Steady moxifloxacin hydrochloride injection

Abstract

The invention discloses a steady moxifloxacin hydrochloride injection. The steady moxifloxacin hydrochloride injection is composed of moxifloxacin hydrochloride, a pH adjusting agent, a stabilizing agent and water for injection. The moxifloxacin disclosed by the invention is steady and easy to store; and the problems that the moxifloxacin is easily crystallized and the colour of solution is deepened in the storage process are solved.

Description

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, and relates to a novel moxifloxacin hydrochloride injection and a preparation method thereof. Background technique

[0002] Moxifloxacin hydrochloride (Moxifloxacin), the fourth generation of extended-spectrum fluoroquinolone antibacterial drugs, has been shown in vitro to Gram-positive bacteria, Gram-negative bacteria, anaerobic bacteria, acid-fast bacteria, and atypical microorganisms such as mycoplasma and chlamydia and Legionella have broad-spectrum antibacterial activity. Topoisomerases are key enzymes that control DNA topology and are involved in DNA replication, repair and transcription. Moxifloxacin exerts antibacterial effect by interfering with II and IV topoisomerases. The structural formula of moxifloxacin hydrochloride is as follows:

[0003]

[0004] Injection is a preparation with rapid curative effect, especially for patients who cannot be administered orally. The...

Examples

Embodiment 1

[0016] Moxifloxacin Hydrochloride Injection (20ml:0.4g)

[0017] prescription

[0018] Moxifloxacin hydrochloride 40g (calculated as moxifloxacin)

[0019] PEG200 13g

[0020] Appropriate amount of sodium hydroxide

[0021] Add water for injection to 2000ml

[0022] A total of 100 sticks were prepared

[0023] Preparation process: Take about 800ml of water for injection, adjust the water temperature to 50-60°C, add the prescribed amount of moxifloxacin and PEG200, stir to dissolve, adjust the pH to 5.5 with 2mol / L sodium hydroxide solution, and make up water for injection to Full amount. Add 0.5% activated carbon to adsorb for 30 minutes, filter and decarbonize; the liquid medicine is filtered through 0.45 μm and 0.22 μm filter membranes respectively; after potting, it is sterilized by flowing steam at 121°C / 15min. Moxifloxacin hydrochloride injection was obtained.

Embodiment 2

[0025] Moxifloxacin Hydrochloride Injection (20ml:0.4g)

[0026] prescription

[0027] Moxifloxacin hydrochloride 40g (calculated as moxifloxacin)

[0028] PEG200 65g

[0029] Appropriate amount of sodium hydroxide

[0030] Add water for injection to 2000ml

[0031] A total of 100 sticks were prepared

[0032] Preparation process: Take about 800ml of water for injection, adjust the water temperature to 50-60°C, add the prescribed amount of moxifloxacin and PEG200, stir to dissolve, adjust the pH to 4.5 with 2mol / L sodium hydroxide solution, and make up water for injection to Full amount. Add 0.5% activated carbon to adsorb for 30 minutes, filter and decarbonize; the liquid medicine is filtered through 0.45 μm and 0.22 μm filter membranes respectively; after potting, it is sterilized by flowing steam at 121°C / 15min. Moxifloxacin hydrochloride injection was obtained.

Embodiment 3

[0034] Moxifloxacin Hydrochloride Injection (20ml:0.4g)

[0035] prescription

[0036] Moxifloxacin hydrochloride 40g (calculated as moxifloxacin)

[0037] Appropriate amount of sodium hydroxide

[0038] PEG200 300g

[0039] Add water for injection to 2000ml

[0040] A total of 100 sticks were prepared

[0041] Preparation process: Take about 800ml of water for injection, adjust the water temperature to 50-60°C, add the prescribed amount of moxifloxacin and PEG200, stir to dissolve, adjust the pH to 4.5 with 2mol / L sodium hydroxide solution, and make up water for injection to Full amount. Add 0.5% activated carbon to adsorb for 30 minutes, filter and decarbonize; filter the liquid medicine through 0.45 μm and 0.22 μm filter membranes; Moxifloxacin hydrochloride injection was obtained.

