Tebipenem pivoxil granule and preparation method thereof

A technology of tipipenem ester and granules, which is applied in the field of medicine and its preparation, can solve the problems of highly allergenic substances, affecting product quality and curative effect, poor stability of tipipenem ester, etc., so as to facilitate dissolution and absorption, and improve packaging Coating efficiency, the effect of improving coating quality
CN105963261AInactive Publication Date: 2016-09-28HENAN QUANYU PHARMA CO LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
HENAN QUANYU PHARMA CO LTD
Publication Date
2016-09-28
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides a tipipenem pectin granule and a preparation method thereof, and relates to the technical field of medicine and its preparation. A tipipenem granule, comprising the following raw materials in parts by weight: 600 to 700 parts of tipipenem, 3500 to 4500 parts of diluent, 40 to 50 parts of hydroxypropyl cellulose, and 455 to 470 parts of coating agent I 380-400 parts of coating agent II, the coating agent I is composed of ethyl cellulose suspension and talcum powder at a weight ratio of 10-20:1, the coating agent II is composed of gastric-soluble acrylic resin, Talc powder, hydroxypropyl methylcellulose and aspartame are composed in a weight ratio of 25-40:1-3:1:1.5-2.5. The tipipenem ester granule of the present invention uses tipipenem ester as the main drug, strictly screens and controls the ingredients of the excipients, optimizes the proportion, has stable drug efficacy under high temperature and high humidity environment, safe quality, high dissolution rate and excellent process. Easy to control and suitable for industrial production.
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Description

Technical field

[0001] The invention relates to the technical field of medicines and their preparation, in particular to a granule of tipipenem ester and a preparation method thereof. Background technique

[0002] Tippenem ester ( Tebipenempivoxil ) Is a new broad-spectrum antibiotic of oral penem. It was originally researched and developed by Wyeth Rieter Co., Ltd., and then transferred to Meiji Confectionery Pharmaceutical Co., Ltd. in Japan in March 2002. It was approved by the Ministry of Health and Welfare in Japan in April 2009. It was first launched in Japan on 26th. Tippenem ester, chemical name is (1R, 5S, 6S)-6-[1(R)-hydroxyethyl]-1-methyl-2-[1-(2-thiazolin-2-yl) Azetidine-3-ylthio]-1-carbapenem-2-ene-3-carboxylic acid pivaloyloxymethyl ester, its chemical structure is: , The molecular formula is: C 22 H 31 N 3 O 6 S 2 .

[0003] The structural feature of Tippenem Ester is that the C3 side chain is a thiazolyl substituted azetidinyl group, and the prodrug is formed by ...

Claims

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