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Cefixime granular preparation and preparation method thereof

A technology for cefixime and granule preparations, applied in the field of cefixime granule preparations and its preparation, can solve the problems of reduced drug quality and safety, slow dissolution, and low bioavailability, and achieve low cost, simple equipment, and easy operation simple effect

Inactive Publication Date: 2020-12-18
KAMP PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0005] However, during the manufacturing process and storage process of the existing technical prescription, the related substances and polymers grow rapidly, dissolve slowly, and have low bioavailability, resulting in reduced drug quality and safety.

Method used

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  • Cefixime granular preparation and preparation method thereof
  • Cefixime granular preparation and preparation method thereof
  • Cefixime granular preparation and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0029] A prescription of cefixime granules is shown in the table below:

[0030]

[0031]

[0032] The preparation method of above-mentioned cefixime granules comprises the following steps:

[0033] Use a low-temperature vortex mill to micronize the API at low temperature, pulverize the sucrose with a 120-mesh sieve, and sieve the hydroxypropyl cellulose through a 60-mesh sieve;

[0034] Add 50% sucrose, API, hydroxypropyl cellulose, poloxamer 188 and the remaining sucrose in sequence, mix for 30 minutes, then add an appropriate amount of gum arabic aqueous solution to obtain a wet and soft material, which is kneaded into a ball by hand and kneaded. scattered state;

[0035] Use a 24-mesh sieve to make granules through a swinging granulator, and the granules enter the boiling dryer for drying at 40-45°C, and the moisture content is lower than 2.5% after drying;

[0036] The dry particles are sieved through a 18-mesh sieve, and the particles that pass through the 18-mes...

Embodiment 2

[0038] A prescription of cefixime granules is shown in the table below:

[0039] Material name Prescription amount (mg / packet) Quantity for 1000 packs (g) Cefixime (API) 56 (dry discount pure) 56 sucrose 900 900 Hydroxypropyl Cellulose 41 41 Poloxamer 188 1.5 1.5 gum arabic 2 2 essence 0.5 0.5

[0040] The preparation method of above-mentioned cefixime granules comprises the following steps:

[0041] Use a low-temperature vortex mill to micronize the API at low temperature, pulverize the sucrose with a 120-mesh sieve, and sieve the hydroxypropyl cellulose through a 60-mesh sieve;

[0042] Add 50% sucrose, API, hydroxypropyl cellulose, poloxamer 188 and the remaining sucrose in sequence, mix for 30 minutes, then add an appropriate amount of gum arabic aqueous solution to obtain a wet and soft material, which is kneaded into a ball by hand and kneaded. scattered state;

[0043] Use a 24-mesh sieve to make granules thr...

Embodiment 3

[0046] A prescription of cefixime granules is shown in the table below:

[0047] Material name Prescription amount (mg / packet) Quantity for 1000 packs (g) Cefixime (API) 56 (dry discount pure) 56 sucrose 904.5 904.5 Hydroxypropyl Cellulose 35 35 Poloxamer 188 2 2 gum arabic 2 2 essence 0.5 0.5

[0048] The preparation method of above-mentioned cefixime granules comprises the following steps:

[0049] Use a low-temperature vortex mill to micronize the API at low temperature, pulverize the sucrose with a 120-mesh sieve, and sieve the hydroxypropyl cellulose through a 60-mesh sieve;

[0050] Add 50% sucrose, API, hydroxypropyl cellulose, poloxamer 188 and the remaining sucrose in sequence, mix for 30 minutes, then add an appropriate amount of gum arabic aqueous solution to obtain a wet and soft material, which is kneaded into a ball by hand and kneaded. scattered state;

[0051] Use a 24-mesh sieve to make granules thr...

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PUM

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Abstract

The invention discloses a cefixime granular preparation. Raw materials of the cefixime granular preparation comprises in percentage by mass: 4.5 to 5.5% of cefixime, 85.5 to 95% of sweetening agent, 3to 5% of hydroxy propyl cellulose, 0.5 to 2.0% of surfactant and 0.5 to 2% of edible gum. The invention discloses a preparation method of the cefixime granular preparation, which comprises the following steps of: micronizing the cefixime at low temperature until D90 is 120 mum; sequentially adding the sweetening agent, the hydroxy propyl cellulose and the surfactant; then adding the sweetening agent; then adding aqueous solution of the edible gum to prepare a wet and soft material; then carrying out sieving and granulation; and drying particles at a drying temperature of 40 to 45 DEG C untilwater content is less than or equal to 2.5%, and carrying out sieving. According to the invention, by controlling related production processes, the content of impurities and polymers is reduced, and the dissolution efficiency and bioavailability are improved, so that the medicine quality and safety are improved.

Description

technical field [0001] The invention relates to the technical field of biomedicine, in particular to a cefixime granule preparation and a preparation method thereof. Background technique [0002] Cefixime (Cefixime) is a third-generation cephalosporin antibiotic for oral administration, suitable for the treatment of respiratory, urinary and biliary tract infections caused by sensitive bacteria. Cefixime is highly stable to the β-lactamase produced by Gram-negative bacilli, and its antibacterial effect on Gram-negative bacilli is stronger than that of the first-generation and second-generation cephalosporins, but its antibacterial effect on Gram-positive cocci is not as good as that of the first-generation and second-generation cephalosporins. At present, the cefixime drugs approved by the State Food and Drug Administration have various dosage forms such as tablets, capsules, dispersible tablets, dry suspensions and granules, all of which are prescription drugs. [0003] CN...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/546A61P31/04A61J3/00
CPCA61K31/546A61K9/1652A61P31/04A61J3/00A61K9/1682
Inventor 巫治国贺莲杨世平张静刘娟
Owner KAMP PHARMA
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