Preparation method of dry suspension granules of cefixime

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

Active Publication Date: 2017-05-10
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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  • Preparation method of dry suspension granules of cefixime
  • Preparation method of dry suspension granules of cefixime
  • Preparation method of dry suspension granules of cefixime

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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 particles, wherein, by weight percentage, comprising:

[0037] Step A, get 5-20% of cefixime, 1-10% of disintegrant, 30-70% of sweetener a and 1-10% of suspending agent after sieving respectively, after fully mixing, add wetting agent to make. The soft material is sieved and then dried to obtain cefixime dry suspension intermediate particles.

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

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

[0040] Preferably, the sweetener a can be sucrose, f...

Embodiment 1

[0058] The preparation process is as follows:

[0059] The first step: under the condition of 23 ℃ / 55% RH, take cefixime, disintegrating agent, sweetener a, and suspending agent to pass through an 80-mesh sieve, put them in a multi-directional mixer and mix for 15 minutes, add 50 % ethanol is used as a wetting agent, and it is made into a soft material and sieved through a 30-mesh sieve, and then dried in a fluidized bed at 50 ° C to obtain cefixime dry suspension intermediate granules; the second step is to take the sweetener b. , colorant and hydroxypropyl methylcellulose are added to 50% ethanol solution, fully dissolved to obtain auxiliary material solution, add pH adjuster to adjust pH value to 3.0, then slowly spray on the surface of cefixime dry suspension intermediate particles, After drying at 40°C, the solubilizer and the flavoring agent are finally added and mixed in a multidirectional mixer for 15 minutes to obtain cefixime dry suspension granules. In the preparat...

Embodiment 2

[0069] The preparation process is as follows:

[0070] The first step: under the condition of 22 ℃ / 60% RH, take cefixime, disintegrating agent, sweetener a and suspending agent and pass through 80 mesh sieves, put them in a multidirectional mixer and mix for 25min, add 50 % ethanol is used as a wetting agent, and it is made into a soft material and passed through a 30-mesh sieve, and then dried in a fluidized bed at 45 ° C to obtain cefixime dry suspension intermediate granules; the second step is to take the sweetener b , colorant and hydroxypropyl methylcellulose are added to 30% ethanol solution, fully dissolved to obtain auxiliary material solution, add pH adjuster to adjust pH value to 3.5, then slowly spray on the surface of cefixime dry suspension intermediate particles, Drying treatment at 40°C, finally adding solubilizer and flavoring agent and mixing in a multidirectional mixer for 20 minutes to obtain cefixime dry suspension granules. In the preparation process, th...

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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 developed by Fujisawa Pharmaceutical Co., Ltd. (now Astellas Corporation). It has broad-spectrum antibacterial effect on Gram-positive and negative bacteria, especially Streptococcus, Pneumococcus in Gram-positive bacteria, Neisseria gonorrhoeae and Branhamococcus catarrhalis 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 in the body, and the drug concentration is high; it is stable to β-lactamase; it is convenient to administer, and the dosage is small. It is administered once or twice a day, and the dosage is 50-200 mg. It is currently used in cephalosporin antibiotics. One of the small...

Claims

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Application Information

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Patent Type & Authority Applications(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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