Cefcapene pivoxil hydrochloride composition and preparation method thereof

A technology of cefcapene hydrochloride and composition, which is applied in the direction of pharmaceutical formulations, medical preparations containing active ingredients, sugar-coated pills, etc., and can solve problems such as unqualified dissolution rate and difficulty in disintegrating cefcapene hydrochloride tablets

Active Publication Date: 2012-11-28
CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the cefcapene hydrochloride tablets prepared according to the composition of the above auxiliary materials still have disintegration difficulties, resulting in unqualified dissolution rate

Method used

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  • Cefcapene pivoxil hydrochloride composition and preparation method thereof
  • Cefcapene pivoxil hydrochloride composition and preparation method thereof
  • Cefcapene pivoxil hydrochloride composition and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0093] Embodiment 1: Cefcapene Pixil Hydrochloride Tablets

[0094] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0095] Cefcapene pivoxil hydrochloride 137 62.3

[0096] Starch 45.6 20.7

[0097] Sucrose 13.2 6

[0098] Croscarmellose sodium 11 5

[0099] Micronized silica gel 11 5

[0100] Magnesium stearate 2.2 1

[0101] Preparation method: first crush and sieve the cefcapene pivoxil hydrochloride raw material to control the particle size to be less than 80 μm, then mix the cefcapene pixil hydrochloride with the micropowder silica gel in the prescribed amount, add the starch, sucrose, and cross-linked carboxymethyl Sodium cellulose, mixed evenly, dry granulated, after granulation, add the prescribed amount of magnesium stearate, mixed evenly, compressed into tablets, coated with film.

[0102] Determination of dissolution: in 1000ml of buffered saline solution with a pH value of 6.8, the paddle method was used to determine the speed of ro...

Embodiment 2

[0103] Embodiment 2: Cefcapene Pixil Hydrochloride Tablets

[0104] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0105] Cefcapene pivoxil hydrochloride 137 62.3

[0106] Starch 45.6 20.7

[0107] Sucrose 13.2 6

[0108] Croscarmellose sodium 11 5

[0109] Micronized silica gel 11 5

[0110] 30% ethanol solution appropriate amount

[0111] Magnesium stearate 2.2 1

[0112] Preparation method: first crush and sieve the cefcapene pivoxil hydrochloride raw material to control the particle size to be less than 80 μm, then mix the cefcapene pixil hydrochloride with the micropowder silica gel in the prescribed amount, add the starch, sucrose, and cross-linked carboxymethyl Cellulose sodium, mix well, add appropriate amount of 30% ethanol solution, wet granulate, dry at 40°C, add prescription amount of magnesium stearate, mix well, compress into tablets, and coat with film.

[0113] Determination of dissolution: in 1000ml of buffered saline solutio...

Embodiment 3

[0114] Embodiment 3: Cefcapene Pixil Hydrochloride Tablets

[0115] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0116] Cefcapene pivoxil hydrochloride 137 62.3

[0117] Starch 34.6 15.7

[0118] Sucrose 13.2 6

[0119] Sodium carboxymethyl starch 22 10

[0120] Micronized silica gel 11 5

[0121] Magnesium stearate 2.2 1

[0122] Preparation method: first crush and sieve the cefcapene pivoxil hydrochloride raw material to control the particle size to be less than 80 μm, then mix the cefcapene pivoxil hydrochloride with micropowder silica gel in the prescribed amount, add starch, sucrose, and sodium carboxymethyl starch in the prescribed amount , mixed, dry granulated, after granulated, add the prescribed amount of magnesium stearate, mixed, pressed into tablets, film-coated.

[0123] Determination of dissolution: in 1000ml of buffered saline solution with a pH value of 6.8, the paddle method was used to determine the speed of rotation at 50 r...

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Abstract

The invention relates to a cefcapene pivoxil hydrochloride composition and a preparation method thereof. The composition comprises a tablet core and a coating layer, wherein the tablet core comprises cefcapene pivoxil hydrochloride, a filler, a disintegrating agent, an antisticking agent and a lubricating agent; the particle size of the raw material of cefcapene pivoxil hydrochloride is smaller than 100 microns; the antisticking agent accounts for 2%-10% in percentage by weight of the tablet core; the filter comprises a filler such as starch and the like and soluble auxiliary materials; and the soluble auxiliary materials accounts for 1%-10% in percentage by weight of the tablet core. The prepared cefcapene pivoxil hydrochloride tablet has good disintegration, and the dissolution of the cefcapene pivoxil hydrochloride tablet reaches over 75%.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to a cefcapene hydrochloride composition and a preparation method thereof. Background technique [0002] Cefcapene pivoxil hydrochloride (cefcapene pivoxil hydrochloride), its chemical name is (6R, 7R)-7-[(Z)-2-(2-aminothiazol-4-yl)-2-pentenylamino]-3 -[(aminocarbonyl)oxy]methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (2,2-dimethyl Oxypropoxymethyl) ester hydrochloride monohydrate is an oral broad-spectrum antibiotic with valproyloxymethyl and stable to β-lactamase developed by Shionogi, Japan, in July 1997 It is listed in Japan under the trade name Flomox. It exerts antibacterial effect by blocking the synthesis of bacterial cell walls. It is mainly suitable for respiratory tract infections, otitis media, sinusitis, urinary tract infections, skin and skin tissue infections, and biliary tract infections caused by sensitive bacteria. Tablets are curren...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K31/546A61K9/28A61P31/04
Inventor 杜旭召白敏赫玉霞王蒙吴欢欢陈素锐
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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