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Amoxicillin/clavulanate potassium tablet and preparation method thereof

A technology of potassium clavulanate and amoxicillin, which is applied in the field of medicine, can solve unseen problems, and achieve the effects of simple industrial production, good stability and quality controllability, and good safety

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] Relevant patents and prior art literature search results show that there are no related reports on the preparation of amoxicillin / potassium clavulanate 8:1 tablets of the present invention

Method used

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  • Amoxicillin/clavulanate potassium tablet and preparation method thereof
  • Amoxicillin/clavulanate potassium tablet and preparation method thereof
  • Amoxicillin/clavulanate potassium tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0052] prescription:

[0053]

[0054] Coating prescription:

[0055]

[0056] Preparation Process:

[0057] Take the prescription amount and mix amoxicillin / potassium clavulanate (8:1), crystalline mannitol, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinylpyrrolidone, lactose, and magnesium stearate over 80% respectively. Mesh sieve for standby; then take the prescription amount of amoxicillin / potassium clavulanate (8:1) intermediate mixed raw materials, crystalline mannitol, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinylpyrrolidone, lactose in the mixer Take the above mixed powder, place it in a press to granulate by rolling, pass through a 16-mesh sieve to granulate, weigh, mix in the prescribed amount of magnesium stearate, mix evenly, and press it into a tablet containing 500mg of amoxicillin, Clavulanic acid 62.5 mg plain tablets; Opadry is used as the coating material, and the coating solution is prepared with absolute...

Embodiment 2

[0060] prescription:

[0061]

[0062]

[0063] Coating prescription:

[0064]

[0065] Preparation Process:

[0066] Amoxicillin / potassium clavulanate (8:1) intermediate mixed raw materials, compressible starch, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinylpyrrolidone, lactose, and magnesium stearate were mixed separately in the prescribed amount. 80 mesh sieves for subsequent use; then take the intermediate mixed raw materials of amoxicillin / potassium clavulanate (8:1), compressible starch, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinylpyrrolidone, lactose in Mix in a mixer; take the above mixed powder, put it in a press to granulate by rolling, pass through a 16-mesh sieve to granulate, weigh, mix in the prescribed amount of magnesium stearate, mix evenly, and press to make each tablet contain amoxicillin 500mg, clavulanic acid 62.5mg plain tablets; use Opadry as the coating material, and use absolute ethanol to prep...

Embodiment 3

[0069] prescription:

[0070]

[0071] Coating prescription:

[0072]

[0073] Preparation Process:

[0074] Take the prescription amount and pass through 80 meshes of amoxicillin / potassium clavulanate (8:1), compressible starch, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinylpyrrolidone, lactose, and micropowdered silica gel respectively. Sieve for later use; then take the prescription amount of amoxicillin / potassium clavulanate (8:1) intermediate mixed raw materials, compressible starch, low-substituted hydroxypropyl methylcellulose, cross-linked polyvinylpyrrolidone, lactose, micronized silica gel Mix evenly in a mixer; take the above mixed powder, place it in a press for granulation by rolling, pass through a 16-mesh sieve for granulation, weigh, and compress into plain tablets each containing 500 mg of amoxicillin and 62.5 mg of clavulanic acid; Opadry is used as the coating material, and the coating solution is formulated with absolute ethan...

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Abstract

The invention provides an amoxicillin / clavulanate (8:1) tablet and a preparation method thereof. The amoxicillin / clavulanate (8:1) tablet has the advantages of simple preparation process, good quality controllability and stability and low forming-production cost by adopting the mixed amoxicillin / clavulanate (8:1) intermediate materials having good quality controllability and stability as the main drug resource.

Description

technical field [0001] The invention belongs to the technical field of medicine, and relates to an amoxicillin / potassium clavulanate 8:1 tablet and a preparation method 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 penicillins and cephalosporins It inactivates the act...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/43A61K31/424A61K9/20A61P31/04
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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