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Cefaclor granule and preparation method thereof

A technology of cefaclor granules and cefaclor, which is applied in the field of pharmaceutical and chemical technology synthesis, can solve the problems of poor stability, slow cefaclor granules, and inability to achieve cefaclor encapsulation effect, and achieve high stability and high dissolution rate Good, product quality is easy to control the effect

Active Publication Date: 2018-11-06
苏州盛达药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It can be seen that in this patent, cefaclor is only coated by polyvinyl alcohol-polyethylene glycol graft copolymer, and fillers and flavoring agents do not coat cefaclor, and, from the comparative implementation of this patent Example 2 shows that when polyvinyl alcohol and Polyethylene Glycol do not form grafting, when only physically mixing, the dissolution rate of cefaclor granule is slow, and the dissolution rate of 5min is 54.5%, and the dissolution rate of 30min is 96.7%, and cannot It has a wrapping effect on cefaclor, but the stability is poor

Method used

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  • Cefaclor granule and preparation method thereof
  • Cefaclor granule and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0028] 1. Raw material composition:

[0029] 100 grams of cefaclor inclusion compound, 120 grams of mannitol, 5 grams of binder, 2 grams of disintegrant, 1.5 grams of flavoring agent, and 1.5 grams of glidant;

[0030] Wherein, cefaclor inclusion compound is prepared as follows:

[0031] Dissolve polyethylene glycol in ethanol, then add cefaclor, remove ethanol under reduced pressure under agitation, and dry to obtain cefaclor inclusion compound; the weight ratio of cefaclor to polyethylene glycol is 1:2 .

[0032] The binder is curdlan gum; the disintegrant is sodium carboxymethyl starch; the flavoring agent is steviol glycoside; the glidant is magnesium stearate.

[0033] 2. Preparation process:

[0034] (1) adding water to the adhesive to prepare a concentration of 3wt% aqueous solution;

[0035] (2) Add cefaclor clathrate, disintegrant, flavoring agent and glidant to the aqueous solution of step (1), stir until completely dissolved, and obtain material solution;

[00...

Embodiment 2

[0038] 1. Raw material composition:

[0039] 100 grams of cefaclor inclusion compound, 100 grams of mannitol, 6 grams of binder, 1 gram of disintegrant, 2 grams of flavoring agent, 1 gram of glidant;

[0040] Wherein, cefaclor inclusion compound is prepared as follows:

[0041] Dissolve polyethylene glycol in ethanol, then add cefaclor, remove ethanol under reduced pressure under agitation, and dry to obtain cefaclor inclusion compound; the weight ratio of cefaclor to polyethylene glycol is 1:2 .

[0042] The binder is xanthan gum; the disintegrating agent is cross-linked povidone; the flavoring agent is steviol glycoside; the glidant is micronized silica gel.

[0043] 2. Preparation process:

[0044] The preparation process is the same as in Example 1.

Embodiment 3

[0046] 1. Raw material composition:

[0047] 100 grams of cefaclor inclusion compound, 120 grams of mannitol, 4 grams of binder, 3 grams of disintegrant, 1 gram of corrective agent, 2 grams of glidant;

[0048] Wherein, cefaclor inclusion compound is prepared as follows:

[0049] Dissolve polyethylene glycol in ethanol, then add cefaclor, remove ethanol under reduced pressure under agitation, and dry to obtain cefaclor inclusion compound; the weight ratio of cefaclor to polyethylene glycol is 1:2 .

[0050] The binder is xanthan gum; the disintegrating agent is cross-linked povidone; the flavoring agent is steviol glycoside; the glidant is micronized silica gel.

[0051] 2. Preparation process:

[0052] The preparation process is the same as in Example 1.

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Abstract

The invention relates to a cefaclor granule, which comprises following raw materials in parts by weight: 100 parts of cefaclor inclusion complex, 100 to 120 parts of mannitol, 4 to 6 parts of adhesive, 1 to 3 parts of disintegrating agent, 1 to 2 parts of flavoring agent, and 1 to 2 parts of flow aid. The provided cefaclor granule has the advantages of good dissolution rate, high stability, and uniform particle size. Furthermore, the technology of provided preparation method is simple, and the product quality is easy to control.

Description

technical field [0001] The invention belongs to the technical synthesis field of medicine and chemical industry, and in particular relates to a cefaclor granule and a preparation method thereof. Background technique [0002] Cefaclor is a second-generation oral cephalosporin, a broad-spectrum semi-synthetic cephalosporin antibiotic, which has a strong killing effect on a variety of Gram-positive and Gram-negative bacteria. Cefaclor has the same antibacterial effect as cefadroxil on penicillinase-producing Staphylococcus aureus, group A hemolytic streptococcus, viridans streptococcus and staphylococcus epidermidis. Cefadroxil is 2 to 4 times stronger. The activity against Gram-negative bacilli, including Escherichia coli and Klebsiella pneumoniae, is stronger than cephalexin, similar to cefadroxil, and the activity against Proteus mirabilis, Salmonella and Shigella is stronger than cefadroxil . Clinically, cefaclor is applied to infections caused by sensitive bacteria, suc...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/545A61P31/04
CPCA61K9/1623A61K31/545A61P31/04
Inventor 胡礼勇刘要武黄军豪周自金
Owner 苏州盛达药业有限公司