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Azithromycin dispersible tablet, as well as preparation method and application thereof

A technology of azithromycin and dispersible tablets, which is applied in the directions of non-active ingredient medical preparations, medical preparations containing active ingredients, pharmaceutical formulas, etc., can solve the problems of hidden dangers of drug safety, unqualified friability, poor compressibility, etc. Achieving safe selection, avoiding degradation, and good performance

Inactive Publication Date: 2013-04-17
SICHUAN KELUN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the listed azithromycin dispersible tablets have the following problems: the existing preparation methods of azithromycin dispersible tablets are all wet granulated and then pressed into tablets, but azithromycin is a macrolide antibiotic and is unstable under hot and humid conditions. Inevitably exposed to hot and humid environment, the main drug will be degraded, and related substances will increase significantly, making the drug may have certain safety hazards
However, the inventors found that because azithromycin itself has poor compressibility and viscosity, it is easy to cause problems such as sticking, splitting, and unqualified friability in the process of tablet compression. More prominent in powder direct compression process

Method used

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  • Azithromycin dispersible tablet, as well as preparation method and application thereof
  • Azithromycin dispersible tablet, as well as preparation method and application thereof
  • Azithromycin dispersible tablet, as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] The preparation method of embodiment 1 azithromycin dispersible tablet of the present invention

[0038] [prescription]

[0039]

[0040] Preparation:

[0041] 1. Mix azithromycin and micropowder silica gel through an 80-mesh sieve, and mix evenly;

[0042] 2. Mix lactose, microcrystalline cellulose, low-substituted hydroxypropyl cellulose and aspartame evenly;

[0043] 3. Pass the above two powders through a 60-mesh sieve, and after mixing evenly, add magnesium stearate and mix in a mixer for 5-10 minutes;

[0044] 4. Adjust the pressure and tablet weight of the tablet press, take the above mixed powder and perform tablet compression to obtain 1000 dispersible tablets.

[0045] In addition to using aspartame as a flavoring agent, the present invention can also use sucrose, stevioside, sodium saccharin, sucralose, edible essence and their composition.

Embodiment 2

[0046] The preparation method of embodiment 2 azithromycin dispersible tablets of the present invention

[0047] Prepare dispersible tablets according to the prescription and preparation method of Example 1, wherein the sieve mesh numbers of steps 1 and 3 and the final mixing time of step 3 refer to the following table, and the obtained dispersible tablet results are as follows:

[0048] Table 1

[0049]

[0050] From the above results, it can be seen that when the mixing time reaches 30 minutes, the hardness of the tablet drops significantly. In order to ensure the consistency of product quality, the present invention may preferably have a mixing time of 5-30 minutes.

Embodiment 3

[0051] The preferred of embodiment 3 azithromycin dispersible tablet prescription of the present invention

[0052] Due to the poor compressibility and viscosity of azithromycin itself, it is easy to cause problems such as sticking, splitting, and unqualified friability during the tableting process. This phenomenon is more serious when using the powder direct tableting process. for highlighting.

[0053] In order to obtain high-quality azithromycin dispersible tablets, the present invention screened the prescription of dispersible tablets, wherein the prescription ratio and mixing time were in accordance with Table 2, and the preparation method was referred to Example 1.

[0054] Table 2

[0055]

[0056]

[0057] Table 2 continued

[0058]

[0059]

[0060] summary:

[0061] (1) From the comparison of prescriptions 1-13, it can be seen that if micropowder silica gel is not added to the prescription, the sticking phenomenon of the dispersible tablet is more obvi...

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Abstract

The invention provides an azithromycin dispersible tablet which is a preparation prepared from the following raw materials by weight: 10-16 parts of micro-powder silicon gel, 60-120 parts of microcrystalline cellulose, 20-40 parts of low substituted hydroxy propyl cellulose, 8-15 parts of tablet lubricant and 0-50 parts of filler, wherein the filler is one or combination of more than two of lactose, pregelatinized starch, starch, dextrin, mannitol, powdered sugar and calcium carbonate. The invention further provides a preparation method and an application of the dispersible tablet. Through a great deal of experimental research on dispersible tablet recipes, an azithromycin dispersible tablet recipe applicable to the mode that powder is directly pressed into tablets is ultimately found, so that not only are phenomena of sticking, crack, uncovering and the like in the process that the azithromycin powder is directly pressed into tablets solved, but also dispersible tablets with good properties of uniform dispersion, dissolution rate and the like are obtained; and meanwhile the dispersible table ensures the stability of a main medicine, avoids degradation of the main medicine and provides safer choice for clinical medication.

Description

technical field [0001] The invention relates to azithromycin dispersible tablet and its preparation method and application. Background technique [0002] Azithromycin, a macrolide antibiotic, has unique pharmacokinetic characteristics, long biological half-life, high tissue permeability, good chemical and biological stability, broad antibacterial spectrum, small adverse reactions, and good tolerance. Clinically widely used in respiratory tract, skin soft tissue and genitourinary system infection. The dosage forms of this variety currently on the domestic market include ordinary tablets, dispersible tablets, capsules, granules, dry suspensions, etc. [0003] Due to the poor water solubility of azithromycin, the dissolution and absorption of ordinary tablets in the body are greatly affected. Dispersible tablet is a new type of quick-acting preparation developed rapidly in recent years. It can be taken directly or quickly dispersed in water for drinking. The emergence of this...

Claims

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Application Information

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IPC IPC(8): A61K9/20A61K31/7052A61K47/38A61P31/04
Inventor 沈利胡蓉鲜林崔萍扬陈俊蓉梁隆
Owner SICHUAN KELUN PHARMA CO LTD
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