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Azithromycin capsule and preparation method thereof

A technology for azithromycin and capsules, applied in the field of pharmaceutical preparations, can solve the problems of product quality and stability, hidden dangers of clinical safety use, difficult control of moisture indicators, etc. Effect

Inactive Publication Date: 2013-04-17
蚌埠丰原涂山制药有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although there are also dosage forms such as large-capacity injections, azithromycin injections are sterilized, and they are easy to degrade and produce impurities, which bring hidden dangers to safe clinical use.
The oral dosage forms of azithromycin tablets and granules are difficult to cover with flavoring agents, which affects the compliance of clinical use. Therefore, the clinical oral dosage forms are mainly capsules, and the current production of azithromycin capsules generally contains moisture. The problem that the index is not easy to control will have a great impact on product quality and stability

Method used

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  • Azithromycin capsule and preparation method thereof

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Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] Formulation composition (parts by weight):

[0035] Azithromycin: 1 part;

[0036] Pregelatinized starch: 0.5 parts;

[0037] Aqueous solution of polyvinylpyrrolidone (5wt%): 0.02 parts;

[0038] Talcum powder: 0.05 part;

[0039] Magnesium stearate: 0.08 parts.

[0040] The preparation method is as follows:

[0041] (1) Crush each raw material separately, pass through a 100-mesh sieve, and weigh for later use.

[0042] (2) Mix azithromycin and pregelatinized starch evenly, and then add an aqueous solution of polyvinylpyrrolidone as a binder to make a soft material.

[0043] (3) Add talcum powder and magnesium stearate, use the extrusion and spheroidizing method to prepare pellets, control the moisture content of the pellets below 4.0%, and fill the obtained pellets into capsule shells.

Embodiment 2

[0045] Formulation composition (parts by weight):

[0046] Azithromycin: 1 part;

[0047] Pregelatinized starch: 0.4 parts;

[0048] Ethanol solution of polyvinylpyrrolidone (5wt%): 0.04 parts;

[0049] Talcum powder: 0.4 part;

[0050] Magnesium stearate: 0.08 parts.

[0051] The preparation method is as follows:

[0052] (1) Crush each raw material separately, pass through a 100-mesh sieve, and weigh for later use.

[0053] (2) Mix azithromycin and pregelatinized starch evenly, then add polyvinylpyrrolidone ethanol solution as adhesive to make soft material.

[0054] (3) Add talcum powder and magnesium stearate, use the extrusion and spheroidizing method to prepare pellets, control the moisture content of the pellets below 4.0%, and fill the obtained pellets into capsule shells.

Embodiment 3

[0056] Formulation composition (parts by weight):

[0057] Azithromycin: 1 part;

[0058] Pregelatinized starch: 0.8 parts;

[0059] Aqueous solution of polyvinylpyrrolidone (8wt%): 0.06 parts;

[0060] Talcum powder: 0.3 parts;

[0061] Magnesium stearate: 0.15 parts.

[0062] The preparation method is as follows:

[0063] (1) Crush each raw material separately, pass through a 100-mesh sieve, and weigh for later use.

[0064] (2) Mix azithromycin and pregelatinized starch evenly, and then add an aqueous solution of polyvinylpyrrolidone as a binder to make a soft material.

[0065] (3) Add talcum powder and magnesium stearate, use the extrusion and spheroidizing method to prepare pellets, control the moisture content of the pellets below 4.0%, and fill the obtained pellets into capsule shells.

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Abstract

The invention relates to an azithromycin capsule which comprises azithromycin capsule comprises azithromycin, a filling agent, an adhesive and a glidant, and further relates to a preparation method of the azithromycin capsule. In the technical scheme, raw materials are made into a micropill capsule, and medicines are uniformly dispersed, so that the problem that the main medicine has low probability of absorbing water is solved, the product quality is improved, and the medicine stability is guaranteed. The capsule has the advantages of high dissolution speed and high bioavailability, and the preparation method provided by the invention is simple to operate, is under mild conditions and is suitable for large-scale industrial production.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to azithromycin capsules and a preparation method thereof. Background technique [0002] Azithromycin is an azalide antibiotic, and its mechanism of action is to interfere with the synthesis of proteins (without affecting the synthesis of nucleic acids) by binding to the subunit of the 50s ribosome of sensitive microorganisms. It is clinically used for the treatment of: 1. Acute pharyngitis and acute tonsillitis caused by Streptococcus pyogenes. 2. Sinusitis, acute otitis media, acute bronchitis, and acute exacerbation of chronic bronchitis caused by sensitive bacteria. 3. Pneumonia caused by Streptococcus pneumoniae, Haemophilus influenzae and Mycoplasma pneumoniae. 4. Urethritis and cervicitis caused by Chlamydia trachomatis and non-multidrug-resistant Neisseria gonorrhoeae. 5. Skin and soft tissue infection caused by sensitive bacteria. [0003] Azithromycin is rapi...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/7052A61K47/02A61K47/12A61P31/04
Inventor 李保琴
Owner 蚌埠丰原涂山制药有限公司
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