Preparing method for ambroxol hydrochloride injection

Abstract

The invention discloses a preparing method for ambroxol hydrochloride injection. The preparing method for the ambroxol hydrochloride injection includes the following steps that each 2ml of the injection comprises, by weight, 15 mg of ambroxol hydrochloride, 4.0 mg of disodium hydrogen phosphate, 1.16 mg of citric acid and 14 mg-16 mg of sodium chloride; water for injection is cooled to be below 30 DEG C; the disodium hydrogen phosphate and the citric acid are added into the water for injection to be dissolved; a prescribed dosage of ambroxol hydrochloride raw medicine is added to be dissolved; the sodium chloride is added to adjust solution to be isotonic; the solution is filtered through a 0.22-micrometer millipore filter; and the solution is filled and sterilized after high purity nitrogen gas is let in. The preparing method for the ambroxol hydrochloride injection is simple in process and stable in product quality.

Description

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of ambroxol hydrochloride injection. Background technique

[0002] Ambroxol hydrochloride is the most widely used expectorant clinically. It can stimulate the formation of respiratory surfactant and regulate the secretion of serous and mucus, improve the elimination of ciliated area and non-ciliated area of ​​the respiratory tract at the same time, reduce the adhesion of low sputum and cilia, further make sputum easy to cough up, and Relieves the symptoms of coughing. Due to the rapid and reliable effect of this product, good tolerance, and long-term use, it is an ideal and excellent expectorant. Its compound structural formula is as follows:

[0003]

[0004] Ambroxol hydrochloride preparations currently approved for marketing are ambroxol hydrochloride tablets and ambroxol hydrochloride injection, developed by Boehringer Ingelheim. Accord...

Examples

Embodiment 1

[0032] Element

[0033] The preparation method is: take about 1200g of water for injection below 30°C, add the prescribed amount of disodium hydrogen phosphate and citric acid, and dissolve completely; add the prescribed amount of ambroxol hydrochloride into the above solution, stir to dissolve, and add Water for injection to 2000ml; filtered through a 0.22 μm improved PVDF membrane, filled with nitrogen gas, sterilized at 121°C for 15 minutes to obtain ambroxol hydrochloride injection containing 7.5mg of ambroxol hydrochloride per 1ml.

Embodiment 2

[0035] Element

[0036] The preparation method is: take about 1200g of water for injection below 30°C, add the prescribed amount of disodium hydrogen phosphate and citric acid, and dissolve completely; add the prescribed amount of ambroxol hydrochloride into the above solution, stir to dissolve, and add Water for injection to 2000ml; filtered through a 0.22 μm improved PVDF membrane, filled, 121°C for 15min, to obtain ambroxol hydrochloride injection containing 7.5mg of ambroxol hydrochloride per 1ml.

Embodiment 3

[0038] Element

[0039] The preparation method is: take about 1200g of water for injection below 30°C, add the prescribed amount of disodium hydrogen phosphate and citric acid, and dissolve completely; add the prescribed amount of ambroxol hydrochloride into the above solution, stir to dissolve, and add Water for injection to 2000ml; filtered through a 0.22 μm improved PVDF membrane, filled with nitrogen gas, sterilized at 121°C for 15 minutes to obtain ambroxol hydrochloride injection containing 7.5mg of ambroxol hydrochloride per 1ml.

technical field

[0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of ambroxol hydrochloride injection. Background technique

[0002] Ambroxol hydrochloride is the most widely used expectorant clinically. It can stimulate the formation of respiratory surfactant and regulate the secretion of serous and mucus, improve the elimination of ciliated area and non-ciliated area of ​​the respiratory tract at the same time, reduce the adhesion of low sputum and cilia, further make sputum easy to cough up, and Relieves the symptoms of coughing. Due to the rapid and reliable effect of this product, good tolerance, and long-term use, it is an ideal and excellent expectorant. Its compound structural formula is as follows:

[0003]

[0004] Ambroxol hydrochloride preparations currently approved for marketing are ambroxol hydrochloride tablets and ambroxol hydrochloride injection, developed by Boehringer Ingelheim. Accord...

Examples

Embodiment 1

[0032] Element

[0033] The preparation method is: take about 1200g of water for injection below 30°C, add the prescribed amount of disodium hydrogen phosphate and citric acid, and dissolve completely; add the prescribed amount of ambroxol hydrochloride into the above solution, stir to dissolve, and add Water for injection to 2000ml; filtered through a 0.22 μm improved PVDF membrane, filled with nitrogen gas, sterilized at 121°C for 15 minutes to obtain ambroxol hydrochloride injection containing 7.5mg of ambroxol hydrochloride per 1ml.

Embodiment 2

[0035] Element

[0036] The preparation method is: take about 1200g of water for injection below 30°C, add the prescribed amount of disodium hydrogen phosphate and citric acid, and dissolve completely; add the prescribed amount of ambroxol hydrochloride into the above solution, stir to dissolve, and add Water for injection to 2000ml; filtered through a 0.22 μm improved PVDF membrane, filled, 121°C for 15min, to obtain ambroxol hydrochloride injection containing 7.5mg of ambroxol hydrochloride per 1ml.

Embodiment 3

[0038] Element

[0039] The preparation method is: take about 1200g of water for injection below 30°C, add the prescribed amount of disodium hydrogen phosphate and citric acid, and dissolve completely; add the prescribed amount of ambroxol hydrochloride into the above solution, stir to dissolve, and add Water for injection to 2000ml; filtered through a 0.22 μm improved PVDF membrane, filled with nitrogen gas, sterilized at 121°C for 15 minutes to obtain ambroxol hydrochloride injection containing 7.5mg of ambroxol hydrochloride per 1ml.

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