Method for preparing compound amoxicillin and potassium clavulanate injections

A technology of amoxicillin-clavulanate potassium and clavulanate potassium, which is applied in the preparation of compound amoxicillin-clavulanate potassium preparations and compound amoxicillin-clavulanate potassium injections, which can solve the problems of high price and limited Issues such as the scope of application, to achieve the effect of easy absorption and utilization, improved stability and drug effectiveness, and less irritation

Active Publication Date: 2013-01-02
SHANGHAI TONGREN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the prescription components and process conditions of the injection dosage form of compound amoxicillin-clavulanate potassium are confidential, but the compound preparation used in domestic veterinary medicine needs to be imported, and the price is expensive, which limits the scope of its application.

Method used

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  • Method for preparing compound amoxicillin and potassium clavulanate injections
  • Method for preparing compound amoxicillin and potassium clavulanate injections
  • Method for preparing compound amoxicillin and potassium clavulanate injections

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0025] Weigh 14.0g of amoxicillin and 3.5g of potassium clavulanate, put them into a pulverizer and pulverize until more than 90% of the particle size is ≤15-20μm; take 80mL of injection-grade soybean oil, heat it to 130°C in a container, stir and sterilize it for 50 minutes, then cool to 60°C, add 1g of injection-grade aluminum stearate to 20mL of soybean oil after cooling, heat and stir to disperse evenly, cool to 20°C, filter the oil gel through an 80-mesh metal filter; under stirring (speed: 100r / min) slowly add the crushed amoxicillin and potassium clavulanate, stir and disperse evenly, and completely disperse into a suspension; ultrafine the obtained suspension through a homogenizer, and put the suspension into In the four stainless steel containers in the high-performance ball mill, start the ball mill for 5-10 minutes, and make the suspension fine to make it ultra-fine (95% or more to 15μm or less), and make up for the injection cooled to 20 ℃ Soybean oil to a suffici...

Embodiment 2

[0032] Weigh 14.0g of amoxicillin and 3.5g of potassium clavulanate, put them into a pulverizer and pulverize until more than 90% of the particles have a particle size of ≤15-20μm; take 83mL of injection-grade soybean oil, heat it to 140°C in a container, stir and sterilize it for 65 minutes, then cool To 65°C, add 1.5g of injection-grade aluminum stearate to 30mL of soybean oil after cooling, heat and stir to disperse evenly, cool to 28°C, filter the oil glue through a 120-mesh metal filter; under stirring (speed: 125r / min) slowly add the crushed amoxicillin and potassium clavulanate, stir and disperse evenly, and completely disperse into a suspension; superfine the obtained suspension through a homogenizer, and pack the suspension into Put it into four stainless steel containers in a high-performance ball mill, start the ball mill for 5-10 minutes, and make the suspension fine to make it ultra-fine (95% or more to 15μm or less), and make up for the injection that has been coo...

Embodiment 3

[0039] Weigh 14.0g of amoxicillin and 3.5g of potassium clavulanate, put them into a pulverizer and pulverize until more than 90% of the particles have a particle size of ≤15-20μm; take 86mL of injection-grade soybean oil, heat it to 160°C in a container, stir and sterilize it for 80 minutes, then cool To 72°C, add 2g of injection-grade aluminum stearate to 32mL of soybean oil after cooling, heat and stir to disperse evenly, cool to 32°C, filter the oil gel through a 150-mesh metal filter; under stirring (speed: 140r / min) slowly add the crushed amoxicillin and potassium clavulanate, stir and disperse evenly, and completely disperse into a suspension; ultrafine the obtained suspension through a homogenizer, and put the suspension into In the four stainless steel containers in the high-performance ball mill, start the ball mill for 5 to 10 minutes to make the suspension fine to make it ultra-fine (95% reaches 15 μm or less), and make up for the injection cooling to 29±1℃ Soybea...

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Abstract

The invention discloses a novel method for preparing compound amoxicillin and potassium clavulanate injections. The novel method includes the steps of heating oil for injection to 130-150 DEG C, insulating, sterilizing and then cooling the oil for injection to the temperature of 60-90 DEG C; adding aluminium stearate into a part of the sterilized oil for injection, stirring, insulating, cooling to the room temperature after the mixture is uniform, filtering, slowly mixing the mixture with amoxicillin and potassium clavulanate mixture with a certain mass ratio while stirring, and stirring so as to disperse the mixture uniformly until the mixture is completely dispersed into suspension; and refining the mixture via a ball mill, replenishing the sterilized oil for injection to reach a full dose, and continuing stirring till uniform so as to obtain the compound amoxicillin and potassium clavulanate injections. Compared with the prior art, the novel method for preparing the compound amoxicillin and potassium clavulanate injections is simple in preparation process, raw materials and auxiliary materials are low in prices and easy to obtain, the prepared injections are stable in performance and obvious in treatment effect, and is high in cost performance as compared with a like product, the quality of the prepared injections is higher than the quality specified in relative standards of the current pharmacopoeia, and the prepared injections are suitable to be industrially produced in batches.

Description

technical field [0001] The invention relates to a method for preparing a compound amoxicillin-clavulanate potassium preparation, in particular to a method for preparing a compound amoxicillin-clavulanate potassium injection, which belongs to the technical field of veterinary medicines. Background technique [0002] Amoxicillin is a broad-spectrum penicillin antibiotic, and clavulanate potassium itself has only weak antibacterial activity, but has a strong broad-spectrum β-lactamase inhibitory effect. The combination of the two can protect amoxicillin from β-lactamase hydrolysis. The antibacterial spectrum of this product is the same as that of amoxicillin, and it has been expanded. It has a good effect on enzyme-producing Staphylococcus aureus, Staphylococcus epidermidis, coagulase-negative staphylococcus and enterococci, and has good effects on certain β-lactamase-producing Enterobacteriaceae, Haemophilus influenzae, and Moraxella catarrhalis , Bacteroides fragilis, etc. a...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61K9/10A61P31/04
Inventor 陈懿王文可方玮程瑶曹建东
Owner SHANGHAI TONGREN PHARM CO LTD
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