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Cefcapene pivoxil hydrochloride composition and preparation method thereof

A technology of cefcapine hydrochloride and a composition, which can be applied in the directions of pharmaceutical formulations, medical preparations containing active ingredients, sugar-coated pills, etc., can solve the problems of unqualified dissolution rate, difficult disintegration of cefcapine hydrochloride tablets, and the like, To achieve good disintegration effect

Active Publication Date: 2013-03-27
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

[0062] Embodiment 1: Cefcapene Pixil Hydrochloride Tablets

[0063] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0064] Cefcapene pivoxil hydrochloride 137 62.3

[0065] Starch 52.2 23.7

[0066] Sucrose 17.6 8

[0067] Croscarmellose sodium 11 5

[0068] 30% ethanol solution appropriate amount

[0069] Magnesium stearate 2.2 1

[0070] 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 prescribed amount of cefcapene pixil hydrochloride, starch, sucrose, and croscarmellose sodium, and add 30% Appropriate amount of ethanol solution, wet granulation, drying at 40°C, adding the prescribed amount of magnesium stearate, mixing, tableting, film-coating.

[0071] 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 rpm. The disintegration ...

Embodiment 2

[0072] Embodiment 2: Cefcapene Pixil Hydrochloride Tablets

[0073] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0074] Cefcapene pivoxil hydrochloride 137 62.3

[0075] Starch 63.2 28.7

[0076] Sucrose 6.6 3

[0077] Sodium carboxymethyl starch 11 5

[0078] Magnesium stearate 2.2 1

[0079] Preparation method: First, crush and sieve the raw materials of cefcapene hydrochloride to control the particle size to be less than 80 μm, then mix the prescribed amount of cefcapene hydrochloride, starch, sucrose, and sodium carboxymethyl starch, dry granulate After granulation, add the prescribed amount of magnesium stearate, mix well, compress into tablets, and coat with film.

[0080] 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 rpm. The disintegration time is 8 minutes, and the dissolution rate is 75%.

Embodiment 3

[0081] Embodiment 3: Cefcapene Pixil Hydrochloride Tablets

[0082] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0083] Cefcapene pivoxil hydrochloride 137 62.3

[0084] Starch 36.7 16.7

[0085] Sucrose 33 15

[0086] Crospovidone 11 5

[0087] Magnesium stearate 2.2 1

[0088] Preparation method: First, crush and sieve the cefcapene pivoxil hydrochloride raw material to control the particle size to be less than 80 μm; After granulation, add the prescribed amount of magnesium stearate, mix well, compress into tablets, and coat with film.

[0089] 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 rpm. The disintegration time is 4 minutes, and the dissolution rate is 75%.

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Abstract

The invention relates to a cefcapene pivoxil hydrochloride composition and a preparation method thereof. The composition consists of a tablet core and a coating layer, wherein the tablet core contains cefcapene pivoxil hydrochloride, a filler, a disintegrating agent and a lubricating agent; the grain diameter of the cefcapene pivoxil hydrochloride serving as a raw material is less than 100 micrometers; and the filler consists of a starch filler and soluble auxiliary materials, and the soluble auxiliary materials are in an amount which is 3 to 15 percent of the weight of the tablet core. The prepared cefcapene pivoxil hydrochloride tablets have excellent disintegrative property and dissolution of over 75 percent.

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 杜旭召白敏赫玉霞郝卫华金晓利王蒙吴欢欢陈素锐
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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