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Preparation method of levetiracetam injection

A technology for injection and preparation process, which is applied in the field of medicine, can solve the problems of inability to guarantee the clinical safety of levetiracetam injection, failure to achieve sterility, etc., and achieve the effect of stable product quality and simple production process

Active Publication Date: 2014-02-05
ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In the current Chinese market, drug injuries of injections frequently occur, most of which are caused by lack of sterility, so the non-terminal sterilization process cannot guarantee the clinical safety of levetiracetam injection

Method used

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  • Preparation method of levetiracetam injection
  • Preparation method of levetiracetam injection
  • Preparation method of levetiracetam injection

Examples

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Embodiment 1

5000.0

[0043] The preparation method is to weigh about 4000g of water for injection below 30°C, add the prescribed amount of sodium acetate trihydrate and sodium chloride, stir and dissolve completely; add the prescribed amount of levetiracetam raw material drug into the above solution a, stir Dissolve; adjust the pH value of the solution to 5.0-6.0 with glacial acetic acid; add water for injection to 5000mL; filter through a 0.22μm improved PVDF membrane, fill after filtration, and sterilize at 121°C for 15min to obtain levetirazil per 1mL Levetiracetam injection 100mg.

[0044] According to Chinese Pharmacopoeia Appendix XI E bacterial endotoxin detection method, detect the bacterial endotoxin of Comparative Example 1 and Example 1 levetiracetam injection, the results are compared with Table 1.

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Abstract

The invention discloses a preparation method of levetiracetam injection. The preparation method of the levetiracetam injection comprises the following steps: every 5ml of injection contains the following components by mass: 500mg of levetiracetam, 8.2mg of sodium acetate trihydrate and 45mg of sodium chloride; cooling water for injection to the temperature below 30 DEG C, adding sodium acetate and sodium chloride, and dissolving; then adding levetiracetam bulk drug in prescribed dose and dissolving; regulating pH value of a solution to be 5.0-6.0 with glacial acetic acid; filtering by virtue of a microfiltration membrane with the thickness of 0.22 microns, filling and sterilizing. The preparation method of the levetiracetam injection is simple in technology, and product quality is stable.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a preparation method of levetiracetam injection. Background technique [0002] Levetiracetam injection as an adjuvant drug for partial-onset seizures in adults with epilepsy. When oral administration is temporarily unfeasible, this product can be used as an alternative treatment. As a new anti-epileptic drug, levetiracetam has good linear pharmacokinetics, is excreted from the kidneys in the original form, has no liver toxicity, has few drug-drug interactions, has high efficacy, is well tolerated, and has no serious adverse effects reaction. It is expected to be widely used in generalized and partial epilepsy. Its compound structural formula is as follows: [0003] [0004] Levetiracetam was developed by Belgian UCB Company (Belgian United Chemical Enterprise Co., Ltd.). It was first launched in the United States in 1999 as a tablet, initially for partial epil...

Claims

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Application Information

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IPC IPC(8): A61K9/08A61K31/4015A61K47/12A61P25/08
Inventor 施祥杰黄丹胡李斌陈浩李巧霞
Owner ZHEJIANG HUAHAI PHARMACEUTICAL CO LTD
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