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Injection containing moxifloxacin hydrochloride composition

A technology for moxifloxacin hydrochloride and injections, which is applied in the field of injections containing moxifloxacin hydrochloride and mannitol compositions, and can solve problems such as poor solubility

Inactive Publication Date: 2013-06-12
安徽天洋药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Bayer also found in the study that the pharmaceutical preparation of moxifloxacin hydrochloride isotonically adjusted with sodium chloride is not sensitive to iron ions, however, the solubility of moxifloxacin hydrochloride in the presence of sodium chloride is too poor , so that the active compound in a lower concentration range and a certain amount of sodium chloride were finally selected to prepare a large infusion solution of moxifloxacin hydrochloride

Method used

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  • Injection containing moxifloxacin hydrochloride composition
  • Injection containing moxifloxacin hydrochloride composition

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Moxifloxacin hydrochloride injection water preparation, containing moxifloxacin 1.0% (W / V) 400mg / 40ml, containing 5.0% mannitol.

[0028] Moxifloxacin Hydrochloride 437g

[0029] Mannitol 2.0kg

[0030] Add water for injection 40kg

[0031] Preparation Process:

[0032] 1. Dissolution: Weigh 437g of moxifloxacin hydrochloride into the liquid preparation tank, then add about 90% of the total volume of water for injection, keep the temperature of the liquid preparation tank at 50°C-80°C, stir until the liquid medicine is completely dissolved, and then Add 2.0kg of mannitol and stir until completely dissolved, then add the remaining prescription amount of water for injection.

[0033] 2. Adjust pH: Measure the pH of the drug solution prepared in 1, and adjust the pH value to 4.25 with sodium hydroxide solution.

[0034] 3. Decolorization: keep the pH-adjusted solution at 50°C-80°C, add activated carbon, and circulate and stir for about 15 minutes to decolorize.

[003...

Embodiment 2

[0040] Moxifloxacin hydrochloride injection water preparation, containing moxifloxacin 2.0% (W / V) 400mg / 20ml, containing mannitol 2.0%.

[0041] Moxifloxacin Hydrochloride 437g

[0042] Mannitol 0.4kg

[0043] Add water for injection to 20kg

[0044] Preparation Process:

[0045] 1. Dissolution: Weigh 437g of moxifloxacin hydrochloride into the liquid preparation tank, then add about 90% of the total volume of water for injection, keep the temperature of the liquid preparation tank at 50°C-80°C, stir until the liquid medicine is completely dissolved, and then Add 0.4kg of mannitol and stir until completely dissolved, then add the remaining prescription amount of water for injection.

[0046] 2. Adjust pH: Measure the pH of the drug solution prepared in 1, and adjust the pH value to 4.25 with sodium hydroxide solution.

[0047] 3. Decolorization: keep the pH-adjusted solution at 50°C-80°C, add activated carbon, and circulate and stir for about 15 minutes to decolorize.

[...

Embodiment 3

[0053] Moxifloxacin hydrochloride injection water preparation, containing moxifloxacin 2.0% (W / V) 400mg / 20ml, containing 5.0% mannitol.

[0054] Moxifloxacin Hydrochloride 437g

[0055] Mannitol 1.0kg

[0056] Add water for injection 20kg

[0057] The preparation process is the same as in Example 2, and the amounts of mannitol and water for injection are changed accordingly.

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Abstract

The invention relates to an injection containing a moxifloxacin hydrochloride and mannitol composition. The injection prepared from the composition can be used for obviously improving the stability of drug solution. The prepared moxifloxacin hydrochloride injection is stable in quality and can be used for realizing the industrial production. The composition is used for treating or preventing human or animals from bacterial infection.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to an injection containing moxifloxacin hydrochloride and mannitol, and the prepared preparation is used for treating or preventing human or animal bacterial infection. Background technique [0002] Moxifloxacin hydrochloride (Moxifloxacin, CAS No.: 151096-09-2) is a fourth-generation fluoroquinolone chemically synthesized antibacterial drug. Moxifloxacin hydrochloride inhibits bacterial DNA helicase A subunit and topoisomerase IV. Activity, blocking the replication of DNA, thereby exerting a bactericidal effect. It has strong antibacterial activity against Gram-negative bacteria and Gram-positive bacteria, effective against mycoplasma, chlamydia, and Legionella, effective against anaerobic infection, and especially effective against some clinically common drug-resistant bacteria. It has the advantages of high drug concentration in the body, long plasma elimination half-lif...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K9/08A61K31/4709A61K47/10A61P31/04
Inventor 朱雄刘嵘丁雁苏晴唐开天王桂有王殿基黄玮朱永胜
Owner 安徽天洋药业有限公司
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