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Moxifloxacinhydrochloride sodium chloride injection, preparation method thereof and use thereof

A technology of moxifloxacin hydrochloride and sodium chloride injection, which is applied in the direction of pharmaceutical formulas, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as poor stability

Inactive Publication Date: 2010-11-17
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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  • Moxifloxacinhydrochloride sodium chloride injection, preparation method thereof and use thereof
  • Moxifloxacinhydrochloride sodium chloride injection, preparation method thereof and use thereof
  • Moxifloxacinhydrochloride sodium chloride injection, preparation method thereof and use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Embodiment 1: the preparation of moxifloxacin hydrochloride sodium chloride injection (0.4g / 250ml)

[0019] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0020] Sodium chloride 2.0kg

[0021] Sodium acetate 250g

[0022] Add water for injection to 250L

[0023]

[0024] 1000 bottles

[0025] 1) Obtain qualified moxifloxacin hydrochloride raw materials, sodium chloride and sodium acetate according to the ingredient list;

[0026] 2) Add water for injection with a batch volume of 95% in the batching tank, add sodium acetate and moxifloxacin hydrochloride in the batching amount, stir to fully dissolve, add sodium chloride in the prescribed amount, adjust the pH value to 4.4 with acetic acid, and adjust the pH value to 4.4 with acetic acid. Add 0.05% of the volume (W / V) to medicinal charcoal and stir evenly, keep warm at 70°C to 80°C for 20 minute...

Embodiment 2

[0033] Embodiment 2: the preparation of moxifloxacin hydrochloride sodium chloride injection (0.4g / 100ml)

[0034] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0035] Sodium chloride 800g

[0036] Sodium citrate 100g

[0037] Add water for injection to 100L

[0038]

[0039] 1000 bottles

[0040] 1) Obtain qualified moxifloxacin hydrochloride raw materials, sodium chloride and sodium citrate according to the ingredient list;

[0041]2) Add water for injection with a batch volume of 90% in the batching tank, add the batching amount, sodium citrate and moxifloxacin hydrochloride, stir to fully dissolve, add the prescribed amount of sodium chloride and stir to dissolve, adjust with citric acid The pH value is 4.0-4.5, add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 70°C-80°C for 20 minutes, and circulate...

Embodiment 3

[0048] Embodiment 3: the preparation of moxifloxacin hydrochloride sodium chloride injection (0.4g / 250ml)

[0049] Prescription: Moxifloxacin Hydrochloride 400g (calculated as Moxifloxacin)

[0050] Sodium chloride 2kg

[0051] Sodium citrate 250g

[0052] Add water for injection to 250L

[0053]

[0054] 1000 bottles

[0055] 1) Obtain qualified moxifloxacin hydrochloride raw materials, sodium chloride and sodium citrate according to the ingredient list;

[0056] 2) Add water for injection with a batch volume of 80% in the batching tank, add the batching amount, sodium citrate and moxifloxacin hydrochloride, stir to fully dissolve, add the prescribed amount of sodium chloride and stir to dissolve, adjust with citric acid The pH value is 4.0-4.5, add medicinal charcoal according to 0.05% (W / V) of the total volume, stir evenly, keep warm at 70°C-80°C for 20 minutes, and circulate and ...

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Abstract

The invention relates to moxifloxacinhydrochloride sodium chloride injection. The injection comprises the following components in percentage by weight / volume: 0.03 to 1 percent of moxifloxacinhydrochloride, 0.01 to 3 percent of weak acid, 0.01 to 3 percent of salt of weak acid, 0.01 to 3 percent of phosphoric acid, 0.01 to 3 percent of amino acid or phosphate and 0.65 to 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): A61K9/08A61K31/4709A61K47/12A61K47/04A61K47/18A61K47/22A61K47/20A61P31/04
Inventor 施维强建华
Owner HC SYNTHETIC PHARMA CO LTD
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