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Amoxicillin/clavulanic acid blended stock preparation and rapid determination method for evenness

A technology of amoxicillin and clavulanic acid, applied in the field of medicine, achieves the effects of controllable process quality, good stability, good precision and reproducibility, and rapid detection

Inactive Publication Date: 2009-08-12
山东淄博新达制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0014] In order to overcome a series of problems in the mixed preparation of amoxicillin / clavulanic acid raw materials caused by the defects in the physicochemical properties of potassium clavulanate itself, the invention provides the preparation and uniformity of amoxicillin / clavulanic acid mixed raw materials rapid assay method

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Amoxicillin / potassium clavulanate (8:1) mixed raw material preparation (A1)

[0050] Proportion:

[0051] Amoxicillin / potassium clavulanate (2:1) mixed powder 1.875Kg

[0052] Amoxicillin raw powder 3.750Kg

[0053] Preparation Process:

[0054] Put the mixed powder of amoxicillin / potassium clavulanate (2:1) stored in cold storage in a high-quality stainless steel mixer, control the temperature in the mixer to be lower than 20°C, and the relative humidity to be lower than 30%, and increase by the same amount Mixing method Mix with amoxicillin raw powder for 20-45 minutes to get amoxicillin / potassium clavulanate (8:1) mixed raw material.

[0055] The amoxicillin / clavulanic acid mixed raw material prepared by the method meets the requirement of mixing uniformity of medicinal raw materials.

Embodiment 2

[0057] Amoxicillin / Potassium Clavulanate (14:1) Intermediate Mixed Raw Material Preparation (A2)

[0058] Proportion:

[0059] Amoxicillin / potassium clavulanate (2:1) mixed powder 1.875Kg

[0060] Amoxicillin raw powder 7.500Kg

[0061] Preparation Process:

[0062] Put the mixed powder of amoxicillin / potassium clavulanate (2:1) stored in cold storage in a high-quality stainless steel mixer, control the temperature in the mixer to be lower than 20°C, and the relative humidity to be lower than 30%, and increase by the same amount Mixing method Mix with amoxicillin raw powder for 20-45 minutes to get amoxicillin / potassium clavulanate (8:1) mixed raw material.

[0063] The amoxicillin / clavulanic acid mixed raw material prepared by the method meets the requirement of mixing uniformity of medicinal raw materials.

Embodiment 3

[0065] Determination of uniformity of amoxicillin / potassium clavulanate (8:1) mixed raw material (A1)

[0066] (1) Calibration of Fischer's test solution Use a moisture analyzer to calibrate directly. Or take a dry Jusi glass bottle, accurately weigh about 30mg of double distilled water, add 2-5ml of anhydrous methanol unless otherwise specified, and titrate with this solution until the solution changes from light yellow to Reddish brown, another blank test, calculated according to the following formula:

[0067] F=W / (A-B)

[0068] In the formula: F is the weight equivalent to water per 1ml of Fertile's test solution, mg;

[0069] A is the volume of Fertilizer test solution consumed for titration, ml;

[0070] B is the volume of Fischer's test solution consumed by the blank, ml;

[0071] (2) Determination of water content in samples Accurately weigh an appropriate amount of the test product (approximately 1-5ml of Fertilizer's test solution is consumed), unless otherwise s...

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Abstract

The invention discloses a method for preparing mixed amoxicillin / clavulanate materials and rapidly measuring the uniformity thereof. The purpose of uniformly mixing the amoxicillin / clavulanate materials can be achieved without forming amoxicillin / clavulanate and amoxicillin powder into granules respectively at first or adding diluting agents, such as microcrystalline cellulose and the like. The invention can provide the amoxicillin / clavulanate preparation with the main drug resource with high concentration ratio of amoxicillin / clavulanate and good quality controllability and mixing uniformity, and has the advantages of simple preparation process, good quality controllability and stability and low forming-production cost; meanwhile, the invention further provides a method for rapidly measuring the uniformity of the mixed amoxicillin / clavulanate materials, and the method, which is characterized in that the purpose of indirectly measuring the uniformity thereof can be achieved by directly measuring the water content of the mixed materials, has the advantages of high precision and repeatability.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to the preparation of amoxicillin / clavulanic acid mixed raw materials and a method for rapidly measuring the mixing uniformity thereof Background technique [0002] Amoxicillin / potassium clavulanate compound preparation is composed of amoxicillin and potassium clavulanate. It is a broad-spectrum enzyme-resistant and highly effective first-line anti-infective drug for severe infections commonly seen in clinical practice. Among them, amoxicillin is a broad-spectrum penicillin β-lactam semi-synthetic antibiotic, the mechanism of action is to inhibit the synthesis of bacterial cell walls, has a rapid bactericidal effect, and is effective against most Gram-positive and negative bacteria. Degraded by β-lactamase; Potassium clavulanate is a β-lactamase inhibitor, which itself has only weak antibacterial activity, and can control β-lactam in a large number of microorganisms resistant to peni...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61P31/04
Inventor 张慧英贺同庆贾法强李华凌宫清霞鲁凤莉
Owner 山东淄博新达制药有限公司
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