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A kind of compound sulfamethoxazole injection and preparation method thereof

A technology of sulfamethoxazole and compound sulfonamide, which is applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, and drug delivery, can solve the problems of high risk of organic solvents, complicated preparation methods, etc., and achieves improved antibacterial efficacy and absorption. Fast, stable results

Inactive Publication Date: 2015-11-18
鼎正生物药业(天津)有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The preparation methods of existing injections are complicated, and the risk of organic solvents in production is also relatively high

Method used

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  • A kind of compound sulfamethoxazole injection and preparation method thereof
  • A kind of compound sulfamethoxazole injection and preparation method thereof
  • A kind of compound sulfamethoxazole injection and preparation method thereof

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preparation example Construction

[0022] The preparation method of above-mentioned compound sulfamethoxazole injection comprises the following steps:

[0023] (1) Add sulfamethoxazole and trimethoprim to 20-30ml sodium hydroxide solution with a concentration of 0.2mol / l;

[0024] (2) Continue to add sodium hydroxide solution with a concentration of 0.4mol / l to adjust the pH value to 10-12 to completely dissolve sulfamethoxazole and trimethoprim;

[0025] (3) Continue to add tartaric acid or lactic acid to adjust the pH value to 3-4, and the solution in step (2) solidifies into a paste;

[0026] (4) Continue to add 0.2-1.0mol / l sodium hydroxide solution into the paste to completely dissolve the paste, and the pH value at this time is 6.5-7.5;

[0027] ⑸ adding antioxidants;

[0028] ⑹ adding chelating agent;

[0029] ⑺ Add water for injection, set the volume to 100 ml, and filter through a microporous membrane to obtain the finished product.

Embodiment 1

[0031] (1) Add 20g of sulfamethoxazole and 4g of trimethoprim into 20ml of sodium hydroxide solution with a concentration of 0.2mol / l, and stir;

[0032] (2) Continue to add 5ml of sodium hydroxide solution with a concentration of 0.4mol / l, adjust the pH value to 12, and completely dissolve sulfamethoxazole and trimethoprim;

[0033] (3) Continue to add 5g of tartaric acid or 5ml of lactic acid to solidify the solution in step (2) into a paste;

[0034] (4) Continue to add 10ml of 0.4mol / l sodium hydroxide solution to the paste to completely dissolve the paste;

[0035] (5) Add 0.2g of antioxidant;

[0036] ⑹Add 0.2g chelating agent;

[0037] (7) Add water for injection, set the volume to 100 ml, and filter through a 0.22um microporous membrane to obtain the finished product.

[0038] In this embodiment, the active ingredient sulfamethoxazole accounts for 20% of the total weight of the injection, and the pH of the injection is 6.8.

Embodiment 2

[0040] (1) Add 25g of sulfamethoxazole and 5g of trimethoprim into 20ml of sodium hydroxide solution with a concentration of 0.2mol / l, and stir;

[0041] (2) Continue to add 8ml of sodium hydroxide solution with a concentration of 0.5mol / l, adjust the pH value to 12, and completely dissolve sulfamethoxazole and trimethoprim;

[0042] (3) Continue to add 10g of tartaric acid or 10ml of lactic acid to solidify the solution in step (2) into a paste;

[0043] (4) Continue to add 10ml of 0.5mol / l sodium hydroxide solution to the paste to completely dissolve the paste;

[0044] (5) Add 0.2g of antioxidant;

[0045] ⑹Add 0.2g chelating agent;

[0046] (7) Add water for injection, set the volume to 100 ml, and filter through a 0.22um microporous membrane to obtain the finished product.

[0047] In this embodiment, the active ingredient sulfamethoxazole accounts for 25% of the total weight of the injection, and the pH of the injection is 7.2.

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Abstract

The invention relates to a compound sulfamethoxazole injection of which the pH value is 6.5-7.5. Every 100ml of injection contains 20-40g of sulfamethoxazole, 4-8g of trimethoprim, antioxidant and chelator. In the invention, the sulfamethoxazole and trimethoprim are combined, wherein the sulfamethoxazole acts on dihydrofolate synthetase in bacteria, and the trimethoprim acts on dihydrofolate reductase; and thus, the sulfamethoxazole and trimethoprim have a dual interception action on the folic acid metabolism of the bacteria, and enhance the antimicrobial efficacy by tens of times. The prepared finished product has the advantages of stable properties and high absorption speed after being injected, and overcomes the defects of low content, high pH value, great irritation, high crystallization tendency after long-term storage, complex and dangerous production technique and the like in the existing injection.

Description

technical field [0001] The invention relates to the technical field of sulfamethoxazole drugs, in particular to a compound sulfamethoxazole injection and a preparation method thereof. Background technique [0002] Sulfamethoxazole (Sulfamethoxazole) molecular formula is C 10 h 11 N 3 o 3 S, is a white crystalline powder, odorless, slightly bitter taste, is a medium-effect sulfonamide drug, has a broad-spectrum antibacterial effect, and is effective against non-enzyme-producing Staphylococcus aureus, Streptococcus pyogenes, Streptococcus pneumoniae, Escherichia coli, Some strains of Enterobacteriaceae such as Klebsiella, Salmonella, and Shigella, Neisseria gonorrhoeae, meningococcus, and Haemophilus influenzae have antibacterial effects. Plasmodium falciparum and Toxoplasma gondii also have antimicrobial activity. [0003] Sulfamethoxazole is often administered in tablets, which are very easily absorbed in the gastrointestinal tract, and can be absorbed completely, about...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/635A61K9/08A61P31/04A61K31/505
Inventor 刘鼎阔万秀静董惠峰王立红张俊霞张勇
Owner 鼎正生物药业(天津)有限公司
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