Ceftriaxone sodium and sulbactam sodium composition, pharmaceutical preparation containing composition and application of pharmaceutical preparation

A technology for ceftriaxone sodium and pharmaceutical preparations, applied to pharmaceutical preparations and their application fields, can solve the problems of short validity period, poor stability, poor efficacy and the like, and achieve the effects of excellent stability and biological activity

Active Publication Date: 2020-06-09
XIANGBEI WELMAN PHARMA CO LTD +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] One of the objectives of the present invention is to provide a stable composition composed of ceftriaxone sodium and sulbactam sodium, to solve the poor stability, poor efficacy or short validity period of the current ceftriaxone sodium and sulbactam sodium compound preparations And other issues

Method used

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  • Ceftriaxone sodium and sulbactam sodium composition, pharmaceutical preparation containing composition and application of pharmaceutical preparation
  • Ceftriaxone sodium and sulbactam sodium composition, pharmaceutical preparation containing composition and application of pharmaceutical preparation
  • Ceftriaxone sodium and sulbactam sodium composition, pharmaceutical preparation containing composition and application of pharmaceutical preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] Get ceftriaxone sodium 1200g and sulbactam sodium 600g prepared according to the method of comparative example 2, grind together to particle diameter D with ball ink machine 5025 μm to 47 μm, and then placed in a conical ribbon mixer (HF1600 type) and mixed evenly, the machine speed was set at 30 revolutions per minute, and the mixing time was 25 minutes. After the operation was completed, the materials were taken out to obtain a crystalline substance, which was named Composition I.

[0088] Sampling was taken to determine its crystal form, and the X-ray powder diffraction pattern was shown in image 3 , Table 1 lists the main data in the spectrum.

[0089] Its infrared absorption is measured by infrared absorption spectrum analysis, and the spectrum is shown in Figure 4 , Table 2 lists the main infrared absorption peak data.

[0090] Differential scanning calorimetry was performed and an exothermic peak was found at 269.51°C.

[0091] Table 1 The main data of the ...

Embodiment 2

[0097] Get 500g of commercially available ceftriaxone sodium and 500g of sulbactam sodium, grind together to particle size D with a ball ink machine 50 38 μm to 62 μm. Then place it in a single-cone ribbon mixer (HF1600 type) and mix evenly, the machine speed is set at 40 revolutions per minute, and the mixing time is 20 minutes. After the operation was completed, the material was taken out to obtain a crystalline substance, which was named Composition II.

[0098] Sampling was taken to determine its crystal form, and the X-ray powder diffraction pattern was shown in Figure 5 , Table 3 lists the main data in the map.

[0099] Its infrared absorption is measured by infrared absorption spectrum analysis, and the spectrum is shown in Figure 6 , Table 4 lists the main infrared absorption peak data.

[0100] Differential scanning calorimetry was performed and an exothermic peak was found at 269.67°C.

[0101] Table 3 X-ray powder diffraction main data of composition II

[0...

Embodiment 3

[0106] Get 930g of commercially available ceftriaxone sodium and grind it; get 310g of sulbactam sodium and grind it, and then grind the two kinds of raw materials together to a particle size of D 50 58 μm to 88 μm. Place in a single-cone ribbon mixer (HF1600 type) and mix evenly, the machine speed is set at 25 revolutions per minute, and the mixing time is 10 minutes. After the operation was completed, the material was taken out, and the obtained crystalline material was named Composition III.

[0107] Sampling was taken to determine its crystal form, and the X-ray diffraction pattern was shown in Figure 7 , Table 5 lists the main data in the map.

[0108] Its infrared absorption is measured by infrared absorption spectrum analysis, and the spectrum is shown in Figure 8 , Table 6 lists the main infrared absorption peak data.

[0109] Differential scanning calorimetry was performed and an exothermic peak was found at 269.69°C.

[0110] Table 5 X-ray powder diffraction m...

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Abstract

The invention provides a composition composed of ceftriaxone sodium and sulbactam sodium, a pharmaceutical preparation containing the composition and application of the pharmaceutical preparation. Thecomposition is characterized in that an X-ray powder diffraction analysis spectrum contains a specific diffraction angle. The pharmaceutical preparation containing the composition provided by the invention has better bacteriostatic activity and stability; therefore, the preparation is very suitable for treatment of bacterial infection, and is especially suitable for treatment of refractory urogenital system infection diseases caused by Neisseria gonorrhoeae resistant to various antibiotics (beta-lactams, tetracyclines, macrolides, fluoroquinolones or aminoglycosides).

Description

technical field [0001] The invention relates to a composition, in particular to a composition composed of ceftriaxone sodium and sulbactam sodium. The present invention also relates to pharmaceutical preparations comprising the composition and applications thereof. Background technique [0002] Ceftriaxone (ceftriaxone) is a third-generation cephalosporin antibiotic, and its sodium salt is commonly used clinically. Ceftriaxone sodium has good antibacterial activity against various Gram-negative bacteria and some Gram-positive bacteria (such as E. Infectious diseases, but not sensitive to methicillin-resistant Staphylococcus aureus (MRSA), Enterobacter cloacae, etc., resulting in certain restrictions on its use. Sulbactam is a β-lactamase inhibitor. In the prior art, someone made sulbactam sodium and ceftriaxone sodium into a compound preparation, which improved the antibacterial spectrum of ceftriaxone and the sensitivity to drug-resistant bacteria. [0003] Stable drug ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K31/43A61K9/14A61K9/19A61K9/08A61P31/04A61P13/00A61P15/00
CPCA61K31/546A61K31/43A61K9/14A61K9/19A61K9/08A61K9/0019A61P31/04A61P13/00A61P15/00A61K2300/00Y02A50/30
Inventor 不公告发明人
Owner XIANGBEI WELMAN PHARMA CO LTD
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