapulmonary) adverse effects. COPD is a common disease of the respiratory tract. As the age increases, the airway cilia clearance function of the elderly decreases, and the antioxidant effect of the lungs decreases. The elderly are prone to COPD. [0003] Chronic irritants such as tobacco smoke act on the lungs, causing abnormal inflammation in the lungs. COPD can involve the airway, lung parenchyma, and pulmonary vessels, manifested by a chronic inflammatory response dominated by infiltration of neutroph...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/46A61K9/19A61P11/00A61K31/137
Inventor 汪六一汪金灿
Owner HAINAN WEI KANG PHARMA QIANSHAN
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