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Cefixime medicine and preparation method of cefixime medicine

A technology of cefixime and medicine, applied in the field of cefixime medicine and its preparation, can solve the problems of increased related substances, easily broken dry granules, low yield, etc., and achieve less generation of impurity substances, simple preparation process, and bioavailability high rate effect

Active Publication Date: 2021-09-28
GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the poor compressibility of the drug components in dry granulation, the prepared dry granules are easily broken, resulting in a large amount of fine powder, low yield, and large differences in loading capacity.
On the other hand, due to the poor compressibility of the drug components, greater pressure is required to obtain stronger dry granules during dry granulation. However, excessive pressure during dry granulation tends to generate a large amount of heat, resulting in the loss of related substances. At the same time, the original stable crystals of cefixime will also be destroyed due to excessive force, and the stable and dense crystals will be broken into fine crystals, resulting in a significant decrease in the stability of the long-term sample retention process

Method used

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  • Cefixime medicine and preparation method of cefixime medicine

Examples

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Effect test

Embodiment 1

[0045] A cefixime drug comprising the following components:

[0046]

[0047] A preparation method of cefixime medicine, comprising the following steps:

[0048] Grind and sieve the sucrose, the particle size D90 of the obtained sucrose is 143 μm, the particle size D90 of the cefixime raw material is 53 μm, take the prescription amount of cefixime, cellulose-lactose C80 pre-mixed, then add the prescription amount of sucrose, and mix well , set the dry pressure to 40bar, the screw feeding speed to 50rpm, the dry press presses the powder into flakes, granulates through a 0.8mm granulator, collects particles from 20 holes / 25.4mm to 80 holes / 25.4mm, and adds sweet orange powder The essence is mixed evenly, and packed into 1000 bags, that is to say.

Embodiment 2

[0050] A cefixime drug comprising the following components:

[0051]

[0052] A preparation method of cefixime medicine, comprising the following steps:

[0053] Grind and sieve the mannitol, the particle size D90 of the obtained mannitol is 109 μm, the particle size D90 of the cefixime raw material is 67 μm, take the prescription amount of cefixime, cellulose-lactose M100 pre-mixed, then add the prescription amount of mannitol , mix evenly, set the dry pressure to 50bar, the screw feeding speed to 55rpm, the dry press presses the powder into flakes, granulates through a 0.8mm granulator, collects particles from 20 holes / 25.4mm to 80 holes / 25.4mm, and adds Mix the apple flavor evenly, pack it into 1000 bags, and get it.

Embodiment 3

[0055] A cefixime drug comprising the following components:

[0056]

[0057] A preparation method of cefixime medicine, comprising the following steps:

[0058] Grind and sieve the sucrose, the particle size D90 of the obtained sucrose is 177 μm, the particle size D90 of the cefixime raw material is 45 μm, take the prescribed amount of cefixime, cellulose-lactose M100 pre-mixed, then add the prescribed amount of sucrose, and mix well , set the dry pressure to 55bar, the screw feeding speed to 60rpm, the dry press presses the powder into flakes, granulates through a 0.8mm granulator, collects granules from 20 holes / 25.4mm to 80 holes / 25.4mm, adds strawberry flavor and mixes Evenly, pack into 1000 bags, that is.

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Abstract

The invention belongs to the technical field of medicines, and discloses a cefixime medicine and a preparation method of the cefixime medicine. The cefixime medicine comprises cefixime and a dispersing agent, wherein the dispersing agent is cellulose-lactose. The cellulose-lactose is adopted as the dispersing agent, the compressibility of materials can be effectively improved by utilizing the excellent flowability, adhesiveness, compressibility and adsorbability of cellulose-lactose powder, and the yield of the cefixime medicine is increased and is larger than 80%; and meanwhile, the pressure required during granulation is also reduced, the stability of the cefixime medicine can be improved, and few related substances are generated in the long-term sample reserving process.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a cefixime drug and a preparation method thereof. Background technique [0002] Cefixime (Cefixime) is a third-generation cephalosporin antibiotic, its chemical name is: (6R, 7R)-7-[(Z)-2-(2-amino-4-thiazolyl)-2-( Carboxymethoxyimino)acetamido]-8-oxo-3-ethylene-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid trihydrate. Cefixime has the characteristics of long half-life, high efficiency and low toxicity, wide distribution in the body, and good tissue penetration. [0003] Cefixime is an oral broad-spectrum cephalosporin, especially for Streptococcus and pneumococcus among Gram-positive bacteria, and Neisseria gonorrhoeae, Escherichia coli, Klebsiella, Serratia and Proteus among Gram-negative bacteria. Bacillus and influenza bacillus and other antibacterial effect is good. It is clinically applicable to respiratory tract infections caused by sensitive bacteri...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/546A61K47/38A61K47/26A61K9/16A61P31/04
CPCA61K31/546A61K9/1652A61K9/1623A61P31/04Y02A50/30
Inventor 王健松叶伟文王玮黄海文罗志波李卓
Owner GUANGZHOU BAIYUNSHAN PHARMA HLDG CO LTD BAIYUNSHAN PHARMA GENERAL FACTORY
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