Cephalosporin suspension granule and preparation method thereof

A technology for suspending granules and cephalosporins, which is applied in the directions of antibacterial drugs, pharmaceutical formulations, and medical preparations of inactive ingredients, etc., can solve problems such as difficulty in guaranteeing the dosage of drugs, poor solution suspension effect, and poor quality stability, etc. To achieve the effect of good medication compliance, good suspension effect and stable quality in children

Active Publication Date: 2010-09-01
广东恒健制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, because the quality of cephalosporin raw materials is unstable and easy to degrade under wet and hot conditions, the quality stability of such products on the market is generally poor
In addition, because the raw materials of cephalosporin antibiotics are difficult to dissolve in w...

Method used

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  • Cephalosporin suspension granule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] A method for preparing cephalosporin suspension particles, the preparation steps are as follows: first, the polyvinylpyrrolidone mixed solution is prepared in advance: the polyvinylpyrrolidone is dissolved in water to prepare a polyvinylpyrrolidone aqueous solution, and the polyvinylpyrrolidone accounts for polyethylene The weight percent of the pyrrolidone aqueous solution is 3-20%; tartrazine (or sunset yellow, carmine) and edetate disodium (EDTA-2Na) are added to the above solution, stirred and dissolved to prepare a polyvinylpyrrolidone mixed solution for use.

[0018] Then, weigh cefixime, sucrose, low-substituted hydroxypropyl cellulose, aspartame, and strawberry essence according to the prescription amount, grind sucrose and cefixime into 120-mesh fine powder and mix with low-substituted hydroxypropyl cellulose, The auxiliary materials such as spathin are mixed evenly, and the polyvinylpyrrolidone mixed solution prepared above is added, and after being stirred eve...

Embodiment 2

[0022] A kind of cephalosporin suspension granule, its prescription composition comprises cefixime, sucrose powder, low-substituted hydroxypropyl cellulose, aspartame, disodium edetate, strawberry essence, tartrazine, polyvinylpyrrolidone (PVPK 30 ). The percentage by weight of the cephalosporin suspension particles in each component is: 3% cefixime; 65% sucrose powder; 30% low-substituted hydroxypropyl cellulose; 0.5% aspartame; 0.02% edetate disodium ; Strawberry essence powder 1%; Yellow pigment 0.05%; 20% polyvinylpyrrolidone (PVPK 30 ) solution in an appropriate amount.

[0023] The cephalosporin suspension granule sample produced by the technology described in Example 1 of the present invention and the commercially available sample of the prior art are carried out to conduct a comparative study of the quality of the above prescription, and the results are shown in Table 1:

[0024] Table 1 The quality test results of cefixime granules produced by different manufacturer...

Embodiment 3

[0027] The cephalosporin suspension granules of present embodiment 2, its prescription composition comprises cefprozil, mannitol, carboxymethyl starch sodium, stevioside, disodium edetate, strawberry essence, yellow pigment, polyvinylpyrrolidone (PVPK 30 ). The percentage by weight of the cephalosporin suspension particles in each component is: 10% cefprozil; 50% sucrose; 20% mannitol; 15% sodium starch glycolate; 1% stevioside; 0.02% edetate disodium; Orange flavor powder 1%; yellow pigment 0.5%; 15% polyvinylpyrrolidone (PVPK 30 ) in an appropriate amount of aqueous solution.

[0028] The sample that this prescription is produced by the technology described in embodiment 1 of the present invention and the commercially available sample of prior art are carried out the comparative study of quality situation, and the result is: the particle size of present embodiment product is better than prior art, and suspension effect is good, High dissolution rate. Good quality and stab...

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Abstract

The invention discloses a cephalosporin suspension granule of which the formula composition comprises drug active ingredients, excipient, suspending agent, disintegrating agent, flavoring agent, coloring agent, stabilizing agent, adhesive and spice. The granule takes cefixime, cefprozil, cefaclor or cefdinir as the main drug ingredient, disintegrating agent and suspending agent with a certain quantity are added into the formula to ensure that the effective ingredients are dissolved out, and the solution has favorable suspending effect. Meanwhile, the invention also discloses a preparation method of the cephalosporin suspension granule, which adopts the wet granulation method to prepare granules and adopts the fluidized bed drying method to dry. The invention adopts the fluidized bed drying technology, so that compared with the traditional oven drying, the invention has the advantages of short drying time, small influence on active matter quality and the like, not only ensures product quality but also improves production efficiency. The granule prepared by the formula of the invention has solid granularity and lowers damage to the granule by fluidized drying.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a cephalosporin suspension granule and a preparation method thereof. Background technique: [0002] Cephalosporins play a bactericidal effect by inhibiting bacterial cell wall synthesis and are stable to most β-lactamases. Many strains producing penicillinase and cephalosporinase are still sensitive to cephalosporins. Cephalosporins are effective in vitro and in vivo against Gram-positive cocci such as pneumococcus, Streptococcus pyogenes, Gram-negative bacilli such as influenza bacilli (including enzyme-producing strains), Moraxella catarrhalis (including enzyme-producing strains), Escherichia coli, Proteus mirabilis, and Neisseria gonorrhoeae (including enzyme-producing strains) all have good antibacterial effects. Cephalosporins in vitro against Streptococcus pneumoniae, Bacillus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Pasteurella multocida, Prov...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/546A61K31/545A61K47/38A61K47/36A61P31/04
Inventor 冯淡开黄聪燕李兵郭环娟江志华卓国祥
Owner 广东恒健制药有限公司
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