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New moxifloxacin hydrochloride injection

A technology of moxifloxacin hydrochloride and injection, applied in the field of medicine, can solve the problems of poor operability, unqualified clarity, aggravated condensation reaction and the like

Active Publication Date: 2011-06-22
NANJING YOKO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is poor in control operability in industrial production, and the production cost is high
And as a pharmaceutical worker, we all know that the amino group and the aldehyde group of glucose are likely to undergo a condensation reaction at high temperature. Moxifloxacin hydrochloride contains a weak amino group. Contact, and the high temperature of terminal sterilization can aggravate the possibility of this condensation reaction, therefore, this kind of infusion solution has a high risk of causing related substances to increase
In our research, we found that the quality of the injection containing moxifloxacin hydrochloride was uniformly mixed with the glucose solution and left for several days, and the clarity remained unchanged; however, the injection containing the active ingredient moxifloxacin hydrochloride was mixed uniformly with the glucose solution After 15 minutes of sterilization at 121 degrees, new related substances appeared, and after being placed at 60 degrees for one month, the clarity was unqualified

Method used

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  • New moxifloxacin hydrochloride injection
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  • New moxifloxacin hydrochloride injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] Example 1. Preparation of Moxifloxacin Hydrochloride Injection 1

[0030] Moxifloxacin Hydrochloride Injection (20ml: 400mg)

[0031] prescription:

[0032] Moxifloxacin hydrochloride: 0.4Kg (based on moxifloxacin)

[0033] Water for injection: 20L

[0034] Total preparation: 1000

[0035] Preparation Process:

[0036] (1) Wash and sterilize the ampoules required for production;

[0037] (2) 80% of the water for injection is kept at 50°C, then add moxifloxacin hydrochloride and stir to dissolve;

[0038] (3) Adjust the pH to 5.0 with 0.5 mol / l sodium hydroxide solution, add water for injection to the full amount, and stir evenly;

[0039] (4) Add 0.1% activated carbon for needles, stir for 15 minutes, filter and remove carbon;

[0040] (5) The medicinal solution is finely filtered through 0.45μm and 0.22μm membrane filters;

[0041] (6) Determine the intermediates and potting after passing the inspection;

[0042] (7) Steam sterilization at 121 degrees for 15 minutes;

[0043] (8) Leak de...

Embodiment 2

[0064] Example 2. Preparation of Moxifloxacin Hydrochloride Injection 2

[0065] Moxifloxacin Hydrochloride Injection (10ml: 200mg)

[0066] prescription:

[0067] Moxifloxacin hydrochloride: 0.2Kg (based on moxifloxacin)

[0068] Water for injection: 10L

[0069] Total preparation: 1000

[0070] Preparation Process:

[0071] (1) Clean and sterile the vials and rubber stoppers required for production;

[0072] (2) 80% of the water for injection is kept at 50°C, then add moxifloxacin hydrochloride and stir to dissolve;

[0073] (3) Adjust the pH to 5.5 with 0.5 mol / l sodium hydroxide solution, add water for injection to the full amount, and stir evenly;

[0074] (4) Add activated carbon for needles with a solution amount of 0.05%, stir for 20 minutes, filter and remove carbon;

[0075] (5) The medicinal solution is finely filtered through 0.45μm and 0.22μm membrane filters;

[0076] (6) Determine the intermediates and potting after passing the inspection;

[0077] (7) Steam sterilization at 115 ...

Embodiment 3

[0086] Example 3. Preparation of Moxifloxacin Hydrochloride Injection 3

[0087] Moxifloxacin Hydrochloride Injection (20ml: 400mg)

[0088] prescription:

[0089] Moxifloxacin Hydrochloride: 400g (based on Moxifloxacin)

[0090] Calcium edetate sodium: 50g

[0091] Water for injection: 20L

[0092] Total preparation: 1000

[0093] Preparation Process:

[0094] (1) Clean and sterile the vials and rubber stoppers required for production;

[0095] (2) 80% of the water for injection is kept at 50°C, and the raw and auxiliary materials are added and stirred to dissolve;

[0096] (3) Adjust the pH to 5.0 with 0.5 mol / l sodium hydroxide solution, add water for injection to the full amount, and stir evenly;

[0097] (4) Add activated carbon for needles with a dosage of 0.05%, stir for 15 minutes, filter and remove carbon;

[0098] (5) The medicinal solution is finely filtered through 0.45μm and 0.22μm membrane filters;

[0099] (6) The liquid medicine is sterilized through a 0.22μm filter membrane in ...

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PUM

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Abstract

The invention relates to a medicament, namely moxifloxacin hydrochloride injection for treating or preventing human or animal bacteria infection, and application of a preparation in regulation of physiological isotonic osmotic pressure of the moxifloxacin hydrochloride injection.

Description

Technical field: [0001] The invention belongs to the technical field of medicine, and relates to a medicine for treating or preventing bacterial infections in humans or animals, especially moxifloxacin hydrochloride injection. technical background: [0002] Moxifloxacin is a new type of fluoroquinolone antibiotic developed by Bayer in recent years. It can effectively act on gram-positive and gram-negative bacteria and has a higher activity against Staphylococcus aureus, streptococcus and enterococcus. Profloxacin is strong and has a strong effect on tuberculosis bacilli. [0003] The antibacterial mechanism of moxifloxacin is to interfere with II and IV topoisomerases. Topoisomerase is a key enzyme in controlling DNA topology and in DNA replication, repair and transcription. The bactericidal curve shows that the bactericidal activity of moxifloxacin is concentration-dependent, and its minimum bactericidal concentration and minimum inhibitory concentration are basically the same. ...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K9/10A61K9/107A61K9/14A61K31/4709A61K47/10A61K47/26A61P31/04A61P31/06
Inventor 包玉胜陈爱萍沈飞姚洛芫刘杉高建兴
Owner NANJING YOKO PHARMA
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