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Preparation method of fine tebipenem pivoxil granules

A technique for tipipenem ester and fine granules, which is applied in the field of preparation of tipipenem ester fine granules, can solve problems such as poor taste of the drug, instability of the sample of tipipenem ester, etc., and achieve improvement of the bad taste of the drug. Good, improve the effect of sample instability

Active Publication Date: 2019-03-08
SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] The purpose of the present invention is to provide a preparation method of tipipenem pectinate fine granules, which effectively solves the problems of unstable tipipenem pectinate samples and poor taste of medicines, etc.

Method used

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  • Preparation method of fine tebipenem pivoxil granules
  • Preparation method of fine tebipenem pivoxil granules
  • Preparation method of fine tebipenem pivoxil granules

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] The present embodiment relates to a kind of preparation method of tipipenem pectinate fine granule:

[0042] Composition of prescription components:

[0043]

[0044] Preparation:

[0045] Ⅰ. Preparation of core granules: After pulverizing the raw drug tebipenem, mix it with microcrystalline cellulose and hydroxypropyl cellulose in a high-shear mixing granulator, and adjust the process parameters of the granulator: mixing speed 3r / s, shearing speed 25r / s, after stirring evenly, add pure water to make wet soft material, mix and make soft material for 20min, pass through 40 mesh sieve for granulation, after drying, pass through 40 mesh sieve for granulation, pass through 120 mesh Sieve out fine powder and collect 40-120 mesh particles;

[0046]Ⅱ. Pack isolation coat: preparation of isolation layer coating solution: swell hypromellose in pure water, add talcum powder, make up pure water, stir evenly for later use; put the collected particles in a multifunctional flui...

Embodiment 2

[0050] The present embodiment relates to a kind of preparation method of tipipenem pectinate fine granule:

[0051] Composition of prescription components:

[0052]

[0053] Preparation:

[0054] Ⅰ. Preparation of core granules: After pulverizing the raw drug tebipenem, mix it with microcrystalline cellulose and hydroxypropyl cellulose in a high-shear mixing granulator, and adjust the process parameters of the granulator: mixing speed 5r / s, the shear speed is 30r / s, after stirring evenly, add pure water to make wet soft material, mix the soft material for 10min, pass through a 40 mesh sieve to granulate, after drying, pass through a 40 mesh sieve for granulation, and pass through a 120 mesh sieve Sieve out fine powder and collect 40-120 mesh particles;

[0055] Ⅱ. Pack isolation coat: preparation of isolation layer coating solution: swell hypromellose in pure water, add talcum powder, make up pure water, stir evenly for later use; put the collected particles in a multifu...

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Abstract

The invention relates to a preparation method of fine tebipenem pivoxil granules. Each fine tebipenem pivoxil granule comprises four parts as follows: a core granule, an isolation coat, a taste masking coat and a coloring and corrigent layer, wherein the core granule is prepared with a high shear mixed granulator, the isolation coat and the taste masking coat are prepared with a fluidized bed cutting and spraying technology, after the coloring and corrigent layer, a taste masking granule, a corrigent, a colorant and flavor are added, the granule is prepared with the high shear mixed granulator; the obtained granules are uniform in size, drug dissolution can be guaranteed, drug stability is improved, further, bad smell of the drug can be masked, and the granules are suitable for children; the adopted preparation process is simple, continuous proceeding of the process can be guaranteed, and the method can be applied to mass production.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a preparation method of tipipenem pectinate fine granules. Background technique [0002] Tipipenem was originally developed in Japan by Leaderle of Wyeth Pharmaceuticals. Tipipenem was developed by Meiji Corporation of Japan. It was approved by the Ministry of Health and Welfare of Japan in April 2009 and was first listed in Japan in August 2009. ,Product name (Orapene ). [0003] Generic name: tipipenem axetil fine granule [0004] English name: Tebipenempivoxil granules [0005] Chemical name: (+)-Hydroxymethyl(4R,5S,6S)-6-[(1R)-1-Hydroxyethyl]-4-methyl-7-oxo-3{[1-(2- Thiazolin-2-yl)-3-azetidinyl]thio}-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylate, 2-pivalate [0006] The chemical structural formula is: [0007] [0008] Molecular formula: C 22 h 31 N 3 o 6 S 2 [0009] Molecular weight: 497.63 [0010] Tipipenem ester is the prodrug of tipipenem. After...

Claims

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Application Information

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IPC IPC(8): A61K9/50A61K47/38A61K31/427A61P31/04A61P11/00A61P11/02A61P27/16
CPCA61K9/5042A61K9/5047A61K31/427A61P11/00A61P11/02A61P27/16A61P31/04
Inventor 张菊红祝美华孙慧娟王丽丽汤漩陈建英刘正平李大伟张建强
Owner SHANDONG ACADEMY OF PHARMACEUTICAL SCIENCES
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