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Cefprozil tablet and preparation method thereof

A technology of cefprozil and propylene tablets, which is applied in the direction of pharmaceutical formulations, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., and can solve problems such as difficult to meet quality requirements, low dissolution rate, poor stability, etc. , to achieve the effect of reducing ring-opening degradation, simple steps, good stability and dissolution rate

Active Publication Date: 2013-12-04
NORTH CHINA PHARMA HEBEI HUAMIN PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although this method can avoid the hydrolysis of cefprozil, when the obtained tablet is placed for a long time, the stability is not good enough, the dissolution rate is low, and it is difficult to meet the quality requirements under the long-term storage conditions of the drug.
At present, there is a lack of a cefprozil preparation that can maintain good stability and dissolution rate during preparation and long-term storage, and has a simple and economical preparation method

Method used

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  • Cefprozil tablet and preparation method thereof
  • Cefprozil tablet and preparation method thereof
  • Cefprozil tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] According to the following formula, cefprozil tablets were prepared with batch number 142111102.

[0037]

[0038]

[0039] The preparation steps are as follows:

[0040] (1) Sieving

[0041] Pass the cefprozil, crospovidone, and microcrystalline cellulose through an 80-mesh sieve, and directly press the lactose through a 60-mesh sieve, and collect the powder under the sieve; the purity of the cefprozil is 96.3%; the model of the microcrystalline cellulose is Microcrystalline cellulose 101.

[0042] (2) Premix

[0043] Weigh the cefprozil, microcrystalline cellulose, direct-pressed lactose, and crospovidone that have been sieved in step (1), add them to the mixer, and premix for 10 minutes;

[0044] (3) Total mixing

[0045] Weigh magnesium stearate and silicon dioxide respectively, add them to the mixer described in step (2), and mix for 10 minutes.

[0046] After mixing, insert a sampling probe into the upper, middle, and lower parts of the mixer barrel, and take samples respecti...

Embodiment 2

[0063] According to the following formula, cefprozil tablets were prepared with batch number 142111103.

[0064]

[0065] The preparation steps are as follows:

[0066] (1) Sieving

[0067] Pass the cefprozil, crospovidone, and microcrystalline cellulose through an 80-mesh sieve, and directly press the lactose through a 60-mesh sieve, and collect the powder under the sieve; the purity of the cefprozil is 96.3%; the model of the microcrystalline cellulose is Microcrystalline cellulose 101.

[0068] (2) Premix

[0069] Weigh the cefprozil, microcrystalline cellulose, direct-pressed lactose, and crospovidone that have been sieved in step (1), add them to the mixer, and premix for 10 minutes;

[0070] (3) Total mixing

[0071] Weigh magnesium stearate and silicon dioxide respectively, add them to the mixer described in step (2), and mix for 10 minutes.

[0072] After mixing, insert a sampling probe into the upper, middle, and lower parts of the mixer barrel, and take samples respectively, of ...

Embodiment 3

[0085] According to the following formula, cefprozil tablets were prepared with batch number 142111104.

[0086]

[0087] The preparation steps are as follows:

[0088] (1) Sieving

[0089] Pass the cefprozil, crospovidone, and microcrystalline cellulose through an 80-mesh sieve, and directly press the lactose through a 60-mesh sieve, and collect the powder under the sieve; the purity of the cefprozil is 96.3%; the model of the microcrystalline cellulose is Microcrystalline cellulose 101.

[0090] (2) Premix

[0091] Weigh the cefprozil, microcrystalline cellulose, direct-pressed lactose, and crospovidone that have been sieved in step (1), add them to the mixer, and premix for 10 minutes;

[0092] (3) Total mixing

[0093] Weigh magnesium stearate and silicon dioxide respectively, add them to the mixer described in step (2), and mix for 10 minutes.

[0094] After mixing, insert a sampling probe into the upper, middle, and lower parts of the mixer barrel, and take samples respectively, of ...

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Abstract

The invention provides a cefprozil tablet which comprises a tablet core and a thin-film coating. The cefprozil tablet is characterized in that the tablet core is composed of cefprozil and medicinal excipients, and the medicinal excipients include microcrystalline cellulose, vertical-compression lactose, cross-linked polyvinylpolypyrrolidone, magnesium stearate and silicon dioxide. The invention further provides a preparation method of the cefprozil tablet. The preparation method includes under the conditions that the temperature is 18 DEG C-26 DEG C and relative humidity is 45-65%, sieving, premixing, tableting and coating. The cefprozil tablet prepared by the method can maintain high stability and dissolubility in the process of preparation and long-term storage.

Description

Technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and specifically relates to a cefprozil tablet and a preparation method thereof. Background technique [0002] Cefprozil is a second-generation cephalosporin oral broad-spectrum antibiotic. Its mechanism of action is to inhibit the synthesis of bacterial cell walls. Cefprozil has the advantages of strong antibacterial effect, resistance to penicillinase, good clinical efficacy, low toxicity, and less allergic reactions than penicillin. Its structural formula is as follows: [0003] [0004] Similar to other cephalosporins, cefprozil contains a β-lactam ring in its molecular structure. The β-lactam ring is the most unstable part of the structure of such compounds. If the ring is broken, the antibacterial effect will disappear. In general, cefprozil is prone to hydrolysis and ring-opening when it encounters acid, alkali or β-lactamase and loses antibacterial activity; and metal ions...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/36A61K31/545A61K47/38A61P31/04
Inventor 李艳敏郭洪茹张莉柳世萍刘东张锁庆刘海席王朝卿张文盛李敏
Owner NORTH CHINA PHARMA HEBEI HUAMIN PHARMA
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