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Compound pharmaceutical composition of piperacillin sodium and tazobactam sodium and preparation method thereof

A technology of tazobactam sodium and piperacillin sodium, which is applied in the directions of drug delivery, active ingredients of heterocyclic compounds, and medical preparations of non-active ingredients, etc., can solve the problem of high substance content, large number of impurities, poor stability, etc. problems, to achieve the effect of simple preparation process, overcoming complex formula and small fluctuation range

Active Publication Date: 2018-09-25
FUAN PHARM (GRP) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] At present, the piperacillin sodium-tazobactam sodium compound preparation for injection on the domestic market is prepared by directly packing the aseptic powder of piperacillin sodium and tazobactam sodium according to the weight ratio of 4:1, and its disadvantage is that Poor stability, high content of related substances
[0004] Chinese patent application CN101632670A discloses a piperacillin sodium tazobactam suspension powder injection, which is made into a powder injection by freeze-drying using emulsification suspension technology, and its components include: 4-8 parts of piperacillin sodium, tazobactam 1 part of bactam sodium, 10-30 parts of emulsifier, 3-20 parts of co-emulsifier, 5-40 parts of freeze-dried support agent. Stability, but the production is difficult and the cost is high, so it is not suitable for industrial production
[0005] Chinese patent application CN103550216A discloses a piperacillin sodium tazobactam sodium powder injection containing disodium hydrogen phosphate-sodium dihydrogen phosphate buffer pair, its production process is simple, and solves the problem of piperacillin sodium tazobactam sodium The problem of poor stability of the piperacillin sodium content in the composition, the pH value of the obtained powder injection has no obvious change, but when the pH value is adjusted with this buffer solution, the number of impurities in the obtained product is large, and the total impurity content is high

Method used

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  • Compound pharmaceutical composition of piperacillin sodium and tazobactam sodium and preparation method thereof
  • Compound pharmaceutical composition of piperacillin sodium and tazobactam sodium and preparation method thereof
  • Compound pharmaceutical composition of piperacillin sodium and tazobactam sodium and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Prescription Screening of Piperacillin Sodium and Tazobactam Sodium

[0037] Taking the dissolution time as an index and using water for injection as a solvent, the preliminary selection of the prescription was carried out. The results of the investigation are shown in Table 1:

[0038]

[0039]

[0040] The results showed that when the dissolution time was used as an index, the pH value was adjusted with citric acid-sodium citrate buffer solution in the formula of piperacillin sodium+tazobactam sodium+mannitol+lactose (4:1:2:1), The dissolution time is the shortest.

Embodiment 2

[0042] Prescription 1.25g, 1000 bottles

[0043]

[0044] Dissolve the prescribed amount of piperacillin sodium, tazobactam sodium, mannitol, and lactose in 1600ml of water for injection. After the dissolution is complete, adjust the pH value to 6.0-6.4 with citric acid-sodium citrate, and add 400ml of Add water for injection, add activated carbon for needles to absorb the heat source, sterilize and filter with membrane filters with 0.45 μm and 0.22 μm pore size respectively, put the sterile solution into bottles, and freeze-dry it.

Embodiment 3

[0050] Prescription 2.5g, 1000 bottles

[0051]

[0052] Dissolve the prescribed amount of piperacillin sodium, tazobactam sodium, mannitol, and lactose in 3200ml of water for injection. After the dissolution is complete, adjust the pH value to 5.8-6.2 with citric acid-sodium citrate, and add 800ml of Add water for injection, add activated carbon for needles to absorb the heat source, sterilize and filter with membrane filters with 0.45 μm and 0.22 μm pore size respectively, put the sterile solution into bottles, and freeze-dry it.

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Abstract

The invention discloses a compound pharmaceutical composition containing piperacillin sodium and tazobactam sodium. The compound pharmaceutical composition contains piperacillin sodium, tazobactam sodium, an excipient and a pH regulator, wherein the ratio of piperacillin sodium to tazobactam sodium is 4:1. Moreover, the invention also discloses a preparation method of the pharmaceutical composition. Compared with the prior art, the pharmaceutical composition disclosed by the invention not only is good in stability, low in impurity content and high in safety, but also is improved in dissolution rate and is more suitable for industrialization.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a compound pharmaceutical composition of piperacillin sodium and tazobactam sodium. Background technique [0002] Piperacillin Sodium and Tazobactam Sodium is a compound antibiotic developed by Dapeng Pharmaceutical Co., Ltd. of Japan. It has two ratios of 8:1 and 4:1. The ratio of 8:1 was first introduced in France in 1992. The 4:1 ratio was first listed in Japan in 2001. In the compound preparation, piperacillin sodium is a broad-spectrum semi-synthetic penicillin antibiotic, and tazobactam sodium is a β-lactamase inhibitor. When the two are used in combination, they can produce obvious synergistic effects. They are mainly used clinically. In the treatment of sepsis, pneumonia, pyelonephritis and complicated cystitis. [0003] At present, the piperacillin sodium-tazobactam sodium compound preparation for injection on the domestic market is prep...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/496A61K9/19A61K47/26A61P31/04A61K31/431
CPCA61K9/0019A61K9/19A61K31/431A61K31/496A61K47/26A61K2300/00
Inventor 蒋晨
Owner FUAN PHARM (GRP) CO LTD
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