Piperacillin sodium-tazobactam sodium medicine composition and preparation method thereof

A technology of piperacillin sodium and tazobactam sodium, which is applied in the field of medicine, can solve the problems of great harm to patients, poor stability of preparations, and easy triggering of allergic reactions, etc., and achieve the effect of low polymer content and good stability

Active Publication Date: 2013-10-09
CHINA MEHECO SANYANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] The piperacillin sodium-tazobactam sodium compound preparation described in the above-mentioned published patents has the same defect of poor preparation stability as the marketed compound preparation, and cannot meet the quality requirements of the validity period, which seriously affects the clinical efficacy
[0008] Moreover, because the piperacillin sodium-tazobactam sodium compound preparation belongs to antibiotic drugs, it is easy to cause allergic reactions, leading to skin rashes or anaphylactic shock, which is extremely harmful to patients.

Method used

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  • Piperacillin sodium-tazobactam sodium medicine composition and preparation method thereof
  • Piperacillin sodium-tazobactam sodium medicine composition and preparation method thereof
  • Piperacillin sodium-tazobactam sodium medicine composition and preparation method thereof

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Effect test

Embodiment 1

[0041] The preparation of embodiment 1, piperacillin sodium

[0042] 1) Prepare a mixed solvent with isopropanol and N-methylpyrrolidone at a volume ratio of 3:1;

[0043] 2) Take 100 g of the piperacillin sodium raw material, dissolve it in 1000 ml of the mixed solvent of isopropanol and N-methylpyrrolidone in step 1), and stir until completely dissolved to obtain a piperacillin sodium solution;

[0044] 3) Add the piperacillin sodium solution in step 2) into acetone (the volume ratio of acetone to piperacillin sodium solution is 18:1) at a temperature of 3°C and a stirring speed of 2200r / min, and mix to form suspension;

[0045]4) After the suspension was aged for 10 minutes, suction filtered, washed, and then the filter cake was vacuum-dried at 45°C to obtain a white crystalline powder, which was the piperacillin sodium.

[0046] The X-ray powder diffraction pattern that the obtained piperacillin sodium is measured with powder X-ray diffractometry is as follows figure 1 ...

Embodiment 2

[0047] The preparation of embodiment 2, piperacillin sodium

[0048] 1) Mix isopropanol and N-methylpyrrolidone at a volume ratio of 5:1 to make a mixed solvent;

[0049] 2) Take 50 g of the piperacillin sodium raw material, dissolve it in 1000 ml of the mixed solvent of isopropanol and N-methylpyrrolidone in step 1), stir until completely dissolved, and obtain the piperacillin sodium solution;

[0050] 3) Add the piperacillin sodium solution in step 2) into acetone (the volume ratio of acetone to piperacillin sodium solution is 22:1) at a temperature of 8°C and a stirring speed of 1800r / min, and mix to form suspension;

[0051] 4) After the suspension was aged for 5 minutes, suction filtered, washed, and then the filter cake was vacuum-dried at 40°C to obtain a white crystalline powder, which was the piperacillin sodium.

[0052] The X-ray powder diffraction pattern that the obtained piperacillin sodium is measured with powder X-ray diffractometry is as follows figure 1 Sh...

Embodiment 3

[0053] The preparation of embodiment 3, piperacillin sodium

[0054] 1) Mix isopropanol and N-methylpyrrolidone at a volume ratio of 4:1 to make a mixed solvent;

[0055] 2) Take 80 g of the piperacillin sodium raw material, dissolve it in 1000 ml of the mixed solvent of isopropanol and N-methylpyrrolidone in step 1), and stir until completely dissolved to obtain the piperacillin sodium solution;

[0056] 3) Add the piperacillin sodium solution in step 2) into acetone (the volume ratio of acetone to piperacillin sodium solution is 20:1) at a temperature of 6°C and a stirring speed of 2000r / min, and mix to form suspension;

[0057] 4) After the suspension was aged for 8 minutes, suction filtered, washed, and then the filter cake was vacuum-dried at 42°C to obtain a white crystalline powder, which was the piperacillin sodium.

[0058] The X-ray powder diffraction pattern that the obtained piperacillin sodium is measured with powder X-ray diffractometry is as follows figure 1 ...

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Abstract

The invention belongs to the technical field of medicine, and in particular relates to a piperacillin sodium-tazobactam sodium medicine composition and a preparation method of the medicine composition. The medicine composition is a sterile powder injection; the mass ratio of the piperacillin sodium to the tazobactam sodium in the medicine composition is 4-20:1; the X-ray powder diffraction pattern of the piperacillin sodium measured by means of powder X-ray diffraction measurement method is shown in Figure 1; the chemical structural formula of the piperacillin sodium is shown in Formula (I); and the content of the piperacillin sodium polymer in the medicine composition provided by the invention is quite low and is not changed obviously in an accelerated test condition and in a long-term test condition. The medicine composition prepared from the piperacillin sodium and the tazobactam sodium provided by the invention also has the advantages of low polymer content and good stability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pharmaceutical composition of piperacillin sodium and tazobactam sodium and a preparation method thereof. Background technique [0002] Piperacillin is a broad-spectrum semi-synthetic penicillin antibiotic that has been widely used in clinic. Due to the long-term use and improper use of piperacillin, the therapeutic effect of piperacillin is declining, which affects the application of piperacillin to a large extent. Tazobactam sodium is a lactamase inhibitor and belongs to the third-generation antibacterial potent synergist. Combining it with piperacillin or cefoperazone can enhance the efficacy and prolong the action time of the two. When tazobactam sodium is used in combination with piperacillin sodium, it produces a significant synergistic effect, and is widely used in the treatment of severe systemic and local infections, abdominal infection, lower respiratory...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/496A61P31/04A61K31/431
Inventor 闫晓晔
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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