Sodium fusidate crystal and preparation method thereof

A technology for sodium fusidate and crystals, applied in the field of compound crystals and preparation thereof, can solve the problems of high production cost, unfavorable preservation and sub-packaging, poor stability of sodium fusidate crystals, etc., and achieves low production cost and stable production. Sexual and environmentally friendly effects

Active Publication Date: 2013-07-24
NCPC NEW DRUG RES & DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

Though this method has improved the purity of sodium fusidate crystal to a certain extent, there are still many weak points, such as using the stability of th...

Method used

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  • Sodium fusidate crystal and preparation method thereof
  • Sodium fusidate crystal and preparation method thereof
  • Sodium fusidate crystal and preparation method thereof

Examples

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Effect test

Embodiment 1

[0027] Weigh 9.0g of fusidic acid solid, add absolute ethanol, heat to 45°C, after dissolving, add 4M aqueous sodium hydroxide solution under stirring, the molar ratio of added sodium hydroxide to fusidic acid is 0.8:1 to obtain 25ml of sodium fusidate solution; control the temperature at 20°C, add ethyl acetate solution under stirring, the flow rate is 25ml / h, when the amount of ethyl acetate is 375ml, stop feeding, Stir for another 0.5 h, filter with suction, and dry the filter cake at 35° C. for 36 h to obtain 8.3 g of sodium fusidate crystals. After testing its X-ray powder diffraction pattern is as follows figure 1 shown. As determined by HPLC, its purity was 99.83%. The yield was 88.46%.

Embodiment 2

[0029] Weigh 9.0g of fusidic acid solid, dissolve it in absolute ethanol at 40°C, add 4M aqueous sodium hydroxide solution under stirring, and the molar ratio of added sodium hydroxide to fusidic acid is 1:1 , to obtain 30ml of sodium fusidate solution; control the temperature at 25°C, add ethyl acetate solution under stirring state, when the flow rate is 510ml, after the addition is completed, stir for 1h, filter with suction, and place the filter cake at 40°C After drying for 42 hours, 8.7 g of sodium fusidate crystals were obtained. After testing its X-ray powder diffraction pattern is as follows figure 1 shown. As determined by HPLC, its purity was 99.98%. The yield was 92.72%.

Embodiment 3

[0031] Weigh 9.0 g of fusidic acid solids, dissolve and clarify it with absolute ethanol at 35° C., and add 4 M aqueous sodium hydroxide solution under stirring. The molar ratio of added sodium hydroxide to fusidic acid is 1.2:1, to obtain 35ml of sodium fusidate solution; control the temperature at 40°C, add ethyl acetate solution under stirring, the flow rate is 35ml / h, when the amount of ethyl acetate is 700ml, stop feeding, Stir again for 1.5h, filter with suction, place the filter cake at 45°C and dry for 48h to obtain 8.5g of sodium fusidate crystals, whose X-ray powder diffraction pattern is as follows: figure 1 shown. As determined by HPLC, the purity was 99.89%, and the yield was 90.59%.

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Abstract

The invention relates to a sodium fusidate crystal and a preparation method thereof. The X-ray powder diffraction spectrum characteristic peaks of the sodium fusidate crystal newly provided by the invention, represented by 2theta+/-0.2 degrees, are at 6.960, 7.117, 8.180, 8.355, 11.895, 14.460, 15.176, 16.389, 16.574, 24.837, 28.967 and 36.344. The preparation method comprises the following steps of: 1) dissolving fusidic acid in a low alcohol solution to obtain a sodium fusidate solution; 2) feeding an ethyl acetate solution into the sodium fusidate solution to crystallize sodium fusidate, and collecting a solid phase; and 3) drying the solid phase, thus obtaining a sodium fusidate crystal. The sodium fusidate crystal provided by the invention has the advantages of being glittering and translucent in appearance, uniform in granule, stable in crystal form, favorable for sub-package and storage, and the like. The method provided by the invention has the advantages that the prepared sodium fusidate crystal is good in stability, the process is simple in process and environment-friendly, and the adopted solvent is reusable and recoverable, low in production cost and the like.

Description

technical field [0001] The invention relates to a compound crystal and a preparation method thereof, more specifically relates to a sodium fusidate crystal and a preparation method thereof. Background technique [0002] Fusidate Sodium (Fusidate Sodium, trade name Lisidine) is the sodium salt of Fusidic acid (Fusidate acid), which was first obtained from the shuttle in the fermentation broth by Leo Pharmaceutical Products of Denmark in 1962. Extracted from the fungus streptosporic liposome, which belongs to the class of fusidic acid antibiotics. Sodium fusidate is a brand-new antibiotic, which is applied to various infections caused by various sensitive bacteria, especially staphylococcus, such as osteomyelitis, sepsis, endocarditis, surgical and traumatic infections, etc. At the same time, it has good safety, and its toxicity is low, and allergic reactions are rare. [0003] At present, the industrial method for preparing sodium fusidate crystals usually uses various orga...

Claims

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Application Information

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IPC IPC(8): C07J13/00
Inventor 李敏娜魏增辉常亮仲伟潭郭月玲王崔岩张雪霞张宇婷李耿宋霏
Owner NCPC NEW DRUG RES & DEV
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