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A kind of preparation method of cefixime dry suspension granule

A technology of cefixime and dry suspension, applied in the field of medicine, can solve the problems of poor solubility and instability of cefixime preparations, and achieve the effects of improving stability and solubility, increasing acceptability, and strong operability

Active Publication Date: 2018-03-27
SHENZHEN LIJIAN PHARM CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] In view of the above-mentioned deficiencies in the prior art, the object of the present invention is to provide a method for preparing cefixime dry suspension granules, aiming to solve the problems of instability and poor solubility of the cefixime preparation prepared by the existing method

Method used

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  • A kind of preparation method of cefixime dry suspension granule
  • A kind of preparation method of cefixime dry suspension granule
  • A kind of preparation method of cefixime dry suspension granule

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preparation example Construction

[0036] According to the above formula, the present invention also provides a preparation method of cefixime dry suspension granules, wherein, by weight percentage, comprising:

[0037] Step A, take 5-20% of cefixime, 1-10% of disintegrating agent, 30-70% of sweetener a and 1-10% of suspending agent which have been sieved and mix thoroughly, then add wetting agent to prepare The soft material is sieved and then dried to obtain the dry-suspended intermediate granules of cefixime.

[0038] The particle size distribution figure of cefixime of the present invention is as follows figure 1 As shown, among them, Dv(10)100um. Among them, Dv (Volume Density) is the volume density.

[0039] Preferably, the disintegrant can be starch, pregelatinized starch, sodium carboxymethyl starch, hydroxypropyl starch, dextrin, cross-linked carmellose sodium, cross-linked carmellose calcium low-substituted One or more of hydroxypropyl cellulose, cross-linked polyvinylpyrrolidone, etc.

[0040] Pr...

Embodiment 1

[0058] The preparation process is as follows:

[0059] Step 1: Under the condition of 23°C / 55%RH, take cefixime, disintegrating agent, sweetener a, and suspending agent to pass through 80-mesh sieve respectively, place them in a multi-directional mixer and mix for 15 minutes, add 50 % ethanol is used as a wetting agent, made into a soft material, passed through a 30-mesh sieve, and then dried in a fluidized bed at 50°C to obtain dry-suspended intermediate granules of cefixime; the second step is to take the sweetener b , coloring agent and hydroxypropyl methylcellulose are added in 50% ethanol solution, fully dissolved to obtain the auxiliary material solution, after adding a pH regulator to adjust the pH value to 3.0, slowly spray on the surface of the cefixime dry-suspended intermediate granules, After drying at 40°C, finally add a solubilizer and a flavoring agent and mix in a multi-directional mixer for 15 minutes to obtain dry suspension granules of cefixime. During the ...

Embodiment 2

[0069] The preparation process is as follows:

[0070] Step 1: Under the condition of 22°C / 60%RH, take cefixime, disintegrant, sweetener a, and suspending agent to pass through 80-mesh sieve respectively, place them in a multi-directional mixer and mix for 25 minutes, add 50 % ethanol is used as a wetting agent, made into a soft material, passed through a 30-mesh sieve, and then dried in a fluidized bed at 45°C to obtain dry-suspended intermediate granules of cefixime; the second step is to take the sweetener b , coloring agent and hydroxypropyl methylcellulose are added in 30% ethanol solution, and after fully dissolving, adjuvant solution is obtained, after adding pH adjuster to adjust the pH value to 3.5, slowly spray on the surface of cefixime dry-suspended intermediate granules, after Dry at 40°C, and finally add a solubilizer and a flavoring agent and mix in a multi-directional mixer for 20 minutes to obtain dry suspension granules of cefixime. During the preparation pr...

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Abstract

The invention discloses a preparation method of dry suspension granules of cefixime. The method comprises the following steps: fully mixing 5-20% by weight of sieved cefixime, 1-10% by weight of a disintegrating agent, 30-70% by weight of a sweetening agent a and 1-10% by weight of a suspending aid, then adding a wetting agent into the prepared mixture to prepare a soft material, sieving and then drying to obtain dry suspension intermediate granules of cefixime; adding 20-60% by weight of a sweetening agent b, 0.1-0.5% by weight of a coloring agent and 0.5-5% by weight of non-ionic cellulose ether into a solvent for fully dissolving the materials, then adding 1-10% by weight of a pH regulator for regulating the pH value to 1-5, then spraying the materials on the surfaces of the dry suspension intermediate granules of cefixime, drying, and finally adding 0.1-1.5% by weight of a solubilizer and 1-3% by weight of a flavor modifying agent, then uniformly mixing to obtain the dry suspension granules of cefixime. The stability of the dry suspension granules of cefixime prepared by the method is obviously improved; the increase level of all the main degradation impurities is controlled at a safe and acceptable level.

Description

technical field [0001] The invention relates to the field of medicine, in particular to a preparation method of cefixime dry suspension granules. Background technique [0002] Cefixime is a third-generation cephalosporin antibiotic researched and developed by Japan Fujisawa Pharmaceutical Co., Ltd. (now Astellas). It has a broad-spectrum antibacterial effect on both Gram-positive bacteria and negative bacteria, especially Streptococcus and Pneumococcus in Gram-positive bacteria, Neisseria gonorrhoeae and Branhamella catarrh in Gram-negative bacteria , Escherichia coli, Klebsiella, Serratia, Proteus, Influenza, etc. showed stronger antibacterial activity than other oral cephalosporins. After absorption, it is widely distributed throughout the body with high drug concentration; it is stable to β-lactamase; it is convenient to administer, and the dosage is small, once or twice a day, the dosage is 50-200mg, which is currently used in cephalosporin antibiotics One of the small...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K31/546A61K47/12A61K47/38A61K47/36A61P31/04A61P27/16A61P11/02A61P13/00A61P13/12A61P13/08A61P13/02A61P11/00
CPCA61K9/0095A61K9/1617A61K9/1652A61K9/1682A61K31/546
Inventor 宋珊珊彭国维欧浩荣陈达红
Owner SHENZHEN LIJIAN PHARM CO LTD
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