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Roxithromycin capsule and preparation method thereof

A technology of roxithromycin and capsules, applied in the field of pharmaceutical preparations, can solve problems such as no further prompts are given, and achieve the effects of good dissolution uniformity, good fluidity, and improved dissolution rate

Active Publication Date: 2013-05-08
SICHUAN KELUN PHARMA RES INST CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, how to adjust the dissolution rate of roxithromycin, formula and process adjustment to obtain better dissolution rate, the prior art does not provide further hints

Method used

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  • Roxithromycin capsule and preparation method thereof
  • Roxithromycin capsule and preparation method thereof
  • Roxithromycin capsule and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0056] Embodiment 1 pharmaceutical composition capsule of the present invention

[0057]

[0058] Prepare as follows:

[0059] Mix and pulverize roxithromycin and micropowder silica gel through a 100-mesh sieve to obtain a mixed powder of roxithromycin and micropowder silica gel; take the remaining auxiliary materials and mix them through an 80-mesh sieve, add the above-mentioned mixed powder, mix evenly, and after the quality inspection is qualified, Pack capsules to get roxithromycin capsules.

Embodiment 2

[0060] Embodiment 2 pharmaceutical composition capsule of the present invention

[0061]

[0062] Prepare as follows:

[0063] Mix and pulverize the raw material roxithromycin and 3 / 4 amount of micropowder silica gel and pass through a 100 mesh sieve to obtain a mixed powder of raw material roxithromycin and micropowder silica gel; take carboxymethyl starch sodium and pregelatinized starch and pass through 80 Mix evenly after the mesh sieve; add 50% ethanol soft material, granulate through a 20 mesh sieve to obtain wet granules; dry the above wet granules at 60°C until the moisture content is ≤ 3wt%, to obtain dry granules; pass the dry granules through 20 Mesh sieve for granulation, then add talcum powder and the remaining micropowder silica gel, after the quality inspection is qualified, pack into capsules to obtain the roxithromycin capsule of the present invention.

Embodiment 3

[0064] Embodiment 3 pharmaceutical composition capsule of the present invention

[0065]

[0066] Prepare as follows:

[0067] Mix and pulverize the raw material roxithromycin and 3 / 4 amount of micropowder silica gel and pass through an 80 mesh sieve to obtain a mixed powder of raw material roxithromycin and micropowder silica gel; take carboxymethyl starch sodium and pregelatinized starch and pass through 80 mesh Mix evenly after mesh sieving; add 5% povidone ethanol solution to make soft material, pass through 30 mesh sieve and granulate to obtain wet granules; dry the above wet granules at 70°C until the moisture content is ≤3wt%, to obtain dry granules; Dry granules pass through a 30-mesh sieve for granulation, then add talcum powder and remaining micropowdered silica gel, after passing the quality inspection, pack into capsules to obtain the roxithromycin capsules of the present invention.

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PUM

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Abstract

The invention discloses a roxithromycin capsule and a preparation method thereof. The roxithromycin capsule pharmaceutical composition comprises the roxithromycin, silica powder, a disintegrating agent, a filler, a lubricant, etc. The preparation technology of the roxithromycin capsule comprises a direct filling technology and a wet granulation process. The method can satisfy demands of different equipment and is beneficial for production. The prepared roxithromycin capsule is good in dissolution and small in loading difference, and is a safe, stable and effective product.

Description

technical field [0001] The invention relates to a pharmaceutical composition and a preparation method thereof, in particular to a roxithromycin capsule and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Molecular formula of Roxithromycin: C 41 h 76 N 2 o 15 , Molecular weight: 837.03, its chemical name is: 9-[O-[(2-methoxyethoxy) methyl] oxime] erythromycin. The chemical structural formula is as follows: [0003] [0004] Roxithromycin is a semi-synthetic 14-membered ring macrolide antibiotic. Its antibacterial spectrum and antibacterial effect are basically similar to erythromycin, but its antibacterial effect is 6 times stronger than that of erythromycin. Among them, the effect on Legionella pneumophila Stronger than erythromycin. The antimicrobial effect on Chlamydia pneumoniae, Mycoplasma pneumoniae, and Ureaplasma urealyticum is similar to or slightly stronger than that of erythromyci...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/7048A61K47/04A61K47/36A61K47/32A61K47/38A61P31/04
Inventor 沈利鲜林胡蓉崔平扬邓璐霞梁隆程志鹏
Owner SICHUAN KELUN PHARMA RES INST CO LTD
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