Method for preparing roxithromycin dispersible tablet

Abstract

The invention discloses a method for preparing a roxithromycin dispersible tablet. The method comprises the following steps: (1) pre-grinding roxithromycin, pregelatinized starch and lauryl sodium sulfate to obtain a roxithromycin pre-ground material for later use; (2) mixing the roxithromycin pre-ground material, microcrystalline cellulose and low substituted hydroxypropy cellulose, adding an ethanol aqueous solution, granulating by a wet method, drying, screening through a 20-60-mesh screen to obtain a pre-mixed granular material for later use; (3) mixing the pre-mixed granular material, silicon dioxide and magnesium stearate, and tabletting to prepare the roxithromycin dispersible tablet. According to the method, roxithromycin and partial auxiliaries are together ground, so that the hydrophilicity of a medicine is improved, the contact angle is reduced, and the bioavailability of the medicine is improved; furthermore, high-efficiency wet-process granulation and boiling drying are adopted at the same time, so that the labor intensity is reduced, the production efficiency is improved, and the prepared dispersible tablet can be quickly uniformly dispersed in water to facilitate effective absorption of a human body after the dispersible tablet is taken.

Description

technical field [0001] The invention relates to a pharmaceutical preparation, in particular to a roxithromycin tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Roxithromycin is a semi-synthetic 14-membered ring macrolide antibiotic. It is clinically used for pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, and acute chronic bronchitis caused by sensitive bacteria. Outbreak, pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethritis and cervicitis caused by Chlamydia trachomatis; skin and soft tissue infection caused by sensitive bacteria. [0003] Existing roxithromycin tablets and preparation methods thereof mainly have the following problems. [0004] 1. The traditional tablet preparation process is "screening and mixing→trough mixing and granulation→oven drying→blending→tabletting→packaging". This process has th...

AI Technical Summary

Problems solved by technology

[0005] ①The sieving and mixing process is labor-intensive and dusty, which is unfavorable to the labor protection of employees; it is also difficult to ensure the uniformity of mixing, and it cannot effectively reduce the contact angle of raw materials, and the product has problems of uneven content and low dissolution rate

[0006] ②Trough mixing granulation and oven drying process are labor-intensive, material exposure time is long, and the risk of pollution is high; in addition, the oven drying heat is unevenly distributed and the drying efficiency is low, which not only prolongs the wet and hot time of the material, but also makes it difficult to ensure the moisture content of the granules Uniformity

It increases the difficulty of tableting and the potential quality risk of finished products

[0007] 2. Ordinary tablets, which can only be swallowed

It cannot meet the medication needs of patients with severe dysphagia and patients with low consciousness

In addition, its disintegration is relatively slow, which is not conducive to the disintegration of the drug into the original particles of the drug, and the bioavailability is relatively low

Images