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Levetiracetam injection and preparation method thereof

A technology for injection and water for injection, which can be used in pharmaceutical formulations, drug delivery, nervous system diseases, etc., and can solve problems such as the inability to guarantee the clinical safety of levetiracetam injection.

Inactive Publication Date: 2012-07-04
南京恒道医药科技股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

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

Method used

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  • Levetiracetam injection and preparation method thereof
  • Levetiracetam injection and preparation method thereof
  • Levetiracetam injection and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0041] prescription

[0042]

[0043]

[0044] Preparation Process

[0045] 1) Weigh levetiracetam into the liquid mixing tank according to the regulations.

[0046] 2) Add water for injection of 75% of the prescribed amount into the above-mentioned liquid preparation tank according to the regulations, and mix until completely dissolved.

[0047] 3) Weigh the sodium acetate into the liquid mixing tank according to the regulations and mix until completely dissolved.

[0048] 4) Weigh the acetic acid according to regulations into the liquid mixing tank and mix until completely dissolved.

[0049] 5) Weigh the sodium chloride according to the regulations and mix it in the liquid mixing tank until it is completely dissolved.

[0050] 6) Add water for injection to the prescribed amount and mix.

[0051] 7), add 0.05% (W / V) activated carbon for needles to the solution, stir for 15 minutes, pressurize to make the medicinal solution pass through 1 μm and 0.45 μm titanium rod...

Embodiment 2

[0058] prescription

[0059]

[0060] 1) Weigh levetiracetam into the liquid mixing tank according to the regulations.

[0061] 2) Add water for injection of 75% of the prescribed amount into the above-mentioned liquid preparation tank according to the regulations, and mix until completely dissolved.

[0062] 3) Weigh the sodium acetate into the liquid mixing tank according to the regulations and mix until completely dissolved.

[0063] 4) Weigh the acetic acid according to regulations into the liquid mixing tank and mix until completely dissolved.

[0064] 5) Weigh the sodium chloride according to the regulations and mix it in the liquid mixing tank until it is completely dissolved.

[0065] 6) Add water for injection to the prescribed amount and mix.

[0066] 7), add 0.05% (W / V) activated carbon for needles to the solution, stir for 15 minutes, pressurize to make the medicinal solution pass through 1 μm and 0.45 μm titanium rod filters wrapped with neutral filter paper...

Embodiment 3

[0073] prescription

[0074]

[0075] 1) Weigh levetiracetam into the liquid mixing tank according to the regulations.

[0076] 2) Add water for injection of 75% of the prescribed amount into the above-mentioned liquid preparation tank according to the regulations, and mix until completely dissolved.

[0077] 3) Weigh the sodium acetate into the liquid mixing tank according to the regulations and mix until completely dissolved.

[0078] 4) Weigh the acetic acid according to regulations into the liquid mixing tank and mix until completely dissolved.

[0079] 5) Weigh the sodium chloride according to the regulations and mix it in the liquid mixing tank until it is completely dissolved.

[0080] 6) Add water for injection to the prescribed amount and mix.

[0081] 7), add 0.1% (W / V) activated carbon for needles to the solution, stir for 15 minutes, pressurize to make the medicinal solution pass through a 1 μm and 0.45 μm titanium rod filter wrapped with neutral filter paper...

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Abstract

The invention designs a prescription of a levetiracetam injection and a preparation method thereof. The prescription is mainly composed of levetiracetam as an active component as well as an acetate buffer solution, sodium chloride and water for injection. The preparation method of the prescription comprises the steps of: weighing the components, stirring for dissolving, adding 0.05%-0.2%(W / V) activated carbon for injection, performing pressure filtration on the liquor to remove pyrogen, regulating the pH value of the solution to be in a range of 5.0-6.0, performing coarse filtration with a 0.45mu m filter membrane, then performing fine filtration with a 0.22mu m filter membrane, filling into 5ml penicillin bottles after quality inspection pass, capping and sealing, and sterilizing under a terminal sterilizing condition of 121 DEG C for 15 minutes. The levetiracetam injection produced by the invention has a high sterility level, and the safety performance is more fully guaranteed for clinical medication.

Description

technical field [0001] The invention relates to a proportioning method of levetiracetam injection and a brand-new preparation process. In particular, the prescription can be sterilized by adopting terminal sterilization conditions, which can ensure the sterility of the product, and belongs to the field of pharmaceutical preparations. Background technique [0002] Levetiracetam is a new type of antiepileptic drug, which has a different structure from other antiepileptic drugs and has a new antiepileptic mechanism. The exact antiepileptic mechanism of levetiracetam is unknown, but it is different from traditional antiepileptic drugs in acting on ion channels or excitatory and inhibitory neurotransmitter systems. Levetiracetam has almost all the pharmacokinetic properties of better antiepileptic drugs: high bioavailability, linear curve, low protein binding rate, and no liver enzyme induction. Various animal models have shown that levetiracetam has antiepileptic properties. ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/08A61K31/4015A61K47/12A61P25/08
Inventor 黄迎春刘小斌
Owner 南京恒道医药科技股份有限公司
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