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Roxithromycin dispersible tablets and preparation method thereof

A technology of roxithromycin and dispersible tablets, which is applied in the directions of non-active ingredients medical preparations, medical preparations containing active ingredients, and pharmaceutical formulas, etc. The improvement of the taste of the dispersion solution and the quality stability during the validity period can reduce the risk of destroying the colloid space, the production process is simple and feasible, and the curing and drying time can be shortened.

Active Publication Date: 2020-12-29
DISHA PHARMA GRP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The experiment found that in the development process of roxithromycin dispersible tablet preparations, there are the following key problems: improving the solubility of roxithromycin; improving the dispersion uniformity of the preparation within the validity period and the stability of the in vitro dissolution behavior, ensuring bioavailability ;Improve the taste and improve the clinical compliance of infants and young children;Prolong the dispersion uniformity and decrease the dissolution rate during storage
[0005] Chinese patent CN104739792 discloses a method for preparing roxithromycin dispersible tablets. Roxithromycin is first co-developed with some auxiliary materials to improve the hydrophilicity of the drug and reduce the contact angle, and then wet granulate to prepare roxithromycin dispersible tablets. Tablets, quickly and evenly dispersed in water, which is helpful for the effective absorption of the human body after taking, but there are no problems related to the improvement of the taste of the dispersion solution and the quality stability within the validity period
[0006] Chinese patent CN105919960 discloses a roxithromycin dispersible tablet and a preparation method thereof. Roxithromycin, hydrophilic filler lactose monohydrate, mannitol, superdisintegrating agent and other auxiliary materials are screened out to form a certain proportion of the prescription, and the wet method is prepared. Roxithromycin dispersible tablets, prepared into roxithromycin dispersible tablets, effectively solve the problem of roxithromycin dispersible tablets with good dispersion uniformity, high dissolution rate, and stable quality and the preparation method, and the degree of improvement in taste has also not been submitted
[0007] Chinese patent CN103977016 discloses a compound roxithromycin dispersible tablet and a preparation method thereof. Roxithromycin and auxiliary materials are wet granulated, sieved, and then the granules are coated to mask the taste and then pressed into tablets. Although the dispersion of the tablet is solved Uniformity and taste, but the preparation process is complicated, the particle size control of intermediate products is strict, and the production cost is high
[0008] The currently marketed dispersible tablet preparations are used to improve the solubility and taste of active substances. The most common method is to add surfactant to improve solubility and add flavoring agents to improve taste. However, surfactants have certain toxicity and should be used with caution. ; In addition, high-precision equipment is used to prepare microcapsules, liposomes, solid dispersions and other technologies to improve solubility and taste, but the production process is complicated and the cost is high. During the stable storage process, the key points such as dispersion uniformity and dissolution rate Indicators are easily affected by environmental factors and change in the direction that is not conducive to product quality

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0031] Embodiment 1: prescription:

[0032] .

[0033] Prepare 1000 tablets according to the preparation method described in the technical scheme of the specification.

Embodiment 2

[0034] Embodiment 2: prescription:

[0035] .

[0036] Prepare 1000 tablets according to the preparation method described in the technical scheme of the specification.

Embodiment 3

[0037] Embodiment 3: prescription:

[0038] .

[0039] Prepare 1000 tablets according to the preparation method described in the technical scheme of the specification.

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PUM

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Abstract

The invention relates to roxithromycin dispersible tablets and a preparation method thereof, and belongs to the technical field of medicinal preparations. Roxithromycin dispersible tablets contain 8%-12% of carboxymethyl starch sodium and other pharmaceutic adjuvants; carboxymethyl starch sodium transparent semisolid colloid with the mass percent of 8%-12% is prepared; roxithromycin and 95% of ethyl alcohol are prepared into a roxithromycin ethyl alcohol solution with the mass percent of 50%-80%; and the roxithromycin ethyl alcohol solution and the carboxymethyl starch sodium transparent semisolid colloid are mixed evenly and then mixed with other adjuvants, granulated and tabletted. According to the roxithromycin dispersible tablets provided by the invention, the solubility of roxithromycin in water is effectively improved, the dissolution rate of a preparation of roxithromycin in water is increased, and the taste is improved.

Description

technical field [0001] The invention relates to a roxithromycin dispersible tablet and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. Background technique [0002] Roxithromycin is a new generation of macrolide antibiotics. Its mechanism of action is the same as that of erythromycin. It mainly binds to the bacterial 50S ribosomal subunit and inhibits bacterial transpeptidation and mRNA translocation. Protein synthesis, which plays an antibacterial role. In clinical application, the absorption rate of roxithromycin is not affected by age, with few adverse reactions and low toxicity. It is suitable for children to take when they have a cold and fever, and the elderly do not need to adjust the dose when using this product, which has high safety. [0003] Roxithromycin is a white or off-white crystalline powder, odorless, bitter in taste, and almost insoluble in water; the dosage forms that have been marketed in China are: tablets...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/36A61K47/38A61K31/7048A61P31/04
CPCA61K9/2059A61K9/2095A61K9/2054A61K31/7048A61P31/04
Inventor 李林波张辉李小霞张愉
Owner DISHA PHARMA GRP
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