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Moxifloxacin hydrochloride sodium chloride injection and preparation method 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., which can solve product pollution, mismatching of content determination results, and influence on Product quality and other issues

Active Publication Date: 2014-08-20
WUHAN WUYAO SCI & TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This point is that the patent CN1246039C of German Bayer and other documents have no report and solution, that is, after moxifloxacin hydrochloride and sodium chloride are thickly mixed with decarburization and constant volume, there is no industrial problem that the content measurement results of the final product do not match at present. Solution
In order to ensure the content of the product, the conventional method is to reduce the constant volume or add raw materials later, but this may cause pollution to the product, and the operation process is complicated, which affects the product quality

Method used

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  • Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof
  • Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof
  • Moxifloxacin hydrochloride sodium chloride injection and preparation method thereof

Examples

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Effect test

Embodiment example 1

[0049] Implementation case 1: Preparation of Moxifloxacin Hydrochloride and Sodium Chloride Injection (250ml: 0.4g Moxifloxacin)

[0050] prescription:

[0051] (1) Weigh the qualified moxifloxacin hydrochloride raw materials and sodium chloride according to the prescription;

[0052] (2) Add 70% of the total volume of injection water to the batching tank and cool to 45~55℃;

[0053] (3) Add the moxifloxacin hydrochloride raw material weighed according to the prescription and stir to make it fully dissolved;

[0054] (4) Put in sodium chloride in the batching amount and stir until it is completely dissolved;

[0055] (5) Add activated carbon for injection at 0.025% (w / v) of the volume of the concentrated solution, stir for 10-30 minutes at 45-55°C, filter back for 5-10 minutes, pass through the titanium rod filter with a pump A set of 0.45μm cartridge type microporous filter membrane is hit to the rare distribution tank;

[0056] (6) Add water for injection to the batch mark. After stir...

Embodiment example 2

[0061] Implementation case 2: Preparation of Moxifloxacin Hydrochloride and Sodium Chloride Injection (250ml: 0.4g Moxifloxacin)

[0062] prescription:

[0063] (1) Weigh the qualified moxifloxacin hydrochloride raw materials and sodium chloride according to the prescription;

[0064] (2) Add 70% of the total volume of injection water to the batching tank and cool to 45~55℃;

[0065] (3) Add the moxifloxacin hydrochloride raw material weighed according to the prescription and stir to make it fully dissolved;

[0066] (4) Put in sodium chloride in the batching amount and stir until it is completely dissolved;

[0067] (5) Add activated carbon for injection according to 0.05% (w / v) of the volume of the concentrated solution, stir for 10-30 minutes at 45-55°C, filter back for 5-10 minutes, pass through the titanium rod filter with a pump A set of 0.45μm cartridge type microporous filter membrane is hit to the rare distribution tank;

[0068] (6) Add water for injection to the batch mark. A...

Embodiment example 3

[0073] Implementation case 3: Preparation of Moxifloxacin Hydrochloride and Sodium Chloride Injection (250ml: 0.4g Moxifloxacin)

[0074] prescription:

[0075] (1) Weigh the qualified moxifloxacin hydrochloride raw materials and sodium chloride according to the prescription;

[0076] (2) Add 70% of the total volume of injection water to the batching tank and cool to 45~55℃;

[0077] (3) Add the moxifloxacin hydrochloride raw material weighed according to the prescription and stir to make it fully dissolved;

[0078] (4) Put in sodium chloride in the batching amount and stir until it is completely dissolved;

[0079] (5) Add activated carbon for injection according to 0.1% (w / v) of the volume of the concentrated solution, stir for 10-30 minutes at 45-55°C, filter back for 5-10 minutes, pass through the titanium rod filter with a pump A set of 0.45μm cartridge type microporous filter membrane is hit to the rare distribution tank;

[0080] (6) Add water for injection to the batch mark. Af...

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Abstract

The invention relates to moxifloxacin hydrochloride sodium chloride injection and a preparation method thereof, and aims at overcoming the shortage of the prior art, solving the problem that the detection result shows that moxifloxacin content is inconsistent in final moxifloxacin hydrochloride sodium chloride injection in the background technology, as well as solving the problem of complexity of the existing process. The preparation method, provided by the invention, is a novel preparation method capable of avoiding product pollution and ensuring the safety and stability of the product quality. The moxifloxacin hydrochloride sodium chloride injection is characterized by containing 0.05 to 0.3% (w / v) of moxifloxacin based on the amount of moxifloxacin, 0.8 to 0.85% (w / v) of sodium chloride, and water of injection, wherein the concentrated preparation volume is 70 to 80%, 0.025 to 0.1% (w / v) of activated carbon is added and agitated for 10 to 30 minutes, and hydrochloric acid or sodium hydroxide is used as a pH modifier. The preparation method is simple and feasible in process and can be used for producing medicines for treating or preventing human or animal bacterial infection.

Description

Technical field: [0001] The invention belongs to the field of pharmaceutical preparations, and particularly relates to an injection with moxifloxacin hydrochloride as the main drug and a preparation method thereof. technical background: [0002] Moxifloxacin is a broad-spectrum quinolone drug developed by Bayer in Germany. It belongs to the fourth-generation quinolone drug. It was listed in Germany in 1999 and passed the FDA approval in December 1999. The brand name is Avelox. It is currently used in clinical practice in many countries and regions around the world. In April 2003, Moxifloxacin eye drops developed by Alcon was also approved by the FDA for marketing. [0003] Moxifloxacin shows broad-spectrum antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, anaerobic bacteria, acid-fast bacteria and atypical microorganisms such as Mycoplasma, Chlamydia and Legionella in vitro. The antibacterial mechanism is interference with topoisomerase II and IV. To...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4709A61K47/04A61P31/04
Inventor 向文殿于艳春杨波耿海明王松笛
Owner WUHAN WUYAO SCI & TECH
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