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Cefradine dispersible tablet and preparation method thereof

A technology for cefradine and dispersible tablets, applied in the field of cefradine dispersible tablets and their preparation, can solve the problems of easy generation of degraded impurities, slow growth and reduction of degraded impurities and the like

Active Publication Date: 2021-07-09
HEBEI MEDICAL UNIVERSITY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to solve problems such as poor stability of cephradine dispersible tablets in storage, easy to produce degradation impurities, by controlling the weight ratio of mannitol, taurine, guar gum in the prescription, can effectively reduce the paracephalexin in the preparation , 7-aminodesacetoxycephalosporanic acid, cephradine polymer and other specific degraded impurities, and can keep the specific degraded impurities growing slowly after the drug is placed for a long time, which is conducive to the long-term stability of the preparation, thus ensuring the safety of the drug

Method used

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  • Cefradine dispersible tablet and preparation method thereof
  • Cefradine dispersible tablet and preparation method thereof
  • Cefradine dispersible tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0054] Embodiment 1: Cephradine dispersible tablet

[0055] 1. Prescription composition:

[0056]

[0057] Feed intake by the prescription quantity of 1000, prepare cephradine dispersible tablet, the same below

[0058] 2. Preparation method:

[0059] (1) Preparation of binder solution: the binder guar gum is dissolved in water to prepare a guar gum solution with a concentration of 5.0% (w / w);

[0060] (2) Premixing and wet granulation: first add cephradine, mannitol, sodium starch glycolate, and taurine into a wet mixing granulator for premixing, then add the binder solution under stirring conditions, and wet granulate grain;

[0061] (3) Drying: Use a fluidized granulator to dry the wet granules, adopt low-temperature drying technology, set the inlet air temperature to 45°C, the outlet air temperature to 38°C, and the material temperature to 41°C. Take samples to measure the moisture, and the moisture reaches 1.2 %, after drying, the drying time is about 35 minutes; ...

Embodiment 2

[0069] Embodiment 2: Cephradine dispersible tablet

[0070] 1. Prescription composition:

[0071]

[0072] 2, preparation method: with embodiment 1.

[0073] 3. Test results:

[0074] The prepared cephradine dispersible tablets were tested for friability, uniformity of dispersion and dissolution, and the results are shown in table 3.

[0075] Table 3: Embodiment 2 Cephradine Dispersible Tablets carry out friability, uniformity of dispersion, and dissolution results

[0076]

Embodiment 3

[0077] Embodiment 3: Cephradine dispersible tablet

[0078] 1. Prescription composition:

[0079]

[0080] 2, preparation method: with embodiment 1.

[0081] 3. Test results:

[0082] The prepared cephradine dispersible tablets were tested for friability, uniformity of dispersion and dissolution, and the results are shown in table 43.

[0083] Table 4: Embodiment 3 Cephradine Dispersible Tablets carry out friability, uniformity of dispersion, and dissolution results

[0084]

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Abstract

The invention provides a cefradine dispersible tablet and a preparation method thereof. The cefradine dispersible tablet contains the following components in parts by weight: 250 parts of cefradine, 37-41 parts of mannitol, 8-12 parts of carboxymethyl starch sodium, 8 parts of taurine, 5 parts of guar gum, 8-12 parts of microcrystalline cellulose, 22-28 parts of carboxymethyl starch sodium and 2 parts of magnesium stearate. After 6 months of accelerated stability test, the specific impurity content, the friability and the dissolution rate of the prepared cefaridine dispersible tablet all meet the standards, and the treatment effect of the medicine in the storage period is ensured.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cephradine dispersible tablet and a preparation method thereof. Background technique [0002] Cephradine chemical name: (6R,7R)-7-[(R)-2-amino-2-(1,4-cyclohexadien-1-yl)acetamido]-3-methyl-8-oxo -5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid, molecular formula: C16H19N3O4S, molecular weight: 349.40. Its structural formula is: [0003] [0004] Cephradine is a β-lactam antibiotic, which is used for acute pharyngitis, tonsillitis, otitis media, bronchitis and pneumonia and other respiratory infections, urogenital tract infections and skin and soft tissue infections caused by sensitive bacteria; cephradine is widely used in the market, but its chemical The property is unstable, and there are problems such as high impurities and easy hydrolysis during storage, which not only affects the quality of the product, but also brings safety hazards to clinical applic...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/38A61K47/10A61K47/18A61K47/36A61K31/545A61P31/04A61P11/04A61P27/16A61P11/00A61P13/00A61P15/00A61P17/00
CPCA61K9/2018A61K9/2013A61K9/205A61K31/545A61K9/2054A61K9/2059A61P31/04A61P11/04A61P27/16A61P11/00A61P13/00A61P15/00A61P17/00Y02A50/30
Inventor 律涛刘彦李程杨少坤薛忠王嫚张静岩
Owner HEBEI MEDICAL UNIVERSITY
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