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A kind of cefaclor sustained-release composition and preparation method thereof

A technology of cefaclor and its composition, which is applied in the field of pharmaceutical preparation, can solve problems such as failure to maintain therapeutic blood drug concentration, delayed release of target drug release, failure to meet 4 hours, etc., to achieve improved compliance and high safety , the effect of reducing the frequency of administration

Active Publication Date: 2022-04-29
杭州泓友医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] CN102028667A discloses a cefaclor sustained-release tablet (∥) agent and its preparation method; sodium starch glycolate is used as a disintegrant, and HPMC is a dispersive sustained-release preparation with HPMC as a skeleton material, and the sustained-release preparation needs to use The disintegrating agent dissolves the matrix and then diffuses, which can easily cause a sudden release of the drug
[0004] CN101897678A discloses a cefaclor slow-release composition, with acrylic resin as a blocker, high-viscosity HPMC as a skeleton material, and sodium carboxymethyl starch is also used as a disintegrant in the same way, and its requirement is 4-8 Complete release within 1 hour; failed to meet the release profile of the reference agent that accumulated more than 90% of the release within 4 hours (see Hekerau release)
[0005] The composition and preparation process disclosed in the current technology all use high-viscosity materials as the skeleton, and the release target does not meet the requirements of the design of the reference agent Hekerao. The drug is released slowly at a low pH position and completely released in the upper small intestine to maintain a certain The level of therapeutic blood drug concentration, and the release time is too long to reach the goal of maintaining the therapeutic blood drug concentration

Method used

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  • A kind of cefaclor sustained-release composition and preparation method thereof
  • A kind of cefaclor sustained-release composition and preparation method thereof
  • A kind of cefaclor sustained-release composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0048] Embodiment 1 Cefaclor sustained-release tablet (∥) #1 and preparation method thereof

[0049] The present embodiment provides a kind of cefaclor sustained-release tablet (∥) #1, is tablet, and every 1000 tablets content is as follows:

[0050] Element Content (g) Function Cefaclor 375 73.26％ Mannitol 30 5.86％ HPMC-E50 73.2 10.28％ HPC-HXF 50 8.13％ Udage L100-55 19.4 1.31％ stearic acid 3.5 0.68％ Magnesium stearate 2.5 0.49％ Total piece weight 512 Opadry Blue Coating Powder 16 3.12％

[0051] The preparation method of the Cefaclor Sustained Release Tablet (∥) #1 includes: sieving raw and auxiliary materials, weighing and mixing, granulating, drying, tabletting, coating and other processes. The specific process steps are as follows:

[0052] Step 1: Sieve the cefaclor raw material, HPC-HXF, HPMC-E50, and mannitol separately, mix and store for later use;

[0053] Step 2: Dissolve in ethanol ac...

Embodiment 2

[0060] Embodiment 2 Cefaclor sustained release tablet (∥) #2 and preparation method thereof

[0061] The present embodiment provides a kind of cefaclor sustained-release tablet (∥) #2, is tablet, and every 1000 tablets content is as follows:

[0062] Element Content (g) Function Cefaclor 375 72.84％ Mannitol 30 5.83％ HPMC-E5 34 6.60％ HPC-HXF 61.3 11.91％ Udage L100-55 7.5 1.46％ stearic acid 4 0.78％ Magnesium stearate 3 0.58％ Total piece weight 514.8 Opadry Blue Coating Powder 16 3.12％

[0063] The preparation method of the cefaclor sustained-release tablet (∥)#2 includes: sieving raw and auxiliary materials, weighing and mixing, granulating, drying, tableting, coating and other processes. The specific process steps are as follows:

[0064] Step 1: Sieve the cefaclor raw material, HPC-HXF, HPMC-E50, and mannitol separately, mix and store for later use;

[0065] Step 2: Dissolve in ethanol accordin...

Embodiment 3

[0072] Example 3 Cefaclor Sustained Release Tablet (∥) #3 and its preparation method

[0073] The present embodiment provides a kind of cefaclor sustained-release tablet (∥) #3, is tablet, and every 1000 tablets content is as follows:

[0074] Element Content (g) Function Cefaclor 375 72.74％ Mannitol 30 5.82％ HPMC-K100LV 76.6 14.86％ HPMC-E50 21.5 4.17％ Udage L100-55 7.1 1.38％ stearic acid 3.2 0.62％ Magnesium stearate 2.1 0.41％ Total piece weight 515.5 Opadry Blue Coating Powder 16 3.12％

[0075] The preparation method of the cefaclor sustained-release tablet (∥)#3 includes: sieving raw and auxiliary materials, weighing and mixing, granulating, drying, tableting, coating and other processes. The specific process steps are as follows:

[0076] Step 1: Sieve the cefaclor raw material, HPC-HXF, HPMC-E50, and mannitol separately, mix and store for later use;

[0077] Step 2: Dissolve in ethanol acco...

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Abstract

The invention discloses a cefaclor sustained-release composition and a preparation method thereof, belonging to the technical field of medicine preparation. The cefaclor sustained-release composition comprises the following components by weight: 375 parts of cefaclor, 28-35 parts of mannitol, 90-130 parts of HPMC and / or HPC, 5-20 parts of Eudragit L100-55 , 2-5 parts of stearic acid, 1-5 parts of magnesium stearate. The cefaclor sustained-release composition of the present invention has a high degree of fit to the dissolution curve of the reference agent Hekerao, does not release burst in alcohol, and has bioequivalence with the reference agent Hekerao. Because it is a sustained-release preparation, the number of administrations can be reduced, and enteric-coated materials are applied, the release in the body is extended to the intestinal tract, and the adverse reactions of the drug to the gastrointestinal tract are reduced, thereby improving patient compliance and further improving curative effect, which is of great importance. medicinal value.

Description

technical field [0001] The invention belongs to the technical field of medicine preparation, and in particular relates to a cefaclor sustained-release composition and a preparation method thereof. Background technique [0002] Cefaclor sustained-release preparation is a second-generation oral cephalosporin, which has a strong killing effect on a variety of Gram-positive and Gram-negative bacteria. The activity against penicillinase-producing Staphylococcus aureus, group A hemolytic streptococcus, viridans streptococcus and staphylococcus epidermidis is the same as that of cefadroxil, and the antibacterial effect against non-enzyme-producing staphylococcus aureus and pneumococcus is higher than that of cefadroxil 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 cefadrox...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K9/28A61K47/38A61K47/12A61K47/10A61K31/545A61P31/04
CPCA61K9/2018A61K9/2054A61K9/2013A61K9/2866A61K9/2853A61K31/545A61P31/04
Inventor 王再兴吴峰张英刘晓庆芮彬彬
Owner 杭州泓友医药科技有限公司
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