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Preparation methods of sulbenicillin sodium and injection thereof

A technology of sulfobenicillin sodium and solution is applied in the field of preparation of sulfobenicillin sodium and its injection, and can solve the problems of many by-products, complicated reactions, waste of raw materials, etc., and achieve simple steps, high product purity, and few reaction impurities. Effect

Inactive Publication Date: 2010-08-18
HUNAN ERKANG XIANGYAO PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, in the preparation process of sulbenicillin sodium, the reaction is complex, the by-products are many, the yield is low, and the waste of raw materials is serious

Method used

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  • Preparation methods of sulbenicillin sodium and injection thereof
  • Preparation methods of sulbenicillin sodium and injection thereof
  • Preparation methods of sulbenicillin sodium and injection thereof

Examples

Experimental program
Comparison scheme
Effect test

preparation example Construction

[0024] combine figure 1 , in a typical implementation of the preparation method of Sulbenicillin Sodium of the present invention, comprise the steps:

[0025] Sulfonation: Mix and stir dichloroethane and dioxane, lower the temperature to 0-5°C, add sulfur trioxide, then add phenylacetic acid, heat up to 30-45°C and stir to react to obtain solution A.

[0026] Dioxane will form a complex with sulfur trioxide. Therefore, delaying the addition of sulfur trioxide will reduce the consumption of dioxane and sulfur trioxide; Save raw materials.

[0027] The reaction equation that above-mentioned dioxane reacts with sulfur trioxide to generate dioxane sulfonate is as follows:

[0028]

[0029] Hydrolysis: Pour the above solution A into an appropriate amount of purified water at a temperature of 18-22°C, cool down to below 10°C, stir and stand to separate into the upper aqueous layer and the lower organic layer, take the upper aqueous solution, add sodium hydroxide or hydrogen Po...

Embodiment

[0088] In the preparation process of sulbenicillin sodium, all raw material consumptions are as shown in table 1.

[0089] Raw materials and consumption used in the preparation process of table 1 sulbenicillin sodium.

[0090] Excipient name

Dosage

Excipient name

Dosage

Industrial Grade Phenylacetic Acid

20kg

Industrial grade 6-APA

31.8Kg

Industrial grade dichloroethane

42kg

Industrial grade n-butanol

636L

Industrial grade dioxane

20kg

Pharmaceutical Grade Activated Carbon

2.5kg

Industrial Grade Sodium Bicarbonate

25kg

Industrial grade acetone

63.6L

Industrial Grade Sulfur Trioxide

115kg

Industrial Grade Ether

42kg

food grade ethanol

100kg

Pharmaceutical Grade Isopropyl Alcohol

352L

Industrial grade thionyl chloride

180kg

Pharmaceutical grade absolute ethanol

704L

Industrial grade dimethylformamide

1.8kg

Technical gr...

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Abstract

The invention discloses a preparation method of sulbenicillin sodium, which comprises the following steps of: sulfonating, hydrolyzing, crystallizing, ion-exchanging, acidylating, condensing, extracting and salifying to obtain sulbenicillin sodium. The method has the advantages of simple technological steps, fewer reaction impurities and high product purity, and the yield is higher than 50%. Meanwhile, the invention also relates to a preparation method of a sulbenicillin sodium injection.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of sulfbenicillin sodium and its injection. Background technique [0002] Sulbenicillin Sodium, also known as Sulbenicillin Sodium, Sulbenicillin Sodium, Gedacillin; generally white or light yellow powder; odorless, mild taste; hygroscopic; easily soluble in water, easily soluble in methanol , Slightly soluble in ethanol, very slightly soluble in absolute ethanol, insoluble in acetone, chloroform or benzene. [0003] Sulbenicillin sodium is a semi-synthetic anti-pseudomonal penicillin. Its antibacterial spectrum is similar to carbenicillin, and its antibacterial effect is strong. It plays a bactericidal effect by inhibiting the synthesis of bacterial cell walls; Enterobacteriaceae such as Bacillus, Citrobacter, Salmonella, and Shigella, and other Gram-negative bacteria such as Pseudomonas aeruginosa, Haemophilus influenzae, and Neisseria have antibacterial effects; ...

Claims

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Application Information

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IPC IPC(8): C07D499/62C07D499/16A61K9/08A61K31/43A61P31/04
Inventor 帅放文王向峰章家伟杨海明
Owner HUNAN ERKANG XIANGYAO PHARMA
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