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Roxhthromycin soft capsule and its preparing method

A technology of roxithromycin and soft capsules, which is applied in the field of medicine and can solve problems such as unacceptable and bitter taste for children

Inactive Publication Date: 2005-12-21
秦引林
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Due to the extremely bitter taste of roxithromycin, the taste of roxithromycin dry suspension commercially available in China is also bitter, which is difficult for children to accept. It has become necessary to develop a new dosage form suitable for oral administration to children.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0018] Roxithromycin Soft Capsules

[0019] Prescription: Contents Each capsule contains plastic shell

[0020] Roxithromycin 50mg Gelatin 46.00%

[0021] PEG400 0.18ml Glycerin 17.82%

[0022] Propylene Glycol 0.02ml Water 36.18%

[0023] Tartaric acid 10mg

[0024] Take an appropriate amount of absolute ethanol, add PEG400, propylene glycol, and tartaric acid and mix evenly; dissolve roxithromycin in it, and evaporate the ethanol under reduced pressure at 50-60°C to obtain a clear solution; make this solution into soft capsules. Each capsule contains roxithromycin 50mg.

Embodiment 2

[0026] Roxithromycin Soft Capsules

[0027] Prescription: Contents Each capsule contains plastic shell

[0028] Roxithromycin 50mg Gelatin 46.00%

[0029] PEG400 0.14ml Glycerin 17.82%

[0030] Propylene Glycol 0.06ml Water 36.18%

[0031] Tartaric acid 15mg

[0032] Take an appropriate amount of absolute ethanol, add PEG400, propylene glycol, and tartaric acid and mix evenly; dissolve roxithromycin in it, and evaporate the ethanol under reduced pressure at 50-60°C to obtain a clear solution; make this solution into soft capsules. Each capsule contains roxithromycin 50mg.

Embodiment 3

[0034] Roxithromycin Soft Capsules

[0035] Prescription: Contents Each capsule contains plastic shell

[0036] Roxithromycin 50mg Gelatin 46.00%

[0037] PEG400 0.1ml Glycerin 17.82%

[0038] Glycerin 0.02ml Water 36.18%

[0039] Tartaric acid 5mg

[0040] Take an appropriate amount of absolute ethanol, add PEG400, glycerin, and tartaric acid and mix evenly; dissolve roxithromycin in it, and evaporate the ethanol under reduced pressure at 50-60°C to obtain a clear solution; make this solution into soft capsules. Each capsule contains roxithromycin 50mg.

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PUM

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Abstract

The present invention relates to a roxithromycin soft capsule and its preparation method. In the invented roxithromycin soft capsule its liquid medicine contains roxithromycin with effective dose and medicinal auxiliary material. Said medicinal auxiliary material includes dilutent, antioxidant, solubilizing agent, solubility promoter and pH regulator. In the liquid medicine of every standard capsule 0.01-0.25g of roxithromycin is contained. Besides, said invention also provides the concrete steps of its preparation process.

Description

Technical field: [0001] The invention relates to novel roxithromycin formulation soft capsules, which belong to the technical field of medicine. Background technique: [0002] Roxithromycin, a derivative of erythromycin A, is a relatively new semi-synthetic macrolide antibiotic. It was first listed in France in October 1987. At present, large and medium-sized cities in my country have already used it. The antibacterial range is similar to that of erythromycin. It is characterized by being stable to acid, and can be quickly absorbed by the gastrointestinal tract, has a higher blood concentration, stronger antibacterial effect than erythromycin, long drug action time in the body, half-life (the time when the blood concentration is reduced by half) than erythromycin 8 to 10 times longer. It is mainly excreted as the original drug through feces and urine, without accumulation, and the effective blood drug concentration can be maintained by taking the drug once every 12 hours...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048
Inventor 秦引林柯学何龙其
Owner 秦引林
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