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

Method used

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  • Cefaclor sustained-release pellet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Example Embodiment

[0032] Example 1

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

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

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

[0036] The filler is microcrystalline cellulose.

[0037] The lubricant is talcum powder.

[0038] The binder is hypromellose.

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

Example Embodiment

[0040] Example 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, pulverize cefaclor with a pulverizer and pass through a 100-mesh sieve;

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

[0044] Step 3: preparation of adhesive: weigh an appropriate amount of hypromellose according to the above-mentioned mass ratio, add an appropriate amount of hot water to prepare an adhesive with a concentration of 2%, for use;

[0045] Step 4: Pill making: put the mixed drug fine powder into the feeding tank of the centrifugal pill making machine, put the binder into the liquid supply tank, put the blank pill core in the pot, turn on the machine, adjust the parameters,...

Example Embodiment

[0050] Example 3

[0051] medicine interactions

[0052] 1. Antacids: If this product is taken within 1 hour of using aluminum hydroxide or magnesium hydroxide, the absorption of this product will be reduced. H2 receptor antagonists do not alter the extent and rate of absorption of this product.

[0053] 2. Probenecid: Probenecid reduces the renal excretion rate 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 are no specific studies to explore the role of this aspect.

[0055] 4. Laboratory tests: The use of this product can result in a false positive reaction for 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 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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