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
10 Cites 12 Cited by

AI-Extracted 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 sub...
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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.

Application Domain

Antibacterial agentsPowder delivery +4

Technology Topic

DrugMoxifloxacin hydrochloride +2

Image

  • New moxifloxacin hydrochloride injection
  • New moxifloxacin hydrochloride injection
  • New moxifloxacin hydrochloride injection

Examples

  • Experimental program(6)

Example Embodiment

[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 detection and light detection;
[0044] (9) The finished product is packaged after all inspections are passed.
[0045] Special solvent
[0046] Prescription 1 (5.4%):
[0047] Glucose: 12.5Kg
[0048] Water for injection: 230L
[0049] Total preparation: 1000
[0050] Prescription 2 (5.4%):
[0051] Mannitol: 12.5Kg
[0052] Water for injection: 230L
[0053] Total preparation: 1000
[0054] Preparation Process:
[0055] (1) Clean and sterile the injection bottles required for production;
[0056] (2) Add the prescription amount of excipients to 80% of the water for injection, stir and dissolve;
[0057] (3) Add water for injection to the full amount and stir evenly;
[0058] (4) Add activated carbon for needles with a dosage of 0.05%, stir for 15 minutes, filter and remove carbon;
[0059] (5) The medicinal solution is finely filtered through 0.45μm and 0.22μm membrane filters;
[0060] (6) Determine the intermediates and potting after passing the inspection;
[0061] (7) Sterilization with 115 degrees live steam for 30 minutes;
[0062] (8) Leak detection and light detection;
[0063] (9) The finished product is packaged after all inspections are passed.

Example Embodiment

[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 degrees for 30 minutes;
[0078] (8) Leak detection and light detection;
[0079] (9) The finished product is packaged after all inspections are passed.
[0080] Special solvent: (2.8%)
[0081] prescription:
[0082] Glycerin: 2.5Kg
[0083] Water for injection: 90L
[0084] Total preparation: 1000
[0085] Preparation process: see Example 1

Example Embodiment

[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 a sterile environment;
[0100] (7) Determine the intermediates and fill them after passing the inspection;
[0101] (8) The finished product is packaged after all inspections are passed.
[0102] Special solvent: (10.9%)
[0103] prescription:
[0104] Glucose: 12.5Kg
[0105] Sorbitol: 12.5Kg
[0106] Water for injection: 230L
[0107] Total preparation: 1000
[0108] Preparation process: see Example 1

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Description & Claims & Application Information

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