Cefmenoxime hydrochloride compound for injection and pharmaceutical composition thereof

A technology of cefmenoxime hydrochloride and its compound, which is applied in the field of cefmenoxime hydrochloride compound for injection and its pharmaceutical composition, can solve the problems of solubility and stability to be improved, and achieve high yield, good stability and high purity Effect

Inactive Publication Date: 2013-06-12
四川省惠达药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] Patent application 201210137852.6 discloses a cefmenoxime hydrochloride compound and its micronization method, including the following steps: the dried cefmenoxime hydrochloride crystalline powder raw material is accelerated by a supersonic airflow in a jet mill and collides with each other The supersonic airflow is driven by the pressure of 0.4-0.8MPa compressed air, and the temperature of the compressed air is ≤40°C; the crushed materials enter the classification area with the airflow, and the materials that meet the particle size requirements pass through the classification wheel with a set speed , materials that do not meet the particle size requirements return to the crushing area to continue crushing; but its solubility and stability also need to be improved

Method used

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  • Cefmenoxime hydrochloride compound for injection and pharmaceutical composition thereof
  • Cefmenoxime hydrochloride compound for injection and pharmaceutical composition thereof
  • Cefmenoxime hydrochloride compound for injection and pharmaceutical composition thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The preparation of embodiment 1 cefmenoxime hydrochloride compound

[0042] (1) Take cefmenoxime hydrochloride solid, add water and stir to make a suspension, add 15% sodium hydroxide solution at 1 °C, stir and dissolve to obtain a clear liquid, then add a mixture of isopropanol and ethyl acetate solution; the volume ratio of isopropanol and ethyl acetate is 1:0.75; the volume ratio of the mixed solvent of isopropanol and ethyl acetate to the solid solution of cefmenoxime hydrochloride is 0.45:1;

[0043] (2) Add the clarified liquid to 0.01% activated carbon for decolorization, stir for 1 hour and then filter the filtrate;

[0044] (3) Heat the solution obtained in step (2) to 20°C, add hydrochloric acid at 1°C while stirring, adjust the pH value to 1.8, and stir at a speed of 90 rpm; stop stirring after adding the hydrochloric acid, and continue to cool the solution to 1° C., stand for crystal growth for 1 hour, obtain crystals, filter, wash, and vacuum-dry for 4 hou...

Embodiment 2

[0046] The preparation of embodiment 2 cefmenoxime hydrochloride compound

[0047] (1) Take cefmenoxime hydrochloride solid and add water to stir to make a suspension, add 15% sodium hydroxide solution at 0°C, stir and dissolve to obtain a clear liquid, then add a mixture of isopropanol and ethyl acetate solution; the volume ratio of isopropanol and ethyl acetate is 1:0.5; the volume ratio of the mixed solvent of isopropanol and ethyl acetate to the solid solution of cefmenoxime hydrochloride is 0.45:1;

[0048] (2) Add the clarified liquid to 0.01% activated carbon for decolorization, stir for 1.5 hours and then filter the filtrate;

[0049] (3) Heat the solution obtained in step (2) to 25°C, add hydrochloric acid at 1°C while stirring, adjust the pH value to 1.8, and stir at a speed of 120 rpm; stop stirring after adding the hydrochloric acid, and continue to cool the solution to 0° C., stand for crystal growth for 2 hours, obtain crystals, filter, wash, and vacuum-dry for ...

Embodiment 3

[0051] The preparation of embodiment 3 cefmenoxime hydrochloride compound

[0052] (1) Take cefmenoxime hydrochloride solid and add water and stir to make a suspension, add 15% sodium hydroxide solution at 5°C, stir and dissolve to obtain a clear liquid, then add isopropanol and ethyl acetate to mix solution; the volume ratio of isopropanol and ethyl acetate is 1:0.85; the volume ratio of the mixed solvent of isopropanol and ethyl acetate to the solid solution of cefmenoxime hydrochloride is 0.2:1;

[0053] (2) Add the clarified liquid to 0.01% activated carbon for decolorization, stir for 0.5 hours and then filter the filtrate;

[0054] (3) Heat the solution obtained in step (2) to 25°C, add hydrochloric acid at 5°C while stirring, adjust the pH value to 1.8, and stir at a speed of 120 rpm; stop stirring after adding the hydrochloric acid, and continue to cool the solution to 5° C., stand for crystal growth for 3 hours, obtain crystals, filter, wash, and vacuum-dry for 6 hou...

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Abstract

The invention relates to a cefmenoxime hydrochloride compound for injection. The cefmenoxime hydrochloride compound is a crystal; an X-ray powder diffraction pattern measured by Cu-Kalpha rays is shown in a figure 1; and the crystal main granularity of the hydrochloric cefmenoxime is 195-230 microns, and the distribution width is between 150 and 280 microns. The invention also relates to a pharmaceutical composition of the cefmenoxime hydrochloride compound, which comprises 10 parts by weight of hydrochloric cefmenoxime crystal, and 1.5-2.0 parts by weight of anhydrous sodium carbonate, preferably 10 parts by weight of the hydrochloric cefmenoxime crystal and 1.75 parts by weight of anhydrous sodium carbonate. The injection prepared by using the cefmenoxime hydrochloride compound is quickly dissolved, and is good in flowability, good in stability and safe and reliable in clinical application.

Description

technical field [0001] The invention relates to a cefmenoxime hydrochloride, in particular to a cefmenoxime hydrochloride compound for injection and a pharmaceutical composition thereof. Background technique [0002] The molecular formula of cefmenoxime hydrochloride is (C 16 h 17 N 9 o 5 S 3 ) 2 HCl, its structural formula is: [0003] [0004] However, due to the poor water solubility of cefmenoxime hydrochloride, it is only slightly soluble in water, which brings many difficulties in practical application. At present, people have done a lot of research on the preparation of cefmenoxime hydrochloride. [0005] "Preparation of Cefmenoxime Hydrochloride" (Heilongjiang Science and Technology Information No. 8, 2008) discloses a synthesis method of cefmenoxime hydrochloride, specifically: adding sodium bicarbonate to cefmenoxime acid until dissolved, and then adding Hydrochloric acid and ethanol, stirred and crystallized at 5°C for 2 hours, filtered, the filtrate wa...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/36C07D501/12A61K31/546A61P31/04
Inventor 梁宏平
Owner 四川省惠达药业有限公司
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