A kind of roxithromycin ambroxol hydrochloride dry suspension and preparation method thereof

Abstract

The invention discloses a roxithromycin ambroxol hydrochloride dry suspension and a preparation method thereof. The preparation method comprises the following steps: placing roxithromycin in a fluidized bed by a powder coating method, and adjusting the air volume properly to fully fluidize; heating and melting a coating material, uniformly spraying the molten coating material and an emulsifier mixed solution on the surface of the fluidized roxithromycin by a spraying device under the action of compressed air to form a roxithromycin coating, adding ambroxol hydrochloride, a diluent and a bonding agent, performing top spraying and granulating through the fluidized bed, drying, adding a suspending agent and a flavoring agent, and uniformly mixing to obtain a dry suspension. By adopting the roxithromycin ambroxol hydrochloride dry suspension, unwanted flavor of the roxithromycin is masked, in-vivo absorption of medicine is not influenced, and a high dissolution rate is achieved.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, in particular to a roxithromycin ambroxol hydrochloride dry suspension and a preparation method thereof. Background technique [0002] Respiratory tract infection, chronic bronchitis and other diseases are relatively common respiratory diseases. The classic therapy is a combination of drugs, especially for children (whose physiological functions are not perfect) and the elderly (whose physiological functions have degenerated). The combination of drugs will increase the effectiveness of antibiotics. Efficacy. The compound preparation composed of the macrolide antibiotic roxithromycin and the expectorant drug ambroxol hydrochloride can effectively treat bacterial acute bronchitis, acute exacerbation of chronic bronchitis, bronchial pneumonia, and typical pathogenic pneumonia caused by sensitive microorganisms , bronchial asthma or bronchiectasis with bacterial infection, sinusitis and ot...

AI Technical Summary

Problems solved by technology

[0003] For example, Chinese patent application CN1698040A discloses a compound powder of roxithromycin and ambroxol hydrochloride that is suitable for children to take. , hydroxypropyl cellulose, xanthan gum, spices, aspartame, sucrose and other pharmaceutical excipients are made into roxithromycin ambroxol powder in the form of granules, but the powder needs a lot of warm water to dissolve the drug when taking it , which not only reduces the concentration of the drug, leading to a decrease in the bioavailability of the drug, but also makes it difficult to take

[0004] Chinese patent application CN1582954A discloses a kind of compound preparation of roxithromycin and ambroxol hydrochloride, and its specific disclosed preparation form has capsule and tablet, but the roxithromycin ambroxol of this common capsule and tablet form , the dissolution in the body after oral administration is relatively slow, and it is difficult to achieve complete dissolution, resulting in a decrease in the bioavailability of the drug, and the ideal antibacterial effect cannot be achieved

However, roxithromycin belongs to concentration-dependent antibiotics, and the antibacterial effect is closely related to the concentration of the drug. The common preparations in the prior art often affect the full absorption of the drug due to slow disintegration and dissolution, thus it is difficult to achieve a satisfactory effect. treatment effect

[0006] At present, the commonly used clinical dosage forms of oral roxithromycin ambroxol ambroxol preparations are tablets and capsules, but for infants, children and other patients who have difficulty swallowing, tablets and capsules have obvious disadvantages. disadvantages

And because the taste of this product is extremely bitter, conventional taste-masking methods such as adding sweeteners and flavoring agents cannot cover up its bitterness at all, so roxithromycin-ambroxol dry suspension or granules are widely There is a situation of poor taste, which seriously affects the compliance of patients taking medicine, so the taste-masking technology for dry suspension has always been a difficult problem in pharmacy

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