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Liposome injection of pharmaceutical composition comprising piperacillin sodium and tazobactam sodium

A technology of tazobactam sodium and piperacillin sodium, which is applied in the field of medicine, can solve the problems of drug quality degradation, easy deterioration of active ingredients, poor solution stability, etc., and achieve good stability, convenient clinical use, and simple preparation process Effect

Inactive Publication Date: 2012-02-22
HAINAN MEILAN SMITH KLINE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0007] According to the inventor's long-term comparative study, it is found that the combined preparation has a key problem affecting its wide use: although the weight ratio of piperacillin sodium and tazobactam sodium is 8: 1, the active ingredient is very widely used in clinical practice, However, after scale-up production using the preparation process of the prior art, the stability of the solution after reconstitution of the freeze-dried powder is very poor, and it needs to be used up in a short time, otherwise the active ingredient will easily deteriorate, resulting in a decline in the quality of the drug

Method used

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  • Liposome injection of pharmaceutical composition comprising piperacillin sodium and tazobactam sodium
  • Liposome injection of pharmaceutical composition comprising piperacillin sodium and tazobactam sodium
  • Liposome injection of pharmaceutical composition comprising piperacillin sodium and tazobactam sodium

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Effect test

Embodiment 1

[0031] Example 1 Preparation of piperacillin sodium tazobactam sodium pharmaceutical composition liposome injection

[0032] Prescription (100 bottles)

[0033] Piperacillin Sodium 200g

[0034] Tazobactam Sodium 25g

[0035] Soy Lecithin 160.7g

[0036] Sodium Taurocholate 64.3g

[0037] Lactose 15g

[0038] Mannitol 15g

[0039] Sodium sulfite 7.5g

[0040] Vitamin C 7.5g

[0041] Preparation Process:

[0042] (1) 160.7g soybean lecithin, 64.3g sodium taurocholate are dissolved in 500ml ethanol solution, then heated and evaporated to get rid of organic solvent completely, make blank lipid film;

[0043] (2) Add 300ml of phosphate buffer solution with a pH value of 6.5 to the blank lipid film and mix, place in a high-speed homogenizer to stir and emulsify evenly, then add 200g piperacillin sodium, 25g tazobactam sodium and 15g lactose , 15g of mannitol, 7.5g of sodium sulfite, and 7.5g of vitamin C were placed in a water bath at 70°C for 20 minutes of ultrasonic insu...

Embodiment 2

[0048] Example 2 Preparation of Piperacillin Sodium-Tazobactam Sodium Pharmaceutical Composition Liposomal Injection

[0049] Prescription (100 bottles)

[0050] Piperacillin Sodium 100g

[0051] Tazobactam Sodium 12.5g

[0052] Soy Lecithin 9.375g

[0053] Octadecylamine 3.125g

[0054] Hydrolyzed gelatin 7.2g

[0055] Mannitol 14.4g

[0056] Vitamin C 4.5g

[0057] Sodium sulfite 4.5g

[0058] Preparation Process:

[0059] (1) Dissolving 9.375g soybean lecithin and 3.125g octadecylamine in 200ml chloroform solution, then heating and evaporating to get rid of the organic solvent completely to obtain a blank lipid film;

[0060] (2) Add 300ml of phosphate buffer solution with a pH value of 7.5 to the blank lipid film and mix, place in a high-speed homogenizer to stir and emulsify evenly, then add 100g piperacillin sodium, 12.5g tazobactam sodium and 7.2 G hydrolyzed gelatin, 14.4g mannitol, 4.5g vitamin C, and 4.5g sodium sulfite were placed in a water bath at 70°C fo...

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Abstract

The invention discloses a liposome injection of a pharmaceutical composition comprising piperacillin sodium and tazobactam sodium. The liposome injection mainly comprises the following components in part by weight: 4 to 8 parts of piperacillin sodium, 1 part of tazobactam sodium, 4.5 to 13.5 parts of liposome membrane material and membrane material additive, 0.9 to 1.8 parts of frozen dry excipient and 0.45 to 0.9 part of antioxidant.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing piperacillin sodium and tazobactam sodium, specifically a liposome injection, and belongs to the technical field of medicine. 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 tra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K31/431A61K9/127A61P31/04
Inventor 郝志艳
Owner HAINAN MEILAN SMITH KLINE PHARMA
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