Stable oritavancin compound

An oritavancin and compound technology, which is applied in the field of medicine, can solve the problems of a large number of oritavancin impurities and a high total amount of impurities

Inactive Publication Date: 2016-06-01
TIANJIN HANKANG PHARMA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] Oritavancin has a great advantage in effectiveness, but in the research process, repeating the method recorded in the existing literature, the number of oritavancin impurities obtained is more, and the total amount of impurities is higher

Method used

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  • Stable oritavancin compound
  • Stable oritavancin compound
  • Stable oritavancin compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] In a 3000ml reaction bottle equipped with stirring, thermometer and condenser, add 300g oritavancin and 2700ml of acetone-water (2:4.5) mixture, start stirring, heat up to 75°C, wait until all dissolve, Strain while hot. Cool down to 35°C and keep warm for 3 hours; then cool down to 25°C and keep warm for 4 hours to precipitate crystals, filter, and dry to obtain 276.1 g of high-purity oritavancin compound crystals with an optical purity of 99.88%. The detection of solvent residues meets the requirements.

[0032] Microparticles or microspheres are prepared by combining the compounds of the present invention with a pharmaceutically acceptable solid or liquid carrier, and optionally with pharmaceutically acceptable adjuvants and vehicles, using standard and conventional techniques. The composition is used for the preparation of oral preparations. It is given by way of example only and in no way is it intended to limit the scope of the invention in any way.

Embodiment 2

[0034] Tablets containing the oritavancin compound

[0035] Prescription: 300 grams of oritavancin compound, 50 grams of lactose, 260 grams of microcrystalline cellulose, 50 grams of sodium carboxymethyl starch, 5 grams of magnesium stearate, appropriate amount of distilled water, made into 1000 tablets.

[0036] Process: crush the oritavancin compound, pass through a 60-mesh sieve, mix with other materials, use distilled water to make a soft material, granulate with a 16-mesh sieve, dry in a drying oven at 40-45°C, add magnesium stearate to the dry granules Mix well and press into tablets.

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PUM

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Abstract

The present invention belongs to the technical field of medicine, and particularly relates to an oritavancin compound and a preparation method thereof. The oritavancin compound of the present invention has advantages of high purity, good stability, and not significant moisture absorption weight increase under a high humidity condition.

Description

technical field [0001] The invention belongs to the technical field of medicine, and specifically relates to an oritavancin compound and a preparation method thereof. The invention also relates to a composition using the compound and an application of the composition using the compound in treating diseases. Background technique [0002] Oritavancin (oritavancin, Orbactiv, IV) is a lipoglycopeptide antibacterial drug. On August 6, 2014, the FDA has approved oritavancin injection for use by sensitive Gram-positive bacteria (including armor-resistant bacteria). Treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) caused by Staphylococcus aureus (MRSA). [0003] Its structural formula is: [0004] [0005] Oritavancin has a great advantage in effectiveness, but in the research process, repeating the method recorded in the existing literature, the number of oritavancin impurities obtained is relatively high, and the total amount of imp...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07K9/00C07K1/30A61K38/14A61P31/04
Inventor 严洁李轩
Owner TIANJIN HANKANG PHARMA BIOTECH
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