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Moxifloxacin hydrochloride injection, preparation method and application thereof

A technology of moxifloxacin hydrochloride and sodium chloride injection, which is applied in the fields of pharmaceutical formulation, drug delivery, inorganic non-active ingredients, etc., and can solve problems such as poor stability

Inactive Publication Date: 2011-04-06
HC SYNTHETIC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent 00811427.7 records that the water preparation of moxifloxacin hydrochloride and glucose has poor stability due to iron ions

Method used

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

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0020] Embodiment 1: the preparation of moxifloxacin hydrochloride sodium chloride injection (0.4g / 250ml)

[0021] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0022] Sodium chloride 2.0kg

[0023] Sodium acetate 250g

[0024] Edetate Calcium Sodium 25g

[0025] Add water for injection to 250L

[0026]

[0027] 1000 bottles

[0028] 1) Obtain qualified moxifloxacin hydrochloride raw materials, sodium chloride, calcium sodium edetate and sodium acetate according to the ingredient list;

[0029] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium acetate, edetate calcium sodium, and moxifloxacin hydrochloride in the batching amount, stir to fully dissolve, add the prescribed amount of sodium chloride, and adjust with acetic acid The pH value is 4.4, add medicinal charcoal according to 0.05% (W / V) of the total v...

Embodiment 2

[0036] Embodiment 2: the preparation of moxifloxacin hydrochloride sodium chloride injection (0.4g / 100ml)

[0037] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0038] Sodium chloride 800g

[0039] Sodium citrate 100g

[0040] Edetate Calcium Sodium 20g

[0041] Add water for injection to 100L

[0042]

[0043] 1000 bottles

[0044] 1) Obtain qualified moxifloxacin hydrochloride raw materials, sodium chloride, calcium sodium edetate and sodium citrate according to the ingredient list;

[0045] 2) Add water for injection with a batch volume of 90% in the batching tank, add the batching amount, sodium citrate, calcium sodium edetate and moxifloxacin hydrochloride, stir to fully dissolve, then add the prescribed amount of sodium chloride and stir to dissolve , use citric acid to adjust the pH value to 4.0-4.5, add medicinal charcoal according to 0.05% (W...

Embodiment 3

[0052] Embodiment 3: the preparation of moxifloxacin hydrochloride sodium chloride injection (0.4g / 250ml)

[0053] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0054] Sodium chloride 2kg

[0055] Sodium citrate 250g

[0056] Edetate Calcium Sodium 25g

[0057] Add water for injection to 250L

[0058]

[0059] 1000 bottles

[0060] 1) Obtain qualified moxifloxacin hydrochloride raw materials, sodium chloride, calcium sodium edetate and sodium citrate according to the ingredient list;

[0061] 2) Add water for injection with a batch volume of 80% in the batching tank, add the batching amount, sodium citrate, calcium sodium edetate and moxifloxacin hydrochloride, stir to fully dissolve, then add the prescribed amount of sodium chloride and stir to dissolve , use citric acid to adjust the pH value to 4.0-4.5, add medicinal charcoal according to 0.05...

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Abstract

The invention relates to a moxifloxacin hydrochloride injection comprising the following components in percentage by weight / volume: 0.03-1 percent of moxifloxacin hydrochloride, 0.0001-3 percent of pH regulating agent (organic acid, organic base, inorganic acid and inorganic base), 0.0001-0.1 percent of metal ion complexing agent and 0.65-0.95 percent of sodium chloride.

Description

Technical field: [0001] The invention relates to a preparation of an injection containing moxifloxacin hydrochloride as a main medicinal component, a preparation method and an application thereof. technical background: [0002] Fluoroquinolones are fully synthetic antibacterial drugs that have developed very rapidly in the past two decades. They mainly act on the helicase and topoisomerase of bacterial DNA. They have the characteristics of broad antibacterial spectrum, strong antibacterial effect, and high safety. It is widely used clinically to treat respiratory, urinary tract, skin and soft tissue, ENT, gynecology, tuberculosis and other infections caused by Gram-positive bacteria, negative bacteria, and anaerobic bacteria. According to the chemical structure, antibacterial effect and in vivo process of quinolones, they can be divided into first, second, third and fourth generations, among which the third generation drugs such as ciprofloxacin and levofloxacin have excelle...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K47/02A61K47/12A61K47/16A61K31/4709A61P31/04
Inventor 施维强建华
Owner HC SYNTHETIC PHARMA CO LTD
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