technical field

[0001] The invention belongs to the field of pharmaceutical preparations, and relates to a novel moxifloxacin hydrochloride injection and a preparation method thereof. Background technique

[0002] Moxifloxacin hydrochloride (Moxifloxacin), the fourth generation of extended-spectrum fluoroquinolone antibacterial drugs, has been shown in vitro to Gram-positive bacteria, Gram-negative bacteria, anaerobic bacteria, acid-fast bacteria, and atypical microorganisms such as mycoplasma and chlamydia and Legionella have broad-spectrum antibacterial activity. Topoisomerases are key enzymes that control DNA topology and are involved in DNA replication, repair and transcription. Moxifloxacin exerts antibacterial effect by interfering with II and IV topoisomerases. The structural formula of moxifloxacin hydrochloride is as follows:

[0003]

[0004] Injection is a preparation with rapid curative effect, especially for patients who cannot be administered orally. The...

Examples

Embodiment 1

[0016] Moxifloxacin Hydrochloride Injection (20ml:0.4g)

[0017] prescription

[0018] Moxifloxacin hydrochloride 40g (calculated as moxifloxacin)

[0019] PEG200 13g

[0020] Appropriate amount of sodium hydroxide

[0021] Add water for injection to 2000ml

[0022] A total of 100 sticks were prepared

[0023] Preparation process: Take about 800ml of water for injection, adjust the water temperature to 50-60°C, add the prescribed amount of moxifloxacin and PEG200, stir to dissolve, adjust the pH to 5.5 with 2mol / L sodium hydroxide solution, and make up water for injection to Full amount. Add 0.5% activated carbon to adsorb for 30 minutes, filter and decarbonize; the liquid medicine is filtered through 0.45 μm and 0.22 μm filter membranes respectively; after potting, it is sterilized by flowing steam at 121°C / 15min. Moxifloxacin hydrochloride injection was obtained.

Embodiment 2

[0025] Moxifloxacin Hydrochloride Injection (20ml:0.4g)

[0026] prescription

[0027] Moxifloxacin hydrochloride 40g (calculated as moxifloxacin)

[0028] PEG200 65g

[0029] Appropriate amount of sodium hydroxide

[0030] Add water for injection to 2000ml

[0031] A total of 100 sticks were prepared

[0032] Preparation process: Take about 800ml of water for injection, adjust the water temperature to 50-60°C, add the prescribed amount of moxifloxacin and PEG200, stir to dissolve, adjust the pH to 4.5 with 2mol / L sodium hydroxide solution, and make up water for injection to Full amount. Add 0.5% activated carbon to adsorb for 30 minutes, filter and decarbonize; the liquid medicine is filtered through 0.45 μm and 0.22 μm filter membranes respectively; after potting, it is sterilized by flowing steam at 121°C / 15min. Moxifloxacin hydrochloride injection was obtained.

Embodiment 3

[0034] Moxifloxacin Hydrochloride Injection (20ml:0.4g)

[0035] prescription

[0036] Moxifloxacin hydrochloride 40g (calculated as moxifloxacin)

[0037] Appropriate amount of sodium hydroxide

[0038] PEG200 300g

[0039] Add water for injection to 2000ml

[0040] A total of 100 sticks were prepared

[0041] Preparation process: Take about 800ml of water for injection, adjust the water temperature to 50-60°C, add the prescribed amount of moxifloxacin and PEG200, stir to dissolve, adjust the pH to 4.5 with 2mol / L sodium hydroxide solution, and make up water for injection to Full amount. Add 0.5% activated carbon to adsorb for 30 minutes, filter and decarbonize; filter the liquid medicine through 0.45 μm and 0.22 μm filter membranes; Moxifloxacin hydrochloride injection was obtained.

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