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Novel ampicillin sodium compound

A technology of ampicillin sodium and compound, applied in the field of medicine, can solve problems such as inconvenience in clinical use

Inactive Publication Date: 2016-08-24
石药集团中诺药业(石家庄)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This brings a lot of inconvenience to clinical use

Method used

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  • Novel ampicillin sodium compound

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0032] Embodiment 1 prepares new ampicillin sodium compound of the present invention

[0033] Add 100 g of ampicillin sodium crude product into a 15 L three-necked flask, add 6000 mL of isobutanol and 200 mL of N-methylpyrrolidone, stir and heat to reflux to dissolve, then add 800 mL of ether to the solution, then slowly cool down to 10 °C, stir and analyze crystallized, filtered, washed with ether, and dried under vacuum at 65°C to obtain 956 g of the new ampicillin sodium compound with a yield of 95.6%.

[0034] The X-ray powder diffraction pattern of the new ampicillin sodium compound prepared in embodiment 1 is (accuracy is ± 0.1 °): 4.95 °, 6.38 °, 10.11 °, 11.53 °, 12.63 °, 12.82 °, 13.91 ° ​​at reflection angle 2θ °, 14.17°, 14.56°, 14.87°, 15.08°, 15.57°, 16.26°, 16.60°, 18.73°, 18.93°, 19.29°, 19.93°, 20.28°, 20.73°, 20.98°, 21.23°, 21.92°, Features at 22.56°, 22.81°, 23.01°, 23.80°, 24.14°, 24.47°, 25.43°, 25.63°, 26.08°, 26.33°, 26.74°, 27.07°, 27.78°, 28.43°, 29.0...

Embodiment 2

[0036] Embodiment 2 prepares new ampicillin sodium compound of the present invention

[0037] Add 100g of ampicillin sodium crude product into a 15L three-necked flask, add 8000mL of isobutanol and 100mL of N-methylpyrrolidone, stir and heat to reflux to dissolve, then add 1000mL of ether to the solution, then slowly cool down to 15°C, stir and analyze crystallized, filtered, washed with ether, and dried under vacuum at 55°C to obtain 913g of the new ampicillin sodium compound with a yield of 91.3%.

[0038] The X-ray powder diffraction pattern and the DSC collection of illustrative plates of the new ampicillin sodium compound prepared in embodiment 2 are the same as in embodiment 1.

Embodiment 3

[0039] Embodiment 3 prepares new ampicillin sodium compound of the present invention

[0040] Add 100 g of ampicillin sodium crude product into a 15 L three-necked flask, add 5000 mL of isobutanol and 240 mL of N-methylpyrrolidone, stir and heat to reflux to dissolve, then add 600 mL of ether to the solution, then slowly cool down to 5 °C, stir and analyze crystallized, filtered, washed with ether, and dried under vacuum at 75°C to obtain 928g of the new ampicillin sodium compound with a yield of 92.8%.

[0041] The X-ray powder diffraction pattern and the DSC collection of illustrative plates of the new ampicillin sodium compound prepared in embodiment 3 are the same as in embodiment 1.

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Abstract

The invention relates to a novel ampicillin sodium compound and a preparation method thereof and belongs to the technical field of medicine. According to the ampicillin sodium compound, in an X-ray powder diffraction spectrum obtained through Cu-Ka radionetric measurement, characteristic peaks are displayed at the positions where 2theta equals to 14.17 + / -0.1 degrees, 14.56 + / -0.1 degrees, 14.87 + / -0.1 degrees and 26.74 + / -0.1 degrees. The prepared novel ampicillin sodium compound is good in mobility, more meets requirements of technology of pharmaceutics and is more suitable for preparing various pharmaceutic preparations. Due to the fact that powder-injection prepared from the novel ampicillin sodium compound is good in stability, besides, stability can reach 36 hours or above after the powder-injection is prepared into an injection solution, storage time is greatly prolonged, therefore safety and efficiency of drug use are improved, and the occurrence rate of adverse reactions is reduced.

Description

technical field [0001] The invention relates to a novel compound and a preparation method thereof, in particular to a novel ampicillin sodium compound and a preparation method thereof, belonging to the technical field of medicine. Background technique [0002] Ampicillin Sodium, chemical name: (2S,5R,6R)-3,3-Dimethyl-6-[(R)-2-amino-2-phenylacetamido]-7-oxo- 4-Thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid sodium salt. Molecular formula is C 16 h 18 N 3 NaO 4 S, the molecular weight is 371.39. Chemical Structure: [0003] [0004] Ampicillin sodium is a broad-spectrum semi-synthetic penicillin antibiotic drug. It exerts a bactericidal effect by inhibiting the synthesis of bacterial cell walls. inferior to penicillin. Ampicillin also has a good antibacterial effect on Streptococcus viridans, and its effect on Enterococcus and Listeria is better than that of penicillin. It has antibacterial activity against Corynebacterium diphtheriae, Bacillus anthracis, Actinom...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): C07D499/68C07D499/18A61K31/43A61K9/14A61P31/04
CPCA61K9/0019A61K9/14C07B2200/13C07D499/18C07D499/68
Inventor 马慧丽王荣端康辉李冬梅
Owner 石药集团中诺药业(石家庄)有限公司