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New crystal form α of clindamycin phosphate and its preparation method

A technology of clindamycin phosphate and crystal form, which is applied in the field of medicine and can solve the problems of poor stability and unstable dissolution of clindamycin phosphate

Active Publication Date: 2016-06-08
TIANJIN UNIV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The purpose of the present invention is to introduce the new crystal form of clindamycin phosphate found in the research process and the crystallization method of different crystal forms, in order to solve the defects of poor stability and unstable dissolution of clindamycin phosphate in the current technology Provide new crystal form resources

Method used

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  • New crystal form α of clindamycin phosphate and its preparation method
  • New crystal form α of clindamycin phosphate and its preparation method
  • New crystal form α of clindamycin phosphate and its preparation method

Examples

Experimental program
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Effect test

Embodiment 1

[0022] Example 1 Preparation of Clindamycin Phosphate Crystal Form α

[0023] Dissolve 5g of crude lindamycin phosphate in a mixed solvent of 20mL ethanol and 20mL water, then heat up to 65°C and dissolve, heat filter to remove insoluble impurities, stir, cool down to 35-37°C to produce crystals, and keep warm for 2- After 3 hours, the temperature was lowered to 5°C, and dried at 50°C for 24 hours to obtain the crystal form α of clindamycin phosphate. The powder X-ray diffraction pattern of the product and figure 1 unanimous.

Embodiment 2

[0024] Example 2 Preparation of Clindamycin Phosphate Crystal Form α

[0025] Dissolve 4g of crude lindamycin phosphate in a mixed solvent of 20mL ethanol and 10mL water, then heat up to 50°C and dissolve, heat filter to remove insoluble impurities, stir, cool to 30-32°C to produce crystals, and keep warm for 2- After 3 hours, the temperature was lowered to 5°C, and dried at 55°C for 24 hours to obtain the crystal form α of clindamycin phosphate. The powder X-ray diffraction pattern of the product and figure 1 unanimous.

Embodiment 3

[0026] Example 3 Preparation of Clindamycin Phosphate Crystal Form α

[0027] Dissolve 4.5g of crude lindamycin phosphate in a mixed solvent of 30mL of ethanol and 6mL of water, then heat up to 60°C and dissolve, heat filter to remove insoluble impurities, stir, cool to 45-47°C to produce crystals, and keep warm for 2 -3h, then lower the temperature to 5°C, and dry at 60°C for 24 hours to obtain the crystal form α of clindamycin phosphate. The powder X-ray diffraction pattern of the product and figure 1 unanimous.

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Abstract

The invention relates to a novel crystal form (alpha) of clindamycin phosphate, and a preparation method. The novel crystal form (alpha) of clindamycin phosphate is obtained by dissolving crude clindamycin phosphate in a mixed solvent of deionized water and a low alcohol, wherein an initial mass concentration of the crude clindamycin phosphate is 0.11-0.13 g / mL; heating the solution with stirring until the clindamycin phosphate is dissolved and the solution is clear; thermal filtering; cooling to a state that crystals are precipitated; further cooling; filtering; heating to the temperature of 50-60 DEG C and drying. In an XRD powder diffraction pattern irradiated by Cu-K[alpha], characteristic peaks appear at 2[theta] angles of 5.6+ / -0.1 degrees, 9.7+ / -0.1 degrees, 11.3+ / -0.1 degrees, 14.9+ / -0.1 degrees, 21.9+ / -0.1 degrees and 22.1+ / -0.1 degrees. The novel crystal form (alpha) has good stability; the crystal remains white powder after being placed 10 days at the high temperature of 50 DEG C; and the X-ray diffraction pattern has no obvious change.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a new crystal form α of clindamycin phosphate and a preparation method thereof. Background technique [0002] Clindamycin Phosphate is an antibiotic drug, its chemical name is: methyl 6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-7 (S)-Chloro-6,7,8-trideoxy-L-threo-α-D-galactopyranoside-2-phosphate. Since it was launched in my country in 1970, clindamycin phosphate is a semi-synthetic clindamycin derivative, which has no antibacterial activity in vitro and is rapidly hydrolyzed into clindamycin in the body to exert pharmacological effects. 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 lac...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07H15/16C07H1/06
Inventor 龚俊波冉媛媛董伟兵王静康尹秋响张美景王永莉侯宝红郝红勋鲍颖陈巍
Owner TIANJIN UNIV
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