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Cefixime dispersing tablet and preparation methods thereof

A technology of cefixime and dispersible tablets, which is applied in the field of cefixime dispersible tablets and its industrialized preparation, can solve the problems of short disintegration time and dissolution performance, and achieve the effects of healthy and clean production environment, cost reduction and good prescription

Active Publication Date: 2009-12-23
GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0009] The purpose of the present invention is to provide a kind of cefixime dispersible tablet and preparation method thereof, the technical problem to be solved in the present invention is to make cefixime preparation have shorter disintegration time, better stripping property, have higher simultaneously Main drug content, reduce production costs, reduce quality inspection time, and reduce pollution to the production environment

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0087] (a) Take by weighing 250g of cefixime, 50g of starch, 60g of mannitol, 60g of microcrystalline cellulose, and 12g of sodium starch glycolate, sieve, and mix uniformly to obtain mixed powder;

[0088] (b) Add 304g of povidone K and 0.1g of stevioside in 60% ethanol solution, adjust the amount of 60% ethanol to obtain 86.4g of binder solution, add binder solution to the above mixed powder, and use Shanghai Sine Pharmaceutical Co., Ltd. The KJZ-10 fast stirring granulator manufactured by the equipment company granulates;

[0089] (c) Adjust the air inlet temperature of the DLB-3 multifunctional granulating and coating machine (Chongqing Guangsha) to 70°C, and the material temperature to 50°C, and fluidize and boil the granules for 2 minutes;

[0090] (d) Take the dried granules, add remaining 48 g of carboxymethyl starch sodium, 0.5 g of sweet orange essence, and 4.8 g of magnesium stearate after granulation, and mix well;

[0091] (e) Compress into 1000 tablets with a ro...

Embodiment 2

[0094] (a) Take by weighing 120g of cefixime, 70g of starch, 30g of mannitol, and 10g of sodium starch glycolate, sieve, and mix uniformly to obtain mixed powder;

[0095] (b) Add 3.6 g of povidone K30 and 0.3 g of stevioside to 50% ethanol solution, adjust the amount of 50% ethanol to obtain 69 g of binder solution, add binder solution to the above mixed powder, and use Shanghai Sine The KJZ-10 fast stirring granulator manufactured by the pharmaceutical equipment company granulates;

[0096] (c) Adjust the air inlet temperature of the DLB-3 multifunctional granulating and coating machine (Chongqing Guangsha) to 60°C, the material temperature to 40°C, and fluidize and boil the granules for 6 minutes;

[0097] (d) Take the dried granules, add remaining 10 g of carboxymethyl starch sodium, 1.5 g of sweet orange essence, and 2.5 g of magnesium stearate after sizing, and mix well;

[0098] (e) Compress into 1000 tablets with a rotary tablet press.

[0099] The hardness of the obta...

Embodiment 3

[0101] (a) Take by weighing 30g of starch, 35g of mannitol, 35g of microcrystalline cellulose, and 11g of sodium starch glycolate, sieve, and mix uniformly to obtain mixed powder;

[0102] (b) Add 304g of povidone K and 0.4g of stevioside to the 40% ethanol solution, adjust the amount of 40% ethanol to obtain 22.5g of the binder solution, add the binder solution to the above mixed powder, and use Shanghai Sine Pharmaceutical Co., Ltd. The soft material of the KJZ-10 fast stirring granulation mechanism manufactured by the equipment company is granulated with the DGN multifunctional pharmaceutical testing machine produced by Shanghai Yali Pharmaceutical Machinery Co., Ltd.;

[0103] (c) Adjust the air inlet temperature of the DLB-3 multifunctional granulating and coating machine (Chongqing Guangsha) to 60°C, the material temperature to 40°C, and fluidize and boil the granules for 6 minutes;

[0104] (d) Take the dried granules, add cefixime 65g, remaining sodium starch glycolate...

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Abstract

The invention discloses a cefixime dispersing tablet and preparation methods thereof, belonging to the technical field of pharmaceutical preparation. The cefixime dispersing tablet comprises 40-420 mg of cefixime, 0-100 mg of starch, 0-250 mg of amylum pregelatinisatum, 10-80 mg of mannite, 0-150 mg of microcrystalline cellulose, 10-60 mg of carboxyrnethyl starch sodium, 2-20 mg of polyvidone K30, 0.4-10 mg of magnesium stearate, 0-10 mg of Steviosin and 0-10 mg of orange compound perfume. The preparation method comprises the following steps: evenly mixing basic remedies and excipients; adding adhesive to prepare granulates; drying; sorting and then adding with other excipients; and tabletting. The other preparation method is described as follows: the basic remedies are added after granulating. The invention aims to solve the technical problem that cefixime preparation has shorter disintegration time, better leachability, higher content of the basic remedies, production cost reduction, quality detection time reduction and production environment pollution reduction.

Description

technical field [0001] The invention relates to a medicine and a preparation method thereof, in particular to a cefixime dispersible tablet and an industrializable preparation method thereof. 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 high concentration in lung, gallbladde...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/546A61K47/38A61P31/04
Inventor 卢丹吴振华朱少璇尤孝庆
Owner GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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