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Piperacillin sodium, tazobactam sodium and probenecid sodium three-component freeze-dried preparation for injection

A technology for zobactam sodium probenecid sodium and piperacillin sodium, applied in the field of medicine, can solve the problems of poor fluidity, easy occurrence of unqualified, strong hygroscopicity and the like

Pending Publication Date: 2020-12-15
安徽康正康仁药业有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Probenecid sodium itself is relatively viscous, has strong hygroscopicity and poor fluidity, so it is difficult to mix it evenly with other components, and the filling volume of each medicine bottle of the finished product varies greatly, and unqualified products are prone to appear

Method used

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  • Piperacillin sodium, tazobactam sodium and probenecid sodium three-component freeze-dried preparation for injection

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] The prescription ratio of the tripartite preparation is: piperacillin sodium: tazobactam sodium: probenecid sodium is 8:1:1.

[0030] 1. Three-party preparation solution 1 (piperacillin sodium + probenecid sodium + tazobactam sodium) preparation:

[0031] The total amount of the solution is 2,500ml, which contains: piperacillin sodium 500 g (dry, pure), probenecid sodium 62.5 g (dry, pure), tazobactam sodium 62.5 g (dry, pure) Pure meter), the pH value of the solution is 6.0-7.5;

[0032] 2. Compound preparation solution 2 (piperacillin sodium) preparation:

[0033] The total amount of the solution is 2,500ml, which contains: 500 g of piperacillin sodium (dry and pure), 62.5 g of tazobactam sodium (dry and pure), and the pH value of the solution is 6.0-7.5. The difference between solution 1 and solution 2 is that the former contains 125 g of probenecid sodium and the latter does not.

[0034] 3. Use 10 ml vials, 500 vials each contain 5 ml of solution 1, which contai...

Embodiment 2

[0036] The prescription ratio of the tripartite preparation is: piperacillin sodium: tazobactam sodium: probenecid sodium is 8:0.5:2.

[0037] 1. Three-party preparation solution 1 (piperacillin sodium + probenecid sodium + tazobactam sodium) preparation:

[0038] The total amount of the solution is 2,500ml, which contains: piperacillin sodium 500 g (dry, pure), probenecid sodium 125 g (dry, pure), tazobactam sodium 31.25 g (dry, pure) Pure meter), the pH value of the solution is 6.0-7.5;

[0039] 2. Compound preparation solution 2 (piperacillin sodium) preparation:

[0040] The total amount of the solution is 2,500ml, which contains: 500 g of piperacillin sodium (dry and pure), 31.25 g of tazobactam sodium (dry and pure), and the pH value of the solution is 6.0-7.5. The difference between solution 1 and solution 2 is that the former contains 125 g of probenecid sodium and the latter does not.

[0041] 3. Use 10 ml vials, 500 vials each contain 5 ml of solution 1, which con...

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Abstract

The invention relates to a piperacillin sodium, tazobactam sodium and probenecid sodium tripartite freeze-dried preparation for injection, which is characterized by comprising the following steps: adding piperacillin sodium, tazobactam sodium and probenecid sodium in a ratio of 8: (1-0.5): (1-2) raw material into water for injection for complete dissolution, regulating the pH value to 6.5-7.5, adding the water for injection to full dose, sterilizing, filtering and freeze-drying; wherein the plate layer of the freeze dryer is cooled to-40 DEG C from the room temperature at the speed of about 2DEG C / min, and heat preservation is conducted for 60-90 min; after sublimation drying, performing desorption drying, fully volatilizing moisture, performing judgment according to the pressure change condition in the freeze-drying box body, taking out the freeze-drying box body after being qualified, and the total freeze-drying time is 22 hours; and taking out the sample, capping and inspecting. The three components are completely mixed in the solution, the uniformity is high, the defects of the traditional sterile powder mixing process are overcome, the qualification rate of the finished product is greatly improved, and meanwhile, the activity of the three components is not damaged.

Description

technical field [0001] The invention relates to a tripartite freeze-dried preparation of piperacillin sodium, tazobactam sodium and probenecid sodium for injection, which belongs to the technical field of medicine. Background technique [0002] At present, there is no three-party injection of antibacterial drugs for sale in the world, and there is no three-party freeze-dried injection naturally. Moreover, there is no probenecid sodium product in the world at present, so the tripartite freeze-dried preparation composed of probenecid sodium is also impossible. No matter whether the compound injection is composed of two components or three components, there are two kinds of process routes to prepare it, one is the sterile powder mixing process, and the other is the freeze-drying process. The key to the success of the aseptic powder mixing process is whether the two or three components in the compound preparation have similar physical and chemical properties, otherwise it will ...

Claims

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Application Information

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IPC IPC(8): A61K9/19A61K31/496A61K31/431A61K31/195
CPCA61K9/0019A61K9/19A61K31/496A61K31/431A61K31/195A61K2300/00
Inventor 吴晓辉王曦
Owner 安徽康正康仁药业有限公司
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