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Stable moxifloxacin hydrochloride glucose injection

A technology of moxifloxacin hydrochloride and glucose injection, which is applied in the directions of drug delivery, antibacterial drugs, pharmaceutical formulations, etc., can solve the problems of blood calcium drop, precipitation, non-compliance with injection requirements, etc. The effect of stability

Inactive Publication Date: 2012-10-17
XINAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, moxifloxacin hydrochloride sodium chloride injection is unstable at low temperature and will produce precipitation, which affects clinical use
For this problem, Chinese patent CN00811427.7 has made moxifloxacin hydrochloride glucose injection with glucose as isotonic regulator, which improves the stability of the product to a certain extent, but the product is still not stable enough, and the storage time is short, easy to Formation of insoluble particulates, rendering the product unqualified for parenteral solutions
Another patent CN101836950.A (a moxifloxacin hydrochloride glucose injection and its preparation method and application) reports a moxifloxacin hydrochloride glucose injection, which is added by adding ethylenediaminetetraacetic acid, ethylenediamine Metal ion complexing agents such as disodium tetraacetate and sodium hexametaphosphate improve the stability, but these agents are generally used as metal ion chelating agents in injections, which can promote the excretion of metals from the body, and often cause clinical problems such as decreased blood calcium

Method used

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  • Stable moxifloxacin hydrochloride glucose injection
  • Stable moxifloxacin hydrochloride glucose injection
  • Stable moxifloxacin hydrochloride glucose injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0053] (1) Weigh glucose and sodium citrate and dissolve them in water for injection. After stirring to dissolve, dilute hydrochloric acid to adjust the pH value of the solution to 4.3, add moxifloxacin hydrochloride, stir until completely dissolved, then add medicinal charcoal and stir for 10∽30 minutes. Add water for injection and dilute to total amount 1000ml, stir; The weight of moxifloxacin hydrochloride used is to make the concentration of moxifloxacin in the injection be 1.6mg / ml; The weight of glucose is to make the concentration in the injection to be 55mg / ml; the dosage of sodium citrate is 0.1mg / ml; the concentration of adding medicinal charcoal is 0.01mg / ml;

[0054] (2) Coarsely filter the liquid with a titanium filter rod, and then filter the liquid medicine with a 0.22 μm microporous membrane. The filtrate can be checked for foreign matter, incompatible particles, and pH value, etc., and then filled and sealed in a 250ml glass bottle;

[0055] (3) Sterilize afte...

Embodiment 2

[0057] (1) Weigh glucose and sodium citrate and dissolve them in water for injection. After stirring to dissolve, dilute hydrochloric acid to adjust the pH value of the solution to 4.5, add moxifloxacin hydrochloride, stir until completely dissolved, then add medicinal charcoal and stir for 10∽30 minutes. Add water for injection and dilute to a total amount of 1000ml, stir evenly; the weight of moxifloxacin hydrochloride used is to make its concentration in the injection solution be: 5mg / ml; the weight of glucose is to make its concentration in the injection solution be 40mg / ml ml; the dosage of sodium citrate is 0.05mg / ml, and the concentration of adding medicinal charcoal is 0.01mg / ml.

[0058] (2) Coarsely filter the liquid with a titanium filter rod, and then filter the liquid medicine with a 0.22 μm microporous membrane. The filtrate can be checked for foreign matter, incompatible particles, and pH value, etc., and then filled and sealed in a 250ml glass bottle;

[0059] ...

Embodiment 3

[0061] (1) Weigh glucose and sodium citrate and dissolve them in water for injection. After stirring to dissolve, dilute hydrochloric acid to adjust the pH value of the solution to 3.5, add moxifloxacin hydrochloride, stir until completely dissolved, then add medicinal charcoal and stir for 10∽30 minutes. Add water for injection and dilute to a total amount of 1000ml, stir well; the weight of moxifloxacin hydrochloride used is to make its concentration in the injection solution be: 1mg / ml; the weight of glucose is to make its concentration in the injection solution be 50mg / ml ml; the dosage of sodium citrate is 0.03mg / ml, and the concentration of medicinal charcoal is 0.01mg / ml;

[0062] (2) Coarsely filter the liquid with a titanium filter rod, and then filter the liquid medicine with a 0.22 μm microporous membrane. The filtrate can be checked for foreign matter, incompatible particles, and pH value, etc., and then filled and sealed in a 250ml glass bottle;

[0063] (3) Steri...

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Abstract

The invention provides a stable moxifloxacin hydrochloride glucose injection. The preparation method of the injection is as follows: weighing glucose and sodium citrate, then dissolving in the water for injection, mixing and dissolving, adjusting the pH value of the solution to 3.5 to 4.5 with diluted hydrochloric acid, and then adding moxifloxacin hydrochloride, mixing to dissolve completely, adding the medicinal carbon to mix for 10 to 30min, adding the water for injection to dilute to the total amount, and stirring well, wherein the concentration of moxifloxacin hydrochloride in the injection by moxifloxacin is 0.1mg / ml to 10mg / ml; the concentration of glucose in the injection is 40mg / ml to 60mg / ml; the concentration of sodium citrate in the injection is 0.01mg / ml to 0.2mg / ml; and the concentration of the added medicinal carbon is 0.05 to 0.2mg / ml. The sodium citrate with the concentration added into the agent provided by the invention does not have adverse effects on the human body, can improve the stability of moxifloxacin hydrochloride glucose injection greatly, and therefore the generation of precipitation is prevented even at a low temperature.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a stable moxifloxacin hydrochloride glucose injection and a preparation method thereof. Background technique [0002] The chemical name of moxifloxacin is 1-cyclopropyl-7-(S,S-2,8-diazo-bicyclo[4.3.0]nonan-8-yl)-6-fluoro-8-methoxy -1,4-dihydro-4-oxo-3-quinolinecarboxylic acid, its hydrochloride is commonly used in clinical practice. This product is developed by German Bayer company, and it is the fourth generation of 8-methoxyfluoroquinolone antibacterial drugs with broad-spectrum antibacterial activity. Moxifloxacin has 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. The antibacterial mechanism is to interfere with Ⅱ, Ⅳ topoisomerase. It has been on the market in the world for more than ten years, and is widely used in th...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4709A61K47/12A61P31/04
Inventor 毛先兵徐波程永刚肖中元彭力冉隆富
Owner XINAN PHARMA
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