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Cefminox sodium compound as well as preparation method and pharmaceutical composition of cefminox sodium compound

A technology of cefminox sodium and its compounds, which is applied in the field of medicine, can solve the problems of slow dissolution rate, high bioavailability, and poor stability of cefminox sodium crystals, and achieve improved storage stability, good storage stability, and impurity content little effect

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

The drug in this crystalline form has a large entropy value, good solubility, and high bioavailability. It not only has better dissolution stability, but also uses a new freeze-drying technology, which is easy to operate and is suitable for industrial production; it can solve the problem of the existing technology. The cefminox sodium crystal dissolves slowly, has poor stability, and has the defect of solid precipitation when placed for a long time

Method used

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  • Cefminox sodium compound as well as preparation method and pharmaceutical composition of cefminox sodium compound
  • Cefminox sodium compound as well as preparation method and pharmaceutical composition of cefminox sodium compound
  • Cefminox sodium compound as well as preparation method and pharmaceutical composition of cefminox sodium compound

Examples

Experimental program
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Effect test

Embodiment 1

[0042] The preparation method of cefminox sodium compound:

[0043] The preparation method comprises the steps of: taking cefminox sodium bulk drug, adding dimethyl sulfoxide, the volumetric dosage of dimethyl sulfoxide and the mass ratio of cefminox sodium being 7ml: 1g, stirring until completely dissolved, and adjusting the pH To 4.5, add activated carbon for decolorization, the amount of added activated carbon is 0.2% g / ml of the total volume of the medicinal solution, stir for 30min, filter to obtain a clear solution, move the clear solution into a pressure vessel, and control the pressure in the pressure vessel at Add diethyl ether dropwise under the condition of 1.5Mpa and stirring, the stirring speed is controlled at 25rmp, the amount of diethyl ether used is 3 times the volume of dimethyl sulfoxide, release the pressure after the dropwise addition, cool down to 0°C, let stand for 2h, filter and wash , and dried under reduced pressure to obtain white microcrystalline po...

Embodiment 2

[0046] The preparation method of cefminox sodium compound:

[0047] The preparation method comprises the steps of: taking cefminox sodium bulk drug, adding dimethyl sulfoxide, the volumetric dosage of dimethyl sulfoxide and the mass ratio of cefminox sodium being 10ml: 1g, stirring until completely dissolved, and adjusting the pH To 5.5, add activated carbon for decolorization, the amount of added activated carbon is 0.3% g / ml of the total volume of the medicinal solution, stir for 35min, filter to obtain a clear solution, move the clear solution into a pressure vessel, and control the pressure in the pressure vessel at Under the condition of 1Mpa and stirring, add diethyl ether dropwise, the stirring speed is controlled at 10rmp, the amount of diethyl ether used is 4 times the volume of dimethyl sulfoxide, release the pressure after the dropwise addition, lower the temperature to 5°C, let stand for 1h, filter, wash, Dry under reduced pressure to obtain white microcrystalline ...

Embodiment 3

[0050] Preparation of cefminox sodium sterile powder injection:

[0051] Weigh 99.5 g of cefminox sodium and 0.5 g of sodium benzoate 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 precision metering and subpackaging, each bottle Contains 0.25g of cefminox sodium, stoppered and capped, and 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 cefminox sodium compound. The structural formula of the cefminox sodium compound is shown in the specification and an X-ray powder diffraction spectrum of the cefminox sodium compound, which is measured through Cu-K(alpha) ray, is shown in Figure 1. Furthermore, the invention provides a preparation method of the cefminox sodium compound, a pharmaceutical composition containing the cefminox sodium compound, and a preparation method of the pharmaceutical composition. The dosage form of cefminox sodium medicine is sterile powder injection. The cefminox sodium compound and the pharmaceutical composition thereof provided by the invention, in comparison with the prior art, have better storage stability and liquidity and are easier to sub-package and mix; and the cefminox sodium compound and the pharmaceutical composition thereof greatly enhance the medication safety of patients.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a cefminox sodium compound, a preparation method thereof, a pharmaceutical composition containing the cefminox sodium compound and a preparation method of the pharmaceutical composition. Background technique [0002] There are two forms of cefminox sodium in the prior art, anhydrous and heptahydrate, and the CA registration numbers are respectively 75498-96-3 (anhydrous) and 92636-39-0 (heptahydrate), and the chemical formula is C 16 h 20 N 7 NaO 7 S 3 ·7H 2 O and C 16 h 20 N 7 NaO 7 S 3 ;Chemical name: (6R,7S)-7-[(S)-2-[(2-amino-2-carboxyethyl)sulfur]acetamido]-7-methoxy-3-[(1-methyl yl-1H-tetrazol-5-yl)thio]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid sodium salt; generic drug Name: CEFMINOX SODIUM. [0003] Cefminox sodium is a third-generation cephalosporin, a derivative of cephamycin, which is made into sodium heptahydrate by ...

Claims

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Application Information

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IPC IPC(8): C07D501/57C07D501/12A61K31/546A61P31/04
Inventor 梁宏平
Owner 四川省惠达药业有限公司
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