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Medicinal composition containing cefaclor particles, and preparation method and application thereof

A technology of Cefaclor granules and Cefaclor, which is applied in the direction of pharmaceutical formulas, medical preparations containing active ingredients, antibacterial drugs, etc., can solve problems such as no reports of Cefaclor, and achieve the goal of reducing hydrolysis and thermal damage degree, good water solubility, and reduce the effect of operation links

Active Publication Date: 2013-10-16
HAIKOU PHARMA FACTORY +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

At present, there is no report on the process of granulating cefaclor by using a fluidized bed

Method used

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  • Medicinal composition containing cefaclor particles, and preparation method and application thereof
  • Medicinal composition containing cefaclor particles, and preparation method and application thereof
  • Medicinal composition containing cefaclor particles, and preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] Embodiment 1 The technique that fluidized bed of the present invention prepares cefaclor granule

[0042] (1) Cefaclor granule formula: see Table 1.

[0043] Table 1. Cefaclor Granule Formula

[0044] component name parts by weight role in preparation Cefaclor 10 Main drug sucrose 80 fillers, flavoring agents dextrin 60 filler 5% sodium carboxymethyl cellulose solution 20 Adhesive sodium citrate 10 stabilizer Solid Orange Flavor 5 Taste masking agent

[0045] (2) Preparation process:

[0046]Pass the above-mentioned raw materials and auxiliary materials through 80-mesh sieve respectively, weigh the remaining components except the adhesive according to the prescription in Table 1, place them at the bottom of the fluidized bed container, and control the air intake to 1500M 3 / hour, the inlet air temperature is controlled at 55°C, keep the mixed material for 15 minutes, raise the inlet air temperature t...

Embodiment 2

[0048] Embodiment 2 The technique that fluidized bed of the present invention prepares cefaclor granule

[0049] (1) Cefaclor granule formula: see Table 2.

[0050] Table 2. Cefaclor Granule Formula

[0051] component name parts by weight role in preparation Cefaclor 10 Main drug lactose 40 fillers, flavoring agents corn dextrin 100 filler 3% crospovidone solution 20 Adhesive Sodium acetate 10 stabilizer Solid Orange Flavor 5 Taste masking agent

[0052] (2) Preparation process:

[0053] Pass the above-mentioned raw materials and auxiliary materials through 80 mesh sieves respectively, weigh the remaining components except the binder according to the prescription in Table 2, place them at the bottom of the fluidized bed container, and control the air intake to 1000M 3 / hour, the air inlet temperature is controlled at 35°C, keep the mixed material for 15 minutes, raise the air inlet temperature to 60°C, add ...

Embodiment 3

[0055] Embodiment 3 The technique that fluidized bed of the present invention prepares cefaclor granule

[0056] (1) Cefaclor granule formula: see Table 3.

[0057] Table 3. Cefaclor Granule Formula

[0058] component name parts by weight role in preparation Cefaclor 10 Main drug Mannitol 40 fillers, flavoring agents dextrin 100 filler 5% crospovidone solution 20 Adhesive Sodium hydrogen phosphate 10 stabilizer xylitol 5 Taste masking agent

[0059] (2) Preparation process:

[0060] Pass the above-mentioned raw materials and auxiliary materials through 80-mesh sieve respectively, weigh the remaining components except the binder according to the prescription in Table 3, place them at the bottom of the fluidized bed container, and control the air intake to 1000M 3 / hour, the air inlet temperature is controlled at 40°C, keep the mixed material for 15 minutes, raise the air inlet temperature to 80°C, add the ad...

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Abstract

The invention provides a medicinal composition containing cefaclor particles, and a preparation method and an application thereof. The preparation method which adopts a fluidized bed preparation technology to prepare the medicinal composition comprises the following steps: burdening materials preprocessed by a 80 mesh sieve according to a specific formula, placing the obtained mixture in a fluidized bed granulator, and carrying out intake mixing; and rising the intake temperature, spraying an adhesive solution, and mixing and drying under a continuous intake condition to obtain cefaclor particles. The preparation method of the cefaclor particles, which is a one step granulation method, substantially shortens the production time; the whole production process is carried out in the closed environment and accords with medicinal GMP standard requirements; and the prepared cefaclor particles are porous particles having round shapes, have the characteristics of good water solubility, uniform granularity, good fluidity, uniform distribution of a cefaclor raw material in the cefaclor particles, and very good stability and in-vitro dissolution curve, and can be used for treating clinic indications.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a pharmaceutical composition of cefaclor granules, a preparation method and application thereof. Background technique [0002] Cefaclor is the second-generation oral cephalosporin created by Eli Lilly and Company of the United States. It was first listed in 1982 under the trade name "Xickrao". In 1993, its patent expired. In addition to Lilly Company of the United States and Shionogi Pharmaceutical Company of Japan, the suppliers also included ACS Dobfar Company of Italy and Ranbaxy Company of India. [0003] Cefaclor is a β-lactam antibiotic, chemical name: (6R,7R)-7-[(R)-2-amino-2-phenylacetamido]-3-chloro-8-oxo-5-sulfur Hetero-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate, molecular formula C 15 h 14 ClN 3 o 4 S·H 2 O, molecular weight is 385.82, its chemical structure formula is as follows: [0004] [0005] Cefaclor is a white to light yellow...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/545A61P31/04
Inventor 张志兰廖慧琼李青海
Owner HAIKOU PHARMA FACTORY
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