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...

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

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

PUM

Description & Claims & Application Information

We can also present the details of the Description, Claims and Application information to help users get a comprehensive understanding of the technical details of the patent, such as background art, summary of invention, brief description of drawings, description of embodiments, and other original content. On the other hand, users can also determine the specific scope of protection of the technology through the list of claims; as well as understand the changes in the life cycle of the technology with the presentation of the patent timeline. Login to view more.