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Cefaclor sustained-release pellet and preparation method thereof

A technology of cefaclor and sustained-release pellets, applied in the directions of antibacterial drugs and bulk delivery, can solve the problems of inconvenient packaging, transportation, storage, low stable drug release effect, and large gastrointestinal irritation, etc. The effect of improving bioavailability, small individual differences, and easy absorption

Inactive Publication Date: 2016-01-27
HEILONGJIANG ZHICHENG MEDICAL TECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0008] At present, among the cefaclor drugs on the market for the treatment of infections caused by the above-mentioned sensitive pathogens, there are low drug release stability effects, great irritation to the gastrointestinal tract, and biological Low utilization, inconvenient packaging, transportation and storage, and complicated preparation methods

Method used

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  • Cefaclor sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0033] A cefaclor sustained-release pellet, comprising drug-containing pellets and a coating layer, characterized in that: the coating layer wraps the drug-containing pellets, and the drug-containing pellets include: 188mg cefaclor, 70mg Blank pellet core, 122-172mg filler, 18-68mg lubricant, 2-10mg binder, and the coating layer includes: 45-225mg Eudragit NE30D, 7-68mg talcum powder.

[0034] The optimal mass ratio of raw materials in the drug-containing pellets is: 188mg cefaclor, 70mg blank core, 160mg filler, 22mg lubricant, 10mg binder.

[0035] The optimal mass ratio of raw materials in the coating layer is: 132mg Eudragit NE30D, 30mg talcum powder.

[0036] The filler is microcrystalline cellulose.

[0037] Described lubricant is talcum powder.

[0038] The binder is hypromellose.

[0039] The coating layer also includes traces of sodium lauryl sulfate or polyethylene glycol.

Embodiment 2

[0041] A preparation method of cefaclor sustained-release pellets, comprising the following steps:

[0042] Step 1: material preparation: according to the above mass ratio, cefaclor is pulverized with a pulverizer, and passed through a 100-mesh sieve;

[0043] Step 2: Mixing: Weigh cefaclor and microcrystalline cellulose according to the above mass ratio, put them into a three-dimensional mixer and mix for 30 minutes to make a drug fine powder, take it out for later use;

[0044] Step 3: Preparation of adhesive: Weigh an appropriate amount of hypromellose according to the above mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, and set aside;

[0045] Step 4: Pill making: put the mixed drug fine powder into the feeding tank of the centrifugal pellet machine, put the adhesive into the liquid supply tank, put the blank pellet core into the pot, turn on the machine, adjust the parameters, and start spraying When the ba...

Embodiment 3

[0051] medicine interactions

[0052] 1. Antacids: If you take this product within 1 hour of using aluminum hydroxide or magnesium hydroxide, the absorption of this product will decrease. H2 receptor antagonists will not change the degree and rate of absorption of this product.

[0053] 2. Probenecid: Probenecid can reduce the rate of renal excretion of this product.

[0054] 3. Warfarin: When this product is combined with warfarin, there are few clinical reports that the prothrombin time will be prolonged, with or without bleeding. At present, there is no specific research to explore the role of this aspect.

[0055] 4. Laboratory tests: the use of this product can lead to false positive reactions of glucose in the urine. This phenomenon was also seen in patients taking cephalosporins when the test was performed in Benedict's and Fehling's solutions, and also in the Clinitest tablets.

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Abstract

A cefaclor sustained-release pellet comprises a medicated pellet body and a coating layer which wraps the medicated pellet body, the medicated pellet body is prepared from cefaclor, a blank pellet core, fillers, lubricating agents and binding agents, and the coating layer is prepared from eudragit NE30D and talcum powder. A preparation method of the cefaclor sustained-release pellet comprises the processes of material preparation, mixing, preparation of the binding agents, pelleting, preparation of coating agents, coating, filling and aluminum packing to obtain a finished product. The cefaclor sustained-release pellet is suitable for infection caused by sensitive pathogenic bacteria, the drug-release stabilizing effect is good, irritation to gastrointestinal tracts is small, the bioavailability is good, packing, transportation and storage are convenient, and the cefaclor sustained-release pellet is suitable for industrial production. After the cefaclor sustained-release pellet is orally taken, absorptivity is good, and although the cefaclor sustained-release pellet can be taken before or after a meal, food can increase total absorption of the cefaclor sustained-release pellet.

Description

technical field [0001] The invention belongs to the field of chemical drug sustained-release preparations, and in particular relates to a cefaclor sustained-release pellet and a preparation method thereof. Background technique [0002] Acute bronchitis and exacerbation of chronic bronchitis: Streptococcus pneumoniae, Haemophilus influenzae (including β-lactamase-producing strains), Haemophilus parainfluenzae (including β-lactamase-producing strains), Moraxella catarrhalis (including β-lactamase-producing strains) and Staphylococcus aureus. [0003] Pharyngitis, tonsillitis: caused by Streptococcus pyogenes (Group A Streptococcus). (Penicillin is generally the drug of choice for the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever. Although this product is usually effective in clearing streptococcus in the oropharynx; there is not enough data to prove that this product can prevent rheumatic fever attacks) . [0004] Pneumon...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/545A61K47/38A61P31/04
Inventor 张昕
Owner HEILONGJIANG ZHICHENG MEDICAL TECH
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