Moxifloxacin hydrochloride injection pharmaceutical composition and preparation method and quality control method thereof

A technology for moxifloxacin hydrochloride and injection, which is applied in the field of quality control of moxifloxacin hydrochloride injection pharmaceutical composition, and can solve problems such as poor stability, active ingredient adsorption, slight opalescence, etc.

Active Publication Date: 2017-06-13
成都天台山制药股份有限公司
View PDF7 Cites 2 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Chinese patent 00811427.7 records that the water preparation of moxifloxacin hydrochloride and glucose has poor stability due to iron ions
[0020] CN103543230A (201210236984.4) discloses a method for the separation and determination of moxifloxacin hydrochloride and its enantiomers, which is characterized in that it includes: 1) selection of reference substances: moxifloxacin hydrochloride racemate, moxifloxacin hydrochloride; 2) Sample preparation: take moxifloxacin hydrochloride racemate, add mobile phase to dissolve and dilute, and prepare a moxifloxacin hydrochloride racemate solution of 1 μg/ml to 20 μg/ml; take moxifloxacin hydrochloride, add mobile phase to dissolve and dilute, and prepare 0.4mg/ml~1mg/ml moxifloxacin hydrochloride solution; 3) Chromatographic conditions: high performance liquid chromatography, the chromatographic column used is a reversed-phase chromatographic column, and the mixed aqueous solution of copper sulfate and chiral reagent is the water phase, The mixture of aqueous phase and organic phase is the mobile phase, the column temperature is: 20°C ~ 45°C; the flow rate is: 0.6ml/min ~ 1.4ml/min; the detection wavelength is: 270 ~ 310nm; 4) Determination: separate precision measurement Take 2 μl to 50 μl of the moxifloxacin hydroc

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Image

Smart Image Click on the blue labels to locate them in the text.
Viewing Examples
Smart Image
  • Moxifloxacin hydrochloride injection pharmaceutical composition and preparation method and quality control method thereof
  • Moxifloxacin hydrochloride injection pharmaceutical composition and preparation method and quality control method thereof
  • Moxifloxacin hydrochloride injection pharmaceutical composition and preparation method and quality control method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0153] Embodiment 1: preparation moxifloxacin hydrochloride injection

[0154] prescription:

[0155] Moxifloxacin hydrochloride (calculated as moxifloxacin) 400mg,

[0156] Aspartic Acid 100mg,

[0157] Edetate Calcium Sodium 10mg,

[0158] The acid-base regulator adjusts the pH of the injection in an appropriate amount,

[0159] Appropriate amount of water for injection, up to 20ml.

[0160] Preparation method:

[0161] (a) Dissolve aspartic acid and calcium sodium edetate with 70% water for injection (water temperature 70° C.) of the total amount of the dosing solution, adjust the pH value of the gained medicinal solution with an acid-base regulator to be 4.5, and wait for the temperature of the medicinal solution Add moxifloxacin hydrochloride to it at 60°C, stir to dissolve;

[0162] (b) Add activated carbon (0.1% w / v by solution volume) to the obtained medicinal solution when the temperature of the medicinal solution is 40-70° C., stir and adsorb for 30 minutes, ...

Embodiment 2

[0165] Embodiment 2: preparation moxifloxacin hydrochloride injection

[0166] prescription:

[0167] Moxifloxacin hydrochloride (calculated as moxifloxacin) 350mg,

[0168] Aspartic Acid 80mg,

[0169] Edetate Calcium Sodium 12mg,

[0170] The acid-base regulator adjusts the pH of the injection in an appropriate amount,

[0171] Appropriate amount of water for injection, up to 20ml.

[0172] Preparation method:

[0173] (a) Dissolve aspartic acid and calcium sodium edetate with 60% water for injection (water temperature 75° C.) of the total amount of the dosing solution, adjust the pH value of the gained medicinal solution with an acid-base regulator to be 4.3, and wait for the temperature of the medicinal solution Add moxifloxacin hydrochloride to it at 70°C, stir to dissolve;

[0174] (b) Add active carbon (0.125% w / v by solution volume) to the obtained medicinal solution when the temperature of the medicinal solution is 40-70° C., stir and adsorb for 40 minutes, an...

Embodiment 3

[0177] Embodiment 3: preparation moxifloxacin hydrochloride injection

[0178] prescription:

[0179] Moxifloxacin hydrochloride (calculated as moxifloxacin) 450mg,

[0180] Aspartic Acid 120mg,

[0181] Edetate Calcium Sodium 8mg,

[0182] The acid-base regulator adjusts the pH of the injection in an appropriate amount,

[0183] Appropriate amount of water for injection, up to 20ml.

[0184] Preparation method:

[0185] (a) Dissolve aspartic acid and calcium sodium edetate with 80% water for injection (water temperature 60° C.) of the total amount of the dosing solution, adjust the pH value of the gained medicinal solution with an acid-base regulator to be 4.7, and wait for the temperature of the medicinal solution Add moxifloxacin hydrochloride to it at 40°C, stir to dissolve;

[0186] (b) Add activated carbon (0.075% w / v based on solution volume) to the obtained medicinal solution when the temperature of the medicinal solution is 40-70°C, stir and absorb for 20 minu...

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

PUM

No PUM Login to view more

Abstract

The invention relates to a moxifloxacin hydrochloride injection pharmaceutical composition and a preparation method and a quality control method thereof. The moxifloxacin hydrochloride injection pharmaceutical composition comprises moxifloxacin hydrochloride, aspartic acid, sodium calcium edetate, an optional acidifying or alkalizing agent and water for injection. The quality control method is a method for determining content of RR isomers in the moxifloxacin hydrochloride injection pharmaceutical composition. The moxifloxacin hydrochloride injection pharmaceutical composition and the preparation method and the quality control method thereof have the superior advantages specified in the description.

Description

technical field [0001] The present invention relates to a preparation of an injection containing moxifloxacin hydrochloride as the main medicinal component, a preparation method and application thereof, and a quality control method of the moxifloxacin hydrochloride injection pharmaceutical composition. [0002] technical background [0003] Fluoroquinolones are fully synthetic antibacterial drugs that have developed very rapidly in the past two decades. They mainly act on the helicase and topoisomerase of bacterial DNA. They have the characteristics of broad antibacterial spectrum, strong antibacterial effect, and high safety. It is widely used clinically to treat respiratory, urinary tract, skin and soft tissue, ENT, gynecology, tuberculosis and other infections caused by Gram-positive bacteria, negative bacteria, and anaerobic bacteria. According to the chemical structure, antibacterial effect and in vivo process of quinolones, they can be divided into first, second, third ...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to view more

Application Information

Patent Timeline
no application Login to view more
IPC IPC(8): A61K9/08A61K31/4709A61K47/18A61P31/04A61P11/00G01N30/02
CPCA61K9/0019A61K9/08A61K31/4709A61K47/183G01N30/02
Inventor 赵东明方专陈娟吴国庆张莲莲余茹
Owner 成都天台山制药股份有限公司
Who we serve
  • R&D Engineer
  • R&D Manager
  • IP Professional
Why Eureka
  • Industry Leading Data Capabilities
  • Powerful AI technology
  • Patent DNA Extraction
Social media
Try Eureka
PatSnap group products

Browse by: Latest US Patents, China's latest patents, Technical Efficacy Thesaurus, Application Domain, Technology Topic.

© 2024 PatSnap. All rights reserved.Legal|Privacy policy|Modern Slavery Act Transparency Statement|Sitemap