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Preparation method of roxithromycin capsule

A technology for roxithromycin and capsules, which is applied in the field of preparation of roxithromycin capsules, can solve the problems of inability to better improve drug dissolution, low drug bioavailability, poor water solubility of roxithromycin, and the like, To achieve the effect of being conducive to safe production and environmental protection, a wide range of applicable people, and good stability

Pending Publication Date: 2021-07-30
CHINA MEHECO SANYANG PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The existing capsules are not suitable for children, the elderly and patients with dysphagia, and they have relatively large limitations. For the convenience of taking, some capsules need to be disassembled and the medicine inside should be filled with water. However, because roxithromycin belongs to large Cyclic lactone antibiotics have a very bitter taste and are difficult to take when directly pouring out the medicine inside, and roxithromycin is poorly soluble in water. The bioavailability of the drug is not high. In order to solve the problem of bitter taste and dissolution rate, the existing technology uses an organic solvent to coat the particles before filling the capsules, and then adds a flavoring agent and mixes them evenly before filling. Mask the bitter taste of the drug and improve the dissolution rate of the drug, but this method uses more excipients and cannot better improve the dissolution rate of the drug

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

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

[0028] Roxithromycin 15g;

[0029] Xanthan gum 4g;

[0030] Eudragit E100 (butyl methacrylate: dimethylaminoethyl methacrylate: methyl methacrylate 20:40:20 copolymer) 20g;

[0031] Mannitol 100g;

[0032] Talc powder 25g.

[0033] Preparation Process:

[0034] a): The raw material roxithromycin, the auxiliary materials xanthan gum, Eudragit E100, mannitol and talcum powder were respectively pulverized through a 60-mesh sieve, and set aside;

[0035] b): Eudragit E100 (butyl methacrylate: dimethylaminoethyl methacrylate: methyl methacrylate 20:40:20 copolymer) was dissolved in ethanol solution to prepare a suspension of alcohol solution, Add talcum powder to the suspension and stir continuously with a mixer at a medium speed to make a suspension for coating, and filter the suspension through a 40-mesh sieve;

[0036] c): Put roxithromycin in a fluidized bed granul...

Embodiment 2

[0040] A preparation method of roxithromycin dry suspension, made of 1000 bags of following raw materials:

[0041] Roxithromycin 15g;

[0042] Xanthan gum 4g;

[0043] No. II acrylic resin 30g;

[0044] 150g of sucrose;

[0045] Magnesium Stearate 50g.

[0046] Preparation Process:

[0047] a): the raw material roxithromycin, auxiliary materials xanthan gum, No. II acrylic resin, sucrose and magnesium stearate are respectively pulverized through a 60-mesh sieve, and set aside;

[0048] b): dissolving No. II acrylic resin in ethanol solution to prepare a suspension of alcohol solution, adding magnesium stearate to the suspension and stirring continuously at a medium speed with a mixer to make a suspension for coating, Filter the suspension through a 40 mesh sieve;

[0049] c): Put roxithromycin in a fluidized bed granulator and fully mix with sucrose, and adjust the air volume to 60m 3 / h, the air inlet temperature is 40°C, so that the roxithromycin raw material is fully ...

Embodiment 3

[0053] A preparation method of roxithromycin dry suspension, made of 1000 bags of following raw materials:

[0054] Roxithromycin 15g;

[0055] Xanthan gum 4g;

[0056] Sodium carboxymethyl cellulose 25g;

[0057] Xylitol 120g;

[0058] Glyceryl monostearate 40g.

[0059] Preparation Process:

[0060] a): the raw material roxithromycin, xanthan gum, sodium carboxymethyl cellulose, xylitol and glyceryl monostearate were respectively pulverized through a 60-mesh sieve for subsequent use;

[0061] b): Sodium carboxymethyl cellulose is dissolved in ethanol solution to prepare a suspension of alcohol solution, and glyceryl monostearate is added to the suspension and stirred continuously at a medium speed with a mixer to make it for coating Suspension, the suspension is filtered through a 40 mesh sieve;

[0062] c): Put roxithromycin in a fluidized bed granulator and fully mix it with xylitol, and adjust the air volume to 60m 3 / h, the air inlet temperature is 40°C, so that t...

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PUM

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Abstract

The invention discloses a preparation method of roxithromycin capsules. The roxithromycin capsules comprise the following components in parts by weight: 8-20 parts of roxithromycin, 2-8 parts of xanthan gum, 20-30 parts of a macromolecular adhesive, 100-150 parts of a diluent and 25-50 parts of an anti-sticking agent. The roxithromycin capsule can be directly taken or taken after the capsule is disassembled according to needs and the medicines in the capsule are taken after being flushed with water, the aqueous dispersion of the polymer adhesive is used for replacing the traditional organic solvent coating, the roxithromycin capsule with high dissolution rate and better stability is obtained, the raw material cost is saved, and the roxithromycin capsule is suitable for industrial production; the preparation method reduces the use of a coating material and an emulsifier, saves the production cost, is beneficial to safe production and environmental protection, can cover the bitter taste of the medicine, can improve the dissolution rate of the medicine, and is wider in applicable crowd range and smaller in limitation.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a preparation method of roxithromycin capsules. Background technique [0002] Roxithromycin is a macrolide antibiotic, which mainly acts on Gram-positive bacteria, anaerobic bacteria, chlamydia and mycoplasma. Its in vitro antibacterial effect is similar to that of erythromycin. The activity against Streptococcus, Haemophilus ducrei, Chlamydia trachomatis, Mycoplasma pneumoniae, oral or vaginal anaerobic bacteria is similar to that of erythromycin; the effect on Campylobacter, pertussis and Haemophilus influenzae is not as good as erythromycin; Mycobacterium tuberculosis, most atypical mycobacteria, Campylobacter jejuni, diphtheria, Pasteurella multocida also have inhibitory effect; no antibacterial activity on G bacteria. Some bacteria have cross-resistance to erythromycin and this product, and this product is particularly effective against mycoplasma, chla...

Claims

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Application Information

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IPC IPC(8): A61K9/48A61K31/7048A61K47/32A61P31/04
CPCA61K9/1635A61K31/7048A61P31/04Y02A50/30
Inventor 章世舜李文强陈晞高芳珍符惠金王宁李坤萍莫秀娟
Owner CHINA MEHECO SANYANG PHARMA CO LTD
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