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Levetiracetam medicine composition and preparation method thereof

A kind of composition and medicine technology, applied in the field of medicine

Inactive Publication Date: 2013-10-16
通辽市华邦药业有限公司 +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Therefore, we urgently need to find a pharmaceutical composition, which is suitable for various levetiracetam crystals, and the difference in tablet weight, dissolution effect, and tablet hardness can all achieve satisfactory results. For the conversion of the crystals of Etiracetam, it is necessary to adjust the ratio of excipients or even change the types of excipients to make the produced tablets comply with the standards stipulated in the Pharmacopoeia.

Method used

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  • Levetiracetam medicine composition and preparation method thereof
  • Levetiracetam medicine composition and preparation method thereof

Examples

Experimental program
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Effect test

Embodiment 1

[0070] Example 1 to Example 20 and Comparative Examples 1, 5, and 6 were all tested according to the method for testing the dissolution rate of levetiracetam tablets stipulated in the "United States Pharmacopoeia". The test uses the paddle method, the speed is 50 rpm, the dissolution medium is water, the volume is 900mL, and the temperature is 37°C. The dissolution percentage is detected at 5min, 15min, 20min, 25min, and 30min respectively. Further testing its dissolution rate. Test result shows, the dissolution rate of embodiment 1 to embodiment 20 and comparative example 1,5,6 is all greater than 70% at 15min, meets " United States Pharmacopoeia " standard, wherein preferred prescription embodiment 4, embodiment 10, embodiment 14. The dissolution rate of Example 20 is greater than 92% at 15 minutes, and the dissolution rate of Example 1, Example 6, Example 11, and Example 16 are all greater than 96% at 15 minutes, and the effect is the best.

[0071] In summary, the prescri...

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Abstract

The invention relates to a levetiracetam medicine composition and a preparation method thereof. The composition comprises levetiracetam, a filling agent, a disintegrating agent, a lubricant and a flow aid; and the preparation method is a direct compression method. The medicine composition is suitable for multiple levetiracetam crystals; the tablet weight variation of the prepared tablet conforms to the provisions of the Chinese Pharmacopoeia, and the dissolution rate conforms to the provisions of the United States Pharmacopoeia; and the hardness is improved by more than half over the tablets of the prior art under the condition of meeting the provisions for the dissolution rate of the tablets.

Description

technical field [0001] The invention belongs to the field of medicine, and relates to a levetiracetam pharmaceutical composition and a preparation method thereof. Background technique [0002] Levetiracetam is a pyrrolidine derivative and a new type of antiepileptic drug (AED), mainly used for the treatment of localized and secondary generalized epilepsy. It is a new type of anti-epileptic drug developed by UCB Company in Belgium. It was approved by FDA in April 2000 and listed in the United States and the European Union. It is currently listed in more than 66 countries and regions around the world. new antiepileptic drugs. [0003] Levetiracetam has a broad anti-epileptic spectrum and good curative effect. It has a wide therapeutic window for partial seizures and epilepsy. Compared with other drugs, it has a high rate of complete remission. Concentration only takes a few days instead of weeks; good safety, unique mechanism of action, low adverse reactions, the proportion ...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/20A61K31/4015A61K47/38A61P25/08
Inventor 刘新春兰莹杨秀伟闫志刚
Owner 通辽市华邦药业有限公司
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