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Tebipenem pivoxil granule composition as well as preparation method and application thereof

A technology of tipipenem ester and composition, which is applied in the directions of antibacterial drugs, bulk delivery, etc., can solve the problems of easy moisture absorption and degradation, poor stability of tipipenem ester particles, high allergenic impurities, etc., so as to improve the taste, Improve the safety of clinical use and the effect of scientific preparation technology

Inactive Publication Date: 2015-12-30
HAIKOU PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0015] The purpose of the present invention is to solve the problem of poor stability of tipipenem ester granules, easy moisture absorption and degradation, and high allergenic impurities, and provide a stable tipipenem by screening the types and amounts of excipients and optimizing the appropriate production process Ester Granules

Method used

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  • Tebipenem pivoxil granule composition as well as preparation method and application thereof
  • Tebipenem pivoxil granule composition as well as preparation method and application thereof
  • Tebipenem pivoxil granule composition as well as preparation method and application thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0046] prescription

[0047]

[0048] Preparation:

[0049] 1) The tipipenem ester is crushed and passed through a 100-mesh sieve, the sucrose is crushed and passed through an 80-mesh sieve, and the microcrystalline cellulose and vanillin are passed through an 80-mesh sieve;

[0050] 2) Premixing: Weigh tipipenem ester, microcrystalline cellulose, sucrose and other auxiliary materials according to the prescription amount and place them in a wet granulator for premixing for 5 minutes;

[0051] 3) Granulation: adopt the top spraying process, take the mixed material and place it in a multifunctional granulation coating machine, spray into the prescribed amount of binder, and dry until the moisture content of the granules is less than 1%;

[0052] 4) Sieve particles: collect dry particles between 50 mesh and 120 mesh sieve;

[0053] 5) Preparation of the coating solution for the isolation layer: weigh cetyl alcohol and dissolve it in ethanol, then mix it with sodium lauryl su...

Embodiment 2

[0061] prescription

[0062]

[0063]

[0064] Preparation method: prepare with reference to the method of Example 1.

Embodiment 3

[0066] prescription

[0067]

[0068] Preparation method: prepare with reference to the method of Example 1.

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Abstract

The invention provides stable tebipenem pivoxil granule composition. The composition comprises tebipenem pivoxil raw material and pharmaceutical excipients, wherein the pharmaceutical excipients comprise a filler, an adhesive and a coating solution; the coating solution comprises an insulation layer, a taste mask layer and a coloring and taste modifying layer; the filler comprises sucrose and microcrystalline cellulose, the amount of the sucrose accounts for 50%-70% of the total weight of the granule composition, and the amount of the microcrystalline cellulose accounts for 5%-15% of the total weight of the granule composition. The invention further provides a preparation method of the composition and an application of the composition in preparation of drugs with an antibacterial function.

Description

technical field [0001] The invention belongs to the technical field of medicines, and in particular relates to a preparation method and application of stable tipipenem granules. The preparation process adopts a fluidized bed granulation coating technology. Background technique [0002] Tipipenem ester is the prodrug of tipipenem, which is a new type of oral carbapenem antibiotic with high efficiency and broad spectrum for the respiratory tract and urinary tract. Its structural feature is that the side chain at the C3 position is an azetidine group substituted by thiazolyl, and at the same time, the prodrug is formed by forming a pivate ester with a carboxylic acid at the C2 position, which improves the oral absorbability. The oral absorbability of this product is better than most of the β-lactam antibiotics that are already on the market. This product was developed by Meiji Seika Co., Ltd. in Japan, and was approved by the Ministry of Health and Welfare in April 2009. It is...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/427A61K47/26A61K47/38A61P31/04
Inventor 曾袆华张志兰苏健强
Owner HAIKOU PHARMA FACTORY
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