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Stable moxifloxacin hydrochloride compound

A technology of moxifloxacin hydrochloride and its compound, which is applied in the field of pharmaceuticals in the field of medicine, and can solve the problems of SFDA not approving the production of domestic manufacturers

Active Publication Date: 2012-07-25
天津汉嘉医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, SFDA has not approved domestic manufacturers to produce

Method used

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  • Stable moxifloxacin hydrochloride compound
  • Stable moxifloxacin hydrochloride compound
  • Stable moxifloxacin hydrochloride compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] In a 5000ml reaction bottle equipped with stirring, thermometer and condenser, add 400g of moxifloxacin hydrochloride and 4000ml of ethanol-acetonitrile-water (6:2:2) mixture, start stirring, and heat up to 55°C-60°C ℃, until all dissolved, add 1 gram of potassium nitrate, filter while hot, naturally cool the filtrate to 30 ℃, add 6mol / L hydrochloric acid dropwise until the pH is 2.0, stir at room temperature for 2 hours, then stir at -5 ℃ for 2 hours , precipitated crystals, filtered, washed with ethanol, and dried at 45°C to obtain 371.8 grams of high-purity white crystals of the above-mentioned moxifloxacin hydrochloride compound. As determined by the Karl Fischer method, it contains 3.96% (weight percent) of water.

[0079] Instrument model and measurement conditions: Rigaku D / max 2500 diffractometer; CuKa 40Kv 100mA; 2θ scanning range: 0-50 ° .

[0080] The structural formula (I) of the compound is shown in figure 1 .

[0081] The X-ray diffraction pattern of ...

Embodiment 2

[0085] Granules containing moxifloxacin hydrochloride compound

[0086] Prescription: 400 grams of moxifloxacin hydrochloride compound as moxifloxacin, 480 grams of lactose, 60 grams of crospovidone, 160 grams of hydroxypropyl methylcellulose, appropriate amount of distilled water, made into 1000 bags.

[0087] Process: Moxifloxacin hydrochloride compound is mixed with various auxiliary materials, passed through an 80-mesh sieve, made into a soft material with distilled water, granulated, dried, and then packed into granules.

Embodiment 3

[0089] Capsules containing the moxifloxacin hydrochloride compound

[0090] Prescription: moxifloxacin hydrochloride compound is calculated as moxifloxacin 400 grams, pregelatinized starch 150 grams, made into 1000 capsules.

[0091] Process: Moxifloxacin hydrochloride compound and starch aqueous solution are moistened, mixed evenly, sieved and granulated, dried at 60°C, granulated, and filled into capsules.

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PUM

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Abstract

The invention discloses a stable moxifloxacin hydrochloride compound. The moxifloxacin hydrochloride compound provided by the invention is prepared through the steps that: moxifloxacin hydrochloride is heated and dissolved in an ethanol-acetonitrile-water solution; proper amounts of potassium nitrate and hydrochloric acid are added to the solution; the pH value is regulated; the solution is stirred, and is washed by using ethanol; the solution is dried, such that the stable moxifloxacin hydrochloride compound is obtained. The stability of the moxifloxacin hydrochloride compound provided by the invention is good, and the compound is convenient to produce, transport, and store. A production technological process is short, the product yield is high, and the production cost is low. Therefore, industrialization can easily be realized.

Description

technical field [0001] The invention relates to medicines in the field of medicine, in particular to a moxifloxacin hydrochloride compound with good stability and a preparation method thereof. Background technique [0002] With the widespread use and even abuse of antibacterial agents, bacterial drug resistance is increasing year by year. Drug-resistant bacterial infections not only seriously endanger human health, but also become a thorny problem worldwide. It is reported that about 2 million nosocomial infections occur annually among hospitalized patients in the United States, and about 90,000 of them die. More than 70% of hospital-acquired infections have developed resistance to commonly used antibacterial drugs in clinical practice. Therefore, accelerating research and development can effectively deal with severe infections and drug resistance caused by Gram-positive bacteria, especially methicillin-resistant Staphylococcus aureus (MRSA). Oral antibacterial drugs for no...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D471/04A61K31/4709A61P31/04A61P11/02A61P11/00
Inventor 严洁黄欣
Owner 天津汉嘉医药科技有限公司
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