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Cefixime dry suspension and preparation method thereof

A cefixime, dry suspension technology, applied in pharmaceutical formulations, medical preparations containing active ingredients, organic active ingredients, etc., can solve problems such as the difficulty of clinical selection, and achieve the guarantee of efficacy and safety, high economic and social Meaning, the effect of accelerating absorption

Active Publication Date: 2014-03-12
SHIJIAZHUANG HUAXIN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] At present, there are many varieties of cefixime dry suspension preparations used in the market, and the quality of the drugs from different manufacturers is different, which brings certain difficulties to clinical selection.

Method used

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  • Cefixime dry suspension and preparation method thereof
  • Cefixime dry suspension and preparation method thereof
  • Cefixime dry suspension and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0023] Example 1 Preparation of Cefixime Dry Suspension

[0024] prescription:

[0025]

[0026] Preparation:

[0027] a. Preparation of cefixime crystal form: dissolve 100g cefixime in 800ml dioxane and warm to 53°C, adjust the pH value to 2.5 with 20% hydrochloric acid solution, then add 16ml n-butane within 5 minutes , keep the solution at 53°C for 20 minutes, add 2400ml of tetrahydrofuran, cool to -7°C for crystallization, filter, and dry at 53°C to obtain 96.4g of cefixime crystal form, with a yield of 96.4% and a purity of 99.57% as determined by HPLC;

[0028] b. Raw material preparation: the cefixime crystal form raw material is passed through a 60-mesh sieve, the auxiliary materials are passed through a 80-mesh sieve, and weighed according to the prescription amount;

[0029] c. Mixing: Add all the materials obtained in step b into a mixer and mix thoroughly. After checking that the semi-finished product is qualified, pack it into aluminum-plastic composite film ...

Embodiment 2

[0034] Example 2 Preparation of Cefixime Dry Suspension

[0035] prescription:

[0036]

[0037]

[0038] Preparation:

[0039] a. Preparation of cefixime crystal form: dissolve 100g cefixime in 500ml dioxane and warm to 50°C, adjust the pH value to 2.0 with 20% hydrochloric acid solution, then add 5ml n-butane within 5 minutes , keep the solution at 50°C for 20 minutes, add 1000ml of tetrahydrofuran and cool to -5°C for crystallization, filter, and dry at 50°C to obtain 95.8g of cefixime crystal form, with a yield of 95.8% and a purity of 99.38% as determined by HPLC;

[0040] b. Raw material preparation: the cefixime crystal form raw material is passed through a 60-mesh sieve, the auxiliary materials are passed through a 80-mesh sieve, and weighed according to the prescription amount;

[0041] c. Mixing: Add all the materials obtained in step b into a mixer and mix thoroughly. After checking that the semi-finished product is qualified, pack it into aluminum-plastic c...

Embodiment 3

[0042] Example 3 Preparation of Cefixime Dry Suspension

[0043] prescription:

[0044]

[0045] Preparation:

[0046] a. Preparation of cefixime crystal form: dissolve 100g cefixime in 1000ml dioxane and warm to 55°C, adjust the pH value to 3.0 with 20% hydrochloric acid solution, then add 30ml n-butane within 5 minutes , keep the solution at 55°C for 20 minutes, add 4000ml of tetrahydrofuran and cool to -10°C for crystallization, filter, and dry at 55°C to obtain 95.4g of cefixime crystal form, with a yield of 95.4% and a purity of 99.33% as determined by HPLC;

[0047] b. Raw material preparation: the cefixime crystal form raw material is passed through a 60-mesh sieve, the auxiliary materials are passed through a 80-mesh sieve, and weighed according to the prescription amount;

[0048] c. Mixing: Add all the materials obtained in step b into a mixer and mix thoroughly. After checking that the semi-finished product is qualified, pack it into aluminum-plastic composite ...

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Abstract

The invention relates to a cefixime dry suspension and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The cefixime dry suspension contains 40-60 parts by weight of cefixime crystal form, wherein the X-ray powder diffraction pattern of the cefixime crystal form has characteristic absorption peaks at reflection angles 2theta of 11.14 degrees, 11.50 degrees, 14.14 degrees, 16.60 degrees, 16.90 degrees, 17.18 degrees, 20.50 degrees, 21.40 degrees, 22.20 degrees, 22.80 degrees, 22.94 degrees and 28.54 degrees. As the cefixime crystal form is used by the cefixime dry suspension, absorption of the cefixime dry suspension in human bodies is accelerated and the bioavailability is improved, thus the curative effects are improved. The cefixime dry suspension has better stability and dissolution effect and improves the use efficiency of unit dose.

Description

technical field [0001] The invention relates to a medicinal dry suspension preparation and a preparation method thereof, in particular to a cefixime dry suspension preparation and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Cefixime is an oral third-generation cephalosporin with a broad antibacterial spectrum. It has antibacterial activity against some Gram-positive bacteria and negative bacteria, especially Streptococcus (except Enterococcus) and pneumonia among Gram-positive bacteria. Neisseria gonorrhoeae, Branhamella, Escherichia coli, Klebsiella, Serratia, Proteus, and influenza bacilli among cocci and Gram-negative bacteria have strong antibacterial effects, and their mechanism of action is It prevents the synthesis of bacterial cell walls, and its action point varies with the species of bacteria. It has high affinity with PBP1 (1a, 1b, 1c) and PBP3 in penicillin-binding proteins (PBP). C...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/546A61P31/04C07D501/22C07D501/12
Inventor 王敏张云张硕郭卿李双梅吴少聪马海波
Owner SHIJIAZHUANG HUAXIN PHARMA
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