Tablet capsule with roxithromycin tablets and ambroxol hydrochloride tablets

Abstract

The invention relates to an oral hard capsule, in particular to a tablet capsule with roxithromycin tablets and ambroxol hydrochloride tablets. The tablet capsule consists of a capsule and tablets in the capsule, wherein the capsule comprises an upper capsule body and a lower capsule body, and at least one tablet of which the active ingredient is roxithromycin and at least one tablet of which the active ingredient is ambroxol hydrochloride are filled in the capsule. Because the active ingredients in the capsule do not contact, chemical changes cannot be generated between the ingredients, side products cannot be generated, and the stability of the product is improved, degradation products generated after the roxithromycin and the ambroxol hydrochloride contact are reduced particularly. In addition, the designs of cylindrical tablets and different colors and the application of transparent capsule shells are adopted, and the product of the invention is particularly suitable for industrial production, thereby the compliance of patients is enhanced. Meanwhile, the active ingredients are respectively tabletted, thus the drug assay and the quality control are easier.

Description

technical field [0001] The invention relates to an oral hard capsule, in particular to a tablet capsule filled with roxithromycin tablets and ambroxol hydrochloride tablets. Background technique [0002] Roxithromycin combined with ambroxol hydrochloride tablets in the treatment of bacterial acute bronchitis, acute exacerbation of chronic bronchitis, bronchopneumonia, typical pathogen pneumonia, bronchial asthma or bronchiectasis with bacterial infection caused by roxithromycin-sensitive microorganisms Wait. [0003] Roxithromycin is used for infections caused by sensitive strains, especially upper and lower respiratory tract infections, ear, nose and throat infections, genitals (except gonococcal infections) and skin infections. [0004] Ambroxol Hydrochloride, whose chemical name is trans-4-[(2-amino 3.5-dibromobenzyl) amino] cyclohexanol hydrochloride, is a viscose used clinically in the early 1980s. Phlegm-dissolving medicine, which has low toxicity and strong effect o...

AI Technical Summary

Problems solved by technology

[0008] However, the two active ingredients of roxithromycin and ambroxol hydrochloride in the same minimum preparation unit will produce many potential safety hazards

If the active ingredients are in contact with each other, there are still the following disadvantages: 1. Due to the influence of multi-component mixing uniformity, it is difficult to quantify each component accurately; 2. During product testing, it is difficult to determine the content of each component due to mutual interference, which affects the qualitative and quantitative analysis results; 3. During long-term storage, due to possible chemical compatibility changes among the components, by-products are likely to be produced, reducing the effect or increasing side effects, and the product stability is not ideal

Due to the existence of the above defects, although there are many advantages in the existing compound dosage form containing roxithromycin, it may still cause adverse effects on product quality and human health

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