Cefixime orally disintegrating tablet and preparation thereof
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A technology of orally disintegrating tablets and cefixime, which is applied in the direction of pharmaceutical formulas, medical preparations containing non-active ingredients, medical preparations containing active ingredients, etc., to achieve the effects of fast absorption, increased absorption area, and fine drug particles
Active Publication Date: 2014-11-05
SHANGHAI SINE PROMOD PHARMA
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Problems solved by technology
The dosage forms currently used in clinical practice include capsules, tablets, dry suspensions, chewable tablets, etc. These common dosage forms have compliance problems for some special groups of people and those with swallowing disorders such as the elderly and young.
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Embodiment 1
[0022]
[0023]
[0024] preparation:
[0025] (1) Take the raw materials of each component in the prescription and pass through a 40-mesh sieve respectively, except for cefixime, and dry them at 60°C for later use;
[0026] (2) Step (1) Mix cefixime and other spare parts evenly, and sieve with 40 mesh.
[0027] (3) Determination of intermediate content (cefixime 334 ~ 340mg / g) and moisture (7.6% ~ 7.8%), calculate the theoretical tablet (0.271g, equivalent to cefixime 100mg), compressed into 1000 tablets, each Sheet thickness: 4.25~4.75mm, hardness: 2.0kg / cm 2 ~4.0kg / cm 2 .
[0028] Die of tablet press (ZP-10 type): ф10mm shallow arc punch.
Embodiment 2
[0030] Recipe and preparation are with embodiment 1.
Embodiment 3
[0032] Recipe and preparation are with embodiment 1.
[0033] The disintegration times of the three batches of trial samples (Example 1, 2, 3) were all within 40 seconds, meeting the preparation requirements for orally disintegrating tablets.
[0034] Dissolution rate: adopt the device of dissolution test method (the first method of appendix XC of Chinese Pharmacopoeia 2005 edition). Using 900ml of water as a solvent, the rotation speed is 100 revolutions per minute, and the dissolution rate of three batches of trial samples (batch numbers: 20090101T, 20090102T, 20090103T) exceeds 80% in 10 minutes.
[0035] The orally disintegrating tablet of the present invention (specification 0.1g, Example 1) and the ordinary tablet on the market (Guangzhou Baiyunshan Pharmaceutical General Factory, specification 0.1g, batch number: 5080001) have carried out comparative research on the difference in in vitro dissolution, which is the formulation of quality standards. And provide a basis f...
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Abstract
The product provides a cefixime orally disintegrating tablet. The cefixime orally disintegrating tablet contains cefixime, microcrystalline cellulose, low-substituted hydroxy propyl cellulose, crosslinking polyvinylpyrrolidone, mannitol, aspartame, magnesium stearate, etc., wherein each tablet contains 100mg of cefixime. The cefixime orally disintegrating tablet of the invention is convenient for taking, can be taken without water, is fast disintegrated in an oral cavity, and has no delay phenomenon in an esophagus. Greatly convenience is provided for children, the elderly, patients with mental diseases, and bedridden patients who are difficult to move. Characteristic of fast disintegration in the oral cavity makes a drug absorption area increase, and the cefixime orally disintegrating tablet has advantage of easy and rapid absorption, small irritation on an alimentary canal mucous membrane and high bioavailability. The cefixime orally disintegrating tablet is convenient for carrying and taking. Compared with a common solid oral preparation, the cefixime orally disintegrating tablet can be fast absorbed, provides greatly convenience for patients, greatly raises treatment compliance, and has a good clinic application prospect. The cefixime orally disintegrating tablet of the invention has a simple preparation method, is suitable for industrialization production, and has a great application value.
Description
technical field [0001] The invention relates to a pharmaceutical preparation, in particular to an orally disintegrating tablet, in particular to a cefixime orally disintegrating tablet and a preparation method thereof. Background technique [0002] Due to the long-term use of cephalosporins, the clinical resistance of bacteria is becoming stronger and stronger. The main mechanisms of bacterial resistance to β-lactam antibiotics are: 1) Permeability barrier of the outer cell membrane; 2) Production of plasmids or chromosomes mediated β-lactamase; 3) changes in the target penicillin-binding protein (PBP). Among the above-mentioned mechanisms, the most clinically significant is the production of β-lactamase. The drug resistance of about 80% of pathogenic bacteria is related to the permeability barrier of the outer cell membrane and the change of the target site; the other about 12% and 8% of the pathogenic bacteria Drug resistance is associated with changes in outer membrane p...
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