Roxithromycin capsule and preparation method thereof

Abstract

The invention relates to a roxithromycin capsule and a preparation method thereof and belongs to the technical field of pharmaceutical preparations. The roxithromycin capsule is prepared from roxithromycin, low-substituted hydroxypropyl cellulose, silicon dioxide, talcum powder and magnesium stearate, wherein the water contents of the roxithromycin and the low-substituted hydroxypropyl cellulose are both lower than 1.5%, preferably the water content of the roxithromycin and the low-substituted hydroxypropyl cellulose are both lower than 1.0%; the ratio of roxithromycin to silicon dioxide is 30:1; the silicon dioxide is heavy silicon dioxide; the ratio of the roxithromycin raw material to talcum powder is 10:(1-1.4); the used amount of the magnesium stearate is 0.2-0.4% by weight of the capsule. The capsule has small content difference and is simple in preparation process and high in production efficiency, the dissolution rate of the capsule is higher than 80% within 45 minutes of the valid period, the quality of the prepared capsule is stable, the curative effect is determined, and the dissolution rate meets the requirements in the long-term storage process.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to a roxithromycin capsule and a preparation method thereof. Background technique [0002] Roxithromycin is a macrolide antibiotic, and its antibacterial spectrum and antibacterial ability are basically equivalent to erythromycin. It has the characteristics of good oral absorption and relatively stable acid. It is suitable for pharyngitis and tonsillitis caused by Streptococcus pyogenes, sinusitis, otitis media, acute bronchitis, acute exacerbation of chronic bronchitis caused by sensitive bacteria, pneumonia caused by Mycoplasma pneumoniae or Chlamydia pneumoniae; urethritis and Cervicitis; skin and soft tissue infection caused by susceptible bacteria. [0003] The basic information of roxithromycin is as follows: [0004] Chemical Chinese name: 9-{O-[(2-methoxyethoxy)-methyl]oximino}erythromycin [0005] Molecular formula: C 41 h 76 N 2 o 5 ...

AI Technical Summary

Problems solved by technology

[0009] At present, the oral preparations of roxithromycin in China are mainly oral tablets and oral hard capsules. The commonly used specification of oral hard capsules is 150mg. There are many manufacturers of roxithromycin capsules, but the quality of samples produced by different manufacturers is quite different. Large, especially the dissolution rate Many manufacturers' products will stick together during storage, and agglomerate will eventually lead to unqualified dissolution

[0010] The patent application whose publication number is CN106138009A discloses a kind of roxithromycin capsule and its preparation process. It adopts wet granulation process to make granules and then fills them in capsules. Its formula consists of roxithromycin, starch, low-substituted hydroxyl Propylene cellulose and solubilizer polysorbate 20 are mixed and then added to ethanol to granulate. The process is complicated, and roxithromycin capsules have good solubility in the dissolution medium of pH 5.5. The effect of adding polysorbate 20 is not obvious. The main problem with the dissolution rate of erythromycin capsules is that after a long storage time, they stick together and form lumps in the basket. This method cannot solve the unqualified dissolution rate during storage.

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