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Crystal form of clindamycin phosphate and preparation method thereof

A technology of clindamycin phosphate and declindamycin, which is applied in the field of medicine and can solve problems such as poor stability of clindamycin phosphate

Inactive Publication Date: 2010-09-22
ZHUHAI EBANG PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The object of the present invention is to solve the defect of poor stability of clindamycin phosphate in the prior art, and provide a crystal form of clindamycin phosphate that is good in stability and convenient for preparation and a preparation method thereof

Method used

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  • Crystal form of clindamycin phosphate and preparation method thereof
  • Crystal form of clindamycin phosphate and preparation method thereof
  • Crystal form of clindamycin phosphate and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Example 1 Preparation of Clindamycin Phosphate Form I

[0060] Dissolve 4.8g of clindamycin phosphate in a mixed solvent of 40ml of n-butanol and 10ml of water, heat and stir at 45°C for 1 hour, filter, and the filtrate evaporates naturally at room temperature, and a white crystalline solid appears after 5 days, filter, and wash the crystalline solid with ether Rinse three times, and dry in a vacuum oven at 80°C for 12 hours to obtain Clindamycin Phosphate Form I.

Embodiment 2

[0061] Example 2 Preparation of Clindamycin Phosphate Form II

[0062] 3.4g of clindamycin phosphate was stirred and dissolved in 30ml of water, then the aqueous solution was dropped into 180ml of absolute ethanol, stirred at room temperature for 1.5 hours to precipitate a white crystalline solid, filtered, and the crystalline solid was vacuum-dried at room temperature to obtain clindamycin phosphate Form II.

Embodiment 3

[0063] Embodiment 3 Preparation of Clindamycin Phosphate Form III

[0064] Dissolve 12.7g of clindamycin phosphate in 100ml of water, filter, let the filtrate stand, and remove the water by rotary evaporation after 2 days to obtain a white crystalline solid. After washing the crystalline solid with absolute ethanol for 3 times, put it in a vacuum oven at 80°C After drying for 12 hours, the crystal form III of clindamycin phosphate was obtained.

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Abstract

The invention belongs to the technical field of medicine, in particular relating to a crystal form of clindamycin phosphate and a preparation method thereof as well as amorphous clindamycin phosphate with stable character and high safety of clinic medication, wherein the crystal form is composed of clindamycin phosphate crystal form I, clindamycin phosphate crystal form II and clindamycin phosphate crystal form III.

Description

1. Technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a crystal form of clindamycin phosphate and a preparation method thereof. 2. Background technology [0002] Clindamycin phosphate is a derivative of clindamycin, which is inactive in vitro. When injected into the body, it is rapidly hydrolyzed into clindamycin to exert pharmacological effects and inhibit bacterial protein synthesis. Clindamycin phosphate has the same antibacterial spectrum and antibacterial activity as clindamycin, and has antibacterial activity against Gram-positive bacteria such as Staphylococcus aureus, Streptococcus pneumoniae and hemolytic streptococcus and most anaerobic bacteria. [0003] Clindamycin phosphate is a lactone compound, which is easy to degrade in water, and its hydrolyzed products are highly toxic. In addition, the structure and pharmacological properties of many degradation products are still unclear, which affects the safety...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07H15/16C07H1/00A61P31/04
Inventor 张在富华荣庆吴建国吴浩山
Owner ZHUHAI EBANG PHARMA
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