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Tebipenem pivoxil preparation and preparation method thereof

A technology of tipipenem ester and preparation, which is applied in the field of tipipenem ester preparation and its preparation, can solve the problems of not being listed in the domestic market, and achieve the effects of high mechanical strength, less water absorption, and reduced pharmaceutical cost

Inactive Publication Date: 2016-10-12
ZHENGZHOU MINGZE MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Currently, the drug is not marketed in China

Method used

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  • Tebipenem pivoxil preparation and preparation method thereof
  • Tebipenem pivoxil preparation and preparation method thereof
  • Tebipenem pivoxil preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0036] Tipipenem ester preparation of the present invention, described tipipenem ester preparation is made of granule, first coating layer and second coating layer, and described first coating layer and second coating layer increase weight average 4% by weight of pellets;

[0037] Expressed in g by weight, the granules are composed of raw materials tipipenem ester 131g (13.94%), D-mannitol 400g (42.55%) microcrystalline cellulose 300g (31.91%), sucrose 100g (10.64%) and hydroxypropyl Cellulose 9g (0.96%) composition;

[0038] Expressed in weight g, the first coating layer consists of raw material ethyl cellulose suspension 115g (55.29%), talcum powder 8g (3.85%), hydroxypropyl cellulose 5g (2.40%) and purified water 80g ( 38.46%) composition;

[0039] Expressed in weight g, the second coating layer is composed of raw material ethyl acrylate-methyl methacrylate copolymer aqueous dispersion 132g (49.77%), talcum powder 8g (3.02%), hydroxypropyl methylcellulose 4g (1.51%), asp...

Embodiment 2

[0041] Tipipenem ester preparation of the present invention, described tipipenem ester preparation is made of granule, first coating layer and second coating layer, and described first coating layer and second coating layer increase weight average 3.5% by weight of the pellets;

[0042] Expressed in g by weight, the granules are composed of raw materials tipipenem ester 131g (13.94%), D-mannitol 380g (40.43%) microcrystalline cellulose 320g (34.03%), sucrose 100g (10.64%) and hydroxypropyl Cellulose 9g (0.96%) composition;

[0043] Expressed in weight g, the first coating layer consists of raw material ethyl cellulose suspension 115g (55.29%), talcum powder 8g (3.85%), hydroxypropyl cellulose 5g (2.40%) and purified water 80g ( 38.46%) composition;

[0044] Expressed in weight g, the second coating layer is composed of raw material ethyl acrylate-methyl methacrylate copolymer aqueous dispersion 132g (49.77%), talcum powder 8g (3.02%), hydroxypropyl methylcellulose 4g (1.51%...

Embodiment 3

[0046] Tipipenem ester preparation of the present invention, described tipipenem ester preparation is made of granule, first coating layer and second coating layer, and described first coating layer and second coating layer increase weight average 3% by weight of pellets;

[0047] Expressed in g by weight, the granules are composed of raw materials tipipenem ester 131g (13.94%), D-mannitol 420g (44.68%) microcrystalline cellulose 280g (29.78%), sucrose 100g (10.64%) and hydroxypropyl Cellulose 9g (0.96%) composition;

[0048] Expressed in weight g, the first coating layer consists of raw material ethyl cellulose suspension 115g (55.29%), talcum powder 8g (3.85%), hydroxypropyl cellulose 5g (2.40%) and purified water 80g ( 38.46%) composition;

[0049] Expressed in weight g, the second coating layer is composed of raw material ethyl acrylate-methyl methacrylate copolymer aqueous dispersion 132g (49.77%), talcum powder 8g (3.02%), hydroxypropyl methylcellulose 4g (1.51%), asp...

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Abstract

The invention discloses a tipipenem ester preparation and a preparation method thereof. The tipipenem preparation is made of granules, a first coating layer and a second coating layer; the granules are made of tipipenem, D-mannitol, microcrystalline cellulose, sucrose and hydroxypropyl Cellulose composition; The first coating layer is made up of ethyl cellulose suspension, talcum powder, hydroxypropyl cellulose and purified water; The second coating layer is made of ethyl acrylate-methyl methacrylate Composition of aqueous copolymer dispersion, talc, hydroxypropyl methylcellulose, aspartame and purified water. The granule that the present invention makes has carried out two-layer coating; Wherein ethyl cellulose is nontoxic, has no pharmacological activity, is ideal insoluble material; And ethyl acrylate-methyl methacrylate copolymer aqueous dispersion is used as granule The film-coating material of gastric dissolving type such as, the film formed can resist saliva, so when taking, can mask the uncomfortable smell of medicine. It is insoluble in water and digestive fluids, but swells and is permeable.

Description

1. Technical field: [0001] The invention belongs to the technical field of medicines, and in particular relates to a tipipenem ester preparation and a preparation method thereof. 2. Background technology: [0002] Tipipenem is a white crystalline powder, odorless. This product is easily soluble in methanol and acetonitrile, soluble in ethanol, slightly soluble in ether, and very slightly soluble in water. It has optical rotation, and its specific rotation is +10.3°~+10.7°. Referring to the content of foreign literature and investigating the stability of the influencing factors, it can be known that tipipenem is sensitive to high temperature, high humidity and light. In order to ensure its stability, it is necessary to research and develop a suitable production process. [0003] Tipipenem ester, its chemical name is: (+)-(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-carboxylic acid tert-pentano...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/427A61K47/32A61K47/38A61P31/04
CPCA61K9/1635A61K9/1652A61K31/427
Inventor 徐培明郭海波王妍秦晴晴陈冠红马兰兰
Owner ZHENGZHOU MINGZE MEDICAL TECH
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