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

A technology of ambroxol hydrochloride and roxithromycin, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc., can solve the problem of bitter taste, difficulty in taking, and inability to obtain antibacterial effects And other issues

Active Publication Date: 2019-09-06
SHANDONG YUXIN PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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

Method used

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

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Experimental program
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Effect test

Embodiment 1

[0027] A kind of roxithromycin ambroxol dry suspension, made of 1000 bags of following raw materials:

[0028]

[0029] Preparation Process:

[0030] a) The raw and auxiliary materials are respectively pulverized and passed through an 80-mesh sieve, and set aside;

[0031] b) take the coating material of prescription quantity as stearic acid and polyvinylpyrrolidone K30 as dissolution modifier and mix uniformly, heating and melting;

[0032] c) in the fluidized bed, adjust a suitable air volume to fully fluidize the roxithromycin raw material;

[0033] d) In the fluidized bed, adjust a suitable temperature, under the action of compressed air, the insoluble material is formed into atomized droplets, which are slowly sprayed on the surface of the fully fluidized roxithromycin raw material, so that it is evenly coated to obtain Roxithromycin-coated clothing;

[0034] e) Mix the roxithromycin coating material obtained in step d) with ambroxol hydrochloride, xanthan gum, and ...

Embodiment 2

[0036] A kind of roxithromycin ambroxol dry suspension, made of 1000 bags of following raw materials:

[0037]

[0038]

[0039] Preparation Process:

[0040] a) The raw and auxiliary materials are respectively pulverized and passed through an 80-mesh sieve, and set aside;

[0041] b) take the coating material of prescription quantity as glyceryl monostearate and sucrose stearate as dissolution modifier and mix uniformly, heating and melting;

[0042] c) in the fluidized bed, adjust a suitable air volume to fully fluidize the roxithromycin raw material;

[0043] d) In the fluidized bed, adjust a suitable temperature, under the action of compressed air, the insoluble material is formed into atomized droplets, which are slowly sprayed on the surface of the fully fluidized roxithromycin raw material, so that it is evenly coated to obtain Roxithromycin-coated clothing;

[0044] e) Mix the roxithromycin coating material obtained in step d) with ambroxol hydrochloride, xant...

Embodiment 3

[0046] A kind of roxithromycin ambroxol dry suspension, made of 1000 bags of following raw materials:

[0047]

[0048] Preparation Process:

[0049] a) The raw and auxiliary materials are respectively pulverized and passed through an 80-mesh sieve, and set aside;

[0050] b) Take the coating material of prescription quantity as glyceryl behenate and sucrose palmitate as dissolution modifier and mix evenly, heat and melt;

[0051] c) in the fluidized bed, adjust a suitable air volume to fully fluidize the roxithromycin raw material;

[0052] d) In the fluidized bed, adjust a suitable temperature, under the action of compressed air, the insoluble material is formed into atomized droplets, which are slowly sprayed on the surface of the fully fluidized roxithromycin raw material, so that it is evenly coated to obtain Roxithromycin-coated clothing;

[0053] e) the roxithromycin coating obtained in step d) is mixed evenly with ambroxol hydrochloride, xanthan gum, sorbitol, and ...

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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...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/50A61K31/7048A61K31/137A61K47/38A61K47/14A61K47/12A61K47/32A61K47/26A61P31/04A61P11/10A61P11/02A61P11/06A61P27/16
Inventor 王军高庶卿刘怀斌
Owner SHANDONG YUXIN PHARMA CO LTD
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