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Cefepime dihydrochloride compound as well as preparation method and medicine composition thereof

A technology of cefepime hydrochloride and its compound, which is applied in the field of medicine, can solve problems such as poor stability, and achieve the effects of less impurity content, good storage stability, and high safety performance

Inactive Publication Date: 2013-09-18
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

[0008] The stability of these two types of cefepime hydrochloride in the prior art is relatively poor, and they all need to be stored in the dark at 0-5°C. In order to obtain a cefepime hydrochloride compound with better stability, this invention

Method used

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  • Cefepime dihydrochloride compound as well as preparation method and medicine composition thereof
  • Cefepime dihydrochloride compound as well as preparation method and medicine composition thereof
  • Cefepime dihydrochloride compound as well as preparation method and medicine composition thereof

Examples

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Effect test

Embodiment 1

[0044] The preparation method of described cefepime hydrochloride compound:

[0045] Take cefepime hydrochloride raw material, add DMF, the ratio of the weight of cefepime hydrochloride to the volume of DMF is 1g: 8ml, stir until completely dissolved, adjust the pH to 1.5, heat to 40 ° C, and then stir Slowly add diethyl ether, the volume ratio of the added diethyl ether to DMF is 2:5, continue to stir for 20 minutes, then add activated carbon, the amount of activated carbon added is 0.2% g / ml of the total volume of the liquid medicine, stir for 30 minutes, filter to remove carbon Bacteria, to obtain a clear solution, move the clear solution into the reaction kettle, place it at 130°C for 36h, let it stand, naturally cool down to 55°C, open the reaction kettle, slowly add acetone dropwise and cool down to 5°C, the amount of acetone is DMF 8 times that of acetone, the stirring speed when adding acetone dropwise was 25rmp, filtered, washed 3 times with acetone, and dried under r...

Embodiment 2

[0048] The preparation method of described cefepime hydrochloride compound:

[0049] Take cefepime hydrochloride raw material, add DMF, the ratio of the weight of cefepime hydrochloride to the volume of DMF is 1g: 10ml, stir until completely dissolved, adjust the pH to 2.0, heat to 60 ° C, and then stir Slowly add diethyl ether, the volume ratio of the added diethyl ether to DMF is 3:5, continue to stir for 30 minutes, then add activated carbon, the amount of activated carbon added is 0.3% g / ml of the total volume of the liquid, stir and absorb for 30 minutes, filter and decarbonize Sterilize to obtain a clear solution, move the clear solution into the reaction kettle, place it at 150°C for 24 hours, let it stand, naturally cool down to 75°C, open the reaction kettle, slowly add acetone dropwise and cool to 0°C, the amount of acetone is 5 times that of DMF, the stirring speed when adding acetone dropwise is 15rmp, filter, wash 3 times with acetone, and dry under reduced pressu...

Embodiment 3

[0052] Preparation of Cefepime Hydrochloride Sterile Powder Injection:

[0053] Weigh 80 g of cefepime hydrochloride and 20 g of arginine prepared in Example 1 under aseptic conditions, place them in a solid powder mixer and mix them uniformly, and the raw materials obtained are transferred to a sterile preparation workshop for precise metering and subpackaging. Each bottle contains Cefepime hydrochloride 0.25g, stoppered and capped, the finished product is packaged for storage and sent for inspection.

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Abstract

The invention belongs to the technical field of medicines, and in particular relates to a cefepime dihydrochloride compound. The structural formula of the cefepime dihydrochloride compound is as shown in the specification; and the X-ray powder diffraction spectrogram obtained through measurement by using Cu-Kalpha rays, of the cefepime dihydrochloride compound is as shown in figure 1. The invention further provides a preparation method of the cefepime dihydrochloride compound, a medicine composition containing the cefepime dihydrochloride compound and the preparation method of the medicine composition. The cefepime dihydrochloride compound is prepared into the dosage form of sterility powder-injection. Compared with the prior art, the cefepime dihydrochloride compound and the medicine composition thereof have better storage stability, and the medication safety of patients is greatly improved.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a cefepime hydrochloride compound, a preparation method of the cefepime hydrochloride compound, a pharmaceutical composition containing the cefepime hydrochloride compound and a preparation method of the pharmaceutical composition. Background technique [0002] In the prior art, there are two forms of cefepime hydrochloride, one is cefepime hydrochloride monohydrate, molecular formula C 19 h 24 N 6 o 5 S 2 ·2HCl·H 2 O, CAS No. 123171-59-5, one is cefepime hydrochloride without crystal water, molecular formula C 19 h 24 N 6 o 5 S 2 • 2HCl, CAS No. 107648-80-6. [0003] Cefepime hydrochloride is a fourth-generation semi-synthetic cephalosporin. The antibacterial spectrum and antibacterial activity are similar to the third-generation cephalosporins, but the antibacterial spectrum has been further expanded. It has strong antibacterial activity against Gram-po...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D501/46C07D501/12A61K31/546A61P31/04
Inventor 梁宏平
Owner 四川省惠达药业有限公司
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