Slow release composition with cefaclor

A slow-release composition, cefaclor technology, applied in drug delivery, pill delivery, pharmaceutical formulations, etc., can solve the problems of low blood drug concentration, difficulty in ensuring curative effect, and difficulty in ensuring blood drug concentration in patients

Inactive Publication Date: 2012-07-18
HAINAN KANGHONG MEDICAL TECH DEV
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Since the half-life of cefaclor is only 0.6-0.9 hours, if it is designed to be sustained release for 12-24 hours, it is difficult to ensure the stability of the blood drug concentration in the patient's blood duri

Method used

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  • Slow release composition with cefaclor
  • Slow release composition with cefaclor
  • Slow release composition with cefaclor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0034] This embodiment is only used for comparison and description, and is not the content of the present invention.

[0035]

[0036] Mix cefaclor with mannitol, hypromellose K4M, and hypromellose K100M evenly, add 5% hypromellose in 80% ethanol aqueous solution to granulate, dry, arrange, and add magnesium stearate Mix well and compress into tablets.

[0037] In this example, only hypromellose is used as the skeleton material, mannitol is used as the porogen, and no pH regulator is used in this prescription.

[0038] Get this product, according to the release assay method (Chinese Pharmacopoeia 2010 edition two appendix X D first method), adopt the device of dissolution assay method first method, respectively with 0.1mol / L hydrochloric acid solution (instead of artificial gastric juice, the same below) , Phosphate buffer (pH6.8) (replacing artificial intestinal juice, the same below) as the release medium, the speed is 100 rpm, operated according to the law, at 30min, 60...

Embodiment 2

[0041] This embodiment is only used for comparison and description, and is not the content of the present invention.

[0042]

[0043] Mix cefaclor with lactose, hypromellose K100M and acrylic resin (Eudragi tL-100-55), add 6% povidone K30 in 70% ethanol aqueous solution to granulate, dry, arrange, add hard Magnesium fatty acid is mixed and pressed into tablets.

[0044] In this case, hypromellose is used as the framework material, lactose as the porogen, and acrylic resin (Eudragit L-100-55) as the pH regulator.

[0045] Get this product, according to the release assay method (Chinese Pharmacopoeia 2010 edition two appendix X D the first method), adopt the device of the dissolution assay method first method, respectively with 0.1mol / L hydrochloric acid solution, phosphate buffer saline (pH6. 8) For the release medium, the rotating speed is 100 revolutions per minute, operated according to the law, sampling at 30min, 60min, 90min, 120min, 180min, 240min, 300min, 360min, 42...

Embodiment 3

[0048] This embodiment is only used for comparison and description, and is not the content of the present invention.

[0049]

[0050] After mixing cefaclor with lactose, hypromellose K100M, and acrylic resin (Eudragit L-100-55), add 6% povidone K30 in 70% ethanol aqueous solution to granulate, dry, arrange, and add stearin Magnesium acid mixed, pressed into tablets.

[0051] In this case, hypromellose is used as the framework material, lactose as the porogen, and acrylic resin (Eudragit L-100-55) as the pH regulator.

[0052] Get this product, according to the release assay method (Chinese Pharmacopoeia 2010 edition two appendix X D the first method), adopt the device of the dissolution assay method first method, respectively with 0.1mol / L hydrochloric acid solution, phosphate buffer saline (pH6. 8) For the release medium, the rotating speed is 100 revolutions per minute, operated according to the law, sampling at 30min, 60min, 90min, 120min, 180min, 240min, 300min, 360mi...

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Abstract

The invention relates to the technical field of medicine preparation, in particular to slow release composition with cefaclor, which comprises materials by weight: 60% to 90% of the cefaclor, 5% to 20% of hydroxypropyl methylcellulose, 0.5% to 5% of a potential of hydrogen (pH) adjusting agent and 3% to 18% of a porogen. The slow release composition with the cefaclor can be completely released in 4 to 7 hours, thereby being good in release characteristics.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to a slow-release composition containing cefaclor Background technique [0002] Cefaclor is a broad-spectrum semi-synthetic β-lactam antibiotic. Pharmacokinetic / pharmacodynamic (PK / PD) research results show that the in vivo antibacterial effect of β-lactam antibiotics depends on the time when the drug concentration in plasma is greater than the minimum inhibitory concentration (MIC) (T>MIC), when T> If the MIC is greater than 40% of the dosing interval, 80-90% of the curative effect can be brought into play (Craig WA. Pharmacokinetic / pharmacodynamic parameters: rationale for antibacterial dosing of mice and men. Clin Infect Dis, 1998, 26:-10; quiz11-2 .). [0003] The half-life of many oral β-lactam antibiotics is very short. For example, the half-life of cefaclor in the body is only 0.6-0.9 hours. The common cefaclor preparation is administered three tim...

Claims

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Application Information

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IPC IPC(8): A61K9/00A61K9/22A61K9/28A61K31/545A61K47/38A61P31/04
Inventor 林巧谭坚杨丽珍
Owner HAINAN KANGHONG MEDICAL TECH DEV
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