Roxithromycin and ambroxol hydrochloride dispersible tablets

A technology of roxithromycin and ambroxol, applied in the direction of organic active ingredients, medical preparations with non-active ingredients, medical preparations containing active ingredients, etc., can solve the problems of high cost, drug safety and bioavailability Influence, high excipients and other issues, to achieve the effect of convenient taking, stable inspection indicators, and small tablet weight

Inactive Publication Date: 2009-07-22
HAINAN HONZ PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

However, the proportion of its excipients is relatively high, more than 50%, which has a...

Method used

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  • Roxithromycin and ambroxol hydrochloride dispersible tablets
  • Roxithromycin and ambroxol hydrochloride dispersible tablets
  • Roxithromycin and ambroxol hydrochloride dispersible tablets

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0017] Embodiment 1: preparation example

[0018] Grind ambroxol hydrochloride and roxithromycin respectively, pass through a 100-mesh sieve, take roxithromycin 150g, ambroxol hydrochloride 30g, mix with microcrystalline cellulose 50g, crospovidone 30g, add 1% Soft material made from 80ml of hypromellose 50% ethanol solution, passed through a 16-mesh sieve, dried at 50°C for two hours, stirred from time to time, granulated with a 18-mesh sieve, added with 3g of magnesium stearate and 10g of talcum powder, mixed evenly, and measured Particle content, compressed into tablets, ready to be obtained.

Embodiment 2

[0019] Embodiment 2: comparative test result

[0020] The inventor made a batch of samples (batch number: 071001) according to the method disclosed in the invention patent of application number 200610007513.0, and carried out content, related substances, dissolution rate and stability with the sample of the present invention (method of embodiment 1, batch number: 071002). (accelerated, long-term) comparative study, the results are as follows.

[0021] 1. Comparison of content, related substances and dissolution rate: See Table 2 for the results.

[0022] Table 2 Content, related substances, dissolution comparison test results

[0023]

[0024] The test results showed that the related substances of the 071002 batch of samples were significantly less than those of the 071001 batch, and there was no significant difference in content and dissolution rate.

[0025] 2. Stability test comparison: the results are shown in Tables 3 and 4.

[0026] Table 3 Accelerated test (40°C, ...

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Abstract

The invention relates to a roxithromycin ambroxol dispersing tablet, which comprises the following components in percentage by weight: 50 to 60 percent of roxithromycin, 10 to 20 percent of ambroxol hydrochloride, 18 to 25 percent of filling agent, 10 to 15 percent of disintegrant, 0.1 to 1 percent of adhesive, and 1 to 5 percent of lubricating agent, wherein the filling agent is microcrystalline cellulose, and the disintegrant is crosslinked polyvidone. The roxithromycin ambroxol dispersing tablet has the advantages of small tablet weight, simple process, low production cost and good safety, and has better therapeutic effect when being clinically applied to upper respiratory tract infections of human bodies.

Description

technical field [0001] The invention relates to a roxithromycin-ambroxol dispersible tablet, the pharmaceutical active ingredients of which are roxithromycin and ambroxol hydrochloride, which are prepared by adding a certain proportion of pharmaceutical excipients. The preparation has a small tablet weight and low production cost. Low, clinically applied to human upper respiratory tract infection has good curative effect, and good safety. Background technique [0002] With the aging of the social population and the increasingly serious air pollution brought about by the development of modern industry, the morbidity and mortality of respiratory diseases are increasing day by day, and the incidence of respiratory diseases ranks first among many diseases in any age group. Pulmonary bacterial infection is a common and frequently-occurring disease of the respiratory system, and antibiotics are generally used for treatment. Roxithromycin is an excellent macrolide antibiotic commo...

Claims

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Application Information

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IPC IPC(8): A61K31/7048A61K31/137A61K9/20A61K47/38A61K47/34A61P31/04A61P11/00A61K47/32
Inventor 洪江游洪丽萍
Owner HAINAN HONZ PHARMA
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