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A method for testing the dissolution profile of immediate-release dosage form drug amoxicillin-clavulanate potassium dispersible tablet

A technology for amoxicillin and clavulanate potassium and dispersible tablets, which is applied in the field of analytical chemistry, and can solve the problem of in vitro release that cannot reflect the in vitro release behavior of amoxicillin and clavulanate potassium dispersible tablets, prescriptions or processes. Regional distinction and other issues to achieve the effect of achieving consistency and ensuring the quality of medicines

Active Publication Date: 2019-02-26
NORTHEAST PHARMA GRP SHENYANG SHIDE PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

These dissolution test conditions cannot reflect the in vitro release behavior of amoxicillin and clavulanate potassium dispersible tablets, and the influence of formulation or process variables on in vitro release cannot be effectively distinguished

Method used

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  • A method for testing the dissolution profile of immediate-release dosage form drug amoxicillin-clavulanate potassium dispersible tablet
  • A method for testing the dissolution profile of immediate-release dosage form drug amoxicillin-clavulanate potassium dispersible tablet
  • A method for testing the dissolution profile of immediate-release dosage form drug amoxicillin-clavulanate potassium dispersible tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] a) Dissolution conditions

[0037] Dissolution tester: RCZ-8M, sampling collection system RZD-8D

[0038] Dissolution medium: medium A, purified water; medium B, pH 1.2 solution; medium C, pH 4.0 acetic acid / sodium acetate buffer; medium D, pH 6.8 phosphate buffer. 900ml each.

[0039] Medium preparation, medium B, take 2.0g of sodium chloride, add appropriate amount of water to dissolve, add 7ml of hydrochloric acid, add water to dilute to 1000ml, and mix well; medium C, mix 0.05mol / L acetic acid solution-0.05mol / L sodium acetate solution by The volume ratio is 16.4:3.6, and it is ready; for medium D, take 1.7g of potassium dihydrogen phosphate and 1.775g of anhydrous disodium hydrogen phosphate, add an appropriate amount of water to dissolve, and set the volume to 1000mll. Speed: Paddle method 65 rpm

[0040] Sampling time points: 1 minute, 5 minutes, 10 minutes, 15 minutes

[0041] Test solution: take 10ml of dissolution solution at the midpoint between the top o...

Embodiment 2

[0077] 1) System suitability test

[0078] Take 20 μl of the system suitability test reference substance solution and inject it into the liquid chromatograph, and inject it twice continuously. The column efficiency is 13017 based on the amoxicillin peak; the separation degree between the amoxicillin peak and the clavulanic acid peak is 13.34.

[0079] 20 μl of the first reference substance solution was injected continuously for 5 times, and 20 μl of the second reference substance solution was injected continuously for 2 times.

[0080] The RSD% of the amoxicillin peak and the clavulanic acid peak area of ​​the first reference substance solution were both 0.1%; the recovery rate of the second reference substance solution and the first reference substance solution was 99.7%.

[0081] (2) Solution stability

[0082] Use medium A, medium B, medium C and medium D to prepare the test solution according to the law, and place them at 8°C, normal temperature, and 37°C respectively. ...

Embodiment 3

[0092] (1) Selection of dissolution medium

[0093] a) Amoxicillin, dissociation constant (25°C), pKa 1 =2.6 (for carboxyl, adopt titration method to measure); pKa 2 =7.3 (for amino group, adopt titration method to measure); pKa 3 =9.7 (measured by titration method for the alcoholic hydroxyl group of phenol). Solubility in each dissolution medium (37°C), pH 1.2: 26.6mg / ml; pH 4.0: 3.3mg / ml; pH 6.8: 4.3mg / ml; water: 3.1mg / ml.

[0094] Determine to adopt pH1.2 solution, pH4.0 buffer solution, pH6.8 buffer solution and water four kinds of solutions, each 900ml is used as dissolution medium. b) Potassium clavulanate, dissociation constant (25°C): pKa=2.36; solubility in each dissolution medium (37°C), pH4.0: 2.5g / ml; pH 6.8: 2.5g / ml; water: 2.5g / ml. Potassium clavulanate was degraded by 80% when sampling in 1 min in the pH1.2 solution, and it was determined that three solutions of pH4.0 buffer, pH6.8 buffer and water were used, and each 900ml was used as the dissolution mediu...

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Abstract

The invention belongs to the field of analytical chemistry, in particular to a method for testing the dissolution curve of amoxicillin-clavulanate potassium dispersible tablets. (1) Through the tests of system applicability, solution stability, linearity, and filter membrane influence factors, etc., determine the test method for high performance liquid phase detection of dissolution; (2) Through the tests of dissolution medium, stirring speed and sampling time point, etc. , to determine the detection method of the dissolution curve; (3) adopt the dissolution curve determination method; adopt the comparative dissolution curve similarity f 2 The factor carries out the comparison of reference sample (sample 1) and 2,3,4,5 sample dissolution curves, and realizes the present invention. The present invention has the advantages of establishing a discriminative dissolution test method, which can well distinguish the impact of the prescription or process variables on the in vitro release of the immediate-release dosage form drug amoxicillin-clavulanate potassium dispersible tablet, thereby ensuring the quality of the drug , to achieve the consistency of quality and efficacy.

Description

technical field [0001] The invention belongs to the field of analytical chemistry, in particular to a method for testing the dissolution curve of amoxicillin-clavulanate potassium dispersible tablets. Background technique [0002] Amoxicillin Potassium Clavulanate Dispersible Tablets are dispersible tablets composed of amoxicillin trihydrate and potassium clavulanate. This product can be swallowed directly with water, or put into an appropriate amount of water and stirred to a suspended state before taking it, but most patients swallow it directly with water. Amoxicillin is a broad-spectrum penicillin antibiotic. Potassium clavulanate itself has only weak antibacterial activity, but it has a strong broad-spectrum β-lactamase inhibitory effect. The combination of the two can protect amoxicillin from β-lactam Enzymatic hydrolysis. It is suitable for upper respiratory tract infection, lower respiratory tract infection, urinary system infection, skin and soft tissue infection ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/02G01N30/06
CPCG01N30/02G01N30/06
Inventor 关旭久周鹏张旭洪晓菲李静
Owner NORTHEAST PHARMA GRP SHENYANG SHIDE PHARMA
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