Cefpodoxime axetil immediate-release preparation and preparation method thereof

Abstract

The invention provides a cefpodoxime axetil immediate-release solid preparation and a preparation method thereof. The cefpodoxime axetil immediate-release solid preparation comprises: cefpodoxime axetil accounting for 2.5-15wt% of the total weight of the preparation, accounting for the total weight of the preparation 0.8-15.0 wt% surfactant. The method for preparing the immediate-release solid preparation is wet granulation, and the specific preparation process is as follows: (1) dissolving cefpodoxime axetil and surfactant in absolute ethanol to obtain mixture 1, (2) diluent and disintegration After the agent is mixed evenly, slowly add or spray into the mixture 1, granulate, and dry in a fluidized bed to obtain the mixture 2, (3) add the suspending agent, corrective agent and lubricant to the mixture 2, mix them all, and pack . The immediate-release solid preparation can be quickly dissolved in water without gelation. At the same time, the improved process avoids the process of raw material crushing and micronization treatment, and does not require special equipment such as dry granulators, which simplifies production operations. At the same time to ensure product stability.

Description

technical field [0001] The invention belongs to the technical field of medicines, in particular to a cefpodoxime axetil immediate-release solid preparation and a preparation method thereof. Background technique [0002] Cefpodoxime axetil chemical name: (6R,7R)-7-[2-(2-aminothiazol-4-yl)-2-(Z)-(methoxyimino)-acetamido]-3-methanol Oxymethyl-8-oxo-5-thio-1-azabicyclo-[4,2,0]oct-2-ene-2-carboxylic acid isopropoxycarbonyloxyethyl ester, its structural formula is: [0003] [0004] Molecular formula: C 21 h 27 N 5 o 9 S 2 [0005] CAS: 87239-81-4 [0006] The trade name of cefpodoxime axetil is: VANTIN, which is the third-generation oral broad-spectrum cephalosporin developed in Japan. On August 7, 1992, cefpodoxime axetil tablet and dry suspension passed the FDA’s marketing application, and it was launched in the United States. listed. Cefpodoxime axetil is a third-generation cephalosporin with the advantages of broad antibacterial spectrum, long half-life, convenien...

AI Technical Summary

Problems solved by technology

[0016] The object of the present invention is to provide a kind of cefpodoxime axetil immediate-release solid preparation and preparation method thereof, to solve the problem that in the existing cefpodoxime axetil immediate-release solid preparation technology, the raw material is in a gel state when meeting water, and the dissolution rate of the preparation is low; Need special treatment and dry granulation requires high equipment requirements and cumbersome production process

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