Cefcapene pivoxil hydrochloride composition and preparation method thereof

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

Active Publication Date: 2013-01-09
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

[0063] Embodiment 1: Cefcapene Pixil Hydrochloride Tablets

[0064] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0065] Cefcapene pivoxil hydrochloride 137 62.3

[0066] Starch 58.8 26.7

[0067] Croscarmellose sodium 11 5

[0068] Micronized silica gel 11 5

[0069] 30% ethanol solution appropriate amount

[0070] Magnesium stearate 2.2 1

[0071] 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 axetil hydrochloride with micropowder silica gel, add the prescribed amount of starch, cross-linked carboxymethyl cellulose Sodium, mix evenly, add appropriate amount of 30% ethanol solution, wet granulate, dry at 40°C, add prescription amount of magnesium stearate, mix evenly, compress into tablets, and coat with film.

[0072] Determination of dissolution: in 1000ml of buffered saline solution with a pH value o...

Embodiment 2

[0073] Embodiment 2: Cefcapene Pixil Hydrochloride Tablets

[0074] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0075] Cefcapene pivoxil hydrochloride 137 62.3

[0076] Starch 58.8 26.7

[0077] Sodium carboxymethyl starch 11 5

[0078] Micronized silica gel 11 5

[0079] 3% Hydroxypropyl Cellulose Appropriate amount

[0080] Talc 2.2 1

[0081] 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 the micropowder silica gel in the prescribed amount, add the starch and sodium carboxymethyl starch in the prescribed amount, mix Mix evenly, add appropriate amount of 3% hydroxypropyl cellulose, wet granulate, dry at 40°C, add prescription amount of talcum powder, mix evenly, compress into tablets, and coat with film.

[0082] Determination of dissolution: in 1000ml of buffered saline solution with a pH value...

Embodiment 3

[0083] Embodiment 3: Cefcapene Pixil Hydrochloride Tablets

[0084] Prescription composition (1000 tablets) weight (g) weight percentage (%)

[0085] Cefcapene pivoxil hydrochloride 137 62.3

[0086] Starch 58.8 26.7

[0087] Carboxymethylcellulose calcium 11 5

[0088] Sodium stearyl fumarate 11 5

[0089] Talc 2.2 1

[0090] Preparation method: First, crush and sieve the raw material of cefcapene axetil hydrochloride to control the particle size to be less than 80 μm, then mix the prescribed amount of cefcapene axetil hydrochloride and sodium stearyl fumarate, add the prescribed amount of starch, carboxymethyl The cellulose calcium is mixed evenly and dry granulated. After granulation, the prescribed amount of talcum powder is added, mixed evenly, compressed into tablets, and film-coated.

[0091] 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 disin...

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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, an antisticking 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 antisticking agent is 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 杜旭召白敏赫玉霞何晓燕王蒙吴欢欢陈素锐吕健
Owner CSPC ZHONGQI PHARM TECH (SHIJIAZHUANG) CO LTD
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