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lomefloxacin aspartate compound

A technology of lomefloxacin aspartate and aspartate, applied in organic chemistry, organic active ingredients, antibacterial drugs, etc., can solve the problems of inconvenient use, storage and transportation

Inactive Publication Date: 2011-12-14
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0018] The lomefloxacin aspartate injection produced by the prior art has very strict requirements on storage and protection from light, and there are inconveniences in use, storage and transportation

Method used

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  • lomefloxacin aspartate compound
  • lomefloxacin aspartate compound
  • lomefloxacin aspartate compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0047] Add 30 grams of lomefloxacin and 180 ml of dimethylformamide into a 1000ml reaction bottle equipped with stirring, thermometer and condenser, start stirring, heat up to 50°C-55°C, filter, and cool the filtrate to 5°C-10°C ℃, add aspartic acid ethyl ether to pH 1-3, then cool to 0℃-5℃, keep stirring for 13 hours. The precipitated crystals were filtered, washed with 50ml of anhydrous ether in equal parts for three times, placed indoors for 1 hour, then moved to a vacuum drying oven, and dried in vacuum at room temperature for 3 hours to obtain 26.1 grams of lomefloxacin aspartate white crystalline Powder, melting point is 262-265°C, purity 99.91% (HPLC normalization method).

[0048] The X-ray diffraction pattern of this crystalline powder is shown in figure 1 . Instrument model and measurement conditions: Rigaku D / max 2500 diffractometer; CuKa 40Kv 100mA; 2θ scanning range: 0-50 ° ;

Embodiment 2

[0050] Granules containing a new crystal form of lomefloxacin aspartate

[0051] Prescription: 100 grams of new crystal form of lomefloxacin aspartate, 650 grams of lactose, 30 grams of microcrystalline cellulose, 68 grams of crospovidone, 80 grams of PEG-4000, 110 grams of hydroxypropyl methylcellulose grams, appropriate amount of distilled water, made into 1000 bags.

[0052] Process: PEG-4000 and the new crystal form of lomefloxacin aspartate are crushed together, passed through an 80-mesh sieve, mixed with other materials, made into soft materials with distilled water, granulated, dried at low temperature, and then packed into granules.

Embodiment 3

[0054] Capsules containing a new crystalline form of lomefloxacin aspartate

[0055] Prescription: 100 grams of new crystal form lomefloxacin aspartate, 16 ml of propylene glycol, 120 grams of starch, 26 grams of magnesium stearate, 35 grams of colloidal silicon dioxide, made into 1000 capsules.

[0056] Process: Moisten the new crystal form of lomefloxacin aspartate, starch, magnesium stearate, and colloidal silicon dioxide with 15% propylene glycol aqueous solution, mix well, sieve and granulate, dry at 60°C, and prepare Capsules, filled capsules.

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Abstract

The present invention relates to a crystal form of lomefloxacin aspartate and a preparation method thereof. The present invention also relates to a pharmaceutical composition containing the above-mentioned crystal form of lomefloxacin aspartate and the crystal form is used to manufacture a treatment for Gram Human or animal respiratory tract infection, genitourinary system infection, gastrointestinal bacterial infection, abdominal cavity, biliary tract, typhoid and other infections, bone and joint infection, skin and soft tissue infection, sepsis and other systemic infection caused by positive or negative bacterial sensitive bacteria, Other infections, such as sinusitis, otitis media, blepharitis and other drugs.

Description

[0001] technical field [0002] The invention relates to a pharmaceutical composition containing a crystal form of lomefloxacin aspartate, a preparation method and an application of the crystal form in the manufacture of medicines for treating depression. Background technique [0003] Infectious disease is the most common clinical disease, involving almost all clinical specialties, and it is also one of the most common causes of patient death. According to the World Health Organization report in 1997, the number of deaths from infectious diseases was as high as 33.3% of the total number of deaths from various causes. In my country, due to the large rural population and the still backward medical insurance system, the main diseases that endanger people's health are still infectious diseases caused by various pathogenic bacteria, and are also the main cause of disability and death. Anti-infective drugs are a powerful weapon for human beings to fight against infectious disease...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D401/04C07C229/24A61K31/496A61P31/04
CPCY02A50/30
Inventor 严洁黄欣
Owner TIANJIN HANKANG PHARMA BIOTECH
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