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Moxifloxacin hydrochloride injection and preparation method thereof

A technology for moxifloxacin hydrochloride and injection, which is applied in the field of moxifloxacin hydrochloride injection and its preparation, can solve the problems such as no mention of metal ions, inability to use sodium chloride injection, instability of moxifloxacin, etc. Easy to industrialize production, solve instability, stable quality effect

Active Publication Date: 2014-01-22
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] In short, Moxifloxacin Hydrochloride Sodium Chloride Injection has compatibility limitations, and some patients with idiosyncratic constitutions, such as patients with heart failure, pulmonary edema, cerebral edema, increased intracranial pressure, pregnancy-induced hypertension, etc., cannot use chlorine sodium chloride injection, while moxifloxacin is unstable in glucose injection
In addition, none of the prior art mentioned how to avoid the influence of metal ions on moxifloxacin, and how to avoid the condensation reaction between the aldehyde group in glucose and the amino group in moxifloxacin hydrochloride

Method used

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  • Moxifloxacin hydrochloride injection and preparation method thereof
  • Moxifloxacin hydrochloride injection and preparation method thereof
  • Moxifloxacin hydrochloride injection and preparation method thereof

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Effect test

Embodiment 1

[0023] Embodiment 1 Moxifloxacin hydrochloride injection and preparation method thereof

[0024]

[0025] Preparation Process:

[0026] (1) Weigh the prescribed amount of ammonium acetate and dissolve it in an appropriate amount of water for injection;

[0027] (2) Add the prescribed amount of glucose to the above solution, stir to dissolve;

[0028] (3) Dissolve moxifloxacin hydrochloride in the above solution, add water for injection to the full amount, add 0.1% activated carbon, and stir;

[0029] (4) Decarburization, filtration, acetic acid to adjust the pH of the injection to 3.0, filtration, filling, and sterilization at 121°C for 15 minutes.

Embodiment 2

[0030] Embodiment 2 moxifloxacin hydrochloride injection and preparation method thereof

[0031]

[0032] Preparation Process:

[0033] (1) Weigh the prescribed amount of ammonium acetate and dissolve it in an appropriate amount of water for injection;

[0034] (2) Add the prescribed amount of glucose to the above solution, stir to dissolve;

[0035] (3) Dissolve moxifloxacin hydrochloride in the above solution, add water for injection to the full amount, add 0.1% activated carbon, and stir;

[0036] (4) Decarbonize, filter, adjust the pH of the injection to 4.0 with acetic acid, filter, fill, and sterilize at 121°C for 15 minutes.

Embodiment 3

[0037] Embodiment 3 moxifloxacin hydrochloride injection and preparation method thereof

[0038]

[0039] Preparation Process:

[0040] (1) Weigh the prescribed amount of ammonium acetate and dissolve it in an appropriate amount of water for injection;

[0041] (2) Add the prescribed amount of glucose to the above solution, stir to dissolve;

[0042](3) Dissolve moxifloxacin hydrochloride in the above solution, add water for injection to the full amount, add 0.1% activated carbon, and stir;

[0043] (4) Decarbonize, filter, adjust the pH of the injection to 3.5 with acetic acid, filter, fill, and sterilize at 121°C for 15 minutes.

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Abstract

The invention discloses moxifloxacin hydrochloride injection and a preparation method thereof. The injection adopts glucose as an isoosmotic adjusting agent, wherein the injection contains ammonium acetate and acetic acid; pH of the injection is adjusted to 3.0-4.0 by the acetic acid. According to the invention, stable moxifloxacin hydrochloride injection which is easy for industrial production is prepared and a novel drug-use choice is supplied to a patient not suitable for adopting sodium chloride injection.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a moxifloxacin hydrochloride injection and a preparation method thereof. Background technique [0002] Moxifloxacin hydrochloride is clinically used in the treatment of upper and lower respiratory tract infections, such as acute sinusitis, chronic bronchitis, community-acquired pneumonia, and skin and soft tissue infections. In recent years, the incidence of respiratory tract infection in my country (especially in large and medium-sized cities) has been increasing, and has become one of the common diseases with a large number of patients. Moxifloxacin has a broad antibacterial spectrum and has strong antibacterial activity against common respiratory pathogens. It has a good curative effect especially on lower respiratory tract infection. It has strong penetrating power and can maintain a high concentration in lung tissue, so it has a remarkable ef...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4709A61K47/16A61K47/26A61P31/04A61P11/00
Inventor 田舟山陈磊
Owner NANJING CHIA TAI TIANQING PHARMA