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Composition containing roxithromycin and ambroxol and preparation method thereof

A technology of roxithromycin and its composition, which is applied in the field of the composition containing roxithromycin and ambroxol hydrochloride and its preparation, can solve the problems of increased production costs, achieve quality control, solve the problem of heavy bitterness, and benefit The effect of controlling costs

Inactive Publication Date: 2010-09-01
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Application No. 200610140552.9 discloses an orally disintegrating tablet of roxithromycin and ambroxol hydrochloride. The auxiliary materials used include synthetic polymer materials, which increases the production cost

Method used

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  • Composition containing roxithromycin and ambroxol and preparation method thereof
  • Composition containing roxithromycin and ambroxol and preparation method thereof
  • Composition containing roxithromycin and ambroxol and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0026] Roxithromycin 5g Ambroxol hydrochloride 1g Sodium citrate 30g

[0027] Sodium cyclamate 2g sucrose 110g starch 30g

[0028] Sodium glutamate 0.5g Hypromellose (made into 10% water concentration) 5g

[0029] The preparation steps are as follows:

[0030] (1) Ambroxol hydrochloride, roxithromycin and each adjuvant are pulverized respectively through an 80 mesh sieve for subsequent use;

[0031] (2) Roxithromycin is fully mixed with sodium citrate, sodium glutamate, sodium cyclamate, sucrose and starch in a composition amount of 1 / 4, and the hypromellose solution with a concentration of 10% is added to granulate , dried at 50°C, granulated through a 14-mesh sieve;

[0032] (3) Ambroxol hydrochloride and the sucrose of the remaining 3 / 4 composition amount are fully mixed evenly, and the hypromellose solution with a concentration of 10% is added to granulate, dried at 50° C., and granulated through a 14-mesh sieve;

[0033] (4) Mix the granules obtained in (2) with the g...

Embodiment 2

[0041] Roxithromycin 5g Ambroxol hydrochloride 1g Sodium citrate 50g

[0042] Aspartam 6g sucrose 110g starch 20g

[0043] Sodium Glutamate 1g Povidone K 30 (make 10% concentration with 50% ethanol solution) 15g

[0044] The preparation steps are as follows:

[0045] (1) Ambroxol hydrochloride, roxithromycin and each adjuvant are pulverized respectively through an 80 mesh sieve for subsequent use;

[0046] (2) Roxithromycin is fully mixed with sodium citrate, sodium glutamate, aspartame, sucrose and starch of 30% composition amount, and adding concentration is 10% povidone K 30 Granulate with ethanol solution, dry at 60°C, pass through a 18-mesh sieve for granulation;

[0047] (3) Ambroxol hydrochloride and the sucrose of the remaining 70% composition amount are fully mixed, and adding concentration is 10% povidone K 30 Granulate with ethanol solution, dry at 60°C, pass through a 18-mesh sieve for granulation;

[0048] (4) Mix the granules obtained in (2) with the granul...

Embodiment 3

[0053] Roxithromycin 5g Ambroxol hydrochloride 1g Sodium citrate 30g

[0054] Sodium cyclamate 10g Sucrose 110g Povidone K 30 (prepared with 75% ethanol solution

[0055] into 5% concentration) 5g

[0056] The preparation steps are as follows:

[0057] (1) Ambroxol hydrochloride, roxithromycin and each auxiliary material are pulverized respectively through 80 sieves for subsequent use;

[0058](2) Roxithromycin is fully mixed with sodium citrate, sodium cyclamic acid, 50% composition amount of sucrose, adding concentration is 5% povidone K 30 Granulate with ethanol solution, dry at 60°C, pass through a 18-mesh sieve for granulation;

[0059] (3) ambroxol hydrochloride and the sucrose of the remaining 50% composition amount are fully mixed, and the addition concentration is 5% povidone K 30 Granulate with ethanol solution, dry at 60°C, pass through a 18-mesh sieve for granulation;

[0060] (4) Mix the granules obtained in (2) with the granules obtained in (3) evenly, and ...

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Abstract

The invention discloses a composition containing roxithromycin and ambroxol and a preparation method thereof. The composition consists of roxithromycin and ambroxolhydrochloride which serve as active ingredients, a flavoring agent and an adhesive, and is made into particles. In preparation, the roxithromycin and the ambroxolhydrochloride are made into particles respectively and then the particles are mixed. In the invention, due to the special composition formula and the separate particle making method, the strong bitter tastes of the roxithromycin and the ambroxolhydrochloride are relieved, the stability of the particles are improved, and the composite is suitable for patients having difficulties in swallowing, particularly children.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a composition containing roxithromycin and ambroxol hydrochloride and a preparation method thereof. Background technique [0002] Roxithromycin is a macrolide antibiotic, which is widely used clinically for upper respiratory tract infection and skin and soft tissue infection caused by sensitive bacteria, especially for respiratory tract infection. Twice), the gastrointestinal side effects are small, and are very popular among patients. The efficacy of roxithromycin is closely related to its drug concentration, and it is a concentration-dependent antibiotic. However, the solubility of roxithromycin in water is very small, and its dissolution rate in preparations directly affects its clinical efficacy. In addition, roxithromycin has a very bitter taste, and patients, especially children, have poor compliance when it is taken orally, which greatly affects its clinical application. [0003]...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K31/137A61K47/26A61K47/16A61P31/00A61P11/10
Inventor 洪江游洪丽萍陈云飞王稳奇
Owner HAINAN HONZ PHARMA
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