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A kind of cefminox sodium crystal and its preparation method and application

A technology of cefminox sodium and crystals, which is applied in the field of cefminox sodium crystals and its preparation, can solve problems such as differences in the crystallization properties of cefminox sodium, achieve improved safety and effectiveness, good thermal stability, and reduce application risk effect

Active Publication Date: 2015-12-02
NAT INST FOR FOOD & DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, depending on the crystallization process, the crystallization properties of cefminox sodium heptahydrate are also different.

Method used

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  • A kind of cefminox sodium crystal and its preparation method and application
  • A kind of cefminox sodium crystal and its preparation method and application
  • A kind of cefminox sodium crystal and its preparation method and application

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] The preparation of embodiment 1 cefminox sodium crystal

[0044] Take the crude product of cefminox sodium and configure it into an aqueous solution, wherein the crude product of cefminox sodium is 2.6g, deionized water is 12ml (solution concentration is 0.22g / ml), adjust the pH value of the aqueous solution to 4.9, and the solution temperature to 23°C;

[0045] Slowly add acetone-isopropanol (1:1) mixed solution to the aqueous solution under stirring at 10rpm, stop stirring when turbidity occurs, and let it stand for 15 minutes; continue to add acetone-isopropanol (1:1) to mix while stirring at 5rpm Solution, the total volume of the mixed solution of acetone-isopropanol (1:1) is 12ml; the obtained solution is placed in the dark, well ventilated, and the ambient temperature is 4°C for crystal growth, and the crystal growth time is After 30 hours, the evaporation volume of the solution was 10 ml; the obtained crystals were filtered, the filter cake was washed 3 times wit...

Embodiment 2

[0047] The preparation of embodiment 2 cefminox sodium crystals

[0048] Take the crude product of cefminox sodium and configure it into an aqueous solution, wherein the crude product of cefminox sodium is 2.6g, deionized water is 12ml (solution concentration is 0.22g / ml), adjust the pH value of the aqueous solution to 5.0, and the temperature of the solution to 25°C;

[0049] Slowly add absolute ethanol to the aqueous solution under stirring at 10 rpm, stop stirring when turbidity occurs, and let it stand for 15 minutes; continue adding absolute ethanol under stirring at 10 rpm, and the total volume of absolute ethanol added is 12ml; Carry out crystal growth under the conditions of avoiding light, good ventilation, and ambient temperature of 4°C. The crystal growth time is 30 hours, and the evaporation volume of the solution is 9ml; the obtained crystals are filtered, and the filter cake is washed 3 times with absolute ethanol. Dry under normal pressure at 19°C. The cefminox...

Embodiment 3

[0051] The preparation of embodiment 3 cefminox sodium crystals

[0052] Take the crude product of cefminox sodium and configure it into an aqueous solution, wherein the crude product of cefminox sodium is 1.2g, deionized water is 12ml (solution concentration is 0.1g / ml), adjust the pH value of the aqueous solution to 4.5, and the solution temperature to 18°C;

[0053] Slowly add dehydrated ethanol to the aqueous solution under 10rpm speed stirring, stop stirring when turbidity occurs, and let it stand for 20 minutes; continue to add dehydrated ethanol under 10rpm speed stirring, the total addition volume of dehydrated alcohol is 7.2ml; the solution obtained, Place it in a place protected from light, with good ventilation and an ambient temperature of 6°C for crystal growth. The crystal growth time is 24 hours, and the evaporation volume of the solution is 9ml; the obtained crystals are filtered, and the filter cake is washed 3 times with absolute ethanol. It can be obtained b...

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Abstract

The invention relates to a cefminox sodium crystal as well as a preparation method thereof. The crystal is measured by using a powder X-ray diffraction measuring method, and an X-ray powder diffraction pattern indicated by an diffraction angle of 2 theta + / -0.2 degree shows a characteristic diffraction peak at 8.60 degrees, 9.00 degrees, 10.68 degrees, 12.58 degrees, 12.74 degrees, 13.70 degrees, 15.34 degrees, 15.60 degrees, 17.00 degrees, 18.00 degrees, 18.54 degrees, 19.18 degrees, 21.02 degrees, 21.52 degrees, 21.86 degrees, 22.70 degrees, 23.86 degrees, 24.24 degrees, 24.90 degrees, 25.18 degrees, 25.90 degrees, 26.54 degrees, 27.12 degrees, 27.54 degrees, 29.38 degrees, 30.62 degrees, 31.22 degrees, 32.24 degrees, 32.84 degrees, 34.30 degrees, 35.88 degrees, 36.32 degrees, 36.44 degrees, 36.54 degrees, 38.14 degrees, 39.10 degrees, 39.62 degrees, 40.32 degrees, 41.04 degrees, 41.78 degrees, 43.44 degrees, 43.70 degrees, 44.04 degrees, 45.02 degrees, 45.88 degrees, 47.64 degrees, 48.20 degrees, 48.80 degrees, 55.90 degrees and 57.64 degrees. The cefminox sodium crystal is a novel crystal, and has lowest amount of substance, highest effectiveness, best thermal stability, quickest red-dissolving velocity and highest safety among all crystals. The preparation method disclosed by the invention is simple and good in reproducibility, and has great practical value.

Description

technical field [0001] The invention relates to a new crystal form of cefminox sodium, in particular to a cefminox sodium crystal and a preparation method and application thereof. Background technique [0002] Cefminox Sodium (Cefminox Sodium) is a cephamycin derivative, developed by Japan's Meiji Seika Co., Ltd., and first listed in Japan in 1987. In 1992, my country began to import this variety, and in 2004, Shenzhen (Nanchang) Lijian Pharmaceutical Co., Ltd. took the lead in making it into the market. Its role and properties are similar to those of the third-generation cephalosporins. It is clinically used for respiratory system, urinary system, abdominal cavity, and pelvic infection caused by sensitive bacteria, and can also be used for the treatment of sepsis. [0003] Structural information: cefminox sodium, chemical name: (+)-(6R,7S)-7-[(S)-2-(2-amino-2-carboxyethylthio)-acetamido]-7-methanol Oxy-3-[[(1-methyl-1H-tetrazol-5-yl)-thio]-methyl]-8-oxo-5-thia-1-azabicyc...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): C07D501/57C07D501/12A61K31/546A61P31/04A61P11/00A61P13/00
CPCC07D501/12C07D501/57
Inventor 胡昌勤王晨冯艳春邹文博张斗胜
Owner NAT INST FOR FOOD & DRUG CONTROL
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