Enoxacin freeze-dried powder needle composing prescription and preparation technique

A preparation technology of enoxacin, which is applied in the field of medicine, can solve the problems of light and high temperature sensitivity of liquid medicine, low bioavailability of solid preparations, poor solubility of enoxacin, etc., and achieve short liquid preparation time and convenient transportation and clinical application, and the effect of improving the safety of clinical use

Inactive Publication Date: 2008-10-29
广州名冠医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the marketed dosage forms of this product mainly include capsules, tablets and aqueous injections, among which the bioavailability of solid preparations is low, enoxacin has poor solubility in water, and the dissolved liquid medicine is sensitive to light and high temperature

Method used

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  • Enoxacin freeze-dried powder needle composing prescription and preparation technique
  • Enoxacin freeze-dried powder needle composing prescription and preparation technique
  • Enoxacin freeze-dried powder needle composing prescription and preparation technique

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] prescription:

[0025] Enoxacin 100g

[0026] Mannitol 50g

[0027] pH3.6 acetic acid-sodium acetate buffer 300g

[0028]

[0029] A total of 1000 bottles were produced

[0030] Preparation process: Take 100g of enoxacin and 50g of mannitol in a liquid mixing tank, add 500ml of water for injection; take 300g of acetic acid-sodium acetate buffer solution with pH 3.6 and slowly add it, stir until completely dissolved; add water for injection to 1000ml, stir well. Add 1g of medicinal charcoal and stir for 30 minutes, then use a titanium filter rod and then use a 0.22μm microporous membrane filter to filter into a sterile room. The detected pH value is 4.8, and 1ml of each bottle is divided into antibiotic glass bottles, and the stopper is half-pressed. Put it in a freeze-drying box, quickly cool down to -50°C, and prefreeze for 2 hours; turn on the vacuum pump, control the temperature of the heat transfer oil to -20°C, and continu...

Embodiment 2

[0032] prescription:

[0033] Enoxacin 200g

[0034] Mannitol 50g

[0035] pH2.0 Phosphate Buffer 150g

[0036]

[0037] A total of 1000 bottles were produced

[0038] Preparation process: Take 200g of enoxacin and 50g of mannitol in a liquid preparation tank, add 1000ml of water for injection; take 150g of pH 2.0 phosphate buffer solution, add slowly, stir until completely dissolved; add water for injection to 2000ml, Stir well. Add 2g of medicinal charcoal and stir for 30 minutes, then use a titanium filter rod and then use a 0.22μm microporous filter membrane to filter it into a sterile room. The detected pH value is 4.6, and 2ml of each bottle is divided into antibiotic glass bottles, and the stopper is half-pressed. Put it in a freeze-drying box, quickly cool down to -50°C, and pre-freeze for 3 hours; turn on the vacuum pump, control the temperature of the heat transfer oil to -20°C, and continuously vacuumize for 15 hours; gradua...

Embodiment 3

[0040] prescription:

[0041] Enoxacin 200g

[0042] Mannitol 50g

[0043] Lactic acid 50g

[0044]

[0045] A total of 1000 bottles were produced

[0046] Preparation process: Take 200g of enoxacin and 50g of mannitol in a liquid mixing tank, add 1000ml of water for injection; slowly add 50g of lactic acid, stir to completely dissolve; add water for injection to 2000ml, and stir evenly. Add 2g of medicinal charcoal and stir for 30 minutes, then use a titanium filter rod and then use a 0.22μm microporous filter membrane to filter it into a sterile room. The pH value was detected to be 4.7, and 2ml of each bottle was divided into antibiotic glass bottles, and the stopper was half-pressed. Put it in a freeze-drying box, quickly cool down to -50°C, and pre-freeze for 3 hours; turn on the vacuum pump, control the temperature of the heat transfer oil to -20°C, and continuously vacuumize for 16 hours; gradually raise the temperature to 25°C, and conti...

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Abstract

The invention discloses a prescription of enoxacin freeze-dried powder injection and a preparation technique thereof, belonging to the field of the medicine technology. The prescription of the enoxacin freeze-dried powder injection essentially consists of the enoxacin, cosolvent and excipient; the preparation technique includes four steps as liquid preparation, medicinal carbon adsorption, filtration and freeze-drying. The method has the advantages of being easy to operate, simple technique, low production cost, stable product quality and being easy to transport and store.

Description

1. Technical field [0001] The invention relates to a prescription of enoxacin freeze-dried powder injection and a preparation process thereof, belonging to the technical field of medicine. 2. Background technology [0002] Enoxacin has a broad-spectrum antibacterial effect, especially high antibacterial activity against aerobic Gram-negative bacilli, and has good antibacterial effect on most bacteria of the Enterobacteriaceae family; Both Haemophilus and Moraxella have high-strength anti-infective activity, and have antibacterial effects on most strains of Pseudomonas such as Pseudomonas aeruginosa. This product has antibacterial activity against methicillin-susceptible staphylococcus and only moderate antibacterial activity against streptococcus pneumoniae, hemolytic streptococcus and enterococcus faecalis. It has good antimicrobial effect on Chlamydia trachomatis, Mycoplasma and Legionella. It also has antibacterial activity against Mycobacterium tuberculosis and atypica...

Claims

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Application Information

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IPC IPC(8): A61K31/496A61K9/19A61K47/10A61K47/26A61K47/36A61P31/04
Inventor 王巍嵩王明霞
Owner 广州名冠医药科技有限公司
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