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Oral disintegrating tablet using roxithromycin and ambroxol hydrochloride as active component and its preparing method and use

A technology of ambroxol hydrochloride and orally disintegrating tablets, which is applied in the direction of organic active ingredients, medical preparations containing active ingredients, and pharmaceutical formulas, and can solve the problems of low bioavailability, slow dissolution, and low solubility of roxithromycin, etc. question

Inactive Publication Date: 2007-04-11
BEIJING RUNDEKANG MEDICAL TECH CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

but common preparations
Roxithromycin has extremely low solubility in water and is almost insoluble in water, so common dosage forms tend to suffer from slow dissolution and low bioavailability

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0024] prescription:

[0025] Roxithromycin 50g

[0026] Ambroxol Hydrochloride 15g

[0027] 15g pregelatinized starch

[0028] Mannitol 20g

[0029] Guar Gum 32g

[0030] Gum Arabic 48g

[0031] Xylitol 30g

[0032] Microcrystalline Cellulose 15g

[0033] Lemon essence 2g

[0034] A total of 1000 pieces were made

[0035] Preparation:

[0036] Add roxithromycin and ambroxol hydrochloride to the mixture of guar gum and gum arabic, stir evenly, then add mannitol, pregelatinized starch, xylitol, microcrystalline cellulose, and lemon flavor, add as you go After being stirred to form a uniform suspension, it is poured into a suitable mold, freeze-dried, sealed and packaged. .

Embodiment 2

[0038] prescription:

[0039] Component dosage

[0040] Roxithromycin 50g

[0041] Ambroxol Hydrochloride 15g

[0042] PEG6000 130g

[0043] L-HPC 6g

[0044] PPVP 24g

[0045] Lactose 40g

[0046] Mannitol 50g

[0047] Protein sugar 8g

[0048]Micronized silica gel 20g

[0049] Peach Flavor 4g

[0050] Preparation:

[0051] Pass roxithromycin and ambroxol hydrochloride through 80-mesh sieve respectively, mix them evenly, add them into the melted PEG6000, stir evenly, cool the eutectic rapidly, pulverize, and screen fine particles between 40-80 meshes, It is reserved, and other auxiliary materials such as mannitol are mixed evenly with it, and the powder is directly pressed into tablets for tableting.

Embodiment 3

[0053] prescription:

[0054] Component Dosage

[0055] Roxithromycin 75g

[0056] Ambroxol Hydrochloride 15g

[0057] Eudragit EPO 90g

[0058] PPVP 16g

[0059] L-HPC 6g

[0060] Microcrystalline Cellulose 120g

[0061] Menthol 4g

[0062] Sweet Orange Powder Flavor 4g

[0063] Micronized silica gel 2g

[0064] Anhydrous ethanol amount

[0065] A total of 1000 pieces were made

[0066] Preparation:

[0067] Dissolve Eudragit EPO in absolute ethanol, add roxithromycin and ambroxol to suspend evenly, dry under reduced pressure, pulverize, and sieve 40-80 mesh particles for future use (yield is about 90%); take another microcrystal Cellulose, etc. pass through 80-mesh sieve respectively, after mixing evenly, add the above granules, dry granulate, crush, granulate, add disintegrants PPVP, L-HPC and glidant micro-powder silica gel, mix evenly and then compress into tablets. .

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PUM

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Abstract

The invention relates to an orally disintegrating tablet comprising roxithromycin id and ambroxol hydrochloride as active ingredients and its preparation method and uses. Said invention is a medical compound resulting from mixing roxithromycin id and ambroxol hydrochloride as active ingredients and auxiliary material acceptable by pharmacology and for treatment of infection of the upper respiratory tract. Said invention provides means for covering bitter from roxithromycin id and ambroxol hydrochloride and preparation method for orally disintegrating tablets of said medical compound.

Description

technical field [0001] The invention relates to an orally disintegrating tablet with roxithromycin and ambroxol hydrochloride as active components, a preparation method and application thereof, and belongs to the technical field of medicine. Background technique [0002] Roxithromycin is a new generation of macrolide antibiotics, mainly acting on Gram-positive bacteria, anaerobic bacteria, chlamydia and mycoplasma. Its in vitro antibacterial effect is similar to that of erythromycin, and its activity against streptococcus, Haemophilus ducrei, Chlamydia trachomatis, Mycoplasma pneumoniae, oral or vaginal anaerobic bacteria is similar to that of erythromycin; The effect of Haemobacter is not as good as that of erythromycins; it also has inhibitory effect on Mycobacterium tuberculosis, most atypical mycobacteria, Campylobacter jejuni, diphtheria bacilli, and Pasteurella multocida; it has no antibacterial activity on G bacteria. Some bacteria have cross-resistance to erythromyc...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/7048A61K9/20A61P31/04A61K31/137
Inventor 路洪书
Owner BEIJING RUNDEKANG MEDICAL TECH CO LTD
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