Injection of piperacillin-sulbactum sodium medicine composition injection and preparation method thereof

A technology for ampicillin-sulbactam sodium and ampicillin, which is applied in the field of injection preparations and their preparation, can solve the problems of unsatisfactory dissolution rate, unsatisfactory dissolution rate, and easily fluctuating pH value, and achieves rapid dissolution and guaranteed Stability, good stability

Active Publication Date: 2013-02-27
哈药集团股份有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] At present, in order to enhance the activity of ampicillin, the combination of ampicillin and sulbactam sodium has been used clinically to achieve a synergistic effect, but the dissolution rate is not satisfactory
[00

Method used

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  • Injection of piperacillin-sulbactum sodium medicine composition injection and preparation method thereof
  • Injection of piperacillin-sulbactum sodium medicine composition injection and preparation method thereof
  • Injection of piperacillin-sulbactum sodium medicine composition injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Screening of Ampicillin-Sulbactam Sodium Pharmaceutical Composition Injection Formulation

[0031] The pharmaceutical composition injection of the present invention comprises ampicillin and sulbactam sodium, and one or more of lactose, sodium chloride or sodium dihydrogen phosphate is added respectively, and the drug combination of the present invention is carried out with the dissolution time as an index. Table 1 shows the results of the screening experiment of the drug injection formulation.

[0032] Table 1: Formula screening experiment based on dissolution time

[0033]

[0034] The experimental results in Table 1 show that when the dissolution time is used as an indicator, formula 4 is the best, that is, under the condition that the content of each component added in the formula is the same, the formula is composed of ampicillin, sulbactam sodium, lactose, sodium chloride, phosphoric acid The formulation consisting of sodium dihydrogen required the s...

Embodiment 2

[0035] Example 2 Ampicillin-sulbactam sodium pharmaceutical composition injection and its preparation

[0036] The prescription of pharmaceutical composition injection (1000):

[0037] Ampicillin 500g;

[0038] Sulbactam sodium 250g;

[0039] Lactose 150g;

[0040] Sodium chloride 150g;

[0041] Appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0;

[0042] Dilute to 5000ml with water for injection;

[0043] Preparation:

[0044] Take the above-mentioned amount of ampicillin, sulbactam sodium, lactose, and sodium chloride, dissolve them in water for injection, use an appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0, then dilute to 5000ml with water for injection, and then pass through the filter membrane Filtrate, the pore size of the filter membrane is preferably 0.22um, spray dry, aseptically pulverize, fill, and obtain the ampicillin-sulbactam sodium pharmaceutical composition ...

Embodiment 3

[0045] Example 3 Ampicillin-sulbactam sodium pharmaceutical composition injection and its preparation

[0046] The prescription of pharmaceutical composition injection (1000):

[0047] Ampicillin 1000g;

[0048] Sulbactam sodium 500g;

[0049] Lactose 800g;

[0050] Sodium chloride 800g;

[0051] Appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0;

[0052] Dilute to 5000ml with water for injection;

[0053] Preparation:

[0054] Take the above-mentioned amount of ampicillin, sulbactam sodium, lactose, and sodium chloride, dissolve them in water for injection, use an appropriate amount of sodium dihydrogen phosphate to adjust the pH value of the solution to 7.0, then dilute to 5000ml with water for injection, and then pass through the filter membrane Filtrate, the pore size of the filter membrane is preferably 0.22um, spray dry, aseptically pulverize, fill, and obtain the ampicillin-sulbactam sodium pharmaceutical composition...

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Abstract

The invention discloses an injection of a piperacillin-sulbactum sodium medicine composition injection and a preparation method thereof. The injection disclosed herein comprises 1-10 weight parts of piperacillin, 0.5-5 weight parts of sulbactam sodium, 0.4-8 weight parts oflactose, 0.4-8 weight parts of sodium chloride and a proper amount of sodium dihydrogen phosphate for adjusting the pH value of the solution to 7.0. The preparation method comprises the following steps: weighing piperacillin, sulbactam sodium, lactose, and sodium chloride based on the weight parts, using water for injection to dissolve, using the sodium dihydrogen phosphate for adjusting the pH value of the solution to 7.0, then diluting with water for injection to obtain 5000 ml of medicine solution; and filtering the medicine solution by a filtering membrane, drying, conducting sterile crushing, and filling to obtain the injection. According to the invention, the injection has the advantages of high solubility, good stability, etc.

Description

technical field [0001] The invention relates to a pharmaceutical preparation composition, in particular to an injection preparation and a preparation method thereof. Background technique [0002] Ampicillin belongs to the β-lactam antibiotics, is a semi-synthetic broad-spectrum penicillin, and belongs to the aminopenicillin class. Its antibacterial mechanism is the same as that of penicillin G, which plays an antibacterial effect by binding to bacterial penicillin-binding proteins (PBPs) and interfering with the synthesis of bacterial cell walls. [0003] Sulbactam sodium is a semi-synthetic β-lactamase inhibitor. It has no antibacterial activity except for Neisseria gonorrhoeae and Acinetobacter, but it has strong irreversible competition for β-lactamase produced by Staphylococcus aureus and most Gram-negative bacteria inhibition. When the drug enters the bacterial body, sulbactam sodium will irreversibly bind to the β-lactamase (or extracellular enzyme) in the bacterial...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/43A61K47/26A61K47/02A61P31/04
Inventor 孙志嘉杨新春王喜军陈桂芹
Owner 哈药集团股份有限公司
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