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Cefixime crystal, preparation method thereof and tablet composition containing same

A technology of cefixime and a composition, applied in the field of pharmaceutical preparations, can solve the problems of high sales price, increased adverse reactions of oxidation or degradation products, and increased economic burden of drugs for low-income groups, etc.

Active Publication Date: 2012-01-11
SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In dispersible tablets, more types and larger dosages of disintegrants should be used, and expensive imported disintegrants are generally used, resulting in higher costs and high sales prices, which increase the economic burden of medication for the vast number of low-income groups.
The widespread use of sodium lauryl sulfate in auxiliary materials has seriously affected the production environment and harmed the health of workers
Orally disintegrating tablets tend to use a large amount of excipients, and the defect of low main drug content cannot be avoided under the premise of a large amount of excipients
[0009] In addition, due to the β-lactam ring on the structure of cefixime, it is easy to hydrolyze and open the ring to produce degradation products under moisture absorption and heat, and gradually lose efficacy. Adverse reactions

Method used

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  • Cefixime crystal, preparation method thereof and tablet composition containing same
  • Cefixime crystal, preparation method thereof and tablet composition containing same
  • Cefixime crystal, preparation method thereof and tablet composition containing same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] The preparation of embodiment 1 cefixime crystal

[0047] (1) Take 10Kg cefixime by weighing, be dissolved in tetrahydrofuran, obtain the cefixime tetrahydrofuran solution that concentration is 0.10g / ml;

[0048] (2) Add pure water dropwise to the tetrahydrofuran solution of cefixime at a stirring speed of 180 r / min until the solution is no longer clear, and maintain the temperature of the solution at 30°C;

[0049] (3) Add an organic mixed solution of ethanol and ether to the solution obtained in step 2 at a stirring speed of 75r / min; the flow rate is 12ml / min; the volume ratio of ethanol and ether in the organic mixed solution is: 1: 3; The volume ratio of the organic mixed solution to THF is 1:1.

[0050] (4) Stand still, grow crystals at 12° C. for 4 hours, filter, wash the filter cake with 65% ethanol solution, and dry in vacuum to obtain cefixime crystals.

[0051] Such as figure 1 As shown, the prepared cefixime crystals use Cu-K α rays to measure the characte...

Embodiment 2

[0052] The preparation of embodiment 2 cefixime crystals

[0053] (1) Take 10Kg cefixime by weighing, be dissolved in tetrahydrofuran, obtain the cefixime tetrahydrofuran solution that concentration is 0.06g / ml;

[0054] (2) Add pure water dropwise to the tetrahydrofuran solution of cefixime at a stirring speed of 160 / min until the solution is no longer clear, and maintain the temperature of the solution at 28°C;

[0055] (3) Add an organic mixed solution of ethanol and ether to the solution obtained in step 2 at a stirring speed of 60r / min; the flow rate is 10ml / min; the volume ratio of ethanol and ether in the organic mixed solution is: 5:18; The volume ratio of the organic mixed solution to THF is 2:3.

[0056] (4) Stand still, grow crystals at 10° C. for 3 hours, filter, wash the filter cake with 60% ethanol solution, and dry in vacuum to obtain cefixime crystals.

[0057] Such as figure 1 As shown, the prepared cefixime crystals use Cu-K α rays to measure the character...

Embodiment 3

[0058] The preparation of embodiment 3 cefixime crystals

[0059] (1) Take 10Kg cefixime by weighing, be dissolved in tetrahydrofuran, obtain the cefixime tetrahydrofuran solution that concentration is 0.16g / ml;

[0060] (2) Add pure water dropwise to the tetrahydrofuran solution of cefixime at a stirring speed of 200 r / min until the solution is no longer clear, and maintain the temperature of the solution at 32°C;

[0061] (3) Add an organic mixed solution of ethanol and ether to the solution obtained in step 2 at a stirring speed of 90r / min; the flow rate is 15ml / min; the volume ratio of ethanol and ether in the organic mixed solution is: 5: 11; The volume ratio of the organic mixed solution to THF is 4:3.

[0062] (4) Stand still, grow crystals at 15° C. for 5 hours, filter, wash the filter cake with 70% ethanol solution, and dry in vacuum to obtain cefixime crystals.

[0063] Such as figure 1 As shown, the prepared cefixime crystals use Cu-K α rays to measure the charac...

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Abstract

The invention relates to a cefixime crystal, a preparation method thereof and a tablet composition containing the crystal. The cefixime crystal can significantly improve the stability and dissolvability. The tablet core of the cefixime tablet composition is prepared by the following components: 35-65 parts of cefixime crystals, 17-29 parts of starch, 3-6 parts of hydroxypropyl cellulose, 3-5 parts of carboxymethyl starch sodium, 7-13.5 parts of microcrystalline cellulose, 0.3-0.7 parts of starch sodium, and 0.3-0.7 parts of magnesium stearate. The cefixime tablet combination prepared by the invention has good stability, and stable effective component contents, and is an ideal cefixime preparation.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a cefixime crystal, a preparation method thereof and a tablet composition containing the crystal. Background technique [0002] Cefixime (Cefixime) is a third-generation oral cephalosporin developed in Japan, which produces a bactericidal effect mainly by destroying the synthesis of bacterial cell walls. Cefixime has a wide range of antibacterial effects on Gram-positive bacteria and Gram-negative bacteria, and its antibacterial activity against Haemophilus influenzae and N. The protective effect of Serratia japonicus on lethal infection in mice is significantly better than other oral cephalosporin antibiotics; cefixime is stable to β-lactamase, has a long-lasting plasma concentration and long plasma half-life, so cefixime can be used daily Take 1-2 times, easy to take; cefixime is effective when taken orally, tasteless and odorless, and has a hig...

Claims

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Application Information

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IPC IPC(8): C07D501/22C07D501/12A61K31/546A61K9/28A61P31/04
Inventor 刘文文韩风生高菲菲
Owner SHANDONG LUOXIN PARMACEUTICAL GROUP STOCK CO LTD
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