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Oral preparation containing tebipenem pivoxil and preparation method thereof

A technology for tipipenem ester and oral preparation, applied in the field of pharmaceutical preparations, can solve the problems of unsatisfactory taste masking effect, low drug dissolution rate, complicated preparation process, etc. Simple preparation process

Active Publication Date: 2018-02-27
北京达因高科儿童药物研究院有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0013] In order to overcome the deficiencies of the prior art and solve the problems of poor preparation stability, complex and time-consuming preparation process, unsatisfactory taste-masking effect and low drug dissolution rate in the preparation of tipipenem pectin oral preparations in the prior art, the present invention provides A kind of preparation method of tipipenem pectin solid dispersion and oral preparation thereof

Method used

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  • Oral preparation containing tebipenem pivoxil and preparation method thereof
  • Oral preparation containing tebipenem pivoxil and preparation method thereof
  • Oral preparation containing tebipenem pivoxil and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0048] Example 1 Preparation of oral preparations of tipipenem pectin

[0049] Prescription (specification: 50mg / 0.5g):

[0050]

[0051] Note: 50mg in the specifications is calculated as telipenem, and 50mg telipenem is equivalent to 65mg telipenem ester (the same below).

[0052] Preparation Process:

[0053] ① Weigh the prescription amount of drug and soluble carrier mixture, namely RL PO and RS PO, add an appropriate amount of absolute ethanol (Eudragit mixture: absolute ethanol = 1:10), stir at high speed to completely dissolve the drug and carrier material;

[0054] ② Take the mannitol that has been passed through a 100-mesh sieve in the prescribed amount and add it to the solution in step 1, stir to form a uniform suspension, dry the solvent by rotary evaporation under reduced pressure, dry in vacuum at 40°C for 2 hours, crush and pass through a 80-mesh sieve, and store in a sealed place in the dark for later use ;

[0055] ③ Mix the prepared tipipenem ester s...

Embodiment 2

[0057] Example 2 Preparation of oral preparations of tipipenem pectin

[0058] Prescription (specification: 50mg / 0.5g):

[0059]

[0060] Preparation process: with embodiment 1.

Embodiment 3

[0061] Example 3 Preparation of oral preparations of tipipenem pectin

[0062] Prescription (specification: 50mg / 0.5g):

[0063]

[0064]

[0065] Preparation process: with embodiment 1.

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Abstract

The invention belongs to the technical field of pharmaceutical preparations and particularly relates to an oral preparation containing tebipenem pivoxil and a preparation method thereof. The pharmaceutical preparation is prepared by the following steps: preparing a solid dispersion from an active ingredient tebipenem pivoxil; then crushing and screening the solid dispersion; and preapring the oralpreparation containing tebipenem pivoxil with proper diluent, adhesive, sweetening agent, lubricant, pigments and essence according to a conventional granulating process. The oral preparation containing tebipenem pivoxil prepared by the method covers strong bitterness of the drug effectively, so that the administrating compliance of a child patient is improved extremely; the dissolution rate andthe solubility of the drug are improved remarkably, and quick release of the drug is accelerated; the drug stability is increased, and the physical aging problem of conventional coating treatment is avoided; and the process is simple to operate, good in repeatability and suitable for industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an oral preparation containing tipipenem ester composition and a preparation method thereof. technical background [0002] Tebipenem pivoxil, chemical name (1R,5S,6S)-6-[(1R)-hydroxyethyl]-1-methyl-2-[1-(1,3-thiazoline -2-yl) azetidin-3-ylthio] carbapenem-2-ene-3-carboxylic acid pivaloyloxymethyl ester, a new broad-spectrum antibiotic for oral carbapenems, applicable For infections caused by penicillin-sensitive or resistant Streptococcus pneumoniae and Haemophilus influenzae, it is currently mainly used for the treatment of pneumonia, ear, nose, throat and upper respiratory tract infections in children. Acute upper respiratory tract infection and pneumonia are serious diseases that threaten the health of children in my country. Especially in recent years, the deterioration of air pollution has made the incidence of acute upper respiratory tract i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/16A61K31/427A61K47/32A61K47/26A61K47/38A61P31/04
CPCA61K9/1623A61K9/1635A61K9/1652A61K31/427
Inventor 杨杰兰颐李树英吴学萍杨琳王英新
Owner 北京达因高科儿童药物研究院有限公司
